Bioequivalence and Bioavailability Forum

Hi Debbie
you are right, there is no recommendation whether the trail related original documents should be kept with trail site (CRO) or the sponsor. This should be clarified in an agreement. Usually the original essential documents are kept with the trial site since also some documents which should not be forwarded to the sponsor (e.g. Subject Identification Log) are kept there together with internal (not essential but original) documents (staff, timetables, certificates) which might become important during an inspection. I know that some sponsor like to have the original documentation but I see no need for that.
I hope this helps.
Kind regards
Dan