Drug Evaluation Committee 2011-44 Contracts for contract clinical testing (specimen analysis)
Related classification: Other
Date of first publication: Apr. 2012
Question
If blood tests such as blood counts and biochemistry are outsourced to an external laboratory, does the outsourcing contract need to cover GCP Article 39-2 (outsourcing of services, etc.) in order to use the test data in a clinical trial?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stipulated in Article 39-2 of the GCP, when outsourcing part of the work related to the conduct of a clinical trial, it is necessary to conclude a written contract with the person who will be entrusted with such work. This contract can be an individual contract concluded for each clinical trial or a comprehensive contract covering all clinical trials.
In the case of your question, we believe that a contract covering the contents of Article 39-2 of the GCP is necessary. Since your hospital has already outsourced the blood tests to an external testing company in the ordinary course of business, it would be one way to address the items stipulated in Article 39-2 of the GCP that are not included in the outsourcing agreement with the external testing company, either for each clinical trial or in an additional memorandum of understanding covering all clinical trials. It may be one way to handle the matters stipulated in Article 39-2 of GCP that are not included in the contract agreement with the external inspection company.