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NIH Online Clinical Research Courses are Now Open

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Want to gain knowledge in clinical research and pharmacology? Start learning now through the FREE self-paced courses offered by the NIH Office of Clinical Research .

Introduction to the Principles and Practice of Clinical Research

This course trains participants on how to effectively and safely conduct clinical research.Topics covered in the course include: study design, measurement, statistics, ethical, legal, monitoring, and regulatory considerations, preparing and implementing clinical studies, additional study designs and more. Both the course and registration for the 2018-2019 course year are now open through June 30, 2019. Please visit the IPPCR website . (Note that this course is not intended to be a replacement for required training in the protection of human subjects.)

Principles of Clinical Pharmacology

This course covers the fundamentals of clinical pharmacology as a translational scientific discipline. The course consists of approximately 50 lectures by thought-leaders from around the world. Topics covered in the course include: pharmacokinetics, drug metabolism and transport, drug therapy in special populations, assessment of drug effects, drug discovery and development, pharmacogenomics and pharmacotherapy. Registration for the 2018-2019 course year is now open through June 30, 2019. Please visit the PCP website .

RELATED NEWS

I need an NIH certificate for extra mural research

It is not entirely clear what you are looking for. If it is a course certificate for Protecting Human Research participants course, unfortunately, NIH no longer offers its Protecting Human Research Participants course and we do not plan not plan to provide an alternative course (see announcement https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-221.html ).

Institutions seeking to fulfill the requirement ( https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html ) for education in the protection of human research will need to use another training program or develop a program to meet the requirement. NIH does not specify or endorse any specific educational programs.

For the course “Introduction to the Principles and Practice of Clinical Research”, it says above that “Both the course and registration for the 2018-2019 course year are now open through June 30, 2019.”, but when I got to the IPPCR website, it says that the registration is closed. Appreciate your response.

The NIH Office of Clinical Research is making some improvements to their technical system to prepare for the upcoming course year, and with the course registration closing in under 2 weeks, they decided to close it a little early to allow for these changes. If you have any other questions or concerns please contact [email protected] .

I would like to inquire courses offered in clinical research

Visit the NIH Office of Clinical Research website for more information on clinical research courses: https://ocr.od.nih.gov/clinical_research_training.html

I WANT TO APPLY FOR CLINICAL RESEARCH CERTIFICATE COURCE FREE ONLINE

I want to learn clinal research

I would like to enroll for clinical course this year,Is it open to register now.

hi would like to enroll for this course

Will I be provided a certificate after completing the course? Is it free or paid?

Hi, I would like to enroll in a clinical trial course

Hi! When I try to access the page, it says “Access Denied”. I already completed all the sign-up requirements.

Hi, please contact [email protected] for help with this issue.

same problem

Will I be able to apply for jobs with this free “Clinical Research” course certificate?

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Foundations of Clinical Research

This Harvard Medical School six-month, application-based certificate program provides the essential skill sets and fundamental knowledge required to begin or expand your clinical research career.

Associated Schools

Harvard Medical School

What you'll learn.

Understand and apply the foundational concepts of biostatistics and epidemiology

Develop a research question and formulate a testable hypothesis

Design and begin to implement a clinical research study

Cultivate the skills required to present a clinical research study

Critically evaluate the research findings in medical literature

Synthesize crucial statistical analyses using Stata software

Course description

The Foundations of Clinical Research program is rooted in the belief that clinical research training is critical to professional development in health care. Clinical research training not only creates potential independent investigators, but also enables clinicians to advance their careers through a greater understanding of research evidence. Designed to provide learners with the foundational knowledge and skill sets required to produce high-quality clinical research, our program will lay the fundamental groundwork in epidemiology and biostatistics required for a multifaceted career in clinical research.

The overarching goal of the Foundations of Clinical Research program is to equip the next generation of researchers with the skill sets essential to evaluating evidence, understanding biostatistics, and beginning their clinical research careers. Our aim is to ensure that learners develop a strong foundation in the design, implementation, analysis and interpretation of clinical research studies.

During the program, our innovative active learning approach emphasizes the traditional tutorial system with weekly live video tutorials, seminars and symposia anchored by 3 live intense weekend online workshops.  The Foundations of Clinical Research program’s six-month online curriculum emphasizes real-time skill-based learning. 

Participants will be eligible for Associate Alumni status upon successful completion of the program. Early tuition and need-based tuition reductions may be available.

Course Outline

Live Workshops

The interactive workshop curriculum will focus on hands-on skill development through active learning. To that end, the intensive schedule is designed to accelerate the growth of high-yield clinical research skills via individual and team-based workshop exercises. Students will be immersed in a dynamic learning environment that encourages collaboration and collegial networking with faculty and peers. 

Essential elements of the workshop include instruction and practical exercises in the core concepts of biostatistics, epidemiology and research question development, as well as critical assessment of the medical literature and practical training in statistical software using real-life datasets. In addition to providing training in mentorship, academic career development and leadership, we create a supportive and active learning environment where opportunities for knowledge retention and networking abound.

Live Symposia, Tutorials and Seminars

Symposia, tutorials and seminars are mandatory and will be delivered live online and organized according to eight specific clinical research topics. 

Eight 3-Hour Symposia

• Instruction on a specific clinical research topic (e.g., cohort study design and interpretation)
• In-depth discussion on a related epidemiology concept (e.g., odds ratio)
• Hands-on guidance for implementing the related analysis with statistical programming in Stata

Eight 1-Hour Tutorials

• Interpret and report on papers related to the specific clinical research topic

Eight 1-Hour Special-Topic Seminars

• The biostatistical and epidemiological concepts to specific clinical research topics with concrete examples

Assignments

All students will be expected to complete all assignments by the due dates. Assignments will be graded as either “pass” or “fail.”

Individual Assignment 1

Individual Research Question and Study Design

• Generate a novel research question in the evidence-based PICO format
• Receive expert faculty review

Individual Assignment 2

Design, Implement and Present an Original Abstract

• Design and implement a clinical research study based on a publicly available dataset
• Analyze and create data visualizations via a user-friendly R Shiny web app
• Write a formal 350-word abstract suitable for submission to an international conference
• Present a digital poster to faculty at Workshop 3

Online Lectures

Research Study Introduction 

• Designing a Clinical Research Study I–III
• Introduction to Evidence-Based Medicine, Systematic Review and Meta-Analysis
• Study Design 1 – Observational
• Study Design 2 – Randomized Controlled Trials
• Study Design 3 – Quasi-Experimental Studies
• Introduction to Biostatistics
• An Investigator’s Responsibility for Protection of Research Subjects
• How to Search PubMed
• Overview of Evidence-Based Medicine

Statistical Programming in Stata

• Loading Data
• Basic Programming Commands
• Data Cleansing
• Data Analytics I – Central Tendency
• Data Analytics II – Statistical Testing
• Data Analytics III – Regression Testing

Instructors

Jamie Robertson

Djøra Soeteman

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• Online Courses

SOCRA has implemented an online component to the already robust array of educational opportunities. These online courses offer affordable, convenient access to quality education.

SOCRA's online courses are intended to provide access to training and continuing education that will promote quality clinical research, protect the welfare of research participants and improve global health.

Katrina A. Croghan, MS, CCRP

Anatoly Gorkun, MD, PhD, Chartered MCIPD and Hugh Devine, IMIS

Managing Data Management: Lessons from a Large CMS Demonstration Project

Erin O'Kelly Phillips, MPH, CCRP

Annette Oeser, BS, MLAS, CCRP

Training Game Plan: Ensuring Successful Project Team Member Transitions Through Training

Carolyn Rugloski, MSc, CCRP

Amber Ashley Parker, BA, CCRP

Rachel Kingsford, MS, CCRP

Resiliency in the Workplace

Barbara van der Schalie, MS

Prevention = Safety: No Tears Approach to Research Compliance

Angie Price, MSN, CCRC

Laura Holtz, MS, CCRP

Patricia Beers Block, MDEd, BS, BS, CCRP

Amy Jo Jenkins, MS, CCRP

SOCRA Recertification Module 

JoAnn Mick, PhD, RN, NEA-BC

Mtonya Hunter, MBA, CCRP

• Program Information
• Register Online
• Program information
• Complete Learning Module

Introduction to Clinical Trials

This training program provides the foundational knowledge upon which one can develop their competence as a clinical research professional..

This 2-hour online course details how medical products are developed, how volunteer patients are protected, and who plays key roles in the development, research, review, and approval of medical products.

In addition to supporting clinical research professionals and organizations, this program is an ideal tool for organizations seeking to help educate the public about clinical research and to raise awareness of clinical trials and the clinical research profession.

Introduction to Clinical Trials is an ideal program for all novice clinical researchers, those interested in the profession, or those indirectly involved in clinical trials.

Upon completion of this training program, participants should be able to:

• Analyze the study and site activities and requirements.
• Explain the core ethical principles of clinical research.
• Discuss how the research subject’s safety, rights and welfare are protected in clinical trials.
• Describe the development process for medical products and the related regulations.
• Determine good clinical practices for ensuring the safety of the research subject and the validity of a clinical trial.

