EMA-compliance

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  • kristiakkristiak Posts: 1,172 ✭✭✭
    I have a related questions for you all! Are the FDA requirements for validation different from EMA?  In a recent project with two almost identical protocols, the only difference being that protocol 1 had one CRF page where pharmacokinetic data was collected. This page was eliminated in protocol 2. We made a complete validation before starting protocol 1 including a validation plan covering all 12 items. For protocol 2 we made an abbreviated validation concentrating only on the items that were different from, protocol 1. This is how we used to validate our systems at Merck. During a recent audit we required to do a complete validation also for protocol 2 due to the fact that the EMA regulations require a full validation for each protocol.  Do you agree or disagree with the auditor?
  • haenselhaensel Posts: 530 ✭✭
    Hi Guys

    That is a very interessting discussion that was long-overdue.

    @Knut

    knelaus said:
    We were a bit surprised when several GCP inspectors (similar to FDA inspectors) approached us and told us that the system we are using (OpenClinica Enterprise) is not GCP compliant in respect of Investigator holding an independent copy of data (Page 10 in European Medicines Agency “Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials” and Page 7 in FDA “Guidance for Industry – Electronic Source Data in Clinical Investigations”.
    EMA "Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials" also says
    In order to meet the requirements a contemporaneous certified copy of the data should be retained at the investigator site in addition to the record maintained on a central server.
    As fare as I'm aware there has to be a paper source at the investigators site. The crf data not included in the paper source can be exported (which should meet the requirement of a
    copy).
    So I agree with all the other saying that this is possible with OC.

    Regards,
    Christian
  • haenselhaensel Posts: 530 ✭✭
    certified: More work is needed to make the copy certified. The documents can be signed independently of the export format (e.g. public/private key infrastructure).

    contemporaneous: I would be surprised if the inspector accepts a period of years for the investigators database beeing behind the sponsors database. Sending the data automatically is a user friendly option.

    Regards,
    Christian

  • haenselhaensel Posts: 530 ✭✭
    Hi Krister

    kristiak said:
    During a recent audit we required to do a complete validation also for protocol 2 due to the fact that the EMA regulations require a full validation for each protocol.  Do you agree or disagree with the auditor?
    I agree. The software is way to complex to guarantee that protocol changes in a running study has neither influence on existing data nor data entered in the future. Even if the difference is a removed crf page only.

    Regards,
    Christian
  • kristiakkristiak Posts: 1,172 ✭✭✭

    Christian, are you saying that a new Validation Plan, IQ, OQ, PQ, Test Plan, Test Report, Validation Report and all 12 standard requirement must be tested and documented for each study protocol?


    Regards


    Krister

  • haenselhaensel Posts: 530 ✭✭
    edited August 2014
    Hi Krister

    If there is a planed modification in study setup, we first implement it in a test environment and repeat all the tests done for IQ, OQ and PQ. These test check data integrity and OC functionality before and after modification.
    Most of it is automated and produces logs for documentation.

    So I think my answer is yes (for community users).

    Regards,
    Christian
  • kristiakkristiak Posts: 1,172 ✭✭✭

    Hi Christian,

    Surely we do as well but they tests are concentrating on the changes, i.e. the modifications. We do not retest any of the unchanged CRF's and neither do we retest the operating system installation and configuration.


    Regards

    Krister

  • haenselhaensel Posts: 530 ✭✭
    Hi Krister

    But one inspector was complaining about this (or did I understand you wrong)?

    Regards,
    Christian
  • kristiakkristiak Posts: 1,172 ✭✭✭
    via Email
    Yes but only one of three inspectors. The other two said it was fine!!
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