Drug Evaluation Committee 2017-32 Medical record screening prior to obtaining consent by dispatched CRC
Related classification: outsourcing of work
Date of first publication: October 2017
Question
The hospital has in-house CRC, but through a business alliance, an SMO has been brought in for some clinical trials. According to the contract between the hospital and the SMO, the duties of the CRC dispatched by the SMO are vaguely defined as "duties necessary for the conduct of the clinical trial.
We have checked with the SMO, and they have told us that other facilities do this. We would have access to the medical records prior to obtaining consent, but as long as they are affiliated with the SMO and are collaborators in the clinical trial, is there any problem with this under GCP?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If an SMO CRC works at the site based on a dispatch contract, there is no problem with medical record screening as long as the CRC is under the direction and supervision of the investigator. On the other hand, if the CRC is to work under an outsourcing agreement between the site and the SMO, the investigator or other staff of the site cannot directly instruct the CRC on the work to be performed, and the work must be clearly defined in the outsourcing agreement in advance and within the scope of that agreement. The work must be clearly defined in advance in the relevant outsourcing agreement and must be within the scope of the work.
Please note that, although screening of medical records is considered to be an acquisition of personal information, the purpose of use of personal information must be promptly notified to the individual or publicly announced, unless the purpose of use is publicly announced in advance (Article 18 of the Act on the Protection of Personal Information). ).
Please also refer to "Guidance for the Appropriate Handling of Personal Information by Medical and Nursing Care Businesses" (April 14, 2009 (partially revised in October 2020), Personal Information Protection Commission, Ministry of Health, Labour and Welfare).