Monitoring Clinical Trials to GCP

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

assessment

• 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