Drug Evaluation Committee 2011-02 Comprehensive Designation of Clinical Trial Collaborators
Related classification: Principal investigators, subinvestigators, etc.
First published: Jul 2011
Revised published: Apr 2013
Question
My question is whether or not blanket nomination of a clinical trial collaborator is possible.
In a clinical trial for other diseases using syringes such as those used in pen-type insulin administration, we have a requirement that all nurses who administer injections be designated as study collaborators. Because of the daily administration, it is not possible to designate a specific nurse, and all nurses may be involved, which means that all nurses in the study must be listed on the "investigator/associate investigator list.
However, nurses often resign or change their positions, and it is very complicated to change or reappoint nurses to the list, which requires the director's seal each time. Therefore, would it be a problem to list "○○ ward nurses" on the "list of investigators and research collaborators" and make a blanket nomination? The investigator (eligibility) is not subject to review by the investigational review committee, and if necessary, it is possible to create a list of nurses separately from the relevant list afterwards.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
According to Article 43, Paragraph 1, Guidance 1 of GCP, when the investigator assigns a part of "important tasks" related to the clinical trial to a subinvestigator or collaborator, the investigator is required to prepare a list of tasks to be assigned and a list of persons to be assigned, and submit it to the head of the site for approval in advance.
The purpose of preparing a list of tasks to be shared and persons to be shared is to identify in advance the persons to whom important tasks of the clinical trial will be assigned, to clarify the tasks to be handled, and to clarify where the responsibilities lie.
In addition, Article 36, Paragraph 2, Guidance 2 of GCP states that one of the "necessary measures" that the head of the site must take to ensure that the clinical trial is conducted appropriately and smoothly is to obtain the approval of the investigators and collaborators, and therefore, the head of the site cannot fulfill his/her responsibilities if the record is made after the fact.
In the "Uniform Form for Requesting a Clinical Trial" as of March 27, 2012, it is not necessary for the director's seal to be affixed to the list of investigators and collaborators. We believe that omitting the seal will reduce the burden of obtaining approval after establishing the procedures in the hospital.
On the other hand, Article 43, Paragraph 2 of the GCP stipulates that "The investigator shall fully explain the contents of the clinical trial to the investigators and collaborators, and ...". Thus, it can be considered that the above "important tasks" are those for which special procedures and techniques specific to the clinical trial are stipulated and which require prior education, and that those who are assigned by the investigator to perform such tasks fall under the category of a subinvestigator or a cooperative investigator. In other words, if there is no special administration (injection) procedure or technique that requires prior education, and the safety of the subject after administration (injection) can be ensured by the investigator or subinvestigator's follow-up observation, the person who only administers the drug (injection) does not necessarily need to be a cooperative investigator.
Therefore, we recommend that the investigator and sponsor consider whether the case in question is an important part of the clinical trial.
Reason for revision of opinion
In accordance with the issuance of "Uniform Forms for Requesting Clinical Trials" (March 7, 2012, NHI/0307 No. 2 and NIH-0307 No. 1), we have added an explanation to the effect that the seal can be omitted.