Clinical Research Certification

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The ICH GCP training modules go over the entire ICH GCP guidelines in detail. They teach you how to apply them rather than just understand the protocols. This is the essential basis of Clinical Research Training.


1.   An Introduction to Clinical Research

2.   An Overview of ICH GCP

3.   Code of Federal Regulations

4. FDA 21 CFR Part 11 ( Part 1 and 2)

5. ICH GCP E6 Section 5 - Sponsors Responsibilities

6. ICH GCP E6 Section 4 - Investigators Responsibilities

7. ICH GCP E6 Section 4 - Investigators Responsibilities – Informed Consent Form

8. Reporting Responsibilities of the Investigators

9. Ethics of Research Involving Children

10. Ethics of Research Involving Mentally Incapacitated

11. Ethics of Research Involving Pregnant Women and Fetuses

12. Ethics of Research Involving Prisoners

13. ICG GCP 5.5 Trial Management – Data Handling and Record Retention

14. ICH GCP E6 and E2A - Adverse Events

15. Safety of Human Subjects in Clinical Research

Reference Modules - to be used for reference purposes only:

a) Common Terminology Used In Clinical Research

b) Commonly Used Abbreviations and Terms in Clinical Research



The quality monitoring modules are needed to work as a supervisor on clinical trials. This is the section not available in any other entry or introductory clinical research training course with more detail than many new Senior CRAs know. These modules allow you to obtain the application, examples, and guidelines needed to monitor trials with ease in your new position.


1.    Duties and Responsibilities of a Clinical Research Associate

2.    Designs of Clinical Trials

3.    Phases of Clinical Trials

4.    Pre-Clinical Trials

 5.    Stakeholders in Clinical Research and Their Relationships

 6.    Contract Research Organization- CRO

 7.    Randomized Controlled Trials

 8.    Types of Monitoring Visits

 9.    Site and Investigator Selection

 10. Site Qualification Visit

 11. Routine Monitoring Visit

12.  Monitoring Tools and Notes

 13.  Checklists for Pharmacy Monitoring and Inspection Visits

14.  Site Close Out Visit

 15.  Source Documents

 16.  Inclusion Exclusion Criteria in Clinical Research

 17.  Interactive Voice Response System - IVRS

 18.  Protocol in Clinical Research

 19.  Protocol Deviations and Violations

 20.  Institutional Review Board

 21.  Quality Control in Clinical Research

 22.  Data Safety Monitoring board- DSMB

 23.  An Overview of Remote Monitoring

 24.  Centralised Versus Onsite Monitoring

 25.  Electronic Data Capture and Remote Data Capture Basics

 26.  Remote Monitoring of Clinical Trials and EMRs

 27.  Blinding in Clinical Trials

 28.  Communication between Blinded and Unblinded Staff

 29.  Investigational Product Storage and Dispensing

 30.  Investigational Product Accountability in Clinical Trials

 31.  Adverse Drug Reactions

 32.  Basics of Adverse Event Monitoring

 33.  Adverse Event Reporting

 34.  Risk Based Monitoring

 35.  Pharmacovigilance (Part 1)

36. Pharmacovigilance (Part 2)

 37. Safety Reporting Requirements for Sponsor Investigators

 38.  Investigator Initiated Multi Center Trails

 39.  IND and NDA Process

 40.  Guidelines for Designing and Completing Case Report Forms

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

 42.  Introduction to Bioresearch Monitoring (BIMO)

 43.  Clinical Trial Management System-CTMS

 44.  Minimising Source Data Queries in Clinical Trials

 45. Role of Local and Central Labs in Clinical Trials


Regulatory training allows you to understand and apply the FDA regulation guidelines to each individual trial you will supervise after your Clinical Research Training.


1.    Regulatory Documents in Clinical Research

 2.    Regulatory Affairs

3.    Essential Regulatory Documents Guidance and Binder Tabs -Part 1

 4.    Essential Regulatory Documents Guidance and Binder Tabs - Part 2

 5.    Electronic Regulatory Submission and Review

 6.    Financial Disclosure- Duties and Strategies for Clinical Studies

 7.    Financial Disclosures and Conflicts of Interest in Clinical Research

 8.    FDA Form 1572 - Part 1

 9.    FDA Form 1571 - Part 2

10.  Delegation of Authority Log – DOAL

11. Investigators Brochures

12. Protocol Continuing

13.  IND Application

14.  Trial Master File Reference Guide

15.  Trial Master File and DIA Model


The auditing and inspections modules train you to prepare clinical trials for auditing by your company, government organisation, or academic organisation after your Clinical Research Training.



1.    Compliance Requirements in Clinical Trials

 2.    Subject Recruitment and Retention (Part 1 and Part 2)

 3.    Increasing Subject Compliance in Clinical Trials

 4.    Ethical Consideration Associated with Investigator Payment and Patient Recruitment

 5.    Advertisement aid in Subject Recruitment and Retention6 MODULES

1.    Audits and Inspections in Clinical Trials

 2.    FDA Warning Letter

 3.    Site FDA Audit Inspection Checklist

 4.    How to Survive Through an FDA Inspection

 5.    Do and Don’ts during an FDA Inspection

 6.    Mock FDA Audits



1.    Scientific Misconduct in Research and How to Prevent It

 2.    Misconduct in Research – Detecting Falsification


These modules immerse you in understanding, applying, and learning to write monitoring reports, follow up letters, and professional write-ups required in the CRA position after each clinical site visit or review after your Clinical Research Training.


1. Site Monitor Transition Letter   

2. Checklist of Activities for Pre-Study Visit Qualification

 3.   Pre-study Visit Assessment and Monitoring Questionnaire

 5.   Pre-Study Visit Follow Up Letter

 6.   Site Initiation Visit Agenda

 7.   Site Initiation Visit Confirmation Letter

 8.   Site Initiation Visit Report

9.   Site Initiation Visit Follow Up Letter

10. Site Monitoring Visit Confirmation Letter/Fax

11. Site Monitoring Visit Report

12. Site Monitoring Visit Follow Up Letter

13. Site Close Out Visit Confirmation Letter

 14. Site Close Out Visit Agenda

 15. Site Close Out Visit Report

 16. Site Close Out Visit Follow Up Letter


The competency testing of your Clinical Research Training modules is the next step needed to ensure that you are ready for your interviews. We establish our CRA’s as future leaders in the clinical trial industry by ensuring you have the full education needed to be promoted in your career quicker than without the course.