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ISO 14155 Good Clinical Investigation Practices Compliance Checklist?


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Hi Covers!
Does anyone have a checklist of the various documents that are required by ISO 14155 (eg. protocol, ethics committee approvals, etc)? My Notified Body reviewer asked me if I had one (to make his job easier) :rolleyes:- I don't and before I reinvent the wheel I thought I would ask you all!



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Re: ISO 14155 compliance checklist?

I know it's weekend, but can someone help by any chance?

Thank you!!

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