Good Clinical Practice Guide
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Thread: Source data queries

  1. #1
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    Source data queries

    I am a new monitor have some queries regarding source data:

    1. Must amendments made to the source data be initialed and dated?
    2. Whilst conducting monitoring, it appears that source documents such as ECG traces, blood results etc are often stored in different locations/programmes. These programmes are not all accessible to monitors. It is recommended that trial teams have all trial-related results printed and filed in 1 location, instead of having the monitor sit with a member of the trial team in order to view the results in the various programmes?

    Thank you for your suggestions.

  2. #2
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    It sounds like you might benefit from training for monitors.
    ICH E6 (R1) has got lots of details about how source documents are to be amended in compliance with GCP. The EMA reflection papers gives the expectation of EU GCP Inspectors for both paper & electronic source including the ALCOACCEA standards. The MHRA GCP Guide (2012) has a wealth information to help you. This includes information about how to monitor electronic source information. This is a hot topic with EU GCP inspectors so it is best if your organisation works out an SOP for monitoring electronic source that is in tune with the guidelines. The FDA has guidance of electronic source that is useful. Various organisations exists with lots of information about these issues, for instance the Research Quality Association (www.theRQA.com).

  3. #3
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    Thanks for the reply.
    I did attend a essential in monitoring course but it was an overview course and did not go into details. I will re-read those resources you said, thanks for that.

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