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How to Create a Structured Research Paper Outline | Example

Published on August 7, 2022 by Courtney Gahan . Revised on August 15, 2023.

A research paper outline is a useful tool to aid in the writing process , providing a structure to follow with all information to be included in the paper clearly organized.

A quality outline can make writing your research paper more efficient by helping to:

• Organize your thoughts
• Understand the flow of information and how ideas are related
• Ensure nothing is forgotten

A research paper outline can also give your teacher an early idea of the final product.

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Table of contents

Research paper outline example, how to write a research paper outline, formatting your research paper outline, language in research paper outlines.

• Definition of measles
• Rise in cases in recent years in places the disease was previously eliminated or had very low rates of infection
• Figures: Number of cases per year on average, number in recent years. Relate to immunization
• Symptoms and timeframes of disease
• Risk of fatality, including statistics
• How measles is spread
• Immunization procedures in different regions
• Different regions, focusing on the arguments from those against immunization
• Immunization figures in affected regions
• High number of cases in non-immunizing regions
• Illnesses that can result from measles virus
• Fatal cases of other illnesses after patient contracted measles
• Summary of arguments of different groups
• Summary of figures and relationship with recent immunization debate
• Which side of the argument appears to be correct?

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Follow these steps to start your research paper outline:

• Decide on the subject of the paper
• Write down all the ideas you want to include or discuss
• Organize related ideas into sub-groups
• Arrange your ideas into a hierarchy: What should the reader learn first? What is most important? Which idea will help end your paper most effectively?
• Create headings and subheadings that are effective
• Format the outline in either alphanumeric, full-sentence or decimal format

There are three different kinds of research paper outline: alphanumeric, full-sentence and decimal outlines. The differences relate to formatting and style of writing.

• Alphanumeric
• Full-sentence

An alphanumeric outline is most commonly used. It uses Roman numerals, capitalized letters, arabic numerals, lowercase letters to organize the flow of information. Text is written with short notes rather than full sentences.

• Sub-point of sub-point 1

Essentially the same as the alphanumeric outline, but with the text written in full sentences rather than short points.

• Additional sub-point to conclude discussion of point of evidence introduced in point A

A decimal outline is similar in format to the alphanumeric outline, but with a different numbering system: 1, 1.1, 1.2, etc. Text is written as short notes rather than full sentences.

• 1.1.1 Sub-point of first point
• 1.1.2 Sub-point of first point
• 1.2 Second point

To write an effective research paper outline, it is important to pay attention to language. This is especially important if it is one you will show to your teacher or be assessed on.

There are four main considerations: parallelism, coordination, subordination and division.

Parallelism: Be consistent with grammatical form

Parallel structure or parallelism is the repetition of a particular grammatical form within a sentence, or in this case, between points and sub-points. This simply means that if the first point is a verb , the sub-point should also be a verb.

Example of parallelism:

• Include different regions, focusing on the different arguments from those against immunization

Coordination: Be aware of each point’s weight

Your chosen subheadings should hold the same significance as each other, as should all first sub-points, secondary sub-points, and so on.

Example of coordination:

• Include immunization figures in affected regions
• Illnesses that can result from the measles virus

Subordination: Work from general to specific

Subordination refers to the separation of general points from specific. Your main headings should be quite general, and each level of sub-point should become more specific.

Example of subordination:

Division: break information into sub-points.

Your headings should be divided into two or more subsections. There is no limit to how many subsections you can include under each heading, but keep in mind that the information will be structured into a paragraph during the writing stage, so you should not go overboard with the number of sub-points.

Ready to start writing or looking for guidance on a different step in the process? Read our step-by-step guide on how to write a research paper .

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Gahan, C. (2023, August 15). How to Create a Structured Research Paper Outline | Example. Scribbr. Retrieved April 9, 2024, from https://www.scribbr.com/research-paper/outline/

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How to Write a Medical Research Paper

Last Updated: February 5, 2024 Approved

This article was co-authored by Chris M. Matsko, MD . Dr. Chris M. Matsko is a retired physician based in Pittsburgh, Pennsylvania. With over 25 years of medical research experience, Dr. Matsko was awarded the Pittsburgh Cornell University Leadership Award for Excellence. He holds a BS in Nutritional Science from Cornell University and an MD from the Temple University School of Medicine in 2007. Dr. Matsko earned a Research Writing Certification from the American Medical Writers Association (AMWA) in 2016 and a Medical Writing & Editing Certification from the University of Chicago in 2017. wikiHow marks an article as reader-approved once it receives enough positive feedback. In this case, 89% of readers who voted found the article helpful, earning it our reader-approved status. This article has been viewed 201,812 times.

Writing a medical research paper is similar to writing other research papers in that you want to use reliable sources, write in a clear and organized style, and offer a strong argument for all conclusions you present. In some cases the research you discuss will be data you have actually collected to answer your research questions. Understanding proper formatting, citations, and style will help you write and informative and respected paper.

Researching Your Paper

• Pick something that really interests you to make the research more fun.
• Choose a topic that has unanswered questions and propose solutions.

• Quantitative studies consist of original research performed by the writer. These research papers will need to include sections like Hypothesis (or Research Question), Previous Findings, Method, Limitations, Results, Discussion, and Application.
• Synthesis papers review the research already published and analyze it. They find weaknesses and strengths in the research, apply it to a specific situation, and then indicate a direction for future research.

• Keep track of your sources. Write down all publication information necessary for citation: author, title of article, title of book or journal, publisher, edition, date published, volume number, issue number, page number, and anything else pertaining to your source. A program like Endnote can help you keep track of your sources.
• Take detailed notes as you read. Paraphrase information in your own words or if you copy directly from the article or book, indicate that these are direct quotes by using quotation marks to prevent plagiarism.
• Be sure to keep all of your notes with the correct source.
• Your professor and librarians can also help you find good resources.

• Keep all of your notes in a physical folder or in a digitized form on the computer.
• Start to form the basic outline of your paper using the notes you have collected.

Writing Your Paper

• Start with bullet points and then add in notes you've taken from references that support your ideas. [1] X Trustworthy Source PubMed Central Journal archive from the U.S. National Institutes of Health Go to source
• A common way to format research papers is to follow the IMRAD format. This dictates the structure of your paper in the following order: I ntroduction, M ethods, R esults, a nd D iscussion. [2] X Research source
• The outline is just the basic structure of your paper. Don't worry if you have to rearrange a few times to get it right.
• Ask others to look over your outline and get feedback on the organization.
• Know the audience you are writing for and adjust your style accordingly. [3] X Research source

• Use a standard font type and size, such as Times New Roman 12 point font.
• Double-space your paper.
• If necessary, create a cover page. Most schools require a cover page of some sort. Include your main title, running title (often a shortened version of your main title), author's name, course name, and semester.

• Break up information into sections and subsections and address one main point per section.
• Include any figures or data tables that support your main ideas.
• For a quantitative study, state the methods used to obtain results.

• Clearly state and summarize the main points of your research paper.
• Discuss how this research contributes to the field and why it is important. [4] X Research source
• Highlight potential applications of the theory if appropriate.
• Propose future directions that build upon the research you have presented. [5] X Research source
• Keep the introduction and discussion short, and spend more time explaining the methods and results.

• State why the problem is important to address.
• Discuss what is currently known and what is lacking in the field.
• State the objective of your paper.
• Keep the introduction short.

• Highlight the purpose of the paper and the main conclusions.
• State why your conclusions are important.
• Be concise in your summary of the paper.
• Show that you have a solid study design and a high-quality data set.
• Abstracts are usually one paragraph and between 250 – 500 words.

• Unless otherwise directed, use the American Medical Association (AMA) style guide to properly format citations.
• Add citations at end of a sentence to indicate that you are using someone else's idea. Use these throughout your research paper as needed. They include the author's last name, year of publication, and page number.
• Compile your reference list and add it to the end of your paper.
• Use a citation program if you have access to one to simplify the process.

• Continually revise your paper to make sure it is structured in a logical way.
• Proofread your paper for spelling and grammatical errors.
• Make sure you are following the proper formatting guidelines provided for the paper.
• Have others read your paper to proofread and check for clarity. Revise as needed.

Expert Q&A

• Ask your professor for help if you are stuck or confused about any part of your research paper. They are familiar with the style and structure of papers and can provide you with more resources. Thanks Helpful 0 Not Helpful 0
• Refer to your professor's specific guidelines. Some instructors modify parts of a research paper to better fit their assignment. Others may request supplementary details, such as a synopsis for your research project . Thanks Helpful 0 Not Helpful 0
• Set aside blocks of time specifically for writing each day. Thanks Helpful 0 Not Helpful 0

• Do not plagiarize. Plagiarism is using someone else's work, words, or ideas and presenting them as your own. It is important to cite all sources in your research paper, both through internal citations and on your reference page. Thanks Helpful 4 Not Helpful 2

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• ↑ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3178846/
• ↑ http://owl.excelsior.edu/research-and-citations/outlining/outlining-imrad/
• ↑ http://china.elsevier.com/ElsevierDNN/Portals/7/How%20to%20write%20a%20world-class%20paper.pdf
• ↑ http://intqhc.oxfordjournals.org/content/16/3/191
• ↑ http://www.ruf.rice.edu/~bioslabs/tools/report/reportform.html#form

About This Article

To write a medical research paper, research your topic thoroughly and compile your data. Next, organize your notes and create a strong outline that breaks up the information into sections and subsections, addressing one main point per section. Write the results and discussion sections first to go over your findings, then write the introduction to state your objective and provide background information. Finally, write the abstract, which concisely summarizes the article by highlighting the main points. For tips on formatting and using citations, read on! Did this summary help you? Yes No

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Article Style and Formats

This section provides detailed general style and formatting requirements for manuscripts published in the AACR journals. For initial submission, the AACR journals do not impose strict article size or formatting requirements. Rather, authors are encouraged to format their manuscript in a manner that makes it easy for peer reviewers to read and assess. Text must be clean with all manuscript sections and items present and legible, the author list must be complete and accurate, and a conflict-of-interest statement present. For initial submission only, authors are encouraged to present each figure and its legend together in sequence to facilitate peer review.

Authors of revised manuscripts must observe all instructions below and in the individual journal instruction pages. See the links below for each journal's specific instructions for the categories of articles, article size recommendations, and any exceptions or additions to the general article style and formatting instructions that follow.

Manuscripts should be written in clear, grammatical English with all pages and/or lines numbered. For the convenience of authors whose native language is not English, we have provided a list of editing and proofreading services for scientific manuscripts in our Author Services Center . Laboratory jargon as well as terminology and abbreviations not consistent with internationally accepted guidelines should be avoided. Numbered and lettered sections in the text should be avoided. Each table and figure must be cited in sequential order in the text. Simple chemical formulas or mathematical equations should be presented in a form that allows their reproduction in single horizontal lines of type.

Manuscripts should be arranged in the following order: title page, text and references, tables, figure legends, and figures (appropriately numbered), but note the exception described above regarding initial submission of figures and legends. See below for a full explanation of what is to be included in these sections.

When submitting manuscripts that include supplementary data, please be sure to upload supplementary files separately, in the appropriate area of the submission form (see also the detailed policies on preparation of Supplementary Data ). Please do not append supplementary files to the main manuscript file.

Title. Write a brief, informative title. Abbreviations should not be used in titles. It is important for literature retrieval to include in the title the key words that identify the nature of the subject matter, including, if applicable, the species on which the work is done.

Authors and affiliations. Authors are urged to include their full names, complete with first and middle names or initials. Academic degrees should not be included. The names and locations of institution or company affiliations at the time the work was completed should be given for all authors. Departments, units, or laboratories should also be specified. If several institutions are listed on a manuscript, it should be clearly indicated with which department and institution each author is affiliated by using corresponding superscript numbers.

Running title. A brief running title of no more than 60 characters should be provided. Choose the running title carefully, as it will be used in electronic alerting services and some mobile device applications. Abbreviations may be used in the running title.

