Following the receipt of clarification from the MHRA on access to the investigator TMF, the Q&A document that was generated following the European TM Summit has been revised. The document has been updated as follows.
“Slides were based on the draft of the TMF guidance at that time. The Q&A question 27 answer is compatible and clarifies why remote access to such information would not be acceptable. The guidance since then has been subject to some revisions. For remote access, the following is now stated:
‘Remote access by sponsor or CRO personnel to the investigator TMF should only be possible to the documents where personal data that enable the data subjects to be directly identified (i.e. direct identifiers of trial subjects) is not present or has been pseudonymised’.”
The full Q&A document is available to download from our Resources page.