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) - 420 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) - 218 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) - 902 download(s) Read more
7Apr2022 Members Release: Best Practice Document on Investigator’s Signature 07 April 2022 Read more Members Release: 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), MR2022”. About the Best Practice Document: There is increased scrutiny by regulatory agencies on the... Documents to download eCF_BestPractices_Inv_Signature_version_MR2(.pdf, 364.68 KB) - 849 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) - 432 download(s) Read more
31Mar2022 eSRA V2022 (eSource Readiness Assessment) Handbook and Assessment Questionnaire 31 March 2022 Read more eSRA V2022 (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) - 2935 download(s) Read more