This course helps clinical researchers of all types build competency in Clinical Trial Operations (GCPs), Ethical and Participant Safety Considerations, and Scientific Concepts and Research Design. Explore Competencies >

Course Not Approved for ACRP Contact Hours | Available 1 Year from Enrollment Date

Clinical Research Associate

Clinical Research Associate Certification

Demo Clinical Research Associate Certification

CRA Training

CCRPS CRA Graduates obtained many job roles including:

Clinical Research Associate, Clinical Trial Monitor II, Research Associate, CRA II, Scientist, Quality Assurance Analyst, Senior Clinical Research Associate, Research Associate in Discovery Immunology, Clinical Trial Monitor/CRA, Clinical Trials Project Manager, Associate Director of Research Nursing, Clinical Trial Navigator, Clinical Director for R&D, Senior Clinical Research Associate, Clinical Research Professional, Medical Science Liaison, Clinical Trial Associate III, Quality Assurance Associate II, IRB/SRC Analyst II, Project Manager, Clinical Trial Associate, Clinical Research Coordinator, Public Health Advisor, Associate Scientist II, Strategy Analyst, Clinical Research Associate II, Clinical Operations Specialist, Advisor - Development Clinical Research Scientist, Neuroscience, Associate Clinical Engineer, Clinical Trial Management Associate, Quality Supervisor, Clinical Research Data Coordinator (2024 CCRPS Graduate LinkedIn Survey).

Clinical Research Associate Training

Advanced clinical research associate certification (acrac), introduction.

CME Handout

Common Terminology Used In Clinical Research - Reference Glossary

Commonly Used Abbreviations and Terms in Clinical Research

Roles and Relationships in Clinical Trials

Duties and Responsibilities of a Clinical Research Associate (CRA, Monitor)

Stakeholders in Clinical Trials (Sponsor, Project Manager, IRB, PI, CRA, CRC, Site Staff, Data Team/DSMB, Patients)

Communication between Blinded and Unblinded Staff

Contract Research Organizations (Delegation, Responsibilities, Management )

Sponsor and Investigator Roles

ICH GCP E6 Sections 2-4 Principles, IRB, & Investigator Roles

ICH GCP E6 Section 4 - Reporting Responsibilities of the Investigators

ICH GCP E6 Section 5 - Sponsor/CRO Responsibilities

Clinical Trial Design

Advanced Designs of Clinical Trials

Advanced Review of Phases of Clinical Trials (Preclinical & Phase 0-4)

Randomized Controlled Trials (Randomization, Allocation Concealment, Validity, Blinding, Controls, Outcomes, Fidelity)

Blinding and Unblinding in Clinical Trials

ICH GCP - Overview

An Introduction to Clinical Research

An Overview of ICH GCP

ICH GCP - Ethical Research in Vulnerable Populations

Ethics of Research Involving Children

Ethics of Research Involving Mentally Incapacitated

Ethics of Research Involving Prisoners

Ethics of Research Involving Pregnant Women and Fetuses

Adverse Events

Advanced Review of Adverse Events

Clinical Trial Protocol

The Clinical Trial Protocol - Advanced Mastery Review

Inclusion and Exclusion Criteria in Clinical Research (Writing, Assessing for Broad vs. Narrow, Organ Dysfunction, Older Adults, Pediatrics, Pregnant Women)

Protocol Deviations and Violations

Protocol Deviations and Violations (Major, Minor, Exceptions, Resolution)

IRB and DSMB

Institutional Review Board/Ethics Committee (IRB/EC) (Requirements, sIRB, Application, Exemptions, Expedited Review, Continuation, and Reporting)

Data Safety Monitoring board- DSMB

Review Questions

REVIEW: Review Questions for ICH GCP (for study purposes, not graded)

Site Monitoring Visits

Types of Monitoring Visits (Selection, Initiation, Routine, Close-Out)

Site Qualification Visit (SQV)

Site and Investigator Selection Criteria (Process, Criteria, Investigator Selection, Agreements, Decision-Making)

Site Selection/Qualification Pre-Study Visit (SSV/SQV) (Before, During, After, Letters, Checklists, and Report)

Site Initiation Visit (SIV)

Site Initiation Visit (SIV) (Before, During, After, Letters, Checklists, and Report) - Review from "Types of Monitoring Visits"

Routine Monitoring Visit (RMV)

Routine/Interim/Periodic Monitoring Visit (RMV/IMV/PMV) (Before, During, After, Remote, Letters, Checklists, and Report)

Site Close-Out Visit (SCOV)

Site Close Out Visit (Before, During, After, Early Termination, Letters, Checklists, and Report)

Tools for Monitoring Visits

Monitoring Tools and Softskills (Tools, Templates, Communication, Metrics, Motivation, Humanistic Qualities)

Develop Templates for Monitoring Visits (Site Preparation, Pre-visit Letter/Agenda, Visit Checklist, Followup Letter, Visit Report)

Audit and Inspections

Audits and Inspections in Clinical Trials

FDA Bioresearch Monitoring Program (BIMO)

FDA Warning Letter

Audits and Inspection Review Questions (for study purposes, not graded)

REVIEW A: Quality Monitoring Review Questions (for study purposes, not graded)

SDV and Informed Consent

ICH GCP Section 4.8 Informed Consent

Source Documents and Informed Consent Forms (SDV Checklist, Informed Consent Checklist)

Minimizing Source Data Queries In Clinical Trials

Case Report Form

Guidelines for Designing and Completing Case Report Forms

Do’s and Don’ts of a Case Report Form Design

Quality Control and Safety

Quality Control in Clinical Trials ( QC/QA, KQI, QMS, Checklist)

ICH GCP - Safety of Human Subjects in Clinical Research

Technology in Trials (IVRS, CTMS, EDC)

ICH GCP - Trial Management, Data Handling, and Record Keeping

Interactive Response Technologies in Clinical Trials (IVRS, IWRS, IRT, RTSM)

Clinical Trial Management System-CTMS

Electronic Data Capture and Remote Data Capture Basics

Electronic Regulatory Submission and Review

Modernized Monitoring (Remote, Risk-based, Centralized)

An Overview of Remote Monitoring - COVID-19 Update

Remote Monitoring of Clinical Trials and EMRs

Centralized Monitoring

Pharmacovigilance and Regulatory Affairs

Advanced Practice of Pharmacovigilance

Regulatory Affairs for Clinical Trials

Investigational Product

Investigational Product Storage and Dispensing

Investigational Product Accountability in Clinical Trials

Local and Central Labs

Local and Central Labs in Clinical Trials (Local, Regional, Central, GLCP, CLIA Cert, Lab Audit Checklist)

REVIEW PART B: Quality Monitoring Review Questions (for study purposes, not graded)

Regulatory Documents

Regulatory Documents in Clinical Trials

Delegation of Authority Log – DOAL

Investigators Brochure (IB)

CFR 21 Part 11 - Electronic Signatures

Code of Federal Regulations

CFR 21 Part 11

New Drug Application

The Investigational New Drug (IND) & New Drug Application (NDA) Process

Investigator Initiated Multi-Center Trials

IND and IDE AE Reporting

Safety Reporting Requirements for Sponsor Investigators of An IND

Trial Master File

Essential Regulatory Documents Binder Tab Organization (Trial Master File)

Trial Master File Reference Guide

Regulatory Training Quiz

Disclosures and Payments for PI, Site, Patients

Financial Disclosure- Duties and Strategies for Clinical Studies

Payments and Budgeting for Investigators and Site

Advertisement Aid in Subject Recruitment and Retention

Patient Recruitment, Retention, and Compliance

Patient Recruitment in Clinical Trials

Patient Engagement and Retention in Clinical Trials

Patient Adherence and Compliance in Clinical Trials

Misconduct and Fraud

Scientific Misconduct and Fraud

Detecting Falsification

REVIEW PART C: Quality Monitoring Review Questions (for study purposes, not graded)

Site Visit Templates

SQV Checklist

SQV Questionnaire

SQV Assessment

SQV Follow Up Letter

SIV Confirmation Letter

RMV Confirmation Letter/Fax

RMV Follow Up Letter

CRA TRANSITION Letter/Email/Fax

SCOV Confirmation Letter

SCOV Agenda

SCOV Report

SCOV Follow Up Letter

REFERENCE Module

Final Examination

Competency Exam

Start Today

• Monitor Trial Sites
• Preferred 4 Year Science Degree or RN License or Prior CRC
• Salary $60-120k+. High promotion rate.

View CCRPS Clinical Research Associate Graduate Case Studies April 2024

Enjoyed Clinical Research Training through Examples  “The real-world examples used throughout the course were incredibly useful for applying theory to practice.”  -Marta Marszalek  ( view full case study )

Case Summary:  Marta Marszalek completed the  CRA certification course seeking to deepen her theoretical knowledge and practical skills in clinical research to complement her monitoring activities and comply with industry standards.  Marta appreciated the self-assessment opportunities, which helped identify areas that needed review. Adding the certification to her CV and LinkedIn profile significantly increased her marketability and helped secure new job opportunities,  affirming the practical benefits of the course. 

From International CRC to U.S. Lead CRC and CRA:   “The flexible online format allowed me to balance my studies with my professional commitments seamlessly.” -  Aishwarya Sukumar  ( view full case study )

Case Summary:   Aishwarya Sukumar completed the CCRPS CRA certification course to enhance her understanding of FDA regulations and adapt to the clinical trials industry in the United States after relocating from abroad.   Chose the CCRPS program for its  affordability and flexibility , crucial as she was adjusting to new motherhood and transitioning careers in a new country . Successfully transitioned from a CRC to a Lead CRC, and then to a CRA role , underscoring the significant career advancement facilitated by the course.  The course facilitated a  smooth transition into the clinical research field in the U.S. , providing her with necessary certifications and boosting her credibility in job interviews.

