CCRPS Clinical Research Training

Course Overview

1. An Introduction to Clinical Research

2. An Overview of ICH GCP

3. Code of Federal Regulations

5. ICH GCP E6 Section 5 - Sponsors Responsibilities

6. ICH GCP E6 Section 4 - Investigators Responsibilities

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

14. ICH GCP E6 and E2A - Adverse Events

15. Safety of Human Subjects in Clinical Research

a) Common Terminology Used In Clinical Research

b) Commonly Used Abbreviations and Terms in Clinical Research

2. Designs of Clinical Trials

3. Phases of Clinical Trials

4.Types of Monitoring Visits

5a.Site and Investigator Selection

5b.Site & Investigator Selection

6.Site Qualification Visit

7a.Routine Monitoring Visit

7b.Routine Monitoring Visit Video

8a.Site Close Out Visit

8b.Site Close Out Visit

9.Source Documents

10. Inclusion Exclusion Criteria in Clinical Research

11. Interactive Voice Response System - IVRS

12.Protocol in Clinical Research

13a.Protocol Deviations and Violations

13b. Protocol Deviations and Protocol Violations Video

14.Institutional Review Board

15.Quality Control in Clinical Research

17. An Overview of Remote Monitoring

18. Centralized Vs. Onsite Monitoring

19.Blinding in Clinical Trials

20. Communication between Blinded and Unblinded Staff

22.Investigational Product Accountability in Clinical Trials

23.Adverse Drug Reactions

24.Risk Based Monitoring

25.IND and NDA Process

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

28.Local and Central Labs in Clinical Trials

1.Regulatory Documents in Clinical Research

3. Essential Regulatory Documents Guidance and Binder Tabs (Part 2)

4. Electronic Regulatory Submission and Review

5.Financial Disclosure- Duties and Strategies for Clinical Studies

7.FDA Form 1572 - Part 2

8. Delegation of Authority Log – DOAL

9. Investigators Brochures

10. Protocol Continuing

11. IND Application

13. Trial Master File Reference Guide

1. FDA Warning Letter

2.How to Survive Through an FDA Inspection

1b.Subject Recruitment and Retention (Part 2)

2.Increasing Subject Compliance in Clinical Trials