Monitoring Course


The aim of this course is to provide training on how to monitor in compliance with the requirements of GCP. Each type of monitoring visit will be discussed in detail so that participants can learn how to manage sites and deal with issues that may arise during monitoring.

What Will I Learn?

  • Monitor’s role
  • Investigator’s role
  • Site selection visit
  • Site initiation visit
  • Routine monitoring visit
  • CRF and data review
  • Investigational Product handling
  • Close out visit
  • Reporting

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  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