Drug Evaluation Committee 2009-59 Designation of an SMO representative as a medical institution's record keeper
Related classification: Record keeping
Initial release date: 2010/04
Revised release date: Mar 2021
Question
We are currently supporting a clinical trial at a medical institution where the president of another SMO has been appointed as the record-keeping supervisor. We are aware that it is usually preferable to have someone from within the hospital appointed as the record keeper, but is there any problem with having someone from outside the hospital appointed as the record keeper?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
According to Article 41, Paragraph 1, Guidance 1 of the GCP, "The head of the implementing medical institution shall, in preserving the records (including documents) to be preserved at the implementing medical institution, be responsible for the preservation of each record. The Guidance 1 of Article 41, Paragraph 1 of the GCP states, "The head of the site shall designate a person responsible for record keeping for each record to be kept at the site (including documents). The person in charge of record keeping in question is the person in charge of record keeping for the implementation medical institution. If the person responsible for record keeping in question is the person designated by the head of the implementing medical institution, and if a contract has been concluded in accordance with Article 39-2 of the GCP regarding the details of the relevant work, then there is no problem.
Regarding the external storage of medical records that should serve as source documents, it is also necessary to follow the "Partial Revision of 'Where Medical Records Should Be Stored'" (Medical Affairs Bureau No. 0325-15, Pharmaceutical Affairs Bureau No. 0325-9, and Health Insurance Bureau No. 0325-5, dated March 25, 2013). In this notice, the external storage of medical records, etc. "must ensure the protection of personal information by paying sufficient attention to the protection of patient privacy." The hospitals, clinics, etc. that are obligated to store medical records, etc. shall do so under their own responsibility. In addition, the responsibility for any accidents that may occur must be clearly defined. The following is a description of the requirements for the maintenance of medical records, etc. For details, please refer to this notice.
Reason for revision of opinion
This change was made in accordance with the revision of "Partial Revision of 'Where to Store Medical Records, etc.'".