Clinical Research Associate
Clinical Research Associate Certification
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.
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.
CCRPS Reviews
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.
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.
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.
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.
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
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.
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.
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.
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
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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