20Apr2021 Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0 20 April 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) - 1406 download(s) Read more
18Mar2021 Public Release: Electronic Informed Consent Implementation Guide Practical Considerations Version 1.0 18 March 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) - 919 download(s) Read more
15Mar2021 eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire 15 March 2021 Read more eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire Version 2021 This is the ONE FILE that you need to perform an eSRA Assessment. Documents to download eSRA Handbook + Site Form V2021.2(.pdf, 751.18 KB) - 157 download(s) Read more
15Mar2021 Implementing eSRA: Sponsor Perspective 15 March 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) - 957 download(s) Read more
15Mar2021 What is the difference between the eSRA 2020 and eSRA 2021? 15 March 2021 Read more What is the difference between the eSRA 2020 and eSRA 2021? Documents to download Comparison of eSRA V2021 question text with eSRA V2020 question text(.pdf, 264.33 KB) - 606 download(s) Read more
10Mar2021 eCF Requirements for Electronic Data for Regulated Clinical Trials PR2020 10 March 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) - 1031 download(s) Read more