5May2021 eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here Wednesday, May 5, 2021 Read more eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here The eClinical Forum is pleased to offer a recording of our free public webinar – the same as was presented to the FDA CDER Health IT Board on 6-April-2021 – to provide information on our 2 free tools: The “eCF Requirements”... Documents to download eCF Reqs for CR Systems and eSRA Public Webinar 28-Apr-2021(.mp4, 167.92 MB) - 56 download(s) Read more
20Apr2021 Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0 Tuesday, April 20, 2021 Read more Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0 The Society for Clinical Data Management (SCDM) and eClinical Forum (eCF) Joint Task Force are pleased to announce the publication of an industry position paper “AUDIT TRAIL REVIEW: A KEY TOOL TO ENSURE DATA INTEGRITY” final version based... Documents to download 2021 eCF_SCDM ATR Industry Position Paper - Version PR1(.pdf, 2.35 MB) - 460 download(s) Read more
18Mar2021 Public Release: Electronic Informed Consent Implementation Guide Practical Considerations Version 1.0 Thursday, March 18, 2021 Read more Public Release: Electronic Informed Consent Implementation Guide Practical Considerations Version 1.0 The EUCROF and eClinical Forum Electronic Informed Consent (eConsent) Joint Task Force are pleased to announce the publication of the eConsent Implementation Guide (version 1). The joint task force was formed in 2019 with a view to look at some of the... Documents to download Electronic Informed Consent Implementation Guide Practical Considerations Version 1.0 _ March 2021(.pdf, 1.71 MB) - 340 download(s) Read more
15Mar2021 Implementing eSRA: Sponsor Perspective Monday, March 15, 2021 Read more Implementing eSRA: Sponsor Perspective How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2021) Documents to download eCF eSRA Sponsor Guide V2021(.pdf, 785.71 KB) - 360 download(s) Read more
14Mar2021 JAPANESE TRANSLATION of eSRA Handbook and Webinar Sunday, March 14, 2021 Read more JAPANESE TRANSLATION of eSRA Handbook and Webinar This is the 2021JP1 version. Documents to download eSRA Handbook+Site Form V2021JP1(.pdf, 1.53 MB) - 201 download(s) eCF eSRA Rel 2020 Handbook V2 JP2+(.pdf, 1.26 MB) - 374 download(s) Read more
10Mar2021 eCF Requirements for Electronic Data for Regulated Clinical Trials PR2020 Wednesday, March 10, 2021 Read more eCF Requirements for Electronic Data for Regulated Clinical Trials PR2020 The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2020" ABOUT THE ECF REQUIREMENTS: The eClinical Forum has produced a set of Requirements,... Documents to download eCF Requirements PR2020 Public Release V1.1(.pdf, 772.47 KB) - 355 download(s) Read more