An Investigator Meeting is usually a sponsor’s job, but a CRO may also be delegated with this task. For many from the industry, investigator meeting is much targeted and criticized for overspending. It is argued that these meetings are generally hosted to lure investigators in clinical trials but if we try to understand the need of such events they are much more fruitful than being thought of.
What is an investigator meeting? It is nothing but a group meeting conducted on behalf of sponsor/CROs to train investigators and their lead clinical trial staff on trial related activities, standard operating procedures and to discuss the applicable regulatory picture. The content of an investigator meeting is usually trial specific, nevertheless a common agenda, on SOP’s, Adverse Event Reporting, Source Documentation etc are also discussed.
The meeting has multiple sessions on each aspect of the clinical trial, wherein the pros and cons of trial related activities are discussed. The discussion is also extended towards highlighting the expected issues that investigators may face and how to deal with them.
An investigator meeting ensures to:
• Ensure that all investigators have an understanding of how to conduct the trial in strict compliance with the protocol, SOP’s, guidelines and applicable regulations.
• To introduce the investigators with Case Report Forms (CRFs).
• Document the responsibilities of all participating investigators and its staff and train them prior to the start of the trial.
• Discuss the study protocol in detail.
• Facilitate communication between investigators.
The ICH guideline for GCP states that investigators “should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the CRFs” (4.9.1). It is the Investigator Meeting that provides a CRO a premier opportunity to present the clinical trial team to a sponsor. Hence effective execution of IM is perceived as a reflection of the team’s capabilities.
References:
1) ICH – International Conference on Harmonisation Good Clinical Practices, Jan 21st 2012, http://
ichgcp.net/4-investigator