20May2024 Japanese translation of eSRA V2024 20 May 2024 Read more Japanese translation of eSRA V2024 Version 2024JP1 (20-May-2024) Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳) Documents to download Handbook+Site-Form-V2024JP1(.pdf, 1010.78 KB) - 447 download(s) Read more
2Apr2024 eSRA V2024 (eSource-Readiness Assessment) Handbook and Questionnaire 02 April 2024 Read more eSRA V2024 (eSource-Readiness Assessment) Handbook and Questionnaire This is the ONE FILE that you need to perform an eSRA Assessment. Documents to download eSRA-Handbook+Questionnaire-V2024(.pdf, 793.52 KB) - 3246 download(s) Read more
2Apr2024 Investigator Site File System Assessment V2024 Handbook and Questionnaire 02 April 2024 Read more Investigator Site File System Assessment V2024 Handbook and Questionnaire This is the ONE FILE that you need to perform an ISF Assessment. Documents to download eCF-ISF-System-Assessment-Handbook+Form-V2024.1(.pdf, 855.86 KB) - 3263 download(s) Read more
31Jan2024 Implementing eSRA - Sponsor Perspective 31 January 2024 Read more Implementing eSRA - Sponsor Perspective How to assess site's systems for appropriateness of use for regulated clinical research. (Applies to both eSRA and ISF Assessment 2024.) Documents to download eCF-eSRA-Sponsor-Guide-V2024.2(.pdf, 616.94 KB) - 383 download(s) Read more
31Jan2024 Regulatory documents used as a basis for the eClinical Forum Site Assessment Forms (eSRA and ISF Assessment) 31 January 2024 Read more Regulatory documents used as a basis for the eClinical Forum Site Assessment Forms (eSRA and ISF Assessment) Documents to download Regulatory-documents-used-as-a-basis-for-the-eClinical-Forum-eSRA-and-ISF-Assessments-V2024(.pdf, 363.19 KB) - 332 download(s) Read more
31Jan2024 Differences between eSRA V2024 to eSRA V2023 31 January 2024 Read more Differences between eSRA V2024 to eSRA V2023 What has changed? Documents to download Comparison-of-eSRA-V2024-question-text-with-eSRA-V2023-question-text(.pdf, 152.2 KB) - 156 download(s) Read more