Additional information. Include the following notes on the title page (if applicable) in this order:

• Full name, mailing address, and email address of the corresponding author
• A conflict of interest disclosure statement; additional information is available at this link: Conflict of Interest Policy
• Other notes about the manuscript as a whole, including the word count, and the total number of figures and tables Please note that, authors who substantially exceed the word limit given for the type of article (see specific instructions for each journal) may have their manuscript returned. For Clinical Cancer Research only, a 150-word statement of translational relevance describing how the results might be applied to the future practice of cancer medicine, should be provided on a page between the title page and abstract.

The abstract must be concise, yet should accurately outline the content of the manuscript (see the links at the top of this page for abstract length requirements for each type of article). Because these abstracts are used by secondary services (e.g., MEDLINE, Chemical Abstracts, Web of Science, Scopus), they should recapitulate in abbreviated form the purpose of the study and the experimental technique, results, and data interpretations. Data such as the number of test subjects and controls, strains of animals or viruses, drug dosages and routes of administration, tumor yields and latent periods, length of observation period, and magnitude of activity should be included. Vague, general statements such as "The significance of the results is discussed" or "Some physical properties were studied" should be avoided. Important terms relevant to the content of the manuscript should be incorporated into the abstract to assist indexers and searchers. Abbreviations should be kept to an absolute minimum; however, if they are needed, they must be explained at first mention within the abstract so that it can be understood as an independent unit from the remainder of the manuscript. Do not cite references in the abstract.

Introduction

The introduction should provide a brief overview of the background and rationale for the study. It is not necessary to cite all of the background literature in the introduction. Brief reference to the most pertinent articles generally suffices to acquaint the reader with the findings of others in the field and with the problem or question that the investigation addresses.

Materials and Methods

Explanation of the experimental methods should be adequate for repetition by qualified investigators. Authors are encouraged to publish the step-by-step protocol(s) used in their study at protocols.io and then include the unique digital object identifier(s) (DOI) in the Materials and Methods. Please see Improving Reproducibility for more information.

Procedures that have been fully described in detail in a previous publication need not be described in detail but rather cited with appropriate references and details of any modifications to the procedure. New procedures and substantially modified previously published procedures must be described in detail.

If any experiments or analyses were outsourced to an institutional core facility or external service provider, this must be stated in the Materials and Methods along with the name of the provider. If possible, the methodological details of the work conducted by the provider should be included in the manuscript, or a suitable reference cited.

The sources of all reagents and tools used should be provided. Any commercial product that is mentioned should include the name of the manufacturer and catalog number. Authors are strongly encouraged to include a unique searchable Research Resource Identifier (RRID), as assigned by the Resource Identification Initiative, for each relevant reagent, tool, and core facility used. Please see Improving Reproducibility for more information. If statistical analysis was performed as part of the study, please include a Statistical Analysis subsection. A Data Availability Statement must be present at the end of the Materials and Methods in a "Data Availability" subsection.

Include a concise summary of the data presented in all display items (figures and tables). Excessive elaboration of data shown in display items should be avoided.

The data should be interpreted concisely without repeating material already presented in the Results section. Speculation is permissible, but it must be well founded, and discussion of the wider implications of the findings is encouraged.

Acknowledgments

Include funding information and the names of others contributing to the work who are not identified as authors. This should include any people, services, or generative artificial intelligence technologies that contributed to the generation of the manuscript.

Number the references in the order of their first mention in the text; cite only the number assigned to the reference. The reference list should be limited to only those citations essential to the presentation. Before submission of the manuscript, authors should verify the accuracy of all references and check that all references have been cited in the text. For manuscripts with more than 6 authors, the names of the first 6 authors must be listed, followed by " et al. " For manuscripts with 6 or fewer authors, all authors should be listed. Please note that although example references are shown below, a manuscript’s references need not be formatted according to journal style prior to submission.

Reference examples:

Data Availability Statement

All original research must contain a Data Availability Statement describing how readers may obtain the data acquired and/or used in the study. If there are any limitations on availability, these must be explained. Please see Data for details of the AACR journals’ data availability requirements.

Below are example statements for various scenarios. If different datasets used in the study have different data availability terms, please combine appropriate statements, and specify the datasets for which the different terms of availability apply. The Data Availability Statement should be placed at the end of the Materials and Methods (or Methods) section in its own subsection titled "Data Availability."

Data were generated by the authors and deposited in a repository

The data generated in this study are publicly available in [repository name(s)] at [list one or more hyperlinked codes].

Examples: The data generated in this study are publicly available in Gene Expression Omnibus (GEO) at GSE158739 and GSE158812 .

The data generated in this study are publicly available in Genbank at MT006230 and in Gene Expression Omnibus (GEO) at GSE144569 .

Data were generated by the authors and available on request (permitted only for data types for which a community-recognized, structured repository does not exist)

The data generated in this study are available upon request from the corresponding author.

Data were generated by the authors and included in the article

The data generated in this study are available within the article and its supplementary data files.

Note: This statement is only appropriate if the raw data is available in the article or supplementary data files. Plots of data (even individual data points), images displayed in figures, or summary tabular data do not qualify as data included in the article. In these cases, the authors should instead state whether the raw data is available in a suitable repository or on request from the corresponding author.

Raw data were generated in a core facility (and may be unavailable) but processed data are available from the authors

Raw data for this study were generated at [facility name]. Derived data supporting the findings of this study are available from the corresponding author upon request.

Data were generated by the authors but are not publicly available for declared legitimate reason(s)

The data generated in this study are not publicly available due to [describe reasons for restriction such as information that could compromise patient privacy or consent] but are available upon reasonable request from the corresponding author.

Publicly available data generated by others were used by the authors

The data analyzed in this study were obtained from [repository name(s)] at [list one or more hyperlinked codes or urls].

The data that support the findings of this study are available in [repository name(s)] at [list one or more hyperlinked codes]. These data were derived from the following public domain resources: [list resources and hyperlinked codes]

Examples: The data analyzed in this study were obtained from Gene Expression Omnibus (GEO) at GSE22396 , GSE124857 , and GSE124731 .

The data analyzed in this study were obtained from figshare at https://doi.org/10.6084/m9.figshare.12280541.v4 .

Data generated by others were used under license by the authors

The data analyzed in this study are available from [third party name]. Restrictions apply to the availability of these data, which were used under license for this study. Data are available from the authors upon reasonable request with the permission of [third party name].

No data was generated or analyzed in the reported study

Data sharing is not applicable to this article as no data were created or analyzed in this study.

Examples of Combined Data Availability Statements

The data generated in this study are available within the article and its supplementary data files. Expression profile data analyzed in this study were obtained from Gene Expression Omnibus (GEO) at GSE22396 , GSE124857 , and GSE124731 .

The sequence data generated in this study are publicly available in Genbank at MT006230 , in Gene Expression Omnibus (GEO) at GSE144569 , and within the article and its supplementary data files. The data from the Broad Institute’s Cancer Dependency Map project that were analyzed in this study were obtained from figshare at https://doi.org/10.6084/m9.figshare.12280541.v4 .

The human sequence data generated in this study are not publicly available due to patient privacy requirements but are available upon reasonable request from the corresponding author. Other data generated in this study are available within the article and its supplementary data files.

Display Items

A summary of the data should be provided in the text with a callout to the table. Tabular data should not duplicate data already presented in detail in the text. Unnecessary columns of data that can easily be derived from other data in the table should not be included. Large groups of individual values should be avoided; instead, these should be averaged and an appropriate designation of the dispersion, such as standard deviation or standard error, should be included. Authors are obligated to indicate the significance of their observations by appropriate statistical analysis.

Every table must have a descriptive title and enough explanatory information so the reader can understand the data without reference to the text. Table titles should be short and to the point and should generally not include references. Each column must carry an appropriate heading and, if measurements are given, the units should be given with the column heading. Number tables using Arabic numerals; table footnotes should be indicated with lower-case alphabetical letters: a, b, c, etc. Include a note after the footnotes in which all abbreviations used in the table that have not been used in the text are explained. Complex or large tables should be uploaded in a tabular data file format as supplementary data.

Tables should not be included as part of a figure. Authors are discouraged from submitting tables that have been previously published, even with permission.

Please see Statistics and Images for important editorial policy information related to figures. Figures should be used when salient points need illustration for better comprehension by the reader. Figures must be submitted in their final design and color format. All figures that the author intends to have printed in black and white should be supplied in this format so that editors and reviewers can properly evaluate the presentation of the data. For initial submission only, figures may be supplied in pdf, jpg or Word document format and should be on the same page as the legend, either at the end of the manuscript file or embedded in the text near the figure callout. See File Types for details on the allowable file types for revised manuscripts.

Each figure must be accompanied by a figure legend consisting of a short title sentence followed by a description of the figure and the data shown. If the figure consists of multiple panels, each panel should be labeled and described in the legend. Figure legends must include the number of technical and biological replicates performed for the experiment(s) depicted. Legends should not repeat details present in the main text and should generally not include references. Stains and original magnifications should be listed where applicable. Define all symbols and adequately identify all parts of the figure necessary for interpretation. Abbreviations explained in the main text of the manuscript need not be redefined in the figure legend.

Figures must be cited and numbered in the order in which they appear in the text. For revised submissions, all figure legends should be listed together in one section (Figure Legends) directly preceding the appearance of the figures in the manuscript. Ensure that both legends and figures are numbered and match up appropriately.

When graphs are reduced to the size of a single column (7.94 cm / 3.125 in), the text in the graph must be no smaller than 6 pt and no larger than 12 pt, and all symbols must be discernible. In the published form, the minimum thickness of lines (rules) used to present drawn art is 0.5 point. If a drawn image will be reduced in size for publication, the lines used to draw the original art must be thick enough to be reduced and still meet the minimum requirement. Lines thinner than 0.5 point thickness may be completely lost if an image is reduced in size.

Best practices for choice of graph type

• Reserve bar charts for presentation of data such as counts and lengths.
• Use a line graph to display and connect related data points and a bar graph for unrelated data points.
• Sample data is best displayed by plotting individual data points when sample numbers are small. Use a box plot, violin plot, or bean plot for larger sample sizes and to show data distributions. See Statistics for guidelines on sample sizes. A free tool for plotting sample data and generating an EPS file for incorporation into figures is available at http://boxplot.tyerslab.com .
• A pie chart is effective for showing data trends, but, if it is important to provide quantitative comparisons, a bar graph may be preferable.

Best practices for graph design

• Avoid the use of patterned fills. These add visual clutter and impede interpretation. Use black, up to four shades of gray, and white to provide six alternative encodings; or use color if more encodings are required.
• Always use distinct colors and avoid the use of red and green for contrast.
• Avoid background shading.
• Display only the left and bottom axes unless a top and/or right axis is absolutely necessary.
• Axes labels should not extend beyond the axes lines and must include the name and units of the parameter measured.
• Consider whether related data plotted in multiple graphs can and should be shown in a single graph.
• Remove unnecessary tick marks and grid lines. Use grid lines only when necessary and make sure they have substantially less visual prominence than the data and axes lines.
• Avoid axes breaks. These can mask important differences in the data.
• Open symbols, particularly circles, are most appropriate for plotting high-density data points that overlap.

Best practices for images

• When images are related to one another or should be compared, group them together with narrow bands of white space between them. If the image background is close to white, use lines for separation.
• Symbols, arrows, letters, and scale bars overlying the image should strongly contrast with the background so as to be clearly visible and are best provided on a separate layer from the underlying image in a layered image file.
• Single channel fluorescence images are best displayed in grayscale so that intensity differences can be discerned more accurately. Avoid the use of red, which is particularly problematic in this regard.

Figures should be original. Authors are discouraged from submitting figures that have been previously published, even with permission. If use of a previously published figure is necessary, the author must apply for written permission from the copyright holder and supply confirmation of the permission grant before publication.

