Drug Evaluation Committee 2013-22 Standard Operating Procedures for Medical Practitioners in Networks

Related classification: Other

Initial release date: September 2013
Revised publication date: December 2016

Question

Our company is working on network-type clinical trials at medical institutions in the surrounding areas. As stated in the "Five-Year Plan for the Revitalization of Clinical Research and Clinical Trials 2012," we are attempting to standardize SOPs to improve efficiency in order to promote the network, but we are struggling to unify the intentions of each medical institution.

Therefore, we are considering the possibility of creating separate SOPs for conducting networked clinical trials. Is it possible to use each institution's SOP as the main SOP and use a separate SOP (SOP for network clinical trials) when conducting a network clinical trial? Or should the SOPs of each medical institution be unified?

Opinion of the Pharmaceutical Manufacturers Association

As stated in Article 36 Guidance 1 of the GCP, SOPs for medical institutions are established to ensure that operations related to clinical trials are carried out consistently, uniformly, and appropriately. If SOPs unique to each medical institution and SOPs for conducting network-type clinical trials are mixed, it is likely to cause confusion and heterogeneity in operational procedures. Therefore, we believe that it is desirable to unify the SOPs for network-type clinical trials into one SOP.

On the other hand, if it is difficult to unify the intention of each medical institution to use one SOP, it may be acceptable to use different SOPs for each clinical trial for the time being, by giving sufficient consideration to the system to operate two SOPs at the same time, such as thorough prior education of relevant personnel, to avoid confusion and heterogeneity in the work procedures. For the time being, however, we believe that using different SOPs for each clinical trial will not be a problem. However, in the future, it is desirable to unify the SOPs for networked clinical trials.

The "Five-Year Plan for the Revitalization of Clinical Research and Clinical Trials 2012," issued by the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health, Labour and Welfare on March 30, 2012, states that "In a clinical trial network, multiple medical institutions should be built into a system that can function as if they were one medical institution. In order for a clinical trial network to function effectively, it is necessary, at a minimum, to: 1) create SOPs and standardize various forms, 2) establish and utilize joint IRBs and other bodies capable of conducting high-quality reviews, and 3) have an active management function for the clinical trial network secretariat.

Reason for revision of opinion

The description has been reviewed and partially revised.

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