CAPAs: To File or Not to File

[Katie Kelly]

Hello,
Does anyone recommend filing final CAPAs (vendor, CRO, or Sponsor owned) in the TMF?

For vendor or CRO owned CAPAs that aren’t filed in the TMF, where do you keep them?

Thank you!
Katie

[Jennifer Gaskin]

No, this should not be in the TMF. It should be filed within your quality management system and/or CAPA tracking system. External CAPAs need to be filed also so that you show oversight. Again, should be in the QMS.

[Bert Peeters]

Hi All,

Just wondering if others have another opinion about this. Personally I would file study specific CAPA forms in the TMF.

Many thanks,

[Mariz Hanna]

Hi Katie,
This should not be in TM. It should be filed in quality management system.

[Amanda Noel]

Hi All –

I’m also interested in this chain as I have heard both suggestions. File CAPAs if they help tell the story of the TMF or show Sponsor Oversight. I have also heard not to file them and place in QA files like QMS. What about site level CAPAs?

Thanks,
Amanda

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