Drug Evaluation Committee 2012-42 Selection and Approval of Investigator Selection and Order of Agreement on Clinical Trial Protocol
Related classification: Other
First published: February 2013
Question
When requesting a clinical trial, the sponsor is responsible for selecting the Investigator Site and the investigator. The sponsor is also required to obtain the agreement of the investigator on the study protocol.
In many cases, the sponsor's SOPs seem to stipulate a procedure for obtaining agreement on the study protocol with the investigator upon approval of the selection of the Investigator Site and the 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 Investigator Site and investigators must be made before the request for a clinical trial is made, and that the selection is made first and the agreement is made later?
JPMA's Opinion
The selection of the investigator and 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 Guidance 4/5 Guidance 4 must be made by the submission of documents to the head of Investigator Site (GCP Article 10) for the request for a clinical trial. However, there is no specific provision in GCP regarding the order of the 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.