Topics for this course
27 Lessons
Course Introduction
Introduction 2:27
Module 1: Introduction to act of monitoring and monitor’s role
The role of CRA 12:00
Monitoring 16:23
PI Responsibility 7:41
EC responsibilities 14:13
Informed Consent Form 12:48
Non-interventional vs Interventional Studies 10:27
Module 2: Monitoring visits
Feasibility Process and Site Evaluation Visits 37:42
Site Evaluation Visit 20:40
Site Evaluation Visit Report 21:14
Investigators Meeting 14:47
Site Initiation Visit 57:04
Source Document Verification 15:05
Case Report Form – CRF 6:06
Close Out Visit 28:26
Module 3: Soft skills
Soft Skills 1 – Communication skills 17:56
Soft Skills 2 – Time management 15:48
Module 4: Site Management
Drug Accountability 8:10
Financial tracking of the study – Progression Chart 7:37
Fraud/Misconduct and Audits/Inspections 57:32
Essential Documents 16:29
Trial Master File Organization 10:27
Module 5: Safety monitoring
Safety reporting 6:38
Post Authorization Safety Studies – PASS 22:21
Risk Management 13:36
Summary
Summary 1:38
Final Exam
Feedback Form
Target Audience
- Marketing associates
- Regulatory associates
- Newly appointed monitors and clinicians who have recently started working in the pharmaceutical industry
- Pharmaceutical Industry Employees
- Medical Doctors involved in Clinical Research
