This guideline provides additional information to sponsors/CROs evaluating the use of eSRA forms for their organisation.

Comparison of V2026 to V2025 for both Form/S (eSource) and Form/F (eFile) and mapping to regulatory authority document statements

The one file you will need to complete an assessment of your e-Source or e-File systems.

の日本語版2025.2JP1が2025年6月30日にリリースされました。

The one file you will need to complete an assessment of your e-Source or e-File systems.

This guideline provides additional information to sponsors/CROs evaluating the use of eSRA forms for their organisation.

Comparison of V2025 to V2024 for both Form/S (eSource) and Form/F (eFile) and mapping to regulatory authority document statements

This is a categorised list of questions sent in from eSRA users (sites, sponsors, CROs) with the response from the eClinical Forum eSRA Team.

Step-by-step with screen shots

Medical Informatics (Japan Society for Medical Informatics) article on use of eSRA to assess the requirements of the Japan MHLW's "Guideline on security management for medical information systems."

Voluntary Investigator Site Survey survey concluded with 528 responses.