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Unblinded sponsor team



  • Anon
    14/01/2021 14:37
    in case a sponsor would like to set up an internal unblinded team for regulatr review and control of a study, how much "distance" is needed between team members between the unblinded team and the blinded operational team? ie. can 2 different persons from the same department be in the 2 teams.
  • Anon
    15/01/2021 08:56
    I would say total separation. Would need a lot if justification in protocol and application to IEC and Regulators. Is it for an IDMC? in which case follow tge IDMC guidance
  • Anon
    15/01/2021 11:04
    Your Risk Assessment should have a detailed section on the rationale and processes for mitigating risks to trial integrity by having an unblinded team. The risks are high if personnel are close (physically and/or structurally and/or organisationally) to colleagues who may be unblinded.
  • Dominique Chesnais
    17/01/2021 11:20
    Please also refer to the FDA Guidance for Clinical Trial Sponsors - Establishment and Operation of Clinical Trial Data Monitoring Committees, in particular to section 6. INDEPENDENCE OF THE DMC.
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