Supplementary Data

Supplementary data is intended to provide additional substantive information that is directly relevant to the article content but not essential for understanding the conclusions. The article must stand on its own merits and be complete and self-explanatory without the supplementary data. Additional text, such as supplementary results or discussion, is not acceptable and should be included in the main article. Supplementary data should be equal in quality and presentation to material within the main article. The supplementary data are subject to the same scientific standards of peer review and are included at the discretion of the editor. Each supplementary item/file must be referenced at least once in the main article text at an appropriate point. Supplementary items should be referred to in a similar manner to that used for a table or figure in the body of the manuscript, for example, "(Supplementary Fig. S1)" or "(Table 3 and Supplementary Table S3)." Each supplementary file should be accompanied by a brief description to be entered in the submission system when uploading the files. The description will be posted online to communicate the contents of the file and to aid in online indexing. Supplementary figures must include full legends (preferably on the same page as the figure) and tables should include captions.

General Guidelines on Acceptability

• Supplementary data should fall within the conceptual scope of the main manuscript but not extend beyond it. Preliminary data that simply extend the scope of the study should not be included.
• Supplementary material should not repeat information that is already included in the main manuscript.
• Data that have been previously published are not acceptable.
• Supplementary data may also be that which cannot be included in the main version of the manuscript due to space constraints (e.g., limits placed on the number of figures and tables allowed in an article) or format restrictions.
• Figures and tables
• More detailed materials and methods than can be included in the body of the article, but the main text should contain sufficient methodology for an experienced investigator to replicate the experiments
• Electronic multimedia files (e.g., video, audio, or animation)
• Database information
• Three-dimensional structures/images, sequence alignments, and data sets that are very large

The following file types are acceptable file formats for the main manuscript files:

• Manuscript files: Word (doc, docx), Encapsulated Postscript (eps), Rich Text Format (rtf), or pdf (accepted for initial submissions only)
• Graphics files: eps, tiff, ai, psd, png, ps, or jpg (accepted for initial submissions only). Powerpoint (ppt, pptx) files are discouraged but may be acceptable. Color images should be supplied in RGB.

For supplementary data the following file types are preferable: pdf, doc, docx, txt, xls, xlsx, xml, png, avi, mov, mp4, mp3 and zip. Other file types may be acceptable but please contact the journal editorial office.

Terminology and Abbreviations

For information on gene and protein nomenclature and formatting, please see Gene Nomenclature .

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How Can You Create a Well Planned Research Paper Outline

You are staring at the blank document, meaning to start writing your research paper . After months of experiments and procuring results, your PI asked you to write the paper to publish it in a reputed journal. You spoke to your peers and a few seniors and received a few tips on writing a research paper, but you still can’t plan on how to begin!

Writing a research paper is a very common issue among researchers and is often looked upon as a time consuming hurdle. Researchers usually look up to this task as an impending threat, avoiding and procrastinating until they cannot delay it anymore. Seeking advice from internet and seniors they manage to write a paper which goes in for quite a few revisions. Making researchers lose their sense of understanding with respect to their research work and findings. In this article, we would like to discuss how to create a structured research paper outline which will assist a researcher in writing their research paper effectively!

Publication is an important component of research studies in a university for academic promotion and in obtaining funding to support research. However, the primary reason is to provide the data and hypotheses to scientific community to advance the understanding in a specific domain. A scientific paper is a formal record of a research process. It documents research protocols, methods, results, conclusion, and discussion from a research hypothesis .

Table of Contents

What Is a Research Paper Outline?

A research paper outline is a basic format for writing an academic research paper. It follows the IMRAD format (Introduction, Methods, Results, and Discussion). However, this format varies depending on the type of research manuscript. A research paper outline consists of following sections to simplify the paper for readers. These sections help researchers build an effective paper outline.

1. Title Page

The title page provides important information which helps the editors, reviewers, and readers identify the manuscript and the authors at a glance. It also provides an overview of the field of research the research paper belongs to. The title should strike a balance between precise and detailed. Other generic details include author’s given name, affiliation, keywords that will provide indexing, details of the corresponding author etc. are added to the title page.

2. Abstract

Abstract is the most important section of the manuscript and will help the researcher create a detailed research paper outline . To be more precise, an abstract is like an advertisement to the researcher’s work and it influences the editor in deciding whether to submit the manuscript to reviewers or not. Writing an abstract is a challenging task. Researchers can write an exemplary abstract by selecting the content carefully and being concise.

3. Introduction

An introduction is a background statement that provides the context and approach of the research. It describes the problem statement with the assistance of the literature study and elaborates the requirement to update the knowledge gap. It sets the research hypothesis and informs the readers about the big research question.

This section is usually named as “Materials and Methods”, “Experiments” or “Patients and Methods” depending upon the type of journal. This purpose provides complete information on methods used for the research. Researchers should mention clear description of materials and their use in the research work. If the methods used in research are already published, give a brief account and refer to the original publication. However, if the method used is modified from the original method, then researcher should mention the modifications done to the original protocol and validate its accuracy, precision, and repeatability.

It is best to report results as tables and figures wherever possible. Also, avoid duplication of text and ensure that the text summarizes the findings. Report the results with appropriate descriptive statistics. Furthermore, report any unexpected events that could affect the research results, and mention complete account of observations and explanations for missing data (if any).

6. Discussion

The discussion should set the research in context, strengthen its importance and support the research hypothesis. Summarize the main results of the study in one or two paragraphs and show how they logically fit in an overall scheme of studies. Compare the results with other investigations in the field of research and explain the differences.

7. Acknowledgments

Acknowledgements identify and thank the contributors to the study, who are not under the criteria of co-authors. It also includes the recognition of funding agency and universities that award scholarships or fellowships to researchers.

8. Declaration of Competing Interests

Finally, declaring the competing interests is essential to abide by ethical norms of unique research publishing. Competing interests arise when the author has more than one role that may lead to a situation where there is a conflict of interest.

Steps to Write a Research Paper Outline

• Write down all important ideas that occur to you concerning the research paper .
• Answer questions such as – what is the topic of my paper? Why is the topic important? How to formulate the hypothesis? What are the major findings?
• Add context and structure. Group all your ideas into sections – Introduction, Methods, Results, and Discussion/Conclusion.
• Add relevant questions to each section. It is important to note down the questions. This will help you align your thoughts.
• Expand the ideas based on the questions created in the paper outline.
• After creating a detailed outline, discuss it with your mentors and peers.
• Get enough feedback and decide on the journal you will submit to.
• The process of real writing begins.

Benefits of Creating a Research Paper Outline

As discussed, the research paper subheadings create an outline of what different aspects of research needs elaboration. This provides subtopics on which the researchers brainstorm and reach a conclusion to write. A research paper outline organizes the researcher’s thoughts and gives a clear picture of how to formulate the research protocols and results. It not only helps the researcher to understand the flow of information but also provides relation between the ideas.

A research paper outline helps researcher achieve a smooth transition between topics and ensures that no research point is forgotten. Furthermore, it allows the reader to easily navigate through the research paper and provides a better understanding of the research. The paper outline allows the readers to find relevant information and quotes from different part of the paper.

Research Paper Outline Template

A research paper outline template can help you understand the concept of creating a well planned research paper before beginning to write and walk through your journey of research publishing.

1. Research Title

A. Background i. Support with evidence ii. Support with existing literature studies

B. Thesis Statement i. Link literature with hypothesis ii. Support with evidence iii. Explain the knowledge gap and how this research will help build the gap 4. Body

A. Methods i. Mention materials and protocols used in research ii. Support with evidence

B. Results i. Support with tables and figures ii. Mention appropriate descriptive statistics

C. Discussion i. Support the research with context ii. Support the research hypothesis iii. Compare the results with other investigations in field of research

D. Conclusion i. Support the discussion and research investigation ii. Support with literature studies

E. Acknowledgements i. Identify and thank the contributors ii. Include the funding agency, if any

F. Declaration of Competing Interests

5. References

Download the Research Paper Outline Template!

Have you tried writing a research paper outline ? How did it work for you? Did it help you achieve your research paper writing goal? Do let us know about your experience in the comments below.

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Clinical Research Paper Topics

This page aims to provide a comprehensive list of clinical research paper topics spanning various subfields of clinical research. It further guides students on how to choose a fitting topic and how to write an effective clinical research paper. Additionally, it introduces iResearchNet’s writing services, offering a platform for students to order a custom clinical research paper. The ultimate goal of this resource is to support students in their quest for academic excellence and successful navigation through the realm of clinical research.

100 Clinical Research Paper Topics

Navigating through the extensive field of clinical research may seem daunting. To streamline this process, we present a comprehensive list of clinical research paper topics divided into ten categories. Each category features ten engaging and relevant topics that cover a wide range of current issues in the field of clinical research.

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1. Disease Prevention and Management:

• The Role of Clinical Research in the Prevention of Cardiovascular Diseases
• Advancements in Clinical Strategies for Diabetes Management
• Impact of Clinical Research in Cancer Prevention
• Novel Clinical Approaches to Managing Obesity
• Prevention and Control of Sexually Transmitted Infections: Clinical Perspectives
• Clinical Research in the Battle Against Alzheimer’s Disease
• Impact of Lifestyle Changes on Disease Prevention: Clinical Evidence
• Role of Vaccination in the Prevention of Infectious Diseases: A Clinical Overview
• Clinical Trials in the Prevention and Management of Mental Health Disorders
• Osteoporosis: Prevention and Management Strategies in Clinical Research

2. Clinical Trials:

• The Importance of Randomization in Clinical Trials
• Ethical Considerations in Conducting Clinical Trials
• The Role of Placebos in Clinical Trials
• Clinical Trials in Pediatric Populations
• Patient Recruitment Strategies in Clinical Trials
• Advances in Oncology: The Role of Clinical Trials
• The Impact of Clinical Trials on Drug Development
• Adaptive Design in Clinical Trials
• Challenges in the Conduct of Clinical Trials during a Pandemic
• Clinical Trials: From Bench to Bedside

3. Ethical Issues in Clinical Research:

• Informed Consent in Clinical Research
• Confidentiality and Privacy Issues in Clinical Research
• The Ethics of Using Animals in Clinical Research
• Ethical Dilemmas in Genetic Testing and Clinical Research
• Protection of Vulnerable Groups in Clinical Research
• Balancing Benefit and Risk in Clinical Research
• Ethical Aspects of Research using Human Tissue Samples
• Data Integrity and Ethical Considerations in Clinical Research
• Ethical Challenges in Conducting Research on Rare Diseases
• Conflict of Interest in Clinical Research

4. Technological Advancements in Clinical Research:

• The Role of Artificial Intelligence in Clinical Research
• Use of Mobile Technologies in Clinical Trials
• Big Data and Its Impact on Clinical Research
• The Potential of Virtual Reality in Clinical Trials
• The Role of Blockchain Technology in Clinical Research
• Wearable Technology and Patient Monitoring in Clinical Trials
• The Impact of Genomics and Precision Medicine on Clinical Research
• Telemedicine and Its Role in Clinical Research
• The Role of Robotic Surgery in Clinical Trials
• Application of Nanotechnology in Clinical Research

5. Pharmacological Clinical Research:

• Clinical Trials and Drug Development
• Clinical Research in Antibiotic Resistance
• Adverse Drug Reactions: Monitoring and Management in Clinical Research
• Clinical Research in Psychopharmacology
• Pharmacogenetics and Personalized Medicine
• Clinical Research in Opioid Use and Addiction
• Clinical Trials for Novel Vaccines
• Clinical Research and the Development of Anticancer Drugs
• Pediatric Pharmacology and the Challenges in Clinical Research
• Over-the-counter Drugs and Self-Medication: A Clinical Research Perspective

