CCRPS

Introduction to Clinical Research

What is ICH GCP

Code of Federal Regulations

CFR 21 Part 11

Sponsor/CRO Responsibilities

13 Principles, IRB, & Investigator Roles

Reporting Responsibilities of the Investigators

Adverse Events

Ethics of Research Involving Children

Ethics of Research Involving Pregnant Women and Fetuses

Ethics of Research Involving Prisoners

Trial Management – Data Handling and Record Retention

a) Common Terminology Used In Clinical Research

b) Commonly Used Abbreviations and Terms in Clinical Research

ICH GCP Quiz

2. Advanced Designs of Clinical Trials

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

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

5. Contract Research Organizations (Delegation, Responsibilities, Management )

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

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

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

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

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

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

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

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

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

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

Quality Monitoring Quiz Modules 1-15

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

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

18.The Clinical Trial Protocol - Advanced Mastery Review

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

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

22. Data Safety Monitoring board- DSMB

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 Quiz 16-30

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

Quality Monitoring Quiz 31-45

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

1.Regulatory Documents in Clinical Research

2.Regulatory Affairs

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

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