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.