6. Health Policy and Clinical Research:

• The Impact of Health Policy on Clinical Research
• Health Insurance Policies and Accessibility to Clinical Trials
• The Role of Policy in Regulating Clinical Trials
• How Health Policies Influence Patient Participation in Clinical Trials
• Policies for Ethical Conduct in Clinical Research
• Health Policy and Its Influence on Drug Development in Clinical Research
• The Impact of Global Health Policies on Clinical Research
• Policy Considerations for Genetic Testing in Clinical Research
• The Role of Policy in the Prevention of Clinical Research Misconduct
• The Impact of Health Policy Changes on the Scope of Clinical Research

7. Mental Health and Clinical Research:

• Clinical Research on the Efficacy of Cognitive Behavioral Therapy
• Role of Clinical Trials in Developing New Psychotropic Medications
• Advances in Clinical Research for Treating Post-Traumatic Stress Disorder
• The Role of Clinical Research in Understanding the Biology of Depression
• Clinical Research Approaches in Managing Childhood Autism
• Clinical Trials in the Development of Therapies for Schizophrenia
• Impact of Clinical Research on the Treatment of Anxiety Disorders
• Clinical Research on Mental Health in the Elderly
• Novel Clinical Approaches to Treating Eating Disorders
• The Role of Clinical Research in Suicidal Behavior Studies

8. Public Health and Clinical Research:

• The Role of Clinical Research in Advancing Public Health
• The Impact of Public Health Policies on Clinical Research
• Clinical Research on Preventive Measures in Public Health
• Clinical Trials and Their Significance in Public Health Improvement
• The Role of Clinical Research in Reducing Health Disparities
• Clinical Research in the Field of Occupational Health
• The Impact of Environmental Health Factors: A Clinical Research Perspective
• Clinical Research in the Control and Prevention of Epidemics
• The Role of Public Health Interventions in Clinical Research
• Global Public Health and the Need for International Clinical Research

9. Pediatric Clinical Research:

• Ethical Considerations in Pediatric Clinical Research
• The Role of Clinical Trials in Advancing Pediatric Medicine
• Clinical Research on Pediatric Oncology
• The Impact of Clinical Research on Pediatric Neurological Disorders
• Clinical Research on Rare Genetic Disorders in Children
• The Role of Clinical Research in Understanding and Treating Autism in Children
• Clinical Trials in the Development of Pediatric Vaccines
• The Impact of Clinical Research on Neonatal Care
• Challenges and Opportunities in Pediatric Clinical Trials
• Clinical Research in Pediatric Cardiology

10. Clinical Research in the Era of COVID-19:

• The Role of Clinical Research in Understanding COVID-19
• Clinical Trials for the Development of COVID-19 Vaccines
• Impact of the COVID-19 Pandemic on Ongoing Clinical Trials
• The Role of Clinical Research in Understanding Long-COVID
• Clinical Trials for COVID-19 Treatments: Successes and Challenges
• The Impact of COVID-19 on Mental Health: A Clinical Research Perspective
• Clinical Research on the Effect of COVID-19 in Children
• Lessons from COVID-19: Clinical Research for Future Pandemics
• The Role of Telemedicine in Clinical Research During COVID-19
• Ethical Considerations for Clinical Research During a Global Pandemic

This comprehensive list ensures that students have a broad spectrum of contemporary and significant topics to choose from, allowing them to find a subject that fits their interests and the current demands of the field.

Choosing Clinical Research Paper Topics

Choosing the right clinical research paper topic is a critical first step in the writing process. The topic you choose can set the tone for your entire project and greatly affect your experience. Here are ten tips to guide you in making the right choice:

• Understand the Assignment: Before diving into topic selection, ensure you fully understand your assignment’s parameters. Are there specific guidelines about the type of topic you should choose? Is there a certain page or word limit? Do you need to incorporate specific resources? Understanding these requirements can help you tailor your topic appropriately.
• Passion and Interest: Choose a topic that genuinely interests you. Writing a research paper can be a long process, and your passion for the subject can keep you motivated. It also makes it easier to delve deeper and provide new insights.
• Scope of the Topic: Consider the breadth of your topic. Is it too broad to be adequately covered in your paper, or is it too narrow that it lacks sufficient material for research? Aim for a balance where your topic can be fully addressed within the constraints of your assignment.
• Relevance: Opt for topics that are relevant to your field of study and the current climate of research. These could be emerging trends, pressing issues, or gaps in the existing literature that need to be filled.
• Originality: Try to select a topic that is unique and original. While you don’t have to reinvent the wheel, having a fresh perspective or a novel aspect can make your paper more interesting.
• Availability of Resources: Before finalizing a topic, ensure there are enough resources available for you to research. These could be scholarly articles, books, reliable online sources, or primary research materials.
• Consult with Your Instructor or Advisor: If you’re struggling with choosing a topic, don’t hesitate to consult your instructor or advisor. They can provide valuable guidance, help you refine your ideas, and point you towards resources you may not have considered.
• Future Implications: Consider how the topic you choose might impact your future career or academic goals. Is it something that could contribute to your long-term research goals or lead to a specialization?
• Practicality: Consider the feasibility of your topic. Do you have the time and resources to complete this research? For instance, if your topic requires conducting surveys or interviews, will you have access to the required sample population?
• Preliminary Research: Carry out some preliminary research before finalizing your topic. This will give you a better idea of what’s been done before, the arguments that exist around your topic, and how you can contribute to the discussion.

By considering these factors, you can ensure that the topic you choose is suited to your interests, academic goals, and the requirements of the assignment. The right topic can make the research and writing process much smoother and more enjoyable. Remember, a well-chosen topic is the first step towards a successful research paper.

How to Write a Clinical Research Paper

Writing a clinical research paper can be an intimidating task, particularly for students who are just beginning their journey in the health sciences field. The process can be made much easier by breaking it down into manageable steps. Here are ten tips that will help you successfully write a clinical research paper:

• Understand the Assignment: Before starting, ensure you understand the scope and requirements of the assignment. Are there specific formatting guidelines? Are there any required sections? Are certain sources preferred over others? Understanding these elements can guide your writing process.
• Thorough Research: Once you’ve chosen a topic, start your in-depth research. Look for reputable sources, such as peer-reviewed journal articles, textbooks, and government reports. Always cross-check information from multiple sources to ensure accuracy.
• Develop a Thesis Statement: Your thesis statement should concisely summarize your paper’s main argument or focus. It should be clear, specific, and arguable. It will guide your research and writing, helping to keep your paper focused.
• Create an Outline: An outline serves as a roadmap for your paper. It organizes your thoughts and helps ensure you address all necessary points. Your outline should include an introduction, body sections (often following the IMRaD format: Introduction, Methods, Results, and Discussion), and a conclusion.
• Start with the Methods Section: In a clinical research paper, starting with the Methods section can often be easiest as it includes concrete details of the research conducted. Detail the study’s design, participants, procedures, and data analysis. Be thorough so other researchers could replicate your study if needed.
• Write the Results Section: Present your findings without interpretation in this section. Use visuals such as tables, graphs, or charts to help illustrate the data where appropriate.
• Discuss Your Findings: The Discussion section is where you interpret your results. Connect your findings to your original research question and the existing literature in the field. Discuss whether your results met your expectations, what implications they might have, and any limitations of your study.
• Craft Your Introduction and Conclusion: Your Introduction should provide background information, state the research problem, and outline your paper’s structure. The Conclusion should summarize your findings, discuss their implications, and suggest areas for future research.
• Cite Your Sources: Always properly cite your sources to give credit to the original authors and allow readers to refer to the original work. Be consistent with the citation style requested by your instructor or the one generally used in your field (APA, MLA, Chicago/Turabian, Harvard).
• Revise and Proofread: Revision is a critical part of the writing process. Look for areas where clarity or coherence can be improved. Check for grammar, punctuation, and spelling errors.

Remember, writing a clinical research paper is not an overnight process. It takes time and effort to research, write, and refine a scientific paper. Pace yourself and don’t be afraid to ask for help if you need it. Your instructors, advisors, or school’s writing center can all be valuable resources.

iResearchNet’s Custom Writing Services

Navigating the complexities of writing a clinical research paper can be daunting, especially for students who are new to the field or juggling multiple responsibilities. That’s where iResearchNet steps in. Offering a robust suite of writing services tailored to the needs of health science students, iResearchNet is committed to helping you deliver quality research papers that meet academic standards. Here’s a deeper look at what we offer:

• Expert Degree-Holding Writers: Our team comprises skilled writers holding degrees in health sciences. With a deep understanding of clinical research’s intricacies, they can craft papers that reflect rigorous research and sophisticated understanding of the subject matter.
• Custom Written Works: We don’t believe in one-size-fits-all solutions. Our writers work closely with you to understand your unique requirements and create papers tailored to your needs, ensuring your individual voice shines through.
• In-Depth Research: Our services go beyond just writing. Our experts conduct comprehensive research, diving deep into scholarly resources to gather relevant, up-to-date information for your paper.
• Custom Formatting: Proper formatting is crucial in academic writing. Whether your paper requires APA, MLA, Chicago/Turabian, or Harvard style, our writers are well-versed in these formats and will ensure your paper adheres to the requisite style guidelines.
• Top Quality: We strive for excellence. Our rigorous quality control process involves thorough proofreading and editing to ensure that the final paper is of the highest quality, free of grammatical errors and plagiarism.
• Customized Solutions: Whether you need help with topic selection, an outline, or a complete paper, we offer customized solutions to suit your needs. We are here to provide as much (or as little) help as you need.
• Flexible Pricing: We understand that students work with tight budgets. That’s why we’ve designed our pricing to be affordable and flexible, offering various options to cater to different financial capabilities.
• Short Deadlines up to 3 Hours: Facing a time crunch? We have got you covered. Our team can deliver high-quality work even on tight deadlines – as short as three hours, ensuring you never miss your submission deadlines.
• Timely Delivery: We pride ourselves on our punctuality. Our writers work diligently to ensure your paper is completed on time, if not ahead of schedule, allowing you ample time for review.
• 24/7 Support: Our customer support team is available round the clock to answer your queries, address concerns, and facilitate seamless communication between you and the writer.
• Absolute Privacy: We respect your privacy. Our encrypted systems ensure your personal and financial information remains secure. We adhere to strict confidentiality policies, and we never share your information with third parties.
• Easy Order Tracking: With our user-friendly interface, you can easily track your order’s progress. You can also communicate directly with your writer, providing feedback and clarifications where necessary.
• Money Back Guarantee: Your satisfaction is our top priority. If you’re not completely satisfied with the work, we offer a money-back guarantee, standing behind the quality of our services.

With iResearchNet, you don’t have to navigate the demanding process of writing a clinical research paper alone. Our dedicated team of experts is ready to help you every step of the way, ensuring you can focus on mastering your subject matter while we handle the complex task of crafting a compelling research paper.

Empower Your Academic Journey with iResearchNet

You’ve seen what it takes to write a clinical research paper and the breadth of fascinating topics waiting to be explored. The journey may seem challenging, but it is also an opportunity to deepen your understanding of the health sciences, to contribute to the body of knowledge in your field, and to hone your skills as a researcher and writer. But you don’t have to embark on this journey alone. iResearchNet is here to accompany you every step of the way.

We invite you to experience the unparalleled support and expertise that our team offers. With our extensive suite of writing services, you’ll find the tools and resources you need to produce a quality research paper that reflects your hard work and dedication to your studies. Take advantage of our expert degree-holding writers’ knowledge, our commitment to in-depth research, and our proficiency in academic formatting styles to turn the daunting task of writing a research paper into a manageable, even enjoyable, process.

Choosing iResearchNet means choosing peace of mind. With our timely delivery, 24/7 support, and privacy assurance, you can focus on what matters most—your learning. And with our money-back guarantee, you can rest easy knowing that we stand firmly behind the quality of our services.

Don’t miss this opportunity to take your academic journey to the next level. Contact us today, share your clinical research paper needs, and experience firsthand how iResearchNet can help pave your path to academic success. The journey of a thousand miles begins with a single step. Let iResearchNet be that step for you.

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Basic Methods Handbook for Clinical Orthopaedic Research pp 255–262 Cite as

How to Review a Clinical Research Paper?

