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

ICH GCP Quiz

2. Designs of Clinical Trials

3. Phases of Clinical Trials

4. Pre-Clinical Trials

5a.Stakeholders in Clinical Research and Their Relationships

5b.Stakeholders in Clinical Research and Their Relationships Video

6.Contract Research Organization- CRO

7a.Randomized Controlled Trials

7b.Randomized Controlled Trials Video

8.Types of Monitoring Visits

9a.Site and Investigator Selection

9b.Site & Investigator Selection

10.Site Qualification Visit

11a.Routine Monitoring Visit

11b.Routine Monitoring Visit Video

12.Monitoring Tools and Notes

14a.Site Close Out Visit

14b.Site Close Out Visit

15.Source Documents

Quality Monitoring Quiz Modules 1-15

16. Inclusion Exclusion Criteria in Clinical Research

17. Interactive Voice Response System - IVRS

18.Protocol in Clinical Research

19a.Protocol Deviations and Violations

19b. Protocol Deviations and Protocol Violations Video

20.Institutional Review Board

21a.Quality Control in Clinical Research

21b. Quality Control In Clinical Research Video

23a. An Overview of Remote Monitoring

23b. An Overview of Remote Monitoring Video

24. Centralized Vs. 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 Staffsion

30.Investigational Product Accountability in Clinical Trials

Quality Monitoring Modules 16-30 Quiz

31.Adverse Drug Reactions

32.Basics of Adverse Event Monitoring

33.Adverse Event Reporting

34.Risk Based Monitoring

37.Safety Reporting Requirements for Sponsor Investigators of An IND

38.Investigator Initiated Multi-Center Trials

39.IND and NDA Process

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

44.Minimizing Source Data Queries In Clinical Trials

45.Local and Central Labs in Clinical Trials

Quality Monitoring Quiz Modules 31-45

1.Regulatory Documents in Clinical Research

2.Regulatory Affairs

6.Financial Disclosure- Duties and Strategies for Clinical Studies

7.Financial Disclosures and Conflicts of Interest in Clinical Research

9.FDA Form 1572 - Part 2

10. Delegation of Authority Log – DOAL

11. Investigators Brochures

12. Protocol Continuing

13. IND Application

15. Trial Master File Reference Guide

Regulatory Training Quiz (20 Questions)

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

Audits and Inspection Quiz

1.Compliance Requirements in Clinical Trials

2b.Subject Recruitment and Retention (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 Retention