Drug Evaluation Committee 2009-32 Version Control of the Performing Medical Institution Procedure Manual (Part 2)
Related classification: Other
First published: January 2010
Question
A medical institution, which had previously conducted a clinical trial with the support of another SMO, has decided to support a study for the first time (this is the second study to be conducted at the medical institution).
When we asked them to present their SOPs for confirmation, they replied that they had not conducted a clinical trial for about 5 years since the last one, and that they had lost their SOPs due to the relocation of the hospital during this period. In addition, the SMO that previously supported the company went out of business several years ago, and it is no longer possible to obtain information from the SMO.
Since the examination had been conducted previously, it is certain that the first edition of the SOP (first version) exists, but we have no information on the location of the SOP (first version) of the medical institution in question or the date it was enacted.
We have no experience in dealing with such a case, and we are wondering what we should do about version control when preparing SOPs. The following opinions have been raised as a response to this case. What kind of version management is desirable in the future as a response to the loss of SOPs?
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1.Establish a new first edition of the SOP (first edition) since the past SOP (first edition) cannot be located and information cannot be confirmed.
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2.(Since the date of enactment of the first edition cannot be stated in the revision history, a second edition is created after stating in the revision history that the first edition existed in the past but was lost (or the date of enactment is unknown, etc.).
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stated in the 2008-30 "Questions and Opinions on Clinical Trial 119," there are no rules in GCP regarding the number of versions of SOPs for the site of conducting medical institutions.
The person in charge of record keeping at the site is required to keep records in accordance with Article 41 of the GCP. The SOP of the site also falls under this category, so if the retention period for the clinical trial at that time has not yet expired, it is necessary to inform the sponsor of the clinical trial and create a record of the circumstances of the loss. At this time, if the sponsor has a copy of the SOP and retains it, it may be a good idea to retain a copy of the SOP in place of the sponsor's copy.