• Neel K. Patel 8 ,
• Marco Yeung 8 ,
• Kanto Nagai 8 &
• Volker Musahl 8  
• First Online: 02 February 2019

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Critical evaluation of each section of a paper is needed in order to properly assess the purpose and quality of the paper and to understand the degree to which the results can influence clinical practice. Reviewing a paper is a skill that is best honed by practice, but there is no real formal training during medical school or residency on what to evaluate during a review and what the review process involves for a journal. Thus, this chapter will highlight the major points to review in each section of a paper and will provide a guide for young investigators to use while interpreting the findings of a paper. Additionally, the components of a review submission to a journal will be outlined.

• Peer review
• Publication

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Patel, N.K., Yeung, M., Nagai, K., Musahl, V. (2019). How to Review a Clinical Research Paper?. In: Musahl, V., et al. Basic Methods Handbook for Clinical Orthopaedic Research. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-58254-1_28

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Home » Research Paper Outline – Types, Example, Template

Research Paper Outline – Types, Example, Template

Table of Contents

By creating a well-structured research paper outline, writers can easily organize their thoughts and ideas and ensure that their final paper is clear, concise, and effective. In this article, we will explore the essential components of a research paper outline and provide some tips and tricks for creating a successful one.

Research Paper Outline

Research paper outline is a plan or a structural framework that organizes the main ideas , arguments, and supporting evidence in a logical sequence. It serves as a blueprint or a roadmap for the writer to follow while drafting the actual research paper .

Typically, an outline consists of the following elements:

• Introduction : This section presents the topic, research question , and thesis statement of the paper. It also provides a brief overview of the literature review and the methodology used.
• Literature Review: This section provides a comprehensive review of the relevant literature, theories, and concepts related to the research topic. It analyzes the existing research and identifies the research gaps and research questions.
• Methodology: This section explains the research design, data collection methods, data analysis, and ethical considerations of the study.
• Results: This section presents the findings of the study, using tables, graphs, and statistics to illustrate the data.
• Discussion : This section interprets the results of the study, and discusses their implications, significance, and limitations. It also suggests future research directions.
• Conclusion : This section summarizes the main findings of the study and restates the thesis statement.
• References: This section lists all the sources cited in the paper using the appropriate citation style.

Research Paper Outline Types

There are several types of outlines that can be used for research papers, including:

Alphanumeric Outline

This is a traditional outline format that uses Roman numerals, capital letters, Arabic numerals, and lowercase letters to organize the main ideas and supporting details of a research paper. It is commonly used for longer, more complex research papers.

I. Introduction

• A. Background information
• B. Thesis statement
• 1 1. Supporting detail
• 1 2. Supporting detail 2
• 2 1. Supporting detail

III. Conclusion

• A. Restate thesis
• B. Summarize main points

Decimal Outline

This outline format uses numbers to organize the main ideas and supporting details of a research paper. It is similar to the alphanumeric outline, but it uses only numbers and decimals to indicate the hierarchy of the ideas.

• 1.1 Background information
• 1.2 Thesis statement
• 1 2.1.1 Supporting detail
• 1 2.1.2 Supporting detail
• 2 2.2.1 Supporting detail
• 1 2.2.2 Supporting detail
• 3.1 Restate thesis
• 3.2 Summarize main points

Full Sentence Outline

This type of outline uses complete sentences to describe the main ideas and supporting details of a research paper. It is useful for those who prefer to see the entire paper outlined in complete sentences.

• Provide background information on the topic
• State the thesis statement
• Explain main idea 1 and provide supporting details
• Discuss main idea 2 and provide supporting details
• Restate the thesis statement
• Summarize the main points of the paper

Topic Outline

This type of outline uses short phrases or words to describe the main ideas and supporting details of a research paper. It is useful for those who prefer to see a more concise overview of the paper.

• Background information
• Thesis statement
• Supporting detail 1
• Supporting detail 2
• Restate thesis
• Summarize main points

Reverse Outline

This is an outline that is created after the paper has been written. It involves going back through the paper and summarizing each paragraph or section in one sentence. This can be useful for identifying gaps in the paper or areas that need further development.

• Introduction : Provides background information and states the thesis statement.
• Paragraph 1: Discusses main idea 1 and provides supporting details.
• Paragraph 2: Discusses main idea 2 and provides supporting details.
• Paragraph 3: Addresses potential counterarguments.
• Conclusion : Restates thesis and summarizes main points.

Mind Map Outline

This type of outline involves creating a visual representation of the main ideas and supporting details of a research paper. It can be useful for those who prefer a more creative and visual approach to outlining.

• Supporting detail 1: Lack of funding for public schools.
• Supporting detail 2: Decrease in government support for education.
• Supporting detail 1: Increase in income inequality.
• Supporting detail 2: Decrease in social mobility.

Research Paper Outline Example

Research Paper Outline Example on Cyber Security:

A. Overview of Cybersecurity

• B. Importance of Cybersecurity
• C. Purpose of the paper

II. Cyber Threats

A. Definition of Cyber Threats

• B. Types of Cyber Threats
• C. Examples of Cyber Threats

III. Cybersecurity Measures

A. Prevention measures

• Anti-virus software
• Encryption B. Detection measures
• Intrusion Detection System (IDS)
• Security Information and Event Management (SIEM)
• Security Operations Center (SOC) C. Response measures
• Incident Response Plan
• Business Continuity Plan
• Disaster Recovery Plan

IV. Cybersecurity in the Business World

A. Overview of Cybersecurity in the Business World

B. Cybersecurity Risk Assessment

C. Best Practices for Cybersecurity in Business

V. Cybersecurity in Government Organizations

A. Overview of Cybersecurity in Government Organizations

C. Best Practices for Cybersecurity in Government Organizations

VI. Cybersecurity Ethics

A. Definition of Cybersecurity Ethics

B. Importance of Cybersecurity Ethics

C. Examples of Cybersecurity Ethics

VII. Future of Cybersecurity

A. Overview of the Future of Cybersecurity

B. Emerging Cybersecurity Threats

C. Advancements in Cybersecurity Technology

VIII. Conclusion

A. Summary of the paper

B. Recommendations for Cybersecurity

• C. Conclusion.

IX. References

A. List of sources cited in the paper

B. Bibliography of additional resources

Introduction

Cybersecurity refers to the protection of computer systems, networks, and sensitive data from unauthorized access, theft, damage, or any other form of cyber attack. B. Importance of Cybersecurity The increasing reliance on technology and the growing number of cyber threats make cybersecurity an essential aspect of modern society. Cybersecurity breaches can result in financial losses, reputational damage, and legal liabilities. C. Purpose of the paper This paper aims to provide an overview of cybersecurity, cyber threats, cybersecurity measures, cybersecurity in the business and government sectors, cybersecurity ethics, and the future of cybersecurity.

A cyber threat is any malicious act or event that attempts to compromise or disrupt computer systems, networks, or sensitive data. B. Types of Cyber Threats Common types of cyber threats include malware, phishing, social engineering, ransomware, DDoS attacks, and advanced persistent threats (APTs). C. Examples of Cyber Threats Recent cyber threats include the SolarWinds supply chain attack, the Colonial Pipeline ransomware attack, and the Microsoft Exchange Server hack.

Prevention measures aim to minimize the risk of cyber attacks by implementing security controls, such as firewalls, anti-virus software, and encryption.

• Firewalls Firewalls act as a barrier between a computer network and the internet, filtering incoming and outgoing traffic to prevent unauthorized access.
• Anti-virus software Anti-virus software detects, prevents, and removes malware from computer systems.
• Encryption Encryption involves the use of mathematical algorithms to transform sensitive data into a code that can only be accessed by authorized individuals. B. Detection measures Detection measures aim to identify and respond to cyber attacks as quickly as possible, such as intrusion detection systems (IDS), security information and event management (SIEM), and security operations centers (SOCs).
• Intrusion Detection System (IDS) IDS monitors network traffic for signs of unauthorized access, such as unusual patterns or anomalies.
• Security Information and Event Management (SIEM) SIEM combines security information management and security event management to provide real-time monitoring and analysis of security alerts.
• Security Operations Center (SOC) SOC is a dedicated team responsible for monitoring, analyzing, and responding to cyber threats. C. Response measures Response measures aim to mitigate the impact of a cyber attack and restore normal operations, such as incident response plans (IRPs), business continuity plans (BCPs), and disaster recovery plans (DRPs).
• Incident Response Plan IRPs outline the procedures and protocols to follow in the event of a cyber attack, including communication protocols, roles and responsibilities, and recovery processes.
• Business Continuity Plan BCPs ensure that critical business functions can continue in the event of a cyber attack or other disruption.
• Disaster Recovery Plan DRPs outline the procedures to recover from a catastrophic event, such as a natural disaster or cyber attack.

Cybersecurity is crucial for businesses of all sizes and industries, as they handle sensitive data, financial transactions, and intellectual property that are attractive targets for cyber criminals.

Risk assessment is a critical step in developing a cybersecurity strategy, which involves identifying potential threats, vulnerabilities, and consequences to determine the level of risk and prioritize security measures.

Best practices for cybersecurity in business include implementing strong passwords and multi-factor authentication, regularly updating software and hardware, training employees on cybersecurity awareness, and regularly backing up data.

Government organizations face unique cybersecurity challenges, as they handle sensitive information related to national security, defense, and critical infrastructure.

Risk assessment in government organizations involves identifying and assessing potential threats and vulnerabilities, conducting regular audits, and complying with relevant regulations and standards.

Best practices for cybersecurity in government organizations include implementing secure communication protocols, regularly updating and patching software, and conducting regular cybersecurity training and awareness programs for employees.

Cybersecurity ethics refers to the ethical considerations involved in cybersecurity, such as privacy, data protection, and the responsible use of technology.

Cybersecurity ethics are crucial for maintaining trust in technology, protecting privacy and data, and promoting responsible behavior in the digital world.

Examples of cybersecurity ethics include protecting the privacy of user data, ensuring data accuracy and integrity, and implementing fair and unbiased algorithms.

The future of cybersecurity will involve a shift towards more advanced technologies, such as artificial intelligence (AI), machine learning, and quantum computing.

Emerging cybersecurity threats include AI-powered cyber attacks, the use of deepfakes and synthetic media, and the potential for quantum computing to break current encryption methods.

Advancements in cybersecurity technology include the development of AI and machine learning-based security tools, the use of blockchain for secure data storage and sharing, and the development of post-quantum encryption methods.

This paper has provided an overview of cybersecurity, cyber threats, cybersecurity measures, cybersecurity in the business and government sectors, cybersecurity ethics, and the future of cybersecurity.

To enhance cybersecurity, organizations should prioritize risk assessment and implement a comprehensive cybersecurity strategy that includes prevention, detection, and response measures. Additionally, organizations should prioritize cybersecurity ethics to promote responsible behavior in the digital world.

C. Conclusion

Cybersecurity is an essential aspect of modern society, and organizations must prioritize cybersecurity to protect sensitive data and maintain trust in technology.

for further reading

X. Appendices

A. Glossary of key terms

B. Cybersecurity checklist for organizations

C. Sample cybersecurity policy for businesses

D. Sample cybersecurity incident response plan

E. Cybersecurity training and awareness resources

Note : The content and organization of the paper may vary depending on the specific requirements of the assignment or target audience. This outline serves as a general guide for writing a research paper on cybersecurity. Do not use this in your assingmets.

Research Paper Outline Template

• Background information and context of the research topic
• Research problem and questions
• Purpose and objectives of the research
• Scope and limitations

II. Literature Review

• Overview of existing research on the topic
• Key concepts and theories related to the research problem
• Identification of gaps in the literature
• Summary of relevant studies and their findings

III. Methodology

• Research design and approach
• Data collection methods and procedures
• Data analysis techniques
• Validity and reliability considerations
• Ethical considerations

IV. Results

• Presentation of research findings
• Analysis and interpretation of data
• Explanation of significant results
• Discussion of unexpected results

V. Discussion

• Comparison of research findings with existing literature
• Implications of results for theory and practice
• Limitations and future directions for research
• Conclusion and recommendations

VI. Conclusion

• Summary of research problem, purpose, and objectives
• Discussion of significant findings
• Contribution to the field of study
• Implications for practice
• Suggestions for future research

VII. References

• List of sources cited in the research paper using appropriate citation style.

