17Sep2023 Japanese translation of eSRA V2023 17 September 2023 Read more Japanese translation of eSRA V2023 Version 2023.2JP1 (18-Sep-2023) Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳) Documents to download Handbook+Site Form V2023.2JP1(.pdf, 1.05 MB) - 330 download(s) Read more
12Apr2023 Three white papers released by the eCF/EUCROF Archiving and the Decommissioning Team 12 April 2023 Read more Three white papers released by the eCF/EUCROF Archiving and the Decommissioning Team The Archiving and Decommission Team is pleased to announce the public release of three white papers: "The Decommissioning of Computerised Systems Used in Clinical Trials" "Nature of a Distributed Trial Master File ‐... Documents to download Formats White Paper PR1(.pdf, 472.09 KB) - 773 download(s) Decommissioning White Paper version PR1(.pdf, 454.21 KB) - 900 download(s) Nature of a Distributed TMF - Practical Aspects PR1(.pdf, 467.86 KB) - 747 download(s) Read more
24Mar2023 eSRA V2023 (eSource-Readiness Assessment) Handbook and Questionnaire 24 March 2023 Read more eSRA V2023 (eSource-Readiness Assessment) Handbook and Questionnaire This is the ONE FILE that you need to perform an eSRA Assessment. This 2023.2 version has a correction as the previous version incorrectly had two question 26. (July 1, 2023) Documents to download eCF eSRA Handbook+Questionnaire V2023.2(.pdf, 1.05 MB) - 1889 download(s) Read more
24Mar2023 Implementing eSRA - Sponsor Perspective 24 March 2023 Read more Implementing eSRA - Sponsor Perspective How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2023) Documents to download eCF eSRA Sponsor Guide V2023(.pdf, 754.27 KB) - 453 download(s) Read more
24Mar2023 Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA) 24 March 2023 Read more Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA) Documents to download Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment V2023(.pdf, 297.97 KB) - 439 download(s) Read more
24Mar2023 Differences between eSRA V2023 to eSRA V2022 24 March 2023 Read more What has changed? Documents to download Comparison of eSRA V2023 question text with eSRA V2022 question text(.pdf, 161.16 KB) - 389 download(s) Read more