  From IMG to securing roles as a CRC, CRA, and now a project manager:  “Joining this course was a pivotal step in my career advancement.”  - Dr. Vrushali Borawak  ( view full case study )

Case Summary:   Dr. Borawake successfully transitioned from medicine in India to clinical research in Germany, attributing significant career advancements to the CCRPS CRA training.  She secured positions as a Clinical Research Associate (CRA), and has recently advanced to a Project Manager role.  The courses  provided her with essential knowledge and confidence, particularly in job interviews , by familiarizing her with industry-specific terminology and documentation. Dr. Borawake highlighted the c ourse's effectiveness for international medical professionals  seeking to enter the clinical research field in Germany or other countries, noting its comprehensive coverage of relevant regulations and practical applications .

From Masters in Health Safety to Clinical Research Associate:   " I will say quality of delivery, quality of the materials.   - Ossai Opene  ( view full case study )

Case Summary:  Ossai appreciated the straightforward,  easy-to-follow video presentations  and found the sample questions at the end of each module particularly useful for reinforcing learning.  He found the roles and connections between CROs and CPIs most engaging and informative, providing  clear insights into the clinical research operation landscape . Ossai would recommend the course based on the quality of materials, self-paced format, and positive testimonials  from other learners. The course equipped Ossai with the necessary skills and knowledge to transition into clinical research, enhancing his understanding of industry standards and practices.

From Grant Program Manager to Leading Clinical Trials at UCSF :  "it really did a great job of the full scope of clinical research from start to finish. Since completing the course, I've received a promotion at work. "  -Hannah Fischer  (view HF clinical research training case study)

Case Summary:   Before CCRPS, Hannah Fischer Was A Grant Manager having difficulties with Clinical Trial Coordination . After CCRPS She Elevated to Clinical Trial Leader at UCSF, Excelling in Trial Management and Grant Applications. T he certification and the knowledge gained from  the course played a crucial role in Hannah securing a promotion at work , illustrating the career enhancement potential of the program. The content was comprehensive and directly applicable to her current role in managing clinical trials, significantly aiding her daily responsibilities and strategic approach.  Hannah  actively recommended the CCRPS program to her colleagues, emphasizing its thorough approach to explaining the clinical trial process from start to finish.  Her endorsements highlight the program’s applicability and value across her professional network.

Enroll Schedule Advising

CCRPS Reviews

Cra certification, detailed information, oladipo owoyomi.

This is one of the best courses i have ever done. Despite being online, the engagement was topnotch. Participation was of high standard and the knowledge, hi...

This is one of the best courses i have ever done. Despite being online, the engagement was topnotch. Participation was of high standard and the knowledge, highly inspiring. I recommend it for anyone with a research drive.

Lifechanging for my career

Latoya munroe.

The work load of modules are much but through the video lectures and the pdf materials it became very easy to understand and assimilate. It a great experienc...

The work load of modules are much but through the video lectures and the pdf materials it became very easy to understand and assimilate. It a great experience as I was introduced to Clinical Research Associate Certification. Hoping to build a career through this. Awesome experience

Amazing all inclusive course

David narouz.

The test was ever hard, I have studied and passed the CRA in 1 month of intensive study and would encourage anyone to take it.

Extremely well presented CRA course!

Abiodun babayeju.

This course is detailed, well presented, and provides all you need to become a confident CRA!

Fantastic tool to expand my CV

Marquise jeffery, kenny adazie, my thoughts, tondor cleopatra uzosike.

A very educative Course. Highly recommended

It is an excellent presentation with good speed in clear...

Cynthia zhao, patient recruiting and retaining, lynda agboola.

not too long but precise

Phd In Monitoring

Adriana paz mancia.

Very practical given the potential scope of the material. The ability to cover so much material with examples is a real bonus and helps bring the content to ...

Very practical given the potential scope of the material. The ability to cover so much material with examples is a real bonus and helps bring the content to life through discovery and application. So many topics are covered almost like a bootcamp for phd in trials.This is helpful

Subhash Soni

Good to understand, temitope oshineye, accelerated, zehra abbas.

Accelerated course but really concentrated. Practical and clearly explained. Perfect alternance of slides/lecture videos. Easily understandable by with histo...

Accelerated course but really concentrated. Practical and clearly explained. Perfect alternance of slides/lecture videos. Easily understandable by with history background and by other as well with thehelo of the slides.

a fundamental stepping stone for all monitors

George grudziak.

If you want to move up the ladder in clinical trials, this is the best course to take. It’s so affordable even though I’ve paid three times as much to learn ...

If you want to move up the ladder in clinical trials, this is the best course to take. It’s so affordable even though I’ve paid three times as much to learn what is covered in just a chapter. I refer back to the course every time I switch to a new trial to refresh my knowledge.

Mary Dahodu

Great course with high knowledge impaction. Platform also was easy to navigate.

Dedication to real material

Asra feroze.

The diligence and direction provided by this course material has inspired my inner confidence to climb high to reach the pinnacle of my ambitions.

Refreshed my knowledge after 10 years in monitoring

Dr. sharib syed muhammad.

Best refresher for clinical researchers. A lot of content but can skim modules if you know them well.

CCRPS trains monitors to succeed in remote and local site...

Esohe ayanru.

I was recommended to take the course by a friend who was transitioning to clinical trials. I had only worked in remote trials as a CRC before but wanted to m...

I was recommended to take the course by a friend who was transitioning to clinical trials. I had only worked in remote trials as a CRC before but wanted to move up. This course was so advanced and really made sure you understood all the core guidelines and monitoring report processes. It made me feel much more comfortable when applying for new jobs.

two weeks to update your resume

Shivani dhotre.

CRA training took me about 2 weeks straight. I learned a lot and videos were very refreshing. It was noticed by recruiters on resume.

A great review of clinical research for monitors

Jayant shrivastava.

I found this course to be a very advanced, in-depth review of clinical trials. Absolutely everything you need to know is included in the course. There are lo...

I found this course to be a very advanced, in-depth review of clinical trials. Absolutely everything you need to know is included in the course. There are lots of templates in each module for SIV and other things which I really liked.

Learn by examples. Great follow through videos.

Abiodun adegbite.

Exceptional information not found anywhere else. Everything has an example. Content just makes sense as dry as reviewing protocols and guidelines can be.

Remarkabley accurate lectures that go into so many reason...

Vaishnav nath ajeendra nath.

This course was excellently executed, with informative lectures, and with innovative and practical learning plan which I could follow online and learned quit...

This course was excellently executed, with informative lectures, and with innovative and practical learning plan which I could follow online and learned quite a lot of foundation and practical skills. This was an absolute wonderful learning experience on this platform, thanks for the assistance and hope to continue to learn from this experience, thank you...

ACRA Training

Ossai a opene.

Great class and easy to follow. The materials are sequential and great review questions. I strongly recommend the training to any one that wants to get int...

Great class and easy to follow. The materials are sequential and great review questions. I strongly recommend the training to any one that wants to get into the CRA space.

Gertrude Nenanya

Detailed and Informative. A lot to take in yet rich with step-by-step information to prepare anyone new to clinical research

clinical research associate

Khalel imanbayev, sathya ramamoorthy, best way to start a new career as an img.

I decided to switch careers shortly after finishing my bachelors and was recommended to look into clinical trials. This program was essential in my career ch...

I decided to switch careers shortly after finishing my bachelors and was recommended to look into clinical trials. This program was essential in my career change and honestly everything made sense so I felt like I really understand and enjoyed the material! You don’t need a science background to take this.

Knowledgeable

Norah okafor.

It has really been of great impact with my 5 years experience as a CRC.

Very good content

Great course for updating information and knowledge

Mohammad ismail, dr. jennifer campbell-allman, dr. jennifer campbell-allman, phd. msc., rmhci., very detailed information, goliath sakala.

This course is very detailed and informative.

Only resource CRAs need

Husnain arshad.

Very interesting and useful for CRA training

Advance Clinical Research Associate

Charity oparah, acrac review, cyprian suh.

Very, very enriching; content and presentation.

It is informative

Safeyeh alghazali, adeyinka balogun agesin, its a great opportunity for me to review again all aspect..., adam friday.

EXCELLENT EXPERIENCE

Loving my training!

Corinthia mims.

I really appreciate the ability to return to a section to observe again. I like being able to take my time to learn.

Sergiy Ivashchenko

Very Good Course

CRA Training Program

CRAs monitor clinical trial sites for compliance with guidelines and protocols. Salary of $60k to 120k+ based on experience level.

Requirement

A minimum of 4 year degree in science required though scientists, IMGs, nurses, prior coordinators, and even senior CRAs take our course.

Takes 2-4 weeks. Start today. Self-paced. 3k+ enrollees choose us because of our advanced curriculum with practice applications and competitive pricing.

Certification

Triple-accredited course with 17.5 CME. Achieve 70% on 2 attempts on MCQ exam.

How to become a clinical research associate

To become a clinical research associate, you must first complete an accredited clinical research associate training program. The course provides an extensive review of the regulations and principles of clinical research, as well as practical application of the skills needed to execute and manage trials correctly.