Note : This is just an template, and depending on the requirements of your assignment or the specific research topic, you may need to modify or adjust the sections or headings accordingly.

Research Paper Outline Writing Guide

Here’s a guide to help you create an effective research paper outline:

• Choose a topic : Select a topic that is interesting, relevant, and meaningful to you.
• Conduct research: Gather information on the topic from a variety of sources, such as books, articles, journals, and websites.
• Organize your ideas: Organize your ideas and information into logical groups and subgroups. This will help you to create a clear and concise outline.
• Create an outline: Begin your outline with an introduction that includes your thesis statement. Then, organize your ideas into main points and subpoints. Each main point should be supported by evidence and examples.
• Introduction: The introduction of your research paper should include the thesis statement, background information, and the purpose of the research paper.
• Body : The body of your research paper should include the main points and subpoints. Each point should be supported by evidence and examples.
• Conclusion : The conclusion of your research paper should summarize the main points and restate the thesis statement.
• Reference List: Include a reference list at the end of your research paper. Make sure to properly cite all sources used in the paper.
• Proofreading : Proofread your research paper to ensure that it is free of errors and grammatical mistakes.
• Finalizing : Finalize your research paper by reviewing the outline and making any necessary changes.

When to Write Research Paper Outline

It’s a good idea to write a research paper outline before you begin drafting your paper. The outline will help you organize your thoughts and ideas, and it can serve as a roadmap for your writing process.

Here are a few situations when you might want to consider writing an outline:

• When you’re starting a new research project: If you’re beginning a new research project, an outline can help you get organized from the very beginning. You can use your outline to brainstorm ideas, map out your research goals, and identify potential sources of information.
• When you’re struggling to organize your thoughts: If you find yourself struggling to organize your thoughts or make sense of your research, an outline can be a helpful tool. It can help you see the big picture of your project and break it down into manageable parts.
• When you’re working with a tight deadline : If you have a deadline for your research paper, an outline can help you stay on track and ensure that you cover all the necessary points. By mapping out your paper in advance, you can work more efficiently and avoid getting stuck or overwhelmed.

Purpose of Research Paper Outline

The purpose of a research paper outline is to provide a structured and organized plan for the writer to follow while conducting research and writing the paper. An outline is essentially a roadmap that guides the writer through the entire research process, from the initial research and analysis of the topic to the final writing and editing of the paper.

A well-constructed outline can help the writer to:

• Organize their thoughts and ideas on the topic, and ensure that all relevant information is included.
• Identify any gaps in their research or argument, and address them before starting to write the paper.
• Ensure that the paper follows a logical and coherent structure, with clear transitions between different sections.
• Save time and effort by providing a clear plan for the writer to follow, rather than starting from scratch and having to revise the paper multiple times.

Advantages of Research Paper Outline

Some of the key advantages of a research paper outline include:

• Helps to organize thoughts and ideas : An outline helps to organize all the different ideas and information that you want to include in your paper. By creating an outline, you can ensure that all the points you want to make are covered and in a logical order.
• Saves time and effort : An outline saves time and effort because it helps you to focus on the key points of your paper. It also helps you to identify any gaps or areas where more research may be needed.
• Makes the writing process easier : With an outline, you have a clear roadmap of what you want to write, and this makes the writing process much easier. You can simply follow your outline and fill in the details as you go.
• Improves the quality of your paper : By having a clear outline, you can ensure that all the important points are covered and in a logical order. This makes your paper more coherent and easier to read, which ultimately improves its overall quality.
• Facilitates collaboration: If you are working on a research paper with others, an outline can help to facilitate collaboration. By sharing your outline, you can ensure that everyone is on the same page and working towards the same goals.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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Preparing the Research Presentation

If you have never presented a paper at a scientific meeting, you should read this article. Even if you have presented before, it is likely that this article contains information that will improve your presentation. This article contains a set of practical, proven steps that will guide your preparation of the presentation. Our assumptions are that you will schedule appropriate planning and preparation time, are interested in doing the best job possible, and know that a quality presentation is a combination of good research and communication skills. This and subsequent articles will focus on planning, preparation, creating visual aids (slides), and presentation skills for a scientific presentation. The intent of this series of articles is to help you make a favorable impression at the scientific meeting and reap the rewards, personal and professional, of a job well done.

To begin with, you need to create an outline of the topics you might present at the meeting. Your outline should follow the IMRAC format (introduction, methods, results, and conclusion). This format is chosen because your audience understands it and expects it. If you have already prepared a paper for publication, it can be a rich source of content for the topic outline.

To get you started, we have prepared a generic outline  to serve as an example. We recognize that a generic outline does not necessarily adapt to all research designs, but we ask you to think, "How can I adapt this to my situation?" To help you visualize the content you might include in the outline, two types of examples have been included, one that describes a cross-sectional study using a survey methodology (example A), and a second using a combination of a case-control and cohort designs (example B).

Use the Preparing the Research Presentation Checklist  to assist you in preparing the topic outline.

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Clinical Trials and Clinical Research: A Comprehensive Review

Venkataramana kandi.

1 Clinical Microbiology, Prathima Institute of Medical Sciences, Karimnagar, IND

Sabitha Vadakedath

2 Biochemistry, Prathima Institute of Medical Sciences, Karimnagar, IND

Clinical research is an alternative terminology used to describe medical research. Clinical research involves people, and it is generally carried out to evaluate the efficacy of a therapeutic drug, a medical/surgical procedure, or a device as a part of treatment and patient management. Moreover, any research that evaluates the aspects of a disease like the symptoms, risk factors, and pathophysiology, among others may be termed clinical research. However, clinical trials are those studies that assess the potential of a therapeutic drug/device in the management, control, and prevention of disease. In view of the increasing incidences of both communicable and non-communicable diseases, and especially after the effects that Coronavirus Disease-19 (COVID-19) had on public health worldwide, the emphasis on clinical research assumes extremely essential. The knowledge of clinical research will facilitate the discovery of drugs, devices, and vaccines, thereby improving preparedness during public health emergencies. Therefore, in this review, we comprehensively describe the critical elements of clinical research that include clinical trial phases, types, and designs of clinical trials, operations of trial, audit, and management, and ethical concerns.

Introduction and background

A clinical trial is a systematic process that is intended to find out the safety and efficacy of a drug/device in treating/preventing/diagnosing a disease or a medical condition [ 1 , 2 ]. Clinical trial includes various phases that include phase 0 (micro-dosing studies), phase 1, phase 2, phase 3, and phase 4 [ 3 ]. Phase 0 and phase 2 are called exploratory trial phases, phase 1 is termed the non-therapeutic phase, phase 3 is known as the therapeutic confirmatory phase, and phase 4 is called the post-approval or the post-marketing surveillance phase. Phase 0, also called the micro-dosing phase, was previously done in animals but now it is carried out in human volunteers to understand the dose tolerability (pharmacokinetics) before being administered as a part of the phase 1 trial among healthy individuals. The details of the clinical trial phases are shown in Table ​ Table1 1 .

This table has been created by the authors.

MTD: maximum tolerated dose; SAD: single ascending dose; MAD: multiple ascending doses; NDA: new drug application; FDA: food and drug administration

Clinical research design has two major types that include non-interventional/observational and interventional/experimental studies. The non-interventional studies may have a comparator group (analytical studies like case-control and cohort studies), or without it (descriptive study). The experimental studies may be either randomized or non-randomized. Clinical trial designs are of several types that include parallel design, crossover design, factorial design, randomized withdrawal approach, adaptive design, superiority design, and non-inferiority design. The advantages and disadvantages of clinical trial designs are depicted in Table ​ Table2 2 .

There are different types of clinical trials that include those which are conducted for treatment, prevention, early detection/screening, and diagnosis. These studies address the activities of an investigational drug on a disease and its outcomes [ 4 ]. They assess whether the drug is able to prevent the disease/condition, the ability of a device to detect/screen the disease, and the efficacy of a medical test to diagnose the disease/condition. The pictorial representation of a disease diagnosis, treatment, and prevention is depicted in Figure ​ Figure1 1 .

This figure has been created by the authors.

The clinical trial designs could be improvised to make sure that the study's validity is maintained/retained. The adaptive designs facilitate researchers to improvise during the clinical trial without interfering with the integrity and validity of the results. Moreover, it allows flexibility during the conduction of trials and the collection of data. Despite these advantages, adaptive designs have not been universally accepted among clinical researchers. This could be attributed to the low familiarity of such designs in the research community. The adaptive designs have been applied during various phases of clinical trials and for different clinical conditions [ 5 , 6 ]. The adaptive designs applied during different phases are depicted in Figure ​ Figure2 2 .

The Bayesian adaptive trial design has gained popularity, especially during the Coronavirus Disease-19 (COVID-19) pandemic. Such designs could operate under a single master protocol. It operates as a platform trial wherein multiple treatments can be tested on different patient groups suffering from disease [ 7 ].

In this review, we comprehensively discuss the essential elements of clinical research that include the principles of clinical research, planning clinical trials, practical aspects of clinical trial operations, essentials of clinical trial applications, monitoring, and audit, clinical trial data analysis, regulatory audits, and project management, clinical trial operations at the investigation site, the essentials of clinical trial experiments involving epidemiological, and genetic studies, and ethical considerations in clinical research/trials.

A clinical trial involves the study of the effect of an investigational drug/any other intervention in a defined population/participant. The clinical research includes a treatment group and a placebo wherein each group is evaluated for the efficacy of the intervention (improved/not improved) [ 8 ].

Clinical trials are broadly classified into controlled and uncontrolled trials. The uncontrolled trials are potentially biased, and the results of such research are not considered as equally as the controlled studies. Randomized controlled trials (RCTs) are considered the most effective clinical trials wherein the bias is minimized, and the results are considered reliable. There are different types of randomizations and each one has clearly defined functions as elaborated in Table ​ Table3 3 .

Principles of clinical trial/research

Clinical trials or clinical research are conducted to improve the understanding of the unknown, test a hypothesis, and perform public health-related research [ 2 , 3 ]. This is majorly carried out by collecting the data and analyzing it to derive conclusions. There are various types of clinical trials that are majorly grouped as analytical, observational, and experimental research. Clinical research can also be classified into non-directed data capture, directed data capture, and drug trials. Clinical research could be prospective or retrospective. It may also be a case-control study or a cohort study. Clinical trials may be initiated to find treatment, prevent, observe, and diagnose a disease or a medical condition.

Among the various types of clinical research, observational research using a cross-sectional study design is the most frequently performed clinical research. This type of research is undertaken to analyze the presence or absence of a disease/condition, potential risk factors, and prevalence and incidence rates in a defined population. Clinical trials may be therapeutic or non-therapeutic type depending on the type of intervention. The therapeutic type of clinical trial uses a drug that may be beneficial to the patient. Whereas in a non-therapeutic clinical trial, the participant does not benefit from the drug. The non-therapeutic trials provide additional knowledge of the drug for future improvements. Different terminologies of clinical trials are delineated in Table ​ Table4 4 .

In view of the increased cost of the drug discovery process, developing, and low-income countries depend on the production of generic drugs. The generic drugs are similar in composition to the patented/branded drug. Once the patent period is expired generic drugs can be manufactured which have a similar quality, strength, and safety as the patented drug [ 9 ]. The regulatory requirements and the drug production process are almost the same for the branded and the generic drug according to the Food and Drug Administration (FDA), United States of America (USA).

