Reply To: Certified copies and TMF

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Kathie Clark

To add a little to what Todd has said… One important thing in certifying copies is that you have to have access to the paper copy! Thus, it is not something that you can usually have a QC person do, as they receive an already-digitized copy in the workflow and usually don’t have access to a paper original.

Ideally this would be done by the person / function transforming a paper document to an electronic document by scanning or photographing. This may or may not be the person uploading to eTMF.

That person would certainly need to be trained in what it means to certify the copy (check every page? check for skewing, obscuring, extra pages, ???).