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.