Drug Evaluation Committee 2012-42 Selection and Approval of Investigator Selection and Order of Agreement on Clinical Trial Protocol
Related classification: Other
Date of first publication: Feb. 2013
Question
When requesting a clinical trial, it is the responsibility of the sponsor to select the investigational sites and investigators. The sponsor is also required to obtain the agreement of the investigator on the study protocol.
In many cases, the sponsor's SOP seems to stipulate a procedure for reaching agreement on the study protocol with the investigator upon approval of the selection of the site and investigator. Is it your understanding that, as a procedural sequence, it is possible to obtain agreement on the study protocol only after the results of the approval for selection have been obtained? Or, would it be acceptable if the order of the procedures is that the agreement on the study protocol and the selection of the site and investigator are stipulated to be made before the request for a clinical trial, with the selection first and the agreement second?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The selection of the investigator and the site as stipulated in GCP Article 6 Guidance 2 and the agreement on the content of the protocol and its compliance with the person to be the investigator as stipulated in GCP Article 7 Paragraph 4/5 Guidance 4 must be made by the submission of documents to the head of the site (GCP Article 10) for the request for a clinical trial. However, there is no specific provision in GCP regarding the order of such agreement.
Therefore, as long as both tasks are performed in accordance with the sponsor's SOP by the time of submitting the documents to request a clinical trial, there should be no problem regarding the order of these tasks.