Drug Evaluation Committee 2008-33 Conclusion of Additional Memorandum of Understanding and Submission of Written Oath Concerning the Protection of Personal Information of Subjects
Related classification: Other
Initial release date: Mar. 2009
Revised publication date: Mar. 2021
Question
In the conduct of clinical trials, sufficient consideration is required for the protection of patients' personal information, and the sponsor should be aware of this, especially during direct inspection. However, medical institutions are required to conclude a memorandum of understanding in a separate form and submit an application form for direct inspection and a written oath of the monitor to the director for all direct inspections, despite the fact that the head of the medical institution and the sponsor (including CRO) have concluded a confidentiality protection clause in the contract.
Please tell us how to deal with the submission of a memorandum of understanding and a monitor's written oath regarding the contents of the clinical trial agreement, which are not considered to be necessary, from the perspective of improving the efficiency of the clinical trial for the medical institution concerned.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 80-2, Paragraph 10 of the Act on Quality, Efficacy and Safety Assurance of Pharmaceuticals, Medical Devices and Other Products (Pharmaceuticals and Medical Devices Act) stipulates that "The person who requested the clinical trial or who conducted the clinical trial himself/herself or his/her officers or employees shall not divulge any secret of a person who came to know in the course of his/her duties concerning the clinical trial without a just cause. The same shall apply to persons who have been such persons." The regulations require retired persons to maintain confidentiality as well. Those who violate this provision are subject to imprisonment for not more than six months or a fine of not more than 300,000 yen (Article 86-3 of the Pharmaceutical Affairs Law).
In addition, Article 13, Paragraph 1, Guidance 6 of the GCP states, "'Matters concerning preservation of confidentiality of subjects' means that, pursuant to Article 80-2, Paragraph 10 of the Act, the sponsor or its officers or employees shall not divulge any secrets of subjects obtained during monitoring or auditing, and that the same shall apply to persons in these positions. The relevant clauses in the clinical trial agreement are not uniform, but the confidentiality of subjects is clearly stipulated. Therefore, as you pointed out, it is not necessarily necessary to conclude a separate memorandum of understanding or to submit a written pledge by the monitors, etc. Therefore, it would be necessary to confirm the necessity of concluding a memorandum of understanding or submitting a written pledge with the medical institution, and if there is no particular reason, it would be necessary to explain the above and try to gain their understanding. The following is a brief explanation of the above.
Regarding the application form for direct inspection, we believe that it is better to have a form for mutual communication between the monitor and the CRC, etc., in order to avoid problems such as not being able to confirm the date and time of inspection or the subject cases (source documents), or because some medical institutions require procedures such as shipping out medical records, etc. Therefore, a unified form, Reference Form 2 (Direct Inspection Contact Form), was created. However, this form is for reference only, and if the content of the form is reliably communicated to the clinical trial office, it may be sufficient to communicate by fax or email.
Reason for revision of opinion
With the enforcement of the Pharmaceutical Affairs Act (November 25, 2014), minor changes were made to the description.