Drug Evaluation Committee Electronic Detailed Questionnaire for Adverse Event Surveillance (JHPMA electronic model)
Pharmacovigilance Subcommittee
February 2024
However, in response to recent restrictions on visits to medical institutions due to infectious diseases and to reduce the burden on both healthcare professionals and pharmaceutical companies, it is desirable to computerize the detailed survey forms. However, in order to comply with the recent restrictions on visits to medical institutions due to infectious diseases and to reduce the burden on both healthcare professionals and pharmaceutical companies, it is desired to computerize detailed survey forms. However, it is not easy to introduce EDC systems for post-marketing surveillance and clinical trials due to maintenance and management costs and operational issues, and many companies are not making progress.
Therefore, the Pharmacovigilance Subcommittee of the Pharmaceutical Evaluation Committee of the Pharmaceutical Manufacturers Association of Japan (PV Subcommittee KT2) has decided to develop and widely release an electronic detailed survey form in PDF format (the Pharmaceutical Manufacturers Association of Japan Electronic Model (PDF)) as a cost-saving method to conduct detailed surveys electronically. The survey items and format of the electronic model (PDF) were developed based on the paper-based " Detailed Questionnaire for Adverse Reaction Surveillance " (the paper-based model) published on the website of the Pharmaceutical Society of Japan (PSJ). The main features are as follows
- Input check function (expected to reduce the number of resurveys)
- Introduction of a "lock function" (expected to ensure non-tampering)
- Introduction of ICH E2D severity classification (compatible with E2B(R3))
The introduction of the Pharmaceutical Cooperative Electronic Model (PDF) will enable the electronic exchange of information with healthcare professionals other than by hand or mail, and is expected to speed up the process from information collection to evaluation and realize smooth detailed investigations. In the future, it is also expected that the establishment of a system that improves convenience for healthcare professionals, such as a system that enables the extraction of necessary information from electronic medical records, will create an environment in which cooperation in in-depth surveys is more likely to be obtained.
KT2, the PV Subcommittee of the Pharmaceutical Manufacturers Association of Japan, plans to conduct educational activities on the electronic model over a two-year period until March 2026. We believe that the wide use by companies of the Pharmaceutical Affairs Association electronic model (PDF), which standardizes items and specifications, will reduce the burden on healthcare professionals for detailed surveys and make it easier to obtain cooperation for detailed surveys.
- Batch download: Documents related to the Pharmaceutical Cooperative Electronic Model (18MB)
- Electronic Detailed Questionnaire for Adverse Event Surveillance (Jpn e-model) (0.9MB)
- Electronic model (PDF) (5.6MB)
- Template by item (for attachment of drug administration) (1.2 MB)
- Template by item (for attaching adverse events) (0.6 MB)
- Electronic Model (PDF) Manual for Requesters (5.6MB)
- Electronic Model (PDF) Manual for the Pharmaceutical Cooperative Association (4.7 MB)
- Input check specification (55.1KB)
- Input control specifications (50.5 KB)
- Drop-down choices (25.4 KB)
- Other Processing Overview (19.6 KB)
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