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) - 596 download(s) Read more
1Oct2022 Best Practice Document on Investigator’s Signature 01 October 2022 Read more Best Practice Document on Investigator’s Signature The eClinical Forum is happy to announce the release of the "Investigator’s signature on electronic Case Report Forms (eCRFs), PR2.1" About the Best Practice Document: There is increased scrutiny by regulatory agencies on the... Documents to download eCF_BestPractices_Inv_Signature_version_PR2.1(.pdf, 361.56 KB) - 1928 download(s) Read more
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) - 2151 download(s) Read more
4Apr2022 Member Release: "Requirements for Electronic Data for Regulated Clinical Trials" MR2023 04 April 2022 Read more Member Release: "Requirements for Electronic Data for Regulated Clinical Trials" MR2023 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 Requirements MR2023 Members Release V2(.pdf, 1.42 MB) - 275 download(s) Read more
8Mar2022 MEMBERS: Submission of comments to FDA on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations 08 March 2022 Read more MEMBERS: Submission of comments to FDA on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations The eClinical Forum RWE Team discussed Docket No. FDA-2021-D-1128 “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability”.... Documents to download eClinical Forum Comments on FDA CDER DHT Draft Guidance FDA-2021-D-1128(.pdf, 869.23 KB) - 366 download(s) Read more
26Aug2021 eSRA was used in a Japanese research paper on data quality of medical information systems 26 August 2021 Read more eSRA was used in a Japanese research paper on data quality of medical information systems Medical Informatics (Japan Society for Medical Informatics) article on use of eSRA to assess the requirements of the Japan MHLW's "Guideline on security management for medical information systems." Read more