12Apr2023 Three white papers released by the Archiving and the Decommissioning Team 12 April 2023 Read more Three white papers released by the 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) - 248 download(s) Decommissioning White Paper version PR1(.pdf, 454.21 KB) - 266 download(s) Nature of a Distributed TMF - Practical Aspects PR1(.pdf, 467.86 KB) - 214 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. Documents to download Handbook+Site Form(.pdf, 788.58 KB) - 797 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) - 105 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) - 93 download(s) Read more
24Mar2023 Differences between eSRA V2023 to eSRA V2022 24 March 2023 Read more Differences between eSRA V2023 to eSRA V2022 What has changed? Documents to download Comparison of eSRA V2023 question text with eSRA V2022 question text(.pdf, 161.16 KB) - 89 download(s) Read more
23Mar2023 eCF Requirements for Electronic Data for Regulated Clinical Trials PR2022 23 March 2023 Read more eCF Requirements for Electronic Data for Regulated Clinical Trials PR2022 The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2022" ABOUT THE ECF REQUIREMENTS: The eClinical Forum has produced a set of Requirements,... Documents to download eCF Requirements PR2022 Public Release(.pdf, 1.87 MB) - 167 download(s) Read more