Clinical Research Coordinator Course

37 Lessons

Introduction Video
Introduction / CRC in Clinical Trials  3:13

Module 1: Introduction to Clinical Trials
History of Pharmacology  16:16
Overview of drug development process  31:06
Design and Types of studies  24:25

Module 2: Study design
General Considerations for clinical trials  1:05:21
GCP Wheel  1:14:26
Helsinki Declaration, Belmont Report  18:27

Module 3: Roles and Responsibilities
Ethics Committees  14:13
Sponsor’s Responsibilities  17:01
Principal Investigator’s Responsibilities  7:41
Clinical Research Associate – roles and responsibilities  4:47
ICH-GCP: Good Clinical Practice for Study Nurses and Study Coordinators  16:17
Soft Skills 1 – Communication skills  17:56
Soft Skills 2 – Time management  15:48

Module 4: Regulatory
The European Union Clinical Trail Directive  14:29
Clinical Trial Regulation EU No 536/2014  14:15
Final Guidance on Statement of investigator – form FDA 1572  14:40
Compensation in Clinical Trials  7:33
Data Protection  16:53
Informed Consent Form  12:48

Module 5: Essential Documents
Protocol  10:10
Essential Documents  16:29
Trial Master File  10:27
Green Light Package: Documentation for Investigational Drug Release  11:34
Source Documents in Clinical Trials  11:22
Source Document Verification  15:05

Module 6: Patient Documentation in CRF
Case Report Form  6:06
Electronic Data Capture Systems – EDC  7:53
Electronic Patient-Reported Outcome (PRO) systems – ePRO  8:04

Module 7: Safety Reporting
Pharmacovigilance in Clinical Trials – Concept and Definitions  22:25
Serious Adverse Events (SAE) Reporting  21:14

Module 8: Clinical Trial Management
Patient Recruitment  10:56
Drug Accountability  8:10
Fraud and Misconduct/Audit and Inspection  57:32
Site Management Organization  3:41

Summary video
Summary  1:50

Final Exam

Feedback

Target Audience