Clinical research associate certification test covers topics like clinical research protocols, FDA regulations, Good Clinical Practice (GCP), ICH guidelines, data management and more. If you pass the exam, it means you're certified as a CRA.

You can get clinical research associate training online free with webinars, tutorials, eBooks and other materials related to the profession. This can help you learn more about the job before you get certified.

What is a clinical research associate

A CRA makes sure clinical trials are done correctly and on time. They make sure the clinical trial follows the plan, good clinical practice guidelines, ethics, and laws. CRA's must know a lot about trial protocols, patient safety, data integrity and regulatory requirements to guarantee the quality of a clinical trial.

Clinical Trial Associate

A clinical research monitor will review study sites' data collection processes to ensure that all data collected is complete and accurate. This includes conducting on-site visits to assess study sites' compliance with good clinical practices (GCP), review case report forms (CRF), and periodically audit research sites to ensure compliance.

Clinical Trial Monitoring

Clinical research associates do things like teach the protocol; talk to human subjects and their families; get ready for investigator meetings, trainings, documentations; manage study supplies inventory; track subject enrollment, visits, data reports, study timelines; and solve any problems that come up during the study.

Why get clinical research associate training

Clinical trial monitoring job growth.

Getting certified as a Clinical Research Associate (CRA) gives you the opportunity to start earning salaries of up to $100,000 and 33% of new CRAs receive promotions within the first year.

Clinical research association accreditation

The ACRAC training program is internationally accredited by industry standards including IAOCR, ACCRE, AMA, ACPE, ANCC to provide comprehensive training for those holding at least a BA in Science.

Fast track clinical research training

Flexible online training and on-demand video modules that can be completed in as little as 2 weeks for a clinical research associate fast track career.

Clinical Research Associate Salary

Salary for clinical research associate

Clinical research associate salary (CRA) is typically higher than the national average and varies depending on experience, job title, city of employment and industry. The average annual salary for a CRA was estimated to be $80,000 in 2024.

Entry-level clinical research associate salaries can range from $47,000 - $80,000 per year. As a CRA gains more experience and furthers their education, they may be able to negotiate higher salaries due to their valuable knowledge and skills.

can exceed $90,000 in certain geographies or with specialized skillsets. Generally speaking, the higher the level of education or specific certifications held by a CRA, the higher salary they can expect to earn.

Various factors impact how much a CRA can earn such as their employer’s size and industry sector (pharmaceuticals vs biotechnology companies), amount of travel required for research responsibilities and tasks assigned.

Clinical research associate job description

What does a clinical research associate do

Developing Protocols and Case Report Forms

The Clinical Research Associate is responsible for creating clinical research protocols and Case Report Forms. This includes writing instructions, outlining procedures, collecting data, assessing collected samples/specimens, and making sure people follow the protocol/investigational plan.

Monitoring Clinical Study Sites and Teams

The CRA role includes making sure that sites are monitored, data is accurate, and reviewing source documents. They also manage a team of physicians, nurses, support staff (if applicable), vendors (such as laboratories) involved in the clinical trial and providing training on protocol requirements in order to achieve successful outcomes from each trial/study conducted.

Ensuring Regulatory Compliance

CRAs need to make sure they follow all the rules and regulations for conducting studies. This includes making sure the studies are safe for patients, ethical, and accurate. CRAs also need to attend regular meetings with people who are involved with the study to discuss any changes in the rules or regulations that could affect how the study is conducted.

Clinical Research Associate Jobs

How to obtain a CRA job

Utilize online job boards, such as Indeed and Glassdoor, to search for open positions. When searching, use keywords such as "clinical research associate jobs", "clinical research associate job", "clinical research associate jobs entry level" and "remote clinical research associate jobs". Make sure to write a cover letter.

To find potential employers as a Clinical Research Associate, look in directories of medical companies or local businesses.Contact the employer by email or phone and tell them why you would be good for the job they are trying to fill.

Talk to people who have jobs like the one you want, follow professional organizations on LinkedIn, and go to events where you can meet these people. This way, you might hear about job openings.

Check social media for job postings by following accounts related to Clinical Research Associates and checking them regularly for new postings that might be a good fit for you.

Clinical Research Associate Certification FAQs

Clinical research associates (CRAs) are professionals who work in the pharmaceutical and healthcare industries to manage clinical trials and collect evidence. The primary role of a CRA is to ensure that all clinical trials and research studies are conducted according to legal requirements, ethical standards, and good clinical practices. CRAs interact with other healthcare professionals, researchers, patients, and sponsors to coordinate activities related to the trial. A successful CRA must have a strong background in science and medicine, as well as solid communication skills. Candidates for CRA jobs typically undergo training on Good Clinical Practices (GCP) prior to beginning their job duties. Clinical research associate roles include but are not limited to recruiting subjects for studies; designing protocols; performing administrative tasks such as budgeting; coordinating data collection; providing feedback on documents; conducting site visits; monitoring safety reports; reviewing patient records; preparing reports; analyzing data from clinical trials; maintaining records of trial progress; managing study databases; and developing clinical trial databases.

1) Spearhead the planning, implementation and evaluation of clinical studies by preparing study protocols, developing case report forms and managing data collection. This includes creating regulatory documents such as informed consent forms, patient diaries and Investigator's Brochures. 2) Monitor study progress with sites to ensure compliance with protocol requirements and regulations, such as Good Clinical Practice (GCP). Review raw data, verify accuracy and completeness of case report forms, analyze data using statistical software packages and participate in final report preparation. 3) Participate in the selection of sites for trials while maintaining professional working relationships with investigators. Generate metrics from study results and attend investigator meetings to provide target product profiles/project plans that align with organizational objectives.

1) Prepare study documents such as protocols, informed consent forms, case report forms and investigator brochures 2) Monitor sites to ensure compliance with study objectives, protocol requirements, good clinical practices (GCPs) and applicable governmental regulations 3) Ensure the accuracy of subject enrollment, data collection and handling processes 4) Oversee the maintenance of accurate source documents and regulatory binders 5) Manage investigator payments according to contract terms 6) Train site personnel on protocol and GCPs requirements 7) Track necessary regulatory documents such as licensure/DEA/IRB approvals; resolve any related issues with IRBs or other regulatory agencies. 8) Lead study start up activities including sending out essential materials to sites, distributing and completing required training for staff members; verifying that site initiation visits are completed timely 9) Prepare monitoring plans in consultation with the sponsor or CRO leadership; perform pre-study, initiation, interim and closeout visits at investigative sites as per study timelines. 10) Perform remote monitoring activities by regularly reviewing case report forms (CRFs), checking query log resolution status from sites. 11) Provide guidance on data entry queries from clinical research coordinators (CRCs) or other site personnel. 12) Monitor safety events reported by sites; notify appropriate parties promptly regarding serious safety events or protocol deviations. 13) Ensure that all adverse event reports are followed up for completion by review of medical records. 14) Generate routine visit reports using standard CRF formats; track budgets for each site according to protocol specific requirements & perform final reconciliation of monies within sponsor's payment system.

1) In order to become a Certified Clinical Research Associate (CRA) with CCRPS CRA certification, the first step is to research and obtain an undergraduate degree in any field related to clinical research, such as public health, healthcare administration or epidemiology. 2) Prospective CRAs should strive to gain experience in a clinical research setting through volunteer positions or internships within hospitals, clinics, universities or pharmaceutical companies. 3) The next step is to take and successfully pass the Certified Clinical Research Associate (CRA) exam offered through the Certified Clinical Research Professional Society (CCRPS). This comprehensive examination covers topics such as Good Clinical Practice (GCP), study design and implementation, regulatory compliance and ethics.

•CCRAs have a more standardized set of skills, which can help with advancing their career and obtaining higher salaries. • Becoming a CCRA provides greater opportunities for job advancement and the potential to improve salary. • Additionally, CCRA certification is a great way to demonstrate expertise, stay on top of industry developments, network within the field, and have access to exclusive resources.

1) Become an expert in clinical research studies. Take the time to learn as much as possible about different types of trials, protocols and procedures, as well as the regulations governing clinical research. Additionally, take advantage of any available continuing education opportunities and seminars to stay up-to-date on the latest developments in the field. 2) Develop strong organizational skills to effectively manage multiple studies, sites and deadlines. Create a system for tracking tasks and deliverables so that nothing falls through the cracks – this will keep sites, sponsors and investigators happy and maintain your reputation for excellence. 3) Establish yourself as a reliable source for knowledge both inside and outside your organization. Keep abreast of current trends in the industry so you can offer advice to others or answer their questions promptly; gain recognition by authoring publications or presenting at industry events; and always make sure your work is accurate and follows all applicable regulations.

