Drug Evaluation Committee 2007-28 Preservation of original QOL questionnaires completed by subjects
Related classification: Record keeping
Initial release date: 08/2008
Revised release date: Mar 2021
Question
In a global clinical trial, a QOL questionnaire is to be taken from patients. The procedure is that the sponsor obtains the original completed by the patient and a copy is to be stored at the medical institution. We received an opinion from a certain medical institution that the original of such data is to be stored by the medical institution (Mandatory Documentation Notice 40. "etc." is attached to the summary of the original data, but the storage place is only at the medical institution), and that it is not right to submit the original to the sponsor.
Would it be a problem under GCP (or medical care law?) for the sponsor to obtain the original questionnaires, etc. filled out by the subjects in this way? Is this a problem in terms of GCP (or Medical Care Act?)?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
GCP Article 2 Guidance 6 defines "source documents" as "documents, data and records (e.g., hospital records, medical records, laboratory notes, memos, subjects' diaries or evaluation checklists, administration records, data recorded by automatic instruments, etc.) that are the source of information on the factual course of a clinical trial or case report forms, etc." and "source documents" as defined in Paragraph 14 means documents, data and records that are the source of information on the factual course of a clinical trial or case report forms, etc, (e.g., photocopies or transcripts that are certified by verification to be accurate copies, microfiche, photographic negatives, microfilm or magnetic media, radiographs, subject files, and records stored in the drug department, laboratory, or medical technology department involved in the clinical trial)".
Therefore, if the "Quality of Life Questionnaire" is necessary for physicians to make decisions when administering treatment, and if it is the original data to be included in the case report form, the original should naturally be kept at the site of the medical trial. However, from the content of your question, it is considered that the sponsor is the only one to evaluate the data, so if the study protocol clearly states in advance that the sponsor and the site will each keep the original and a copy, and if it is agreed in advance with the site, there is no problem for the sponsor to keep the original. However, the original copy should not be used if the subject can be identified.
However, it goes without saying that the sponsor must obtain the originals after giving consideration to the protection of the subject's privacy, such as by masking information that could identify the subject.
Reason for revision of opinion
In accordance with the revision of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Bureau of Japan, No. 0831-15), some of the referenced clauses and statements of opinion have been changed.