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Thread: Redacted source documents

  1. #1
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    Redacted source documents

    As per protocol, medical monitor will reiew screening data to confirm the Investigators decision regarding eligibility. The sponsor would therefore like the CRA to provide redacted source documents (as well as a eligibility checklist) so they may approve enrollment. My question is whether we may send redacted source documents to the sponsor?

  2. #2
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    I presume that this is a form of central monitoring. I take it that the medical monitor is a sponsor employee or contracted by the sponsor (CRO etc).
    Does the approved protocol (and the Monitoring Plan) clearly explain, in detail, the method and justification for central monitoring (& when on-site monitoring might be required)?
    As a general rule sending source documents (redacted or not) out from the investigator site to the sponsor (or anyone) is not recommended. This process needs to be fully justified in the submissions and approved.
    You have to ask yourself how will the medical monitor determine which subject the source document pertain to, if the subject is not identified? On-site monitoring would check the existence of subjects, against source documents (medical notes etc) and the confidential ID list. Hence they would know if the information pertained to the correct subject.
    There are also problems with de-identification. There may be many sections of the source documents that may directly or indirectly indentify the subject. Hence there may be a great deal of redaction and that may further degrade the usefulness of this method.
    Why is it that “the CRA to provide redacted source documents (as well as an eligibility checklist)”? Surely only authorised site staff can manage and redact source documents!!
    How is the “decision regarding eligibility” performed? Surely the site staff are well trained in GCP, and the protocol and the Protocol & CRF define strictly which subjects are eligible? There are dangers in directly allowing sponsor staff (or agents of sponsor) to become, in effect, investigators in determining eligibility. This is different to a monitor checking information and reporting to the PI and sponsor, on any potential deviations from the protocol.
    The MHRA GCP Guide (2012) as good sections on this sort of thing.

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