1. PRA Health Sciences: A global biopharmaceutical organization that provides contract research services and drug development solutions to pharmaceutical, biotechnology, and medical device companies. 2. Syneos Health: A clinical services organization delivering integrated, tailored solutions to help customers accelerate the delivery of therapies to market with confidence. 3. IQVIA: A leading provider of integrated information and technology solutions for healthcare and life sciences organizations, helping them drive efficiency and effectiveness across all aspects of their business. 4. ICON Clinical Research: Providing strategic development advice and clinical trial execution services from a network of highly qualified site personnel across 63 countries. 5. Covance: A contract research organization (CRO) providing drug development solutions from laboratory testing services through to large-scale clinical trials in more than 25 countries worldwide 6. Chiltern International Ltd.: An award-winning CRO that offers full-service clinical development capabilities such as legal compliance support, project management, medical writing, data management/statistical analysis, safety/pharmacovigilance monitoring and global regulatory submissions assistance for clients in the US, Europe, Asia Pacific, South Africa and Latin America. 7. BioClinica Clinical Trials Solutions: Offering comprehensive eClinical suite that helps streamline processes related to study design, document management & reporting as well as imaging & safety data collection & review process management in real time around the globe for all types of studies—Sponsor-initiated Protocols (SIPs) or Investigator Initiated Studies (IIS). 8. Worldwide Clinical Trials: An award-winning CRO providing comprehensive clinical trial operations & data management services from initial concept development through final report generation across multiple therapeutic areas including oncology & rare diseases for both early phase studies & late phase trials in over 28 countries around the globe. 9. Clinipace Worldwide Clinical Trials Services: Specializing in creating innovative technology platforms for clinical research by combining its expertise in digital media with its deep understanding of regulatory policies thereby helping reduce complexities associated with managing large scale global projects involving multiple stakeholders from different parts of the world from start to finish – protocol design & buildout; patient enrollment & retention; site training; EDC builds; study closeout activities etc., involving both electronic data capture (EDC) based studies as well as non EDC based studies which can be delivered simultaneously or independently depending upon customer's requirements/goals at any one given point in time during the life cycle of a clinical trial project globally - US/EU/ROW markets etc., while adhering to the highest standards of quality assurance (QA), timelines and budget requirements resulting into improved operational efficiencies on part of our customers leading to better ROI figures towards end results achieved by successful completion of projects within stipulated timelines without compromising on Quality whatsoever!

1. Clinical research associates typically make an average of $53,000 a year, with a range between $45,000 to $62,000 annually. 2. The top 10 percent of clinical research associates can expect to make around $70,000 or more annually. 3. The lowest 10 percent of clinical research associates earn around $40,000 or less per year. 4. Mid-level salaries for clinical research associates usually fall within the range of $50,000 to $60,000 annually. 5. Incentives such as bonuses and commissions can significantly increase overall earnings for experienced clinical research associates. 6. Geographical location is often a factor in determining salaries for this profession; locations that tend to pay more include states like New Jersey, California and Massachusetts as well as metropolitan areas such as Seattle and San Francisco. 7. Other factors that may influence how much a clinical research associate earns include experience level and sector of the industry they are employed in (i.e., government, private or academic). 8. A career in this field offers many opportunities for growth and financial advancement; with additional education or certifications an individual could potentially make upwards of six figures annually after several years of experience in the profession.

Clinical Research Associate Course Syllabus

The CCRPS CRA program contents meets AMA requirements for 17.5 CME. This means that the course can help you succeed in your medical career. Additionally, the introductory chapter introduces you to clinical terminology and abbreviations commonly encountered in clinical research.

As a clinical research associate (CRA), it is important to know how to interact with other stakeholders in order to set up and monitor clinical trials for an investigational product or IP. These stakeholders include the Clinical Research Organization (CRO) or Sponsor of the clinical trials, the Principal Investigator (PI) as well as other research site staff, the trials monitoring team including the Clinical Research Coordinator (CRC), other CRAs and the Data Safety Monitoring Board (DSMB), as well as the research ethics committee (Institutional Review Board or IRB).

The ICH-GCP guidelines provide procedures and precautions for protecting human research participants during clinical research. These guidelines cover obtaining informed consent from human subjects, maintaining trial records, reporting compliance and progress, as well as procedures for suspending or terminating trials. The chapter also covers the importance of monitoring for Adverse Events (AEs), including types of AEs and regulations for documentation and reporting.

This chapter will teach you about the different phases of clinical trials, from the pre-clinical phase to Phases 0-4. You will learn about important concepts like the structure and goals of each phase, dosing approaches, toxicology testing, and more. The chapter will also review the FDA's drug approval process.

The chapter provides an overview of GCP, including a review of the history of medical research leading up to the ICH-GCP. The unit covers all four QSEM categories of the guidelines for ensuring Quality, Safety and Efficacy of the IP, as well as Multidisciplinary guidelines (mainly pertaining to documentation and electronic data safety standards). In addition, the chapter includes an overview of MedDRA software that provides a standardized system of terminology and notation for documenting clinical research, as well as principles of budgeting for clinical trials.

In chapter 6, we will learn about ethical research involving vulnerable populations. This includes people who are pregnant, children, mentally incapacitated individuals, and prisoners. We will learn about the challenges of conducting research with these groups of people, including obtaining consent from parents or guardians, providing fair incentives, and using deception or incomplete disclosure in a justified way.

This chapter covers the protocol for documenting, reporting and responding to AEs or adverse events during the clinical trials process. The unit covers concepts such as expectedness, severity and seriousness of AEs, Adverse Drug Reactions (ADRs) as a sub-category of AEs, Investigational New Drug or IND reports, causality analysis for AEs and so on. In addition, the chapter reviews the responsibilities of both research sponsors as well as IRBs in sharing AE information with subjects.

Chapter 8 is all about clinical trial protocols (CTPs). This chapter goes into detail about what a CTP is and how to write one. It also covers important concepts like study risk benefit analysis (RBA), sample size and statistical power, data analysis, risk management, and study administration. Additionally, the chapter addresses concepts related to choosing participants for the study, including inclusion and exclusion criteria, safety concerns, and ethical considerations.

This chapter will teach you about protocol deviations and violations. You will learn about the different types of deviations and violations, and how to distinguish between them. You will also learn about the most common violations, including minor ones (like off-schedule subject assessments) and major ones (like failure to report AEs). Finally, the chapter will review principles for reporting protocol deviations and IRB approval for planned deviations.

The IRB (Institutional Review Board) and DSMB (Data Safety Monitoring Board) are responsible for reviewing and approving research studies involving human subjects. This chapter reviews the history of these boards, and discusses the principles that guide their decision-making. In addition, the unit discusses recent developments in compliance, including sIRB (single IRB) and SmartIRB for institutions that are part of the CTSA (Clinical and Translational Science Awards). The bulk of this module dives into the categories of IRB review, including full board and expedited review, examining criteria for review exemption such as educational or purely behavioral research, as well as studies collecting identifiable data, surveys and interviews.

This module provides an overview of different types of site monitoring visits, including site selection or qualification visit, study initiation visit, routine or progress monitoring visit, as well as study termination or close-out visit. Important concepts discussed include pre-qualification preparations and site feasibility assessment as well as study monitoring criteria (data omission, incorrect entries, inaccurate calculations, documentation of corrections and so on). For each type of site monitoring visit, the chapter reviews relevant documentation.

This chapter provides a thorough understanding of the stages and steps involved in selecting a study site. The module reviews elements such as the process of investigator selection and criteria for site evaluation (the four P’s: Patient, Protocol, Performance, Profit). It is important to learn about the most common errors in feasibility assessment, including overestimation of sample availability at site, selection of site staff with low motivation, poor-performing sites owing to high competition for personnel and resources (for example, owing to multiple studies running on a single site), and so on.

This module goes into detail about site initiation visits (SIVs). You will learn how to prepare for an SIV, including what approvals, permits, and licenses you need. Additionally, the module covers what should be on the SIV agenda, such as orientation and training for site staff. Finally, you will learn about post-SIV procedures, such as filing compliance documents like FDA form 1572 and Financial Disclosure Form (FDF).

This unit will teach you about routine or periodic monitoring visits. You will learn about the agenda of an RMV, which includes receiving updates on AEs from site staff and overseeing the progress of trials. The unit covers different approaches to site monitoring, including traditional (full-scale) monitoring and risk-based monitoring (RBM). It also compares on-site monitoring with remote monitoring. A crucial concept addressed by the unit is Source Data Verification (SDV), which is essential for obtaining accurate data from clinical trials.

This chapter covers everything you need to know about ending or finishing a trial site. This includes things like notifying the IRB and coordinating schedules among site staff (PI, other investigators, medical staff) and the monitoring team (CRC, CRAs, etc.), as well as preparing for an SCOV meeting – drug inventory management, database verification and lockdown, subject notification and completion of all subject-related documents, staff-related documentation, and other administrative tasks like compiling a close-out report.

This unit provides tips and tools to help a CRA (clinical research associate) effectively monitor clinical trials. The chapter lists physical accessories that can be useful for monitoring, including scheduling and calculation aids, ready reckoners for drug information and medical terminology, as well as document templates to speed up the process of obtaining trial updates while also serving as checklists for the site visit agenda. Additionally, the unit highlights helpful strategies that a CRA can use to ensure that site visits go smoothly, from travel advice to team-building suggestions.

This module will help you understand and prepare for audits and inspections by the CRO, FDA, or other regulatory authority. It covers the difference between an audit and an inspection, and provides detailed protocols for both. Additionally, it outlines the sequence of an FDA inspection, including a walk-through of the Biomedical Research Monitoring Program inspection. You will learn about important audit and inspection documents, such as FDA Form 482 (Notice of Inspection) and Form 483 (Notice of Observation). You will also learn about the Establishment Inspection Report (EIR) prepared by the auditor/inspector. Finally, you will understand the different types of observations in an EIR, including NAI (no action indicated), VAI (voluntary action indicated), and OAI (official action indicated).

