1Jul2022 Public Release: English Translation of V2.00 of Japan EDC Management Sheet 01 July 2022 Read more Public Release: English Translation of V2.00 of Japan EDC Management Sheet The Regulatory Expert Group is happy to announce the release of the English translation of the JPMA EDC Management Sheet v2.00. EDC Management Sheet is a tool by which Japan Pharmaceuticals and Medical Devices Agency (PMDA)... Documents to download PMDA EDC Management Sheet v2.0 – Unverified eCF English translation EN2.02(.xlsx, 64.9 KB) - 106 download(s) Read more
9May2022 Japanese translation of eSRA V2022 09 May 2022 Read more Japanese translation of eSRA V2022 Version 2022.1JP1 (10-May-2022) Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳) Documents to download Handbook+Site Form V2022.1JP1(.pdf, 899.47 KB) - 614 download(s) Read more
4Apr2022 eCF Requirements for Electronic Data for Regulated Clinical Trials PR2021 04 April 2022 Read more eCF Requirements for Electronic Data for Regulated Clinical Trials PR2021 The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2021" ABOUT THE ECF REQUIREMENTS: The eClinical Forum has produced a set of Requirements,... Documents to download eCF Requirements PR2021 Public Release 1.0(.pdf, 1.52 MB) - 625 download(s) Read more
4Apr2022 Member Release: "Requirements for Electronic Data for Regulated Clinical Trials" MR2022 04 April 2022 Read more Member Release: "Requirements for Electronic Data for Regulated Clinical Trials" MR2022 ABOUT THE ECF REQUIREMENTSThe eClinical Forum has updated their set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support... Documents to download eCF Reqs MR2022 Members Release(.pdf, 1.32 MB) - 269 download(s) Read more
31Mar2022 eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire 31 March 2022 Read more eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire Version 2022.2 (25-May-2022; only the license agreement for those re-using in another form has been updated) This is the ONE FILE that you need to perform an eSRA Assessment. Documents to download eSRA Handbook+Site Form V2022.2(.pdf, 1.31 MB) - 2126 download(s) Read more
31Mar2022 Implementing eSRA: Sponsor Perspective 31 March 2022 Read more Implementing eSRA: Sponsor Perspective How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2022) Documents to download eCF eSRA Sponsor Guide V2022(.pdf, 756 KB) - 457 download(s) Read more