I am currently evaluating a CRO who will only commit to filing essential documents per GCP and will not file in the eTMF what they consider ‘outside documents’ (eg, vendor or IP documents). My organization does not have an internal eTMF.
Has anyone come across this and how did you manage the documentation?
The MHRA GCP Q&A Forum include a whole section of FAQs on TMF management which include this topic. I would also refer to the EMA/INS/GCP/856758/2018 Guideline on the content, management and archiving of the clinical trial master file (paper and//or electronic), which specifically states (3.5.1) that GCP 8 should not be used as a definitive checklist and is not an exhaustive list.