This chapter discusses the ICH-GCP guidelines on obtaining informed consent from subjects. The highlights include the need to use non-technical language, transparently delineate risks, obtain consent without undue influence, obtain consent (and assent) from minors and their Legally Acceptable Representatives (LARs), as well as consent from non-English speakers and sedated subjects. The chapter additionally covers important aspects of Source Data Verification (SDV) with respect to electronic as well as paper-based medical records, and highlights the central goal of SDV, which is to ensure that subject trial data (as recorded in Case Report Forms or CRFs) correspond to source data (previous medical records).

This module provides a detailed overview of the structure and elements of a Case Report Form (CRF), including different forms for Principal Investigator (PI) verification, subject enrollment, eligibility and randomization, medical history, physical examination and laboratory data, compliance, adverse events, etc. Additionally, the chapter outlines important data notation rules, such as the use of accepted acronyms (e.g., ‘ND’ for missing data and ‘UNK’ for unknown information), MM-DD-YY format, time-stamp data, etc., as well as guidelines for the design of CRFs (e.g., consistency of notation, avoidance of duplicate data fields).

In this unit, you will learn about Quality Control in clinical trials. This includes understanding what Quality Control is, its relationship with Quality Assurance, using Key Performance Indicators, having a Corrective and Preventive Action plan, and more. Additionally, the module will look at the QA process, focusing on risk-based monitoring and providing guidelines on Quality Metrics. The chapter also reviews ICH-GCP guidelines on subject safety, including risk-benefit assessment and stoppage rules in case of serious adverse events. Finally, it introduces the FDA’s Human Research Protection Program.

This tutorial provides an in-depth look at the systems used in modern clinical trials for Electronic Data Capture (EDC) and database management. Systems such as Interactive Response Technologies (IRTs), including IVRS and IWRS, as well as RTSM systems for Randomization and Trial Supply Management are examined. The benefits of standardized data management and data sharing, approaches to database management, and the concept of an Independent Data Monitoring Committee (IDMC) are reviewed. Critical elements of data integrity, such as proper anonymization and coding, completeness of data, data safety precautions, and logging of site visits and other progress reports are highlighted Essential features of a good Clinical Data Management(CDM) system that complies with FDA CFR Title 21and HIPAA regulation.

This chapter offers a detailed walk-through of modern, remote monitoring of clinical trials, which evolved into a full-fledged system in response to the COVID-19 pandemic. Important concepts discussed include the critical site initiation process, Electronic Source Data Verification (ESDV) and FDA regulatory guidance for remote monitoring of clinical trials. In this module, you will learn how FDA’s ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) criteria for data quality have been adapted to remote monitoring. Further, the unit discusses how HIPAA compliance in remote monitoring is achieved by using limited data sets (wherein sensitive individual information is concealed through anonymous subject codes) regulated by data use agreements.

This unit will teach you about pharmacovigilance (PV), which is the process of monitoring the effects of drugs. You will learn about the statistics on adverse events (AEs), how to distinguish between Type A and Type B AEs, and how to assess the severity and probability of an adverse drug reaction (ADR). This unit also covers Individual Case Safety Reports (ICSRs) in detail, including their structure, content, and role in trial monitoring. Other topics include types of PV inspections, periodic safety update reports (PSURs), and study criteria for instituting data safety management boards (DSMBs).

In this chapter, we provide a detailed review of the protocol for receiving, storing and dispensing the investigational product (IP). At every stage, there are guidelines in place to ensure the safety of study subjects and staff. This includes handling the IP with care, logging relevant information such as date of manufacture and batch number, and recording shipping details. Additionally, we address the need for precautions when dispensing the IP, such as limiting access to authorized personnel only.

This section looks at how lab testing in clinical trials has changed over time. It used to be done in local labs, which had a lot of mistakes. Now it is done in central labs, which makes it more accurate and reliable. The section also covers standards for clinical trial laboratories, such as the GLCP (Good Clinical Laboratory Practice) and CLIA norms (Clinical Laboratory Improvement Amendments). Additionally, it provides guidelines for lab audits, including fire safety and staff training.

The chapter reviews essential documentation that needs to be created and maintained throughout the clinical trials. This includes the Trial Master File (TMF), FDA forms 1571, 1572, 3674, 3454/3455 and CFR Title 21 Form 312. You will learn about each of these forms and why it is important to keep records updated, for example by incorporating IRB revisions and amendments, periodic renewals of permissions and licenses and copies of submitted reports. The unit also requires that you submit documents that describe the procedures for the study and site, including an SOP (Standard Operating Procedure), MOP (Manual of Procedures), Investigator Brochure (IB), Delegation of Authority Log (DOAL), site staff CVs, SAE notifications, logs of subject screening and enrollment, IP storage (temperature, humidity, etc.) and all relevant study parameters.

This unit gives you an overview of Title 21 of the FDA Code of Federal Regulations (CFR). This includes Chapter 1 sections on informed consent (Section 50), IRB approval (Section 56), Series on food (100), pharmaceuticals (200 and 300), as well as FDA Drug Schedules. The major part of the module focuses on Part 11 which deals with Electronic Records and Electronic Signatures (ERES). Part 11 lays down the criteria for determining safety and reliability (trustworthiness) of electronic data and signatures.

This module will cover the process of how drugs are evaluated by the FDA, and the role of a CRA in this process. You will learn about the difference between an IND (Investigational New Drug) and an NDA (New Drug Application). The criteria for evaluating an IND, including toxicology and pharmacokinetics data, as well as requirements for different drug classes (oncology vs. non-oncology). Additionally, you will learn about FDA requirements for AE reporting, including assessment of seriousness, expectedness and format for expedited reporting of life-threatening SARs, as well as safety reporting requirements for investigators.

The unit provides a detailed breakdown of the organization of a TMF or Trial Master File, listing the various binders that should be included within the TMF, as well as their contents. Thus, the TMF should contain binders pertaining to the study protocol and IRB, investigator qualifications, FDA forms and correspondence, FDFs or Financial Disclosure Forms, communications with the CRO, and other relevant trial aspects. A helpful templatic guide to creating a TMF is also provided in this chapter, as well as a self-assessment quiz of 10 items on important sections of a TMF.

In this chapter, we will discuss FDA guidelines regulating financial disclosure in depth. This will cover the definition of 'conflict of interest' and the stipulations of Title 21 Section 54 on disclosure requirements. We will also study real life case examples of conflict of interest, as well as lawsuits pertaining to financial disclosure disputes to help gain a better understanding of the potential problems arising from failure to disclose financial interests in clinical trials. Another important dimension covered in the module is the regulation of payments to PIs and other investigators as well as patient payments, which must comply with CMS (Center for Medicare and Medicaid Services) policy on 'fair market value' as well.

The chapter also talks about things that might make it hard to meet recruitment goals, and how to make it easier, like being less picky about who can join, giving people money to cover travel costs, and making it clear what benefits come from participating. The unit also covers why patients might leave a trial early, and how to prevent that from happening as much, like making the experience better for patients (by paying more attention to them and being flexible with when they can come in for visits, etc.), and using technology to make things simpler and more efficient (like having digital forms that can be completed automatically). Finally, the unit discusses some new ways of keeping patients involved and compliant in clinical trials; these techniques use technology to get better results.

This module discusses reasons why people might commit scientific fraud, and the consequences of fraudulent practices in clinical trials. A scale is presented for classifying errors in clinical trial data. At one end of the spectrum is ‘honest, isolated mistake’ and at the other end is ‘deliberate data falsification with malicious intent’. Types of clinical data that may be falsified, methods used in falsification (fabrication, substitution, omission), as well as scenarios in clinical trials where falsification may be occurring are presented. Through this chapter, you will learn how to identify signs of fraud during the actual clinical trials process.

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Good Clinical Practice (GCP)

GCP consists of basic and refresher courses that provide essential good clinical practice training for research teams involved in clinical trials. Improve site activation time and reduce training time with mutually-recognized, effective, engaging training.

About these Courses

Good Clinical Practice (GCP) includes basic courses tailored to the different types of clinical research. Basic courses provide in-depth foundational training. We also offer completely fresh content in Refresher courses for retraining and advanced learners. Our courses include effective and innovative eLearning techniques such as in-module knowledge checks, case studies, and audio-visual delivery.

CITI Program GCP training is used by over 1,500 institutions - (including many leading hospitals, academic medical centers, universities, and healthcare companies) - to meet their GCP training needs. The National Institutes of Health (NIH)* requires completion of GCP training that demonstrates that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording, and reporting trials that involve human research participants.

GCP courses cover applicable U.S. FDA regulations, ICH E6(R2) GCP principles and practices, and the ISO 14155:2020 standard.

The following GCP ICH E6 Investigator Site Training courses also meet the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors and have been updated to include ICH E6(R2):

Basic Courses - English with ICH E6(R2)

• GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
• GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)

Refresher Courses - English with ICH E6(R2)

GCP FDA Refresher

Gcp ich refresher, gcp sbr advanced refresher.

These courses were written and peer-reviewed by experts.

