Drug Evaluation Committee 2021-71 Attribution of ePRO Data
Related classification: Other
Date of first publication: Jul. 2022
Question
This question is regarding the attribution of ePRO data when an ePRO is included as part of an eCOA for efficacy evaluation. An eCOA is used to evaluate the efficacy of a clinical trial, but because a subject self-assessment (PRO) is included in the evaluation items, a part of the eCOA falls under ePRO. The efficacy evaluation will be conducted using a tablet during the Visit clinic, using the investigator's account (the logged-in tablet will be given to the subject to conduct the PRO). The CRC also has an account, but there is no PIN entry.
After the PRO is conducted, the same tablet is used to transfer directly to the ClinRO (physician evaluation), and the investigator (subinvestigator) conducts the efficacy evaluation. Efficacy evaluation is conducted.
The same is true for the confirmation and assurance that the subjects themselves are present at the place where the ClinRO is conducted, and the PRO and ClinRO are both conducted after confirming the identity of the subjects under the responsible (sub)investigator, who is the person responsible for the efficacy evaluation, i.e., the person responsible for the data. Therefore, we believe that special procedures such as setting up the subject's account and entering the subject's PIN are unnecessary only for PROs, which are part of the efficacy evaluation. However, for ePRO such as subject diaries, we believe that identity verification is necessary because the data is not entered under the investigator who is responsible for the data.
Would the lack of subject account and PIN settings mean that the attribution of PRO data is not fulfilled, or does it violate GCP Article 41.1, attribution of original data?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
We are unable to determine the study design and the position of the input data based on your question alone, so we will refrain from answering whether this response is appropriate.
In general, it is not desirable for multiple people to use the same ID (in this case, a physician ID), and at least as far as the question is concerned, it cannot be said that a third party can confirm the attribution of PRO data for the input data of both physicians and subjects. It is desirable to keep records so that a third party can verify that the PRO was conducted in compliance with the procedures for identification of subjects (prevention of impersonation) and the procedures for identification.
In addition, we believe that it would be desirable to have appropriate procedures for the collection of PRO data, including the fact that the subject's responses can be obtained directly without interpretation or influence from other parties such as physicians, and that the subject is able to respond calmly and appropriately.