At the bottom of Section 4 there is the following statement:
[ENTER CRO/VENDOR NAME] agrees to maintain all TMF records in a confidential manner and in compliance with ICH-GCP regulations and local regulatory requirements.
What is the intent of this section? There are many vendors that support studies, e.g., imaging, laboratory, PRO, IRT, etc. We do not duplicate vendor files in Sponsor TMF so there are some documents that will remain in the vendor files and not be transferred to Sponsor TMF. Should these vendors be listed in the table in Section 4? OR, is this section meant to be completed only IF:
1) CRO is running study and maintaining eTMF for the study – list the CRO in Section 4 OR
2) Sponsor is running study BUT vendor is contracted to maintain eTMF (Sponsor TMF resides with vendor) – list the vendor in Section 4
What if part of the eTMF while the trial is ongoing is held by a vendor in their TMF and transferred to Sponsor after trial is over (e.g., unblinded documents)? Would this vendor be listed in Section 4?
Are Section 4 and 5.3 related? So, if you have a CRO or vendor in Section 4 then Section 5.3 is applicable? If you do not have anything listed in Section 4 then is Section 5.3 marked not applicable?