* NIH in fulfillment of their GCP training policy (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148) states that NIH-funded investigators and staff should be trained in GCP. The NIH does not endorse any specific training programs. CITI Program offers several GCP courses that are considered acceptable by many leading organizations to meet their training needs per NIH policy released on 16 September 2016. Course completion certificates and reports are provided to learners at the completion of a course and are sharable via unique hyperlink or PDF making training documentation seamless for sponsors and sites.

Language Availability: Chinese, English, Korean, Spanish, Finnish, French, German

Suggested Audiences: Clinical Research Coordinators (CRCs), Contract Research Organizations (CROs), Investigators, IRB Members, Key Study Personnel, Principal Investigators, Research Nurses, Research Staff, Researchers, Sponsors, Study Coordinators

Basic Courses

Gcp for clinical investigations of drugs and devices (fda).

Ideal for individuals proposing to conduct clinical trials of drugs, biologics, and devices primarily in the U.S.

GCP for Clinical Investigations of Drugs and Biologics (ICH)

Ideal for individuals proposing to conduct clinical trials of drugs and biologics in the U.S. or internationally.

GCP for Clinical Investigations of Devices

This course provides training for research personnel involved in clinical investigations of devices.

GCP - Social and Behavioral Research Best Practices for Clinical Research

This course is suitable for social and behavioral investigators and staff who must be trained in GCP.

Refresher Courses

This refresher course provides retraining on GCP for clinical trials with investigational drugs and medical devices (U.S. FDA f...

This refresher course offers retraining on GCP for clinical trials with investigational drugs and biologics (ICH focus).

GCP Device Refresher

This refresher course provides retraining on GCP for clinical investigations of devices.

Provides retraining on GCP principles suitable for social and behavioral investigators and staff.

Is GCP training the same as human subjects protection training?

No. GCP training is a separate training and is not basic human subjects protection training. GCP principles are specific to clinical trials and include international ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials.

Does CITI Program offer GCP training that is compliant with the NIH policy?

The National Institutes of Health (NIH) in fulfillment of their GCP training policy (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148) states that NIH-funded investigators and staff should be trained in GCP.

The NIH requires completion of GCP training that demonstrates that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording, and reporting trials that involve human research participants.

The NIH does not endorse any specific training programs.

CITI Program offers several GCP courses that are considered acceptable by many leading organizations to meet their training needs per NIH.

See the course descriptions above for more information on individual courses. These articles identify courses that comply with the NIH GCP Policy and answer FAQs for NIH Policy on GCP training .

Who should take GCP training?

GCP content is suitable for research teams involved in clinical trials of drugs, biologics, and devices, as well as those involved in behavioral intervention and social science research studies.

How do I know which GCP course I should take?

Learners should take the GCP course that best meets the type of research they conduct:

• GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) and GCP FDA Refresher are suitable for individuals proposing to conduct clinical trials of drugs and devices primarily in the U.S. and/or who would prefer a more U.S. FDA-centric curriculum.
• GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) and GCP ICH Refresher are suitable for individuals involved in clinical trials of drugs and biologics when the research may be international or where the individuals would prefer a more ICH-focused curriculum.
• GCP for Clinical Investigations of Devices and GCP Device Refresher are most appropriate for organizations or individuals who desire a more international-focused GCP curriculum and a more device-focused program. These device courses cover FDA regulation as well as International Organization for Standardization Guidelines ISO 14155:2011.
• GCP - Social and Behavioral Research Best Practices for Clinical Research and GCP SBR Advanced Refresher are suitable for social and behavioral investigators and staff who must be trained in GCP.

How long does it take to complete a GCP course?

GCP courses vary on the number of modules they contain. Modules consist of detailed content, images, supplemental materials (such as case studies), and a quiz. Learners may complete the modules at their own pace. As a rule of thumb, modules can take about 30 to 45 minutes to complete, which means it could take around three to six hours to complete a GCP course.

How frequently should learners take GCP training?

There is no uniform standard regarding how frequently GCP training should occur. However, most organizations select a three-year period of retraining. The organization could request that the designated refresher course or the same basic course be presented to learners again within a given period.

Are GCP courses mutually recognized by TransCelerate BioPharma as meeting the minimum GCP ICH criteria?

Yes, five of CITI Program's GCP courses are mutually recognized. See the individual course pages for more information on TransCelerate mutual recognition, including requirements (such as module requirements) for organizations and learners to utilize the mutually recognized courses. The Support article  List of TransCelerate Mutually Recognized GCP Training  includes each mutually recognized course and the required modules.

Please also note that organizations and learners that wish to utilize these mutually recognized GCP courses in keeping with the minimum criteria must designate all available modules as “Required.”

How do I know if my GCP course will be mutually recognized by TransCelerate BioPharma and study monitors?

Learners who fulfill a GCP course’s requirements (complete all the required modules after the effective date) will see a statement in the Description field on their Completion Report’s “Transcript Report” (part 2 of a Completion Report) or on their Certificate. The statement identifies the GCP course’s name and information regarding mutual recognition.

• Version 1 refers to the ICH E6(R1) minimum criteria that was used to attest the course for mutual recognition to TransCelerate BioPharma.
• Version 2 refers to the ICH E6(R2) revisions to the TransCelerate BioPharma’s minimum criteria for mutual recognition. CITI Program has updated all TransCelerate attested GCP courses to meet the version 2 minimum criteria. If you complete your GCP course after the effective date for version 2, your Completion Report will indicate that on the Transcript Report (it will include the course name and which version you completed).

If you completed your GCP course before version 2 was available (or before the effective date for version 2), you can return to the course and re-take the modules. After you complete all the required modules, your Completion Report and Certificate will indicate that you completed version 2.

The following Support articles provide additional information:

• CITI Program Guide to GCP Mutual Recognition
• Guide to GCP Mutual Recognition Completion Documentation
• List of TransCelerate Mutually Recognized GCP Training
• Reading and Understanding a CITI Program Completion Report and Certificate for Good Clinical Practice (GCP) TransCelerate BioPharma Mutually Recognized Training

Do I need to submit or self-attest my CITI Program GCP course to TransCelerate BioPharma to receive mutual recognition?

No, you should not submit or self-attest a course to TransCelerate BioPharma. CITI Program submits and self-attests on behalf of our GCP courses.

We ensure that our mutually recognized GCP courses satisfy the requirements for mutual recognition and that completion documentation reflect the course name, version number, and all required elements (including TransCelerate information) if a learner completes a mutually recognized course.

Do the CITI Program GCP courses reflect the changes from ICH E6(R2)?

Yes, after the  ICH Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2 ) was adopted on 15 December 2016, the CITI Program modules were revised to reflect the current guideline. The GCP courses that reference ICH E6 specifically refer to the current guideline.

CITI Program also offers some additional resources on ICH E6(R2).

• An additional module of interest titled “Overview of ICH GCP E6(R2) Revisions” can be added to GCP courses. This module reviews the additions that led to the publication of the ICH E6(R2) guideline and discusses the new approaches for the management of clinical trials – including quality management, risk-based monitoring, and data integrity.
• A free resource that provides an overview of the ICH E6(R2) integrated addendum is available on  CITI Program’s Resources page . This resource covers the revisions to the International Council for Harmonistion (ICH) “Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2),” including a breakdown by section with summaries and analysis. The revised ICH E6(R2) guideline includes changes that affect sponsors, researchers, and IRBs.

Do the CITI Program GCP courses reflect the ISO 14155:2020 updated standard for GCP?

Yes, the CITI Program modules were updated in December 2020 and reflect ISO 14155:2020.

Additionally, the GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) course and the GCP Device Refresher course both include specific content on ISO 14155.

What is the value of a refresher course and what is its role in training?

A refresher course provides retraining. Using CITI Program refresher course options to provide retraining means that the learner will not be completing the same course every time.

When should I take a GCP refresher course?

GCP refresher courses are meant to reinforce the importance of concepts covered in the basic level GCP course. The CITI Program recommends that learners complete the basic level GCP course first, and then take a refresher GCP course at the interval designated by their organization.

As an administrator setting up my organization, how should I select GCP courses for my learner groups?

CITI Program allows organizations to customize their learner groups, which means they can choose the modules their learners need to complete. We will work with your CITI Program designated admin to determine the learner groups that best fit your organizational needs.

For basic GCP courses, it is highly recommended that organizations present all modules in a given course as required for a learner to earn a completion report. Some organizations will make several modules supplemental, particularly when they provide organization-specific training on the topic.

Is this GCP course eligible for continuing medical education credits?

Yes, the following courses are eligible for CME credits:

• GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) Course
• GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) Course
• GCP FDA Refresher Course
• GCP ICH Refresher Course
• GCP for Clinical Investigations of Devices Course
• GCP – Social and Behavioral Research Best Practices for Clinical Research

Click on the course name above for details. For more information on how to ensure CME credit availability for learners at your organization, contact [email protected] or 888.529.5929.

What are the advantages of CITI Program's GCP training?

GCP provides research-specific, peer-reviewed training written by GCP experts. Along with CITI Program's advantages, including our experience, customization options, cost effectiveness, and focus on organizational and learner needs, this makes it an excellent choice for GCP training.

Do social and behavioral researchers need to take GCP?

All NIH-funded investigators and staff who are involved in the conduct, oversight, or management of research that meets the definition of a clinical trial should be trained in GCP.  A clinical trial is defined by NIH as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Will I be notified if this course is significantly revised or updated?

