Drug Evaluation Committee 2012-27 Scope of recommissioning of contract services by CROs
Related classification: Other
Date of first publication: October 2012
Question
Please tell me about "outsourcing" under Article 12 of GCP.
As a CRO, we have different views on the use of an outside printing company to send safety information provided periodically to investigational sites during a clinical trial. Therefore, we would like to confirm to what extent the CRO can outsource the work to a vendor when negotiating with the sponsor in the future.
Our CRO has determined (based on the opinions of our company, legal department, and QA department) that outsourcing the following two aspects of batch safety information dispatch to an outside printing company upon agreement with the sponsor is not in violation of Article 12 of the GCP.
- Printing of Form 2, line list, etc.
- Enclosure and dispatch of materials
On the other hand, the sponsor side has commented that all of the above operations are considered "re-consignment of work" and therefore in violation of GCP Article 12.
Since a CRO such as our company is not a printer or distributor, we think it is possible to request vendors to perform "printing" and "shipping" services. If the "printing" services are in violation of "subcontracting of services," the sponsor will not be able to order the printing of study protocols, etc. in the future, which will make it very difficult for the sponsor to conduct the clinical trial. Incidentally, the printing of study protocols, consent documents, etc., is performed under the direction of the sponsor.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Since there is no provision in GCP that prohibits subcontracting, it is possible for a person who is entrusted by the sponsor (hereinafter referred to as "Trustee A") to entrust a part of such entrusted work to another person (hereinafter referred to as "Trustee B"), but the responsibility for the sponsor regarding such entrusted work lies with the person who was directly entrusted by the sponsor (hereinafter referred to as "Trustee A"). However, the responsibility to the sponsor for such entrusted work rests with the person who was directly entrusted by the sponsor (i.e., Trustee A). The scope of work that can be subcontracted depends on the agreement with the sponsor, but in general, there should be no problem in subcontracting simple work (that can be performed properly even without understanding GCP) to perform tasks related to the request or management of a clinical trial. In the case of your question, we recommend that you discuss with the sponsor whether or not the use of Trustee B will enable the proper and smooth implementation of Trustee A's original entrusted task of "providing safety information to all sites within a timely manner".
It would be desirable to include in the contract between the sponsor and trustee A the scope of subcontracting and responsibility for subcontracting. In addition, depending on the type or scope of subcontracting, it would be desirable to conclude an agreement between Trustee A and Trustee B with contents similar to GCP Article 12, Paragraph 1.