Working with a CRO who won’t file ‘outside’ documents

[Katie Kelly]

Hi all,
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?

Thank you!
Katie

[Karen Roy]

Hi Katie

There are a number of slides that the MHRA have presented that support that section 8 is not sufficient. They may help – email me and I can send them. kroy@phlexglobal.com

Karen

[Tina Belanger]

Hi,

I have run into this issue myself and would like to see the MHRA slides on section 8 as well. Would it be possible to receive them?

Thanks so much!

Tina

[Angela McCullagh]

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.

[Katie Kelly]

Hi all,
Thanks for your input and suggestions. I thought you’d be interested in an update – this CRO agreed to file our ‘outside’ documents as long as we dictate at the beginning of the study which TMF Ref Model sections (note: NOT specific documents) we expect will contain ‘outside’ documents and we have written agreement that the CRO isn’t responsible for review and QC of these documents.

I hope this helps others!

Katie

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