Drug Evaluation Committee 2012-48 Data Entry into Case Report Forms by Administrative Representatives
Related classification: Principal investigators, subinvestigators, etc.
Initial release date: March 2013
Revised release date: December 2021
Question
Although inputting data into EDC is usually performed by CRCs, we are considering assigning administrative staff to assist with inputting the data.
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(1)Is it necessary to register these entry service assistants as a clinical trial collaborator? The definition of a clinical trial collaborator includes "pharmacists, nurses, and other medical personnel" (GCP Article 2, Paragraph 18).
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(2)Do these assistants also need to be medical personnel (pharmacists, nurses, clinical laboratory technicians, etc.)? We believe that they do not necessarily need to be medical personnel, but if we have administrative staff act as entry assistants, do we need to describe this in the clinical trial protocol, "EDC Data Entry Guide," etc.?
Background is as follows. Normally, at our facility, CRCs input data into EDC based on the entries in the electronic medical record. However, since the CRC is very busy, we proposed a method in which a paper-based worksheet is created once and the administrative staff enters the data into the EDC based on the worksheet (input assistance) in order to save the time and effort of direct input into the EDC. The administrative staff was not medical personnel and could not be a clinical trial collaborator. However, the GCP does not include a definition of "medical personnel" and we are unable to provide a rationale for this, which is why we asked the question.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Data entry into EDC is considered to be an important part of clinical trial-related work, so if data entry is to be shared, the investigator must prepare a list of tasks to be shared by the investigator as a research collaborator and a list of persons to be shared, and obtain the approval of the head of the site in advance.
The term "investigator collaborator" is defined in Article 2, Paragraph 18 of the GCP as "a pharmacist, nurse, or other medical personnel who cooperates in the work related to the clinical trial. The term "investigator collaborator" in Paragraph 18 is defined in Guidance 8 of the same article as follows Therefore, as long as the work can be appropriately performed under the guidance and supervision of the investigator, there are no restrictions on the type of work that can be performed at the medical institution by the investigator.
As stated in Article 43, Paragraph 2, Guidance 1 of the GCP, the investigator must provide sufficient information, guidance, and supervision to the collaborator regarding the protocol, investigational drug, and each person's duties, but it is not necessary to state in the protocol or "EDC data entry guide" that the administrative staff is to input or assist in inputting data. However, it is not necessary to include in the clinical trial protocol or "EDC Data Entry Guide" that the administrative staff is required to enter or assist in the entry of data.
However, there are cases where the sponsor has established requirements and training for EDC data entry, etc., so the investigator must determine that the person is capable of fulfilling these requirements and designate him/her as an entry person or an assistant entry person.
Reason for revision of opinion
The opinion has been partially changed in accordance with the issuance of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15).