The bioequivalence (BE) studies review the absorption, distribution, metabolism, and excretion (ADME) of the generic drug. These studies compare the concentration of the drug at the desired location in the human body, called the peak concentration of the drug (Cmax). The extent of absorption of the drug is measured using the area under the receiver operating characteristic curve (AUC), wherein the generic drug is supposed to demonstrate similar ADME activities as the branded drug. The BE studies may be undertaken in vitro (fasting, non-fasting, sprinkled fasting) or in vivo studies (clinical, bioanalytical, and statistical) [ 9 ].

Planning clinical trial/research

The clinical trial process involves protocol development, designing a case record/report form (CRF), and functioning of institutional review boards (IRBs). It also includes data management and the monitoring of clinical trial site activities. The CRF is the most significant document in a clinical study. It contains the information collected by the investigator about each subject participating in a clinical study/trial. According to the International Council for Harmonisation (ICH), the CRF can be printed, optical, or an electronic document that is used to record the safety and efficacy of the pharmaceutical drug/product in the test subjects. This information is intended for the sponsor who initiates the clinical study [ 10 ].

The CRF is designed as per the protocol and later it is thoroughly reviewed for its correctness (appropriate and structured questions) and finalized. The CRF then proceeds toward the print taking the language of the participating subjects into consideration. Once the CRF is printed, it is distributed to the investigation sites where it is filled with the details of the participating subjects by the investigator/nurse/subject/guardian of the subject/technician/consultant/monitors/pharmacist/pharmacokinetics/contract house staff. The filled CRFs are checked for their completeness and transported to the sponsor [ 11 ].

Effective planning and implementation of a clinical study/trial will influence its success. The clinical study majorly includes the collection and distribution of the trial data, which is done by the clinical data management section. The project manager is crucial to effectively plan, organize, and use the best processes to control and monitor the clinical study [ 10 , 11 ].

The clinical study is conducted by a sponsor or a clinical research organization (CRO). A perfect protocol, time limits, and regulatory requirements assume significance while planning a clinical trial. What, when, how, and who are clearly planned before the initiation of a study trial. Regular review of the project using the bar and Gantt charts, and maintaining the timelines assume increased significance for success with the product (study report, statistical report, database) [ 10 , 11 ].

The steps critical to planning a clinical trial include the idea, review of the available literature, identifying a problem, formulating the hypothesis, writing a synopsis, identifying the investigators, writing a protocol, finding a source of funding, designing a patient consent form, forming ethics boards, identifying an organization, preparing manuals for procedures, quality assurance, investigator training and initiation of the trial by recruiting the participants [ 10 ].

The two most important points to consider before the initiation of the clinical trial include whether there is a need for a clinical trial, if there is a need, then one must make sure that the study design and methodology are strong for the results to be reliable to the people [ 11 ].

For clinical research to envisage high-quality results, the study design, implementation of the study, quality assurance in data collection, and alleviation of bias and confounding factors must be robust [ 12 ]. Another important aspect of conducting a clinical trial is improved management of various elements of clinical research that include human and financial resources. The role of a trial manager to make a successful clinical trial was previously reported. The trial manager could play a key role in planning, coordinating, and successfully executing the trial. Some qualities of a trial manager include better communication and motivation, leadership, and strategic, tactical, and operational skills [ 13 ].

Practical aspects of a clinical trial operations

There are different types of clinical research. Research in the development of a novel drug could be initiated by nationally funded research, industry-sponsored research, and clinical research initiated by individuals/investigators. According to the documents 21 code of federal regulations (CFR) 312.3 and ICH E-6 Good Clinical Practice (GCP) 1.54, an investigator is an individual who initiates and conducts clinical research [ 14 ]. The investigator plan, design, conduct, monitor, manage data, compile reports, and supervise research-related regulatory and ethical issues. To manage a successful clinical trial project, it is essential for an investigator to give the letter of intent, write a proposal, set a timeline, develop a protocol and related documents like the case record forms, define the budget, and identify the funding sources.

Other major steps of clinical research include the approval of IRBs, conduction and supervision of the research, data review, and analysis. Successful clinical research includes various essential elements like a letter of intent which is the evidence that supports the interest of the researcher to conduct drug research, timeline, funding source, supplier, and participant characters.

Quality assurance, according to the ICH and GCP guidelines, is necessary to be implemented during clinical research to generate quality and accurate data. Each element of the clinical research must have been carried out according to the standard operating procedure (SOP), which is written/determined before the initiation of the study and during the preparation of the protocol [ 15 ].

The audit team (quality assurance group) is instrumental in determining the authenticity of the clinical research. The audit, according to the ICH and GCP, is an independent and external team that examines the process (recording the CRF, analysis of data, and interpretation of data) of clinical research. The quality assurance personnel are adequately trained, become trainers if needed, should be good communicators, and must handle any kind of situation. The audits can be at the investigator sites evaluating the CRF data, the protocol, and the personnel involved in clinical research (source data verification, monitors) [ 16 ].

Clinical trial operations are governed by legal and regulatory requirements, based on GCPs, and the application of science, technology, and interpersonal skills [ 17 ]. Clinical trial operations are complex, time and resource-specific that requires extensive planning and coordination, especially for the research which is conducted at multiple trial centers [ 18 ].

Recruiting the clinical trial participants/subjects is the most significant aspect of clinical trial operations. Previous research had noted that most clinical trials do not meet the participant numbers as decided in the protocol. Therefore, it is important to identify the potential barriers to patient recruitment [ 19 ].

Most clinical trials demand huge costs, increased timelines, and resources. Randomized clinical trial studies from Switzerland were analyzed for their costs which revealed approximately 72000 USD for a clinical trial to be completed. This study emphasized the need for increased transparency with respect to the costs associated with the clinical trial and improved collaboration between collaborators and stakeholders [ 20 ].

Clinical trial applications, monitoring, and audit

Among the most significant aspects of a clinical trial is the audit. An audit is a systematic process of evaluating the clinical trial operations at the site. The audit ensures that the clinical trial process is conducted according to the protocol, and predefined quality system procedures, following GCP guidelines, and according to the requirements of regulatory authorities [ 21 ].

The auditors are supposed to be independent and work without the involvement of the sponsors, CROs, or personnel at the trial site. The auditors ensure that the trial is conducted by designated professionally qualified, adequately trained personnel, with predefined responsibilities. The auditors also ensure the validity of the investigational drug, and the composition, and functioning of institutional review/ethics committees. The availability and correctness of the documents like the investigational broacher, informed consent forms, CRFs, approval letters of the regulatory authorities, and accreditation of the trial labs/sites [ 21 ].

The data management systems, the data collection software, data backup, recovery, and contingency plans, alternative data recording methods, security of the data, personnel training in data entry, and the statistical methods used to analyze the results of the trial are other important responsibilities of the auditor [ 21 , 22 ].

According to the ICH-GCP Sec 1.29 guidelines the inspection may be described as an act by the regulatory authorities to conduct an official review of the clinical trial-related documents, personnel (sponsor, investigator), and the trial site [ 21 , 22 ]. The summary report of the observations of the inspectors is performed using various forms as listed in Table ​ Table5 5 .

FDA: Food and Drug Administration; IND: investigational new drug; NDA: new drug application; IRB: institutional review board; CFR: code of federal regulations

Because protecting data integrity, the rights, safety, and well-being of the study participants are more significant while conducting a clinical trial, regular monitoring and audit of the process appear crucial. Also, the quality of the clinical trial greatly depends on the approach of the trial personnel which includes the sponsors and investigators [ 21 ].

The responsibility of monitoring lies in different hands, and it depends on the clinical trial site. When the trial is initiated by a pharmaceutical industry, the responsibility of trial monitoring depends on the company or the sponsor, and when the trial is conducted by an academic organization, the responsibility lies with the principal investigator [ 21 ].

An audit is a process conducted by an independent body to ensure the quality of the study. Basically, an audit is a quality assurance process that determines if a study is carried out by following the SPOs, in compliance with the GCPs recommended by regulatory bodies like the ICH, FDA, and other local bodies [ 21 ].

An audit is performed to review all the available documents related to the IRB approval, investigational drug, and the documents related to the patient care/case record forms. Other documents that are audited include the protocol (date, sign, treatment, compliance), informed consent form, treatment response/outcome, toxic response/adverse event recording, and the accuracy of data entry [ 22 ].

Clinical trial data analysis, regulatory audits, and project management

The essential elements of clinical trial management systems (CDMS) include the management of the study, the site, staff, subject, contracts, data, and document management, patient diary integration, medical coding, monitoring, adverse event reporting, supplier management, lab data, external interfaces, and randomization. The CDMS involves setting a defined start and finishing time, defining study objectives, setting enrolment and termination criteria, commenting, and managing the study design [ 23 ].

Among the various key application areas of clinical trial systems, the data analysis assumes increased significance. The clinical trial data collected at the site in the form of case record form is stored in the CDMS ensuring the errors with respect to the double data entry are minimized.

Clinical trial data management uses medical coding, which uses terminologies with respect to the medications and adverse events/serious adverse events that need to be entered into the CDMS. The project undertaken to conduct the clinical trial must be predetermined with timelines and milestones. Timelines are usually set for the preparation of protocol, designing the CRF, planning the project, identifying the first subject, and timelines for recording the patient’s data for the first visit.

The timelines also are set for the last subject to be recruited in the study, the CRF of the last subject, and the locked period after the last subject entry. The planning of the project also includes the modes of collection of the data, the methods of the transport of the CRFs, patient diaries, and records of severe adverse events, to the central data management sites (fax, scan, courier, etc.) [ 24 ].

The preparation of SOPs and the type and timing of the quality control (QC) procedures are also included in the project planning before the start of a clinical study. Review (budget, resources, quality of process, assessment), measure (turnaround times, training issues), and control (CRF collection and delivery, incentives, revising the process) are the three important aspects of the implementation of a clinical research project.

In view of the increasing complexity related to the conduct of clinical trials, it is important to perform a clinical quality assurance (CQA) audit. The CQA audit process consists of a detailed plan for conducting audits, points of improvement, generating meaningful audit results, verifying SOP, and regulatory compliance, and promoting improvement in clinical trial research [ 25 ]. All the components of a CQA audit are delineated in Table ​ Table6 6 .

CRF: case report form; CSR: clinical study report; IC: informed consent; PV: pharmacovigilance; SAE: serious adverse event

Clinical trial operations at the investigator's site

The selection of an investigation site is important before starting a clinical trial. It is essential that the individuals recruited for the study meet the inclusion criteria of the trial, and the investigator's and patient's willingness to accept the protocol design and the timelines set by the regulatory authorities including the IRBs.

Before conducting clinical research, it is important for an investigator to agree to the terms and conditions of the agreement and maintain the confidentiality of the protocol. Evaluation of the protocol for the feasibility of its practices with respect to the resources, infrastructure, qualified and trained personnel available, availability of the study subjects, and benefit to the institution and the investigator is done by the sponsor during the site selection visit.

The standards of a clinical research trial are ensured by the Council for International Organizations of Medical Sciences (CIOMS), National Bioethics Advisory Commission (NBAC), United Nations Programme on Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) (UNAIDS), and World Medical Association (WMA) [ 26 ].

Recommendations for conducting clinical research based on the WMA support the slogan that says, “The health of my patient will be my first consideration.” According to the International Code of Medical Ethics (ICME), no human should be physically or mentally harmed during the clinical trial, and the study should be conducted in the best interest of the person [ 26 ].

Basic principles recommended by the Helsinki declaration include the conduction of clinical research only after the prior proof of the safety of the drug in animal and lab experiments. The clinical trials must be performed by scientifically, and medically qualified and well-trained personnel. Also, it is important to analyze the benefit of research over harm to the participants before initiating the drug trials.

The doctors may prescribe a drug to alleviate the suffering of the patient, save the patient from death, and gain additional knowledge of the drug only after obtaining informed consent. Under the equipoise principle, the investigators must be able to justify the treatment provided as a part of the clinical trial, wherein the patient in the placebo arm may be harmed due to the unavailability of the therapeutic/trial drug.

