Home Forums TMF Management, Content & Processing Working with a CRO who won’t file ‘outside’ documents Reply To: Working with a CRO who won’t file ‘outside’ documents

#3942
Angela McCullagh
Participant

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.