Face-to-face and blended
learning for corporate clients
gcp trainee

Monitoring Clinical Trials to GCP

Duration: 2 days

Key Objectives:

Ensure GCP compliance for monitoring clinical trials


Define the monitoring procedures and SOPs to ensure the GCP quality of clinical trials


Ensure appropriate site selection, initiation, monitoring and close out visits are carried out


Who should take this course?

This course will benefit those involved with monitoring of clinical trials.



Course Syllabus: 

1. Introduction and Objectives


2. GCP Compliance considerations for monitoring clinical trials in

the EU and US

• What is the role of the monitor/CRA to comply with GCP?

• The monitoring role in the content of having a quality system for

clinical trials


3. Monitoring procedures and SOPs and Monitoring Plans Complying

with GCP Requirements

• Requirements for SOPs in clinical research for GCP compliance?

• Risk-based (centralised) management for monitoring

• Increasing the quality of monitoring data – quality and risk


• Monitoring plans

• Co-monitoring considerations


4. Planning Patient recruitment strategies to assist the monitor

• Optimising recruitment to clinical trials

• Common recruitment problems in clinical trials and how these may

be managed (group discussion from experience and real life examples)

• Considerations for recruiting in different countries


5. Ensure appropriate study set up planning and preparation so as to

comply with GCP

• Ensuring that Informed Consent procedures are properly

implemented (exercise)

• Working effectively with Ethics Committees (ECs) and Institutional

Review Boards (IRBs)

• How to select Investigators to comply with GCP

• Patient Recruitment - managing the issues


6. Site Selection

• Criteria for selecting suitable sites (interactive discussion)

• Site Feasibility Assessment

• Laboratories and pharmacy discussions (group discussion)

• Medical vs. marketing perspectives


7. Site Initiation

• Risks of inappropriate site initiation & resulting issues

• Preparing for site initiation (interactive session)

• Generic Agenda

• Content of site initiation visit report to comply with GCP


8. Monitoring Visit Procedures

• Risks of inadequate site monitoring & resulting issues

• Preparing for site monitoring

• Key Activities

• Important consideration during SDV

• Identifying issues and developing solutions (real life examples

and discussion)


9. Study close out visits

• Preparing for site closure

• Final preparing of documentation and entering data

• Follow-up


10. Approaches for collecting data electronically and how the monitor

can successfully monitor EDC trials and Risk Based Monitoring

This session will consider some of the practical issues of monitoring

e-clinical trials including managing e-source documentation

• Complying with 21 CFR Part 11

• FDA guidance on electronic systems

• Issues with electronic data capture, CRFs and medical record systems


11. GCP and Documentation and Archiving

• What are the essential documents that are required to ensure

that the study complies with GCP? (discussion)

• Archiving considerations


12. Preparing for Audit and Inspection visits to comply with GCP

• How to prepare effectively for a study site audit and/or regulatory

inspection to comply with the Clinical Trial Directive and FDA requirements

• What do QA departments and inspectors look for?

• What are the commonly occurring audit and inspection findings?


13. Preventing Fraud and misconduct: What monitors need to know

to be able to detect fraud

• What are the signs a monitor should look for?

• Case examples of fraud in case report forms and trial documents

• What actions should the monitor take?

• How to prevent fraud


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