Drug Evaluation Committee 2007-33 Procedures for changing the surname of a clinical trial coordinator
Related classification: Principal investigators, subinvestigators, etc.
First published: August 2008
Revised publication date: March 2012
Question
Please provide information on the list of nominated investigators (list of investigators and investigator collaborators) for clinical trials.
Our hospital is currently outsourcing to an SMO to perform all aspects of clinical trial collaboration. If a collaborator (CRC, etc.) got married and changed his/her family name (surname), but is still using his/her maiden name at the SMO, etc., which surname should be listed on the list? Is it OK to use either one?
Also, which one should take precedence (use) on the documents (in general) under the GCP?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
According to the provisions of Part 4, Chapter 2 of the Civil Code, when a person's surname is changed due to marriage, the changed surname must be used for legal purposes. However, as seen in the recent debate on the issue of separate surnames for married couples, there are an increasing number of cases in which people continue to use their maiden name after marriage. Regarding your inquiry, we believe that the SMO to which the investigator belongs allows the use of the maiden name. Therefore, as long as the SMO to which the investigator belongs and your medical institution allow the use of the former name, and all the duties and documents are consistent with the former name, and the duties and responsibilities are clear, it is not necessarily necessary for the investigator to change to the new name.
In addition, in accordance with GCP Article 43, Paragraph 1, the investigator must prepare a list of the duties to be shared and the persons who are to share them when assigning investigational tasks to a collaborator. However, unless there is a change in the person in charge, the nature of the work, or the role to be shared, it is not necessarily necessary to revise the list due to a change in surname or job title. If the above list needs to be updated for other reasons, there should be no problem in adding the new surname to the collaborator in question and listing both surnames together.
Reason for revision of opinion
In accordance with the revision (October 24, 2011) of the "Implementation of Standards for Conducting Clinical Trials on Drugs," the explanation regarding the responsibility for creating the list of investigators and collaborators has been changed.