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Trial Management – Lost in delegation?

Clinical trials call upon a complex network of resources i.e. parties contracted by the sponsor and parties subcontracted by such delegates (e.g. CROs). EU GCP Directive 2001/20/EC Section 3 Art. 7.1 and ICH GCP E6(R2) Art. 5.2.1-5.2.4 [EMA/CHMP/ICH/135/1995] provide guidance in this regard specifying that:

  • „… the sponsor shall remain responsible for ensuring that the conduct of the trials and the final data generated by those trials comply with Directive 2001/20/EC as well as the EU GCP Directive„
  • „… Any trial-related duty and function that is transferred to and assumed by a delegate (e.g. CRO) should be specified in writing“.
  • „… The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s)“.

All parties pertinent to the quality management and GCP-compliance of the trial should be identifiable in section G.5 of the Clinical Trial Application Form (Annex 1 of Eudralex 10 CT-1). In this way it is ensured that the delegates are identifiable also with the purpose to ensure that the quality management of their contribution is accessible for inspection.

Delegation may constitute a relevant quality risk, particularly if several parties are involved with partly overlapping functions and authorities. It is therefore recommended to take due precautions to prevent, control and remedy possible defects that might arise, e.g.:

  • Delegation should be addressed in the risk-based Quality Management Plan of the trial.
  • The delegating party is responsible for the selection and documentation of the qualification of the delegate.
  • The delegating party is responsible for the QC/QA of the delegate’s contribution; this may require a system audit as part of the pre-study qualification and due measures for on-trial QC.
  • Delegation should be specified and regulated in writing. Contracts should be accessible to the sponsor in the event the delegate is subcontracted by a primary delegate (e.g. CRO).
  • Delegation should be specified and documented in the Trial Master File (TMF); this may involve the documentation of the qualification of the delegate, documentation of the delegate’s Quality Management System (incl. SOPs and/or reference to the deposit of the delegate’s SOPs) and documentation of the QA/QC of the delegate’s contribution. TMF-Specification should also address which SOPs are/were applicable for a given task.
  • Delegates with GCP-pertinent contributions should be named in the Trial Application, Clinical Trial Protocol, and Clinical Trial Report.
  • A unique Task Assignment List should be in place that specifies the full scope of delegation with sufficient granularity (e.g. for the Clinical trial Protocol: who is responsible for writing the draft, reviewing the draft, finalising, signing and releasing the CTP?)
  • The Task Assignment List should be accessible to all delegates to avoid misunderstandings about who is responsible for what.