P222: Standardizing Site Documentation to Streamline Clinical Trial Operations in Japan
Poster Presenter
Takahiro Sakai
Chief, Clinical Research Coordinating Section
National Cancer Center Hospital Japan
Objectives
In clinical trial, documentation has historically varied across sponsors and sites, resulting in administrative burden and operational inefficiencies. This project, led by the PMDA, aimed to standardize commonly used clinical trial documents through collaboration with key stakeholders.
Method
Stakeholder input was collected through questionnaire surveys involving 83 clinical trial sites, industry associations (43 pharmaceutical companies), CROs, and SMOs. Based on these inputs, draft templates and operational rules were developed, while consensus was built through discussions with industry stakeholders.
Results
The PMDA proposed draft templates for 11 standardized clinical trial documents, including Delegation Logs, Training Logs, and Screening Logs. Stakeholders from medical institutions and industry associations discussed both the scope of form standardization and the implementation strategy for this initiative. As a result of these discussions, it was agreed that 10 forms would be standardized, excluding the template related to investigational product temperature deviations. Within this project, the 10 forms were further streamlined. The Delegation Log and Site Signature Log were consolidated into a single template, and the Screening Log and Enrollment Log were also integrated into a unified format. Several templates were adopted directly from those published by TransCelerate, while others were developed using TransCelerate templates as a reference. A key principle applied across all proposed templates was to limit the content to the minimum necessary data elements. When additional information was required based on specific trial characteristics, sites were allowed to incorporate such elements as needed. To assess whether these standardized templates could improve operational efficiency in clinical trials, a pilot implementation was conducted in collaboration with pharmaceutical companies and contract research organizations (CROs). A total of 21 trials participated in the pilot phase. Although no participant enrollment occurred during the pilot period, the templates were evaluated for usability and completeness. Minor revisions were made to improve clarity and operational feasibility for use in actual trials.
Conclusion
This project developed ten standardized clinical trial document templates and supporting guidance materials. Because no participants were enrolled in trials using the draft templates during the pilot phase, the impact of these templates on operational efficiency at clinical trial sites has not yet been formally evaluated. Nevertheless, the pilot confirmed the usability of the templates and provided an opportunity to refine their structure and content. The standardized templates are expected to be widely implemented following forthcoming guidance from the Ministry of Health, Labour and Welfare (MHLW). As their adoption expands, additional operational challenges may emerge. Continuous education and dissemination efforts will therefore be essential to ensure that both sponsors and clinical trial sites fully understand and appropriately implement the standardized documentation. After sufficient real-world use has accumulated, it will be important for stakeholders across the clinical trial ecosystem to reassess the templates and evaluate their impact on trial efficiency and operational burden. Co-authers: Yukie KIMURA, Masahiko OZAKI, Tomoka OKANO, Miki ITO, Sho MURATA, Chie MIYANO, Hideki UENO and Yasutoshi KUBOKI
