12Apr2023 Three white papers released by the eCF/EUCROF Archiving and the Decommissioning Team 12 April 2023 Read more Three white papers released by the eCF/EUCROF Archiving and the Decommissioning Team The Archiving and Decommission Team is pleased to announce the public release of three white papers: "The Decommissioning of Computerised Systems Used in Clinical Trials" "Nature of a Distributed Trial Master File ‐... Documents to download Formats White Paper PR1(.pdf, 472.09 KB) - 3540 download(s) Decommissioning White Paper version PR1(.pdf, 454.21 KB) - 3565 download(s) Nature of a Distributed TMF - Practical Aspects PR1(.pdf, 467.86 KB) - 3144 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) - 2784 download(s) Read more
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) - 8488 download(s) Read more
26Feb2021 Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1 26 February 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) - 5256 download(s) Read more