Yes, CITI Program will notify administrators via email and post news articles on our website when courses are significantly revised or updated.

Who developed the GCP - Social and Behavioral Research Best Practices for Clinical Research course?

The development of the GCP - Social and Behavioral Research Best Practices for Clinical Research course was supported by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), through the Clinical and Translational Science Awards (CTSA) Program, grant number 3UL1TR000433.

Can I change the passing score for the GCP - Social and Behavioral Research Best Practices for Clinical Research course?

The creators of this course have set the passing score at 100 percent and organizations are not able to change or customize the passing score for this course.

How does the GCP - Social and Behavioral Research Best Practices for Clinical Research course differ from other GCP courses?

The GCP - Social and Behavioral Research Best Practices for Clinical Research course applies GCP principles to behavioral intervention and social science research studies. Other GCP courses cover drug, device, and biologic-related studies.

Can I combine the GCP - Social and Behavioral Research Best Practices for Clinical Research course with other courses?

It is recommend that the course not be combined with other courses.

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Data Management for Clinical Research

Taught in English

Some content may not be translated

Financial aid available

115,199 already enrolled

Gain insight into a topic and learn the fundamentals

Instructors: Stephany Duda, PhD +1 more

Instructors

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Included with Coursera Plus

(1,561 reviews)

Skills you'll gain

• Survey Design
• Data Collection
• Data Management
• Clinical Data Management

Details to know

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There are 6 modules in this course

This course presents critical concepts and practical methods to support planning, collection, storage, and dissemination of data in clinical research.

Understanding and implementing solid data management principles is critical for any scientific domain. Regardless of your current (or anticipated) role in the research enterprise, a strong working knowledge and skill set in data management principles and practice will increase your productivity and improve your science. Our goal is to use these modules to help you learn and practice this skill set. This course assumes very little current knowledge of technology other than how to operate a web browser. We will focus on practical lessons, short quizzes, and hands-on exercises as we explore together best practices for data management.

Research Data Collection Strategy

This introductory module reviews the course structure and basic concepts in clinical research. We also discuss best practices for designing your clinical research data collection.

What's included

6 videos 1 reading 1 quiz 1 peer review 1 discussion prompt

6 videos • Total 69 minutes

• How the Course Works • 7 minutes • Preview module
• Course Introduction • 5 minutes
• Defining the Space • 10 minutes
• Research Data Planning 1 • 13 minutes
• Research Data Planning 2 • 24 minutes
• Approaches to Data Collection • 8 minutes

1 reading • Total 10 minutes

• Course Logistics • 10 minutes

1 quiz • Total 30 minutes

• Quiz 1 • 30 minutes

1 peer review • Total 60 minutes

• Assignment 1 - Survey Question Critique • 60 minutes

1 discussion prompt • Total 10 minutes

• What is your background in this area? • 10 minutes

Electronic Data Capture Fundamentals

This module covers standards for study processes, concepts for regulatory compliance, and electronic data capture fundamentals.

9 videos 1 quiz 1 discussion prompt

9 videos • Total 129 minutes

• Standardization of Study Processes • 14 minutes • Preview module
• Validated Instruments • 13 minutes
• Data Standards: What Can Standards Do for You? • 15 minutes
• Data Standards: Basic Concepts and Overview • 15 minutes
• IRB, HIPAA, and FISMA • 14 minutes
• GCP and 21 CFR Part 11 • 11 minutes
• Introduction to Electronic Data Capture (EDC) • 17 minutes
• EDC Concepts: Data Exports, Logging, User Rights, Project Creation • 12 minutes
• EDC Concepts: Data Imports, Scheduling, Reports, Internationalization • 14 minutes
• Quiz 2 • 30 minutes
• What standards have you used? • 10 minutes

Planning a Data Strategy for a Prospective Study

This module reviews the process of planning data elements for a real-world research study.

9 videos • Total 91 minutes

• Overview of the Study • 10 minutes • Preview module
• Study Procedures • 10 minutes
• Baseline Data and Demographics • 13 minutes
• Visit Data • 5 minutes
• Review of Variables and Forms • 9 minutes
• Logging in to REDCap • 2 minutes
• Walkthrough: Creating a Project and Adding the First Variables • 16 minutes
• Walkthrough: Adding Fields to the Baseline Form • 12 minutes
• Walkthrough: Adding File Fields and Formatting • 10 minutes
• Quiz 3 • 30 minutes
• How have you assembled a study data management plan? • 10 minutes

Practicing What We've Learned: Implementation

This week, we set up an Electronic Data Capture (EDC) instrument in REDCap for the Morphine vs. Marinol Study. We also review data processes that occur during the running of a study, including an overview of key data quality operations.

9 videos 1 quiz 1 peer review 1 discussion prompt

9 videos • Total 101 minutes

• Walkthrough: Creating Visit Forms • 8 minutes • Preview module
• Walkthrough: Copying Variables, Renaming Forms • 9 minutes
• Walkthrough: Using the Shared Library, Longitudinal Events, Optional Modules, and User Rights • 17 minutes
• Walkthrough: Testing the REDCap Project • 7 minutes
• Example Study Wrap-Up • 3 minutes
• Mid Study Activities 1 • 12 minutes
• Mid Study Activities 2 • 15 minutes
• Data Quality • 11 minutes
• Data Quality Monitoring • 15 minutes
• Quiz 4 • 30 minutes
• Assignment 2 - First REDCap Assignment • 60 minutes
• What data quality challenges have you encountered? • 10 minutes

Post-Study Activities and Other Considerations

In this week, we cover activities to wrap up your study and share data and results, as well as two lectures on other electronic sources of data that can be used in research. In response to learner requests, we've also added several lectures on clinical data management in resource-limited settings, in collaboration with research colleagues from Indiana University. This is a long week of videos, but next week will be short on videos in exchange!

12 videos 1 quiz 1 discussion prompt

12 videos • Total 148 minutes

• Wrapping Up Your Study • 8 minutes • Preview module
• Sharing Your Work • 13 minutes
• De-identifying Data • 8 minutes
• De-identifying Dates • 12 minutes
• Common Information Systems Used in Health Care • 13 minutes
• Neuroimaging Data Management • 15 minutes
• mHealth in Developing Countries • 19 minutes
• Data Management for Multi-Center or Network Studies • 10 minutes
• Resource-Limited Settings and Global Health • 13 minutes
• Challenges of Collecting Data in Resource-Constrained Settings • 13 minutes
• Data Privacy in Global Research • 11 minutes
• International Data Sharing • 7 minutes
• Quiz 5 • 30 minutes
• What health care information systems have you worked with? • 10 minutes

Data Collection with Surveys

In the final week, we cover how to collect data using surveys and review an example together. This week's assignment includes designing, distributing, and reporting on your own survey.

7 videos 1 quiz 1 peer review 1 discussion prompt

7 videos • Total 74 minutes

• Benefits, Scope, and Validated Instruments • 12 minutes • Preview module
• Survey Design • 13 minutes
• Survey Procedures and Implementation • 12 minutes
• Survey Testing, Administration, and Analysis • 10 minutes
• Survey Overview and REDCap Setup • 12 minutes
• Survey Testing and Distribution • 12 minutes
• Thank you for participating! • 0 minutes
• Week 6 Quiz • 30 minutes
• Assignment 3 - Build, Deploy, and Report on a Survey • 60 minutes
• Share Assignment 3 survey links (optional) • 10 minutes

Vanderbilt University, located in Nashville, Tenn., is a private research university and medical center offering a full-range of undergraduate, graduate and professional degrees.

Recommended if you're interested in Research

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Learner reviews

Showing 3 of 1561

1,561 reviews

Reviewed on Nov 12, 2019

Very excellent course with fun project assignments. I learned quite alot even though I already have a good amount of knowledge on data management! The professors are also engaging and professional.

Reviewed on Jul 30, 2023

I could not find a better course than this. The most interesting course in my career. I listened to every word of it. Special thanks to Mr. Paul Harris and his team for this masterpiece. Thank you.

Reviewed on Dec 10, 2020

Thanks a lot for the lecturers to provide a piece of knowledge about data management. I gained knowledge from your lectures. Especially Electronic Data Capture concept...

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Frequently asked questions

When will i have access to the lectures and assignments.

Access to lectures and assignments depends on your type of enrollment. If you take a course in audit mode, you will be able to see most course materials for free. To access graded assignments and to earn a Certificate, you will need to purchase the Certificate experience, during or after your audit. If you don't see the audit option:

The course may not offer an audit option. You can try a Free Trial instead, or apply for Financial Aid.

The course may offer 'Full Course, No Certificate' instead. This option lets you see all course materials, submit required assessments, and get a final grade. This also means that you will not be able to purchase a Certificate experience.

What will I get if I purchase the Certificate?

When you purchase a Certificate you get access to all course materials, including graded assignments. Upon completing the course, your electronic Certificate will be added to your Accomplishments page - from there, you can print your Certificate or add it to your LinkedIn profile. If you only want to read and view the course content, you can audit the course for free.

What is the refund policy?

You will be eligible for a full refund until two weeks after your payment date, or (for courses that have just launched) until two weeks after the first session of the course begins, whichever is later. You cannot receive a refund once you’ve earned a Course Certificate, even if you complete the course within the two-week refund period. See our full refund policy Opens in a new tab .

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