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  • in 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.

    in reply to: Where to File Risk Based Monitoring Assessment Checklist #3747
    Angela McCullagh
    Participant

    Are you talking about an assessment checklist that is completed at each individual site in order to rate them against identified risks and determine monitoring approach at that specific site; or a general checklist that is utilised to identify overall risks in order to determine the monitoring approach across the study? Or neither of these options!?

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