Trial Master File key requirements and the essentiality of documents
 A recording of the webinar held Monday October 2

A two hour webinar consisting of presentations, poll question interactions and a Q&A session.

A must attend webinar for those involved in clinical trials.
The EMA has produced some excellent guidance which can be utilised to help prevent TMF inspection findings.
The MHRA has published some excellent blogs outlining TMF expectations.
This guidance is reviewed, together with the test of 'essentiality' brought about by the draft ICH GCP E6(R3) guideline.
Other draft ICH TMF requirements will also be considered, together with the legal requirements imposed by the EU Clinical Trial Regulation.