7th Apr 2017, 04:38 PM
Courses on Sponsor Oversight File
Would anyone know if there are any courses available on what should be kept in the Sponsor oversight file (SOF)? We have recently struggled as seemed to duplicate documents between the SOF and the TMF and wondered if there was specific guidance anywhere that someone could point me towards please? or if anyone knew of any training/courses available for this?
19th Apr 2017, 07:23 PM
Surely the SOF (although this is not a known or recognised acronym) is part of the TMF! If you look at the EMA "Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials" 31 March 2017 EMA/15975/2016. In many places (including the EU Clinical Trial Regulation) it states that the TMF contains all the information to be able to explain and reconstruct what happened in the trial.
You might find the following useful. there is some information on oversight on the RQA webcast on ICH E6 R2 (www.theRQA) and the webcast on the EU Clinical Trial Regulation.. Also the MHRA GCP Guide (2012) has a lots about oversight.