Has it been considered to add a column to the TMF ref model to mark/highlight site documents that refer to ‘Regulatory Green Light” / IP release?
I do not find it clear which documents should be included in a Green Light form, as it is not ALL listed investigator/site documents. Of course Regulatory/ethics approval, PI sign of protocol, CVs, GCP training cert, Financial discl etc need to be there but what about QP release docs, Certificate of Analysis, lables, lab accreditations and similar?
Any advice is appreciated.
Hello Gunilla – this has been proposed once before (about two years ago) as a sub-group initiative, however one of the reasons we did not pursue this is because the documents required for this milestone vary by country, by company policy, by intervention type, and other factors. Beyond that, we could not see an effective way to accurately maintain such a resource over time (as country regulations change).
From time to time, TMF RM members have shared (in this forum and in others) various online resources they use to gather this kind of information.