Good Clinical Practice Guide
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Thread: Continuous Access to CRO SOPs

  1. #1
    Forum Member
    Join Date
    Jul 2018
    Pennsylvania, USA

    Continuous Access to CRO SOPs

    In order for a Sponsor to maintain adequate oversight of a contract Research Organization (CRO) or any other 3rd party to whom they have contracted (or transferred) GCP activities, there is a need for the Sponsor ensure the adequacy of, and continuing compliance with, the CRO Standard Operating procedures (SOPs), and/or other procedural documents.

    For many years now many CROs have refused to allow Sponsors to have full, continuous access to their GCP SOPs, or only to have an arbitrarily limited number of them available, often on the grounds that these documents are "proprietary."

    I find it difficult to defend that a Sponsor can possibly be overseeing the activities of a 3rd party adequately if they do not have permanent access to the procedures that the 3rd party is following (or not) and would be interested in:

    1. the MHRA's position, and
    2. other Sponsors' experiences with obtaining access, for example through making it a contractual requirement.

  2. #2
    From the MHRA perspective there is a legal requirement for the sponsor to ensure GCP compliance throughout the course of the trial. While a sponsor may review the CROs SOPs prior to contracting activities, these can change during the trial period. Therefore, in order for the sponsor to maintain GCP oversight they should have access to the CROs SOPs when required to undertake their oversight obligations. This could be via a number of methods depending on how and when the oversight is undertaken for example, continuous access or notification of when SOPs have changed or during subsequent audits (although this method would be retrospective) to ensure these are still acceptable.

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