Reply To: What Type of Documents Need to be Certified When eFiling?

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March 21, 2023 at 10:11 am #4981
Qiutao Yu
Participant

EMA Guideline: Guideline on the content, management and archiving of TMF_6Dec2018 section 5 has provided clear instructions on this.

For the follow up question, my personal thinking is that it could be acceptable as long as the process is “validated”. For example, set a series of Criteria for risk-based QC:

1. Documents that are essential per ICH GCP 8 should be 100% QCed
2. A certain percentage of other non-essential documents to be verified. If errors, then should expand the scope/volume of documents to be checked.

  • This reply was modified 1 year, 1 month ago by Qiutao Yu.