Clinical Investigators Meeting

Clinical Investigators Meeting at Study StartupOnce a sponsor (or the CRO managing the project) selected the sites for a particular protocol, it will hold a clinical investigators’ meeting. The purpose of this meeting is to review the protocol with the investigators and study coordinators and provide detail training on the study conduct.

This is a requirement for ICH GCP to ensure the safety of the patients and validity of the trial. Issues regarding the study are brought up at the meeting and discussed among all Principal Investigators participating in the trial. For instance, if an investigator believes that the inclusion/exclusion criteria would make it prohibitively difficult to enroll patients; it can be brought up at the meeting. However, changes to a protocol, although common, require time consuming amendments that the sponsor usually prefers not to make. Typical Agenda in Clinical Trial Investigator Meeting

1.Structure and Communication of the Study Team

2.Study Timelines and Milestones

3.Protocol Training

4.Informed Consent Procedure

5.Randomization Procedure and IVRS

6.Drug Supplies Inventory and Control

7.Logistic Supply Inventory

8.Data Collection Procedure (CRF Training or eCRF)

9.Drug Accountability and Storage

10. Safety Reporting and Serious Adverse Event

11. Role and Responsibility of Investigator, Monitor, Sponsor and CRO