Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 70

Meetings with regulatory authorities are encouraged for the Clinical Trial Sponsor at trial milestones. Those times are often just before submission of an application to conduct the trial and before embarking on each of the applicable phases. During such meetings topics such as complexities in the protocol, approach to compliance with elements of GCP can be on the agenda as well as the science of the IP and trial approach. After a trial a meeting may be scheduled to clarify outcomes prior to the submission of any marketing application. Regulatory authorities agree that meetings are useful. For example the US FDA includes specific references to meetings during the conduct of a clinical investigation in the controlling regulations.

In most situations the topics discussed are instrumental in the performance of clinical trial activities so documenting all outcomes, agreements, decisions, and follow‐up steps via a meeting record is important. ICH E6(R2) section 8.3.11 serves as a catch all in the TMF for the written record of such meeting minutes.

Face‐to‐face meetings are usually the most effective forum for ensuring that there is clarity between parties on all aspects of an endeavor such as a clinical trial. Conformance with one or more aspects of GCP can and is on the agenda of many meetings between sponsor and regulatory authority as well as between the parties performing steps in the trial. Therefore, the records of meetings and all forms of communications are vital. An often overlooked benefit of well‐documented communications is that they engender trust among the parties involved. Trust between parties goes a long way when issues arise and explanation must be made for decisions that impact a trial‐related matter.