Clinical trial operations greatly depend on the environmental conditions and geographical attributes of the trial site. It may influence the costs and targets defined by the project before the initiation. It was noted that one-fourth of the clinical trial project proposals/applications submit critical data on the investigational drug from outside the country. Also, it was noted that almost 35% of delays in clinical trials owing to patient recruitment with one-third of studies enrolling only 5% of the participants [ 27 ].

It was suggested that clinical trial feasibility assessment in a defined geographical region may be undertaken for improved chances of success. Points to be considered under the feasibility assessment program include if the disease under the study is related to the population of the geographical region, appropriateness of the study design, patient, and comparator group, visit intervals, potential regulatory and ethical challenges, and commitments of the study partners, CROs in respective countries (multi-centric studies) [ 27 ].

Feasibility assessments may be undertaken at the program level (ethics, regulatory, and medical preparedness), study level (clinical, regulatory, technical, and operational aspects), and at the investigation site (investigational drug, competency of personnel, participant recruitment, and retention, quality systems, and infrastructural aspects) [ 27 ].

Clinical trials: true experiments

In accordance with the revised schedule "Y" of the Drugs and Cosmetics Act (DCA) (2005), a drug trial may be defined as a systematic study of a novel drug component. The clinical trials aim to evaluate the pharmacodynamic, and pharmacokinetic properties including ADME, efficacy, and safety of new drugs.

According to the drug and cosmetic rules (DCR), 1945, a new chemical entity (NCE) may be defined as a novel drug approved for a disease/condition, in a specified route, and at a particular dosage. It also may be a new drug combination, of previously approved drugs.

A clinical trial may be performed in three types; one that is done to find the efficacy of an NCE, a comparison study of two drugs against a medical condition, and the clinical research of approved drugs on a disease/condition. Also, studies of the bioavailability and BE studies of the generic drugs, and the drugs already approved in other countries are done to establish the efficacy of new drugs [ 28 ].

Apart from the discovery of a novel drug, clinical trials are also conducted to approve novel medical devices for public use. A medical device is defined as any instrument, apparatus, appliance, software, and any other material used for diagnostic/therapeutic purposes. The medical devices may be divided into three classes wherein class I uses general controls; class II uses general and special controls, and class III uses general, special controls, and premarket approvals [ 28 ].

The premarket approval applications ensure the safety and effectiveness, and confirmation of the activities from bench to animal to human clinical studies. The FDA approval for investigational device exemption (IDE) for a device not approved for a new indication/disease/condition. There are two types of IDE studies that include the feasibility study (basic safety and potential effectiveness) and the pivotal study (trial endpoints, randomization, monitoring, and statistical analysis plan) [ 28 ].

As evidenced by the available literature, there are two types of research that include observational and experimental research. Experimental research is alternatively known as the true type of research wherein the research is conducted by the intervention of a new drug/device/method (educational research). Most true experiments use randomized control trials that remove bias and neutralize the confounding variables that may interfere with the results of research [ 28 ].

The variables that may interfere with the study results are independent variables also called prediction variables (the intervention), dependent variables (the outcome), and extraneous variables (other confounding factors that could influence the outside). True experiments have three basic elements that include manipulation (that influence independent variables), control (over extraneous influencers), and randomization (unbiased grouping) [ 29 ].

Experiments can also be grouped as true, quasi-experimental, and non-experimental studies depending on the presence of specific characteristic features. True experiments have all three elements of study design (manipulation, control, randomization), and prospective, and have great scientific validity. Quasi-experiments generally have two elements of design (manipulation and control), are prospective, and have moderate scientific validity. The non-experimental studies lack manipulation, control, and randomization, are generally retrospective, and have low scientific validity [ 29 ].

Clinical trials: epidemiological and human genetics study

Epidemiological studies are intended to control health issues by understanding the distribution, determinants, incidence, prevalence, and impact on health among a defined population. Such studies are attempted to perceive the status of infectious diseases as well as non-communicable diseases [ 30 ].

Experimental studies are of two types that include observational (cross-sectional studies (surveys), case-control studies, and cohort studies) and experimental studies (randomized control studies) [ 3 , 31 ]. Such research may pose challenges related to ethics in relation to the social and cultural milieu.

Biomedical research related to human genetics and transplantation research poses an increased threat to ethical concerns, especially after the success of the human genome project (HGP) in the year 2000. The benefits of human genetic studies are innumerable that include the identification of genetic diseases, in vitro fertilization, and regeneration therapy. Research related to human genetics poses ethical, legal, and social issues (ELSI) that need to be appropriately addressed. Most importantly, these genetic research studies use advanced technologies which should be equally available to both economically well-placed and financially deprived people [ 32 ].

Gene therapy and genetic manipulations may potentially precipitate conflict of interest among the family members. The research on genetics may be of various types that include pedigree studies (identifying abnormal gene carriers), genetic screening (for diseases that may be heritable by the children), gene therapeutics (gene replacement therapy, gene construct administration), HGP (sequencing the whole human genome/deoxyribonucleic acid (DNA) fingerprinting), and DNA, cell-line banking/repository [ 33 ]. The biobanks are established to collect and store human tissue samples like umbilical tissue, cord blood, and others [ 34 ].

Epidemiological studies on genetics are attempts to understand the prevalence of diseases that may be transmitted among families. The classical epidemiological studies may include single case observations (one individual), case series (< 10 individuals), ecological studies (population/large group of people), cross-sectional studies (defined number of individuals), case-control studies (defined number of individuals), cohort (defined number of individuals), and interventional studies (defined number of individuals) [ 35 ].

Genetic studies are of different types that include familial aggregation (case-parent, case-parent-grandparent), heritability (study of twins), segregation (pedigree study), linkage study (case-control), association, linkage, disequilibrium, cohort case-only studies (related case-control, unrelated case-control, exposure, non-exposure group, case group), cross-sectional studies, association cohort (related case-control, familial cohort), and experimental retrospective cohort (clinical trial, exposure, and non-exposure group) [ 35 ].

Ethics and concerns in clinical trial/research

Because clinical research involves animals and human participants, adhering to ethics and ethical practices assumes increased significance [ 36 ]. In view of the unethical research conducted on war soldiers after the Second World War, the Nuremberg code was introduced in 1947, which promulgated rules for permissible medical experiments on humans. The Nuremberg code suggests that informed consent is mandatory for all the participants in a clinical trial, and the study subjects must be made aware of the nature, duration, and purpose of the study, and potential health hazards (foreseen and unforeseen). The study subjects should have the liberty to withdraw at any time during the trial and to choose a physician upon medical emergency. The other essential principles of clinical research involving human subjects as suggested by the Nuremberg code included benefit to the society, justification of study as noted by the results of the drug experiments on animals, avoiding even minimal suffering to the study participants, and making sure that the participants don’t have life risk, humanity first, improved medical facilities for participants, and suitably qualified investigators [ 37 ].

During the 18th world medical assembly meeting in the year 1964, in Helsinki, Finland, ethical principles for doctors practicing research were proposed. Declaration of Helsinki, as it is known made sure that the interests and concerns of the human participants will always prevail over the interests of the society. Later in 1974, the National Research Act was proposed which made sure that the research proposals are thoroughly screened by the Institutional ethics/Review Board. In 1979, the April 18th Belmont report was proposed by the national commission for the protection of human rights during biomedical and behavioral research. The Belmont report proposed three core principles during research involving human participants that include respect for persons, beneficence, and justice. The ICH laid down GCP guidelines [ 38 ]. These guidelines are universally followed throughout the world during the conduction of clinical research involving human participants.

ICH was first founded in 1991, in Brussels, under the umbrella of the USA, Japan, and European countries. The ICH conference is conducted once every two years with the participation from the member countries, observers from the regulatory agencies, like the World Health Organization (WHO), European Free Trade Association (EFTA), and the Canadian Health Protection Branch, and other interested stakeholders from the academia and the industry. The expert working groups of the ICH ensure the quality, efficacy, and safety of the medicinal product (drug/device). Despite the availability of the Nuremberg code, the Belmont Report, and the ICH-GCP guidelines, in the year 1982, International Ethical Guidelines for Biomedical Research Involving Human Subjects was proposed by the CIOMS in association with WHO [ 39 ]. The CIOMS protects the rights of the vulnerable population, and ensures ethical practices during clinical research, especially in underdeveloped countries [ 40 ]. In India, the ethical principles for biomedical research involving human subjects were introduced by the Indian Council of Medical Research (ICMR) in the year 2000 and were later amended in the year 2006 [ 41 ]. Clinical trial approvals can only be done by the IRB approved by the Drug Controller General of India (DGCI) as proposed in the year 2013 [ 42 ].

Current perspectives and future implications

A recent study attempted to evaluate the efficacy of adaptive clinical trials in predicting the success of a clinical trial drug that entered phase 3 and minimizing the time and cost of drug development. This study highlighted the drawbacks of such clinical trial designs that include the possibility of type 1 (false positive) and type 2 (false negative) errors [ 43 ].

The usefulness of animal studies during the preclinical phases of a clinical trial was evaluated in a previous study which concluded that animal studies may not completely guarantee the safety of the investigational drug. This is noted by the fact that many drugs which passed toxicity tests in animals produced adverse reactions in humans [ 44 ].

The significance of BE studies to compare branded and generic drugs was reported previously. The pharmacokinetic BE studies of Amoxycillin comparing branded and generic drugs were carried out among a group of healthy participants. The study results have demonstrated that the generic drug had lower Cmax as compared to the branded drug [ 45 ].

To establish the BE of the generic drugs, randomized crossover trials are carried out to assess the Cmax and the AUC. The ratio of each pharmacokinetic characteristic must match the ratio of AUC and/or Cmax, 1:1=1 for a generic drug to be considered as a bioequivalent to a branded drug [ 46 ].

Although the generic drug development is comparatively more beneficial than the branded drugs, synthesis of extended-release formulations of the generic drug appears to be complex. Since the extended-release formulations remain for longer periods in the stomach, they may be influenced by gastric acidity and interact with the food. A recent study suggested the use of bio-relevant dissolution tests to increase the successful production of generic extended-release drug formulations [ 47 ].

Although RCTs are considered the best designs, which rule out bias and the data/results obtained from such clinical research are the most reliable, RCTs may be plagued by miscalculation of the treatment outcomes/bias, problems of cointerventions, and contaminations [ 48 ].

The perception of healthcare providers regarding branded drugs and their view about the generic equivalents was recently analyzed and reported. It was noted that such a perception may be attributed to the flexible regulatory requirements for the approval of a generic drug as compared to a branded drug. Also, could be because a switch from a branded drug to a generic drug in patients may precipitate adverse events as evidenced by previous reports [ 49 ].

Because the vulnerable population like drug/alcohol addicts, mentally challenged people, children, geriatric age people, military persons, ethnic minorities, people suffering from incurable diseases, students, employees, and pregnant women cannot make decisions with respect to participating in a clinical trial, ethical concerns, and legal issues may prop up, that may be appropriately addressed before drug trials which include such groups [ 50 ].

Conclusions

Clinical research and clinical trials are important from the public health perspective. Clinical research facilitates scientists, public health administrations, and people to increase their understanding and improve preparedness with reference to the diseases prevalent in different geographical regions of the world. Moreover, clinical research helps in mitigating health-related problems as evidenced by the current Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) pandemic and other emerging and re-emerging microbial infections. Clinical trials are crucial to the development of drugs, devices, and vaccines. Therefore, scientists are required to be up to date with the process and procedures of clinical research and trials as discussed comprehensively in this review.

The content published in Cureus is the result of clinical experience and/or research by independent individuals or organizations. Cureus is not responsible for the scientific accuracy or reliability of data or conclusions published herein. All content published within Cureus is intended only for educational, research and reference purposes. Additionally, articles published within Cureus should not be deemed a suitable substitute for the advice of a qualified health care professional. Do not disregard or avoid professional medical advice due to content published within Cureus.

The authors have declared that no competing interests exist.