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#4978
Qiutao Yu
Participant

Just sharing my experience here:
This type of documents are named as “CTMS/ETMF Job-Aids” in our knowledge management framework, apart from “PD Guideline”, we have “How to write a MVR in CTMS”, “How to create an Action (Follow-up) Item” etc., these are taken similarly to company level SOPs, and we don’t ask teams to file into their study eTMF respectively. However, they can if they want, add these “References” into their SOP/Training List for indexing as a summary.

What should be filed, it’s study specifications of PD Handling Plan, like PD classifications, PD Review Process etc., under T01 Trial Management.

  • This reply was modified 1 year, 2 months ago by Qiutao Yu.
  • This reply was modified 1 year, 2 months ago by Qiutao Yu.