Drug Evaluation Committee 2020-19 Management by the sponsor of a clinical trial of an outsourced contractor who has been re-commissioned by a CRO

Related classification: outsourcing of work

Date of first publication: September 2020

Question

For example, if we are requested to disclose the selection and audit records of a subcontractor during an audit by the sponsor, we will explain that we cannot disclose the details based on a confidentiality agreement between the two parties and present the selection and audit records with confidential information masked out.

Also, if an auditor comments that it is impossible to confirm whether the selection and audits were conducted properly with the information masked, do we need to request the contractor to disclose the information and make arrangements for disclosure?

Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)

Question 1

The ultimate responsibility for the quality and integrity of clinical trial data must always rest with the sponsor, who must ensure that all work subcontracted to others by the contract research organization is properly supervised (GCP Article 12 Guidance 9). In other words, the primary contractor is directly responsible for the management and supervision of the subcontractor (secondary contractor), and the sponsor fulfills its own responsibility by confirming that the primary contractor is appropriately managing and supervising the secondary contractor.

The method by which the sponsor conducts this confirmation is determined by taking into consideration the importance, scope, and existing risks of the work entrusted to the secondary contractor.

Please also refer to the results of public comments*) for the regulator's position on the said guidance.

Question 2

GCP Article 12 Guidance 8 states that "The contract research organization as a trustee shall accept audits conducted by the sponsor and investigations by the regulatory authorities. The contractor shall, upon request of the sponsor's audit personnel and regulatory authorities, provide documents or records (including data) that should be preserved. The trustee shall make available for direct inspection all clinical trial-related records of the clinical trial (including data)." This is stipulated in the regulations. Therefore, with the exception of confidential business information such as payment terms between the primary contractor and the secondary contractor, all documents and records related to the management and supervision of the secondary contractor by the primary contractor must be presented (upon request) at the audit by the sponsor.

Back to Clinical Trial 119 Top

TOP