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Thread: Editing an Audit Trail

  1. #1
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    Editing an Audit Trail

    The integrity of the audit trail is the backbone of a validated data capture system since it records all changes to data, including who made the initial entry and when in addition to when, why and by whom any subsequent changes to data were made.

    That being said, is it ever acceptable to modify an audit trail?

    The question arises since I have seen this occur in an electronic data capture system and the justification provided for this action was that the edits made to the audit trail were also captured and so the practice was deemed acceptable, and indeed "defensible" in a regulatory inspection.

    Personally, I think this unacceptable, but I would be interested to hear others' opinions, especially those from the Inspectorate.

  2. #2
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    By way of an update to those who may be following this thread I also has correspondence with FDA regarding the use of a date field in an audit trail as a data element and the editing of the audit trail through Data Clarification Forms. This is their response:

    The audit trail in a part 11 compliant data capture system should automatically apply a date/time stamp to data elements entering the system. Modifications can be made to the source data and this is tracked by the audit trail. From your question it appears there may be linkage between the date as a data element and the date in the audit trail, which is not appropriate.
    If a date in a source record is to become part of the data in the EDC, it should become a separate data element with its own date/time stamp in the EDC (See FDA Guidance Electronic Source Data in Clinical Investigations). Changing the audit trail based on changes in the source document would be considered a violation of our part 11 requirement.

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