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) - 1230 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) - 119 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) - 58 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) - 68 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, 573.08 KB) - 151 download(s) Read more
30Jan2024 Questions from eSRA Users 30 January 2024 Read more Questions from eSRA Users This is a categorised list of questions sent in from eSRA users (sites, sponsors, CROs) with the response from the eClinical Forum eSRA Team. Documents to download eSRA-QandA-V2024(.pdf, 625.93 KB) - 121 download(s) Questions-posed-to-eSRA-Team(.pdf, 181.87 KB) - 108 download(s) Read more