Drug Evaluation Committee 2011-14 Pathology Specimen Preparation Agreement
Related classification: Other
First published: Aug 2011
Question
Some of the cancer clinical trials that we are contracted to conduct require the submission of pathology specimens (slides and blocks). We have contracted with the Department of Pathology at XX University to prepare paraffin sections for all of our regular medical services, regardless of whether they are for clinical trials or not. The actual flow of the process is as follows: the Clinical Trial Management Office requests the Pathology Department of this hospital to prepare pathology specimens for subjects who need to submit pathology specimens, the Pathology Department of this hospital requests the University of XX to prepare pathology specimens, and the Department of Pathology of this hospital receives the finished specimens for final confirmation before the Clinical Trial Management Office submits them to the specimen delivery site for the clinical trial.
Article 39-2 of the GCP stipulates that "When entrusting a part of operations related to the conduct of a clinical trial, the implementing medical institution shall conclude a contract in writing with the party entrusted with such operations (omitted). In the above case of our hospital, although a part of the slide preparation was performed at another facility, the final judgment and responsibility for the work was made by the pathologist and hospital director of our hospital, and we judged that these series of work were performed at our hospital.
In addition, we have confirmed that there is no problem with the above details from the study sponsor who is required to submit pathology specimens. However, the SMO, which is in charge of some of the studies at our hospital, pointed out that since clinical trial operations are outsourced to other facilities, it is mandatory to present a written contract. Could you please tell us whether or not the above case falls under the category of "a contract is required to be concluded to outsource a part of the work" under GCP?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stipulated in Article 39-2 of the GCP, when a part of the work related to the conduct of a clinical trial is entrusted, it is necessary to conclude a written contract with the party entrusted with such work.
I do not know what kind of information obtained from the pathology specimen in your question is relevant to the clinical trial, but if the information relates to the efficacy and safety of the investigational drug and is used for the application for approval of the drug in question, a contract in accordance with Article 39-2 of the GCP is considered necessary. In the future, when outsourcing work related to a clinical trial, we recommend that you confirm the position of the work with the sponsor and discuss whether or not a contract is necessary before the start of the clinical trial.