Good Clinical Practice Guide
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Thread: Restriction on number of screening attempts?

  1. #1
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    Restriction on number of screening attempts?

    Hi,

    Does anyone have any guidance on the number of times a participant can be re-screened? Is "at the investigators discretion" acceptable?

    Thanks!

  2. #2
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    There is a similar Q & A about this on the Research Quality Association (www.TheRQA.com) GCP website. Basically your Risk Assessment could address this. There may be many parameters that may affect the question of re-consent. It is important that the statistical, regulatory and ethical questions are satisfied regarding the apriori criteria in the protocol about how investigators may re-screen.
    For instance, repeating tests until a subject qualified would be an inappropriate (& unethical) methodology. Some tests cannot be repeated as this would invalidate them. Other tests may require a time period to elapse and others may require alternative forms to be used in order to be valid. Subjects should not be “coached” into giving the correct test result.

    Also all protocol required (& protocol & GCP Compliant) re-testing should be documented so that it is transparent that the subject has been tested multiple times.

    I would think that giving the investigator "discretion" would allow Data Integrity violations to become the norm. In fact it might be a serious breach of GCP (or at least should be escalated to evaluate this possibility).

  3. #3
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    The protocol must contain a description of the re-screening criteria and process, and as such, must be reviewed and approved by a statistician. The Statistical Analysis Plan should contain a description of the mitigation of bias which may be introduced by re-screening subjects. The CRF should detail how re-screening and repeat testing is captured.

    It would also be wise to address the question about re-consent. If circumstances have changed or if there is a considerable period between test and re-test, then it might be appropriate to re-consent the subject to establish that genuine informed consent is still safe.

    Obviously subject safety and well being is paramount. So if it is necessary to re-test a subject for safety reasons (not just to allow them into the trial) then of course subject safety comes first.

  4. #4
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    Oops third sentence should have been ;- "There may be many parameters that may affect the question of re-screening".

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