26Feb2021 Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1 Friday, February 26, 2021 Read more Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1 The eClinical Forum is happy to announce the public release of a position paper titled “Decentralized TMF Archives and The Decommissioning Of Computerised Systems Used In Clinical Trials”. This position paper was written by a joint... Documents to download Archiving Position Paper version PR1(.pdf, 1.1 MB) - 12 download(s) Read more
13Jul2020 NEW!!! JAPANESE TRANSLATION of eSRA Handbook and Webinar Monday, July 13, 2020 Read more NEW!!! JAPANESE TRANSLATION of eSRA Handbook and Webinar The eClinical Forum is pleased to announce that their eSource-Readiness Assessment (eSRA) Handbook has been translated to Japanese. While the eSRA questionnaire V2020 has not changed and is still required to be completed in English, the Japanese... Documents to download eCF eSRA Rel 2020 Handbook V2 JP2+(.pdf, 1.26 MB) - 67 download(s) Read more
12Mar2020 eCF Requirements for Electronic Data for Regulated Clinical Trials V2019PR Thursday, March 12, 2020 Read more eCF Requirements for Electronic Data for Regulated Clinical Trials V2019PR The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2019PR” The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design,... Documents to download eCF_Requirements_v2019_Pubilc_Release(.pdf, 1.34 MB) - 37 download(s) Read more
19Dec2019 Implementing eSRA: Sponsor Perspective Thursday, December 19, 2019 Read more Implementing eSRA: Sponsor Perspective This document is written specifically for Sponsors to assist them in determining how to fit eCF's eSource-Readiness Assessment (eSRA) into their procedures for determining if data which originated on a site's electronic health record... Documents to download eCF eSRA Sponsor Document R2019(.pdf, 885.17 KB) - 38 download(s) Read more
15Jul2019 Applied Clinical Trials publishes article on eCF Requirements Monday, July 15, 2019 Read more Applied Clinical Trials publishes article on eCF Requirements Applied Clinical Trials has published an article highlighting the eClinical Forum “Requirements for Electronic Data for Regulated Clinical Trials” (or simply, “eCF Requirements”:... Documents to download ACT Article Keeping Up with the Regulatory Expectations July 2019(.pdf, 778.99 KB) - 20 download(s) Read more
29Mar2019 Requirements for Electronic Data for Regulated Clinical Trials V2018PR Friday, March 29, 2019 Read more Requirements for Electronic Data for Regulated Clinical Trials V2018PR The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2018PR”. This is a project the eCF REG team has been working on for a long time and is excited to now be sharing. ABOUT THE ECF... Documents to download eCF_Requirements_PUBLIC_V2018PR(.pdf, 1.05 MB) - 26 download(s) Read more