25Nov2024 Japanese translation of Inv Site File Assessment 25 November 2024 Read more Japanese translation of Inv Site File Assessment Version 2024JP1 (25-Nov-2024) Japanese translation of ISF Assessment Handbook and Assessment Questionnaire (ISFA日本語訳) Documents to download Japanese-translation-eCF-ISF-Assessment-Handbook-V2024-JP1(.pdf, 899.5 KB) - 18 download(s) Read more
8Nov2024 Requirements for Electronic Data for Regulated Clinical Trials - "eCF Requirements" past public releases 2018 - 2023 08 November 2024 Read more The eCF REG team puts out a yearly version of the "eCF Requirements" which many orgainizations use to check compliance of their systems against regulatory authority document statements. The previous versions have been requested in order to... Documents to download eCF-Requirements-PUBLIC-V2018PR(.pdf, 1.05 MB) - 91 download(s) eCF-Requirements-v2019-Pubilc-Release(.pdf, 1.34 MB) - 74 download(s) eCF-Requirements-PR2020-Public-Release-V1.1(.pdf, 772.47 KB) - 94 download(s) eCF-Requirements-PR2021-Public-Release-1.0(.pdf, 1.52 MB) - 73 download(s) eCF-Requirements-PR2022-Public-Release(.pdf, 1.87 MB) - 94 download(s) eCF-Requirements-PR2023-Public-Release-V1(.pdf, 1.85 MB) - 82 download(s) eCF-Requirements-PR2023-Public-Release-V3(.pdf, 1.97 MB) - 100 download(s) Read more
4Sep2024 Digital Health Technologies Governance 04 September 2024 Read more Digital Health Technologies Governance This group will develop standard approaches, processes, expectations - generate minimum standards for us to meet the opinions of global regulators. Address the problem of generic regulations and create industry guidelines more tangible and... Read more
16Jul2024 Audit Trail Review Analytics (ATRA) 16 July 2024 Read more Audit Trail Review Analytics (ATRA) Team started in August 2024. The goal is to review, prioritize and standardize the audit trail review data checks based on the eCF ATR position paper (2021) and create a list of high impact checks that can be implemented by sponsor... Read more
29Jan2024 Essential Metadata 29 January 2024 Read more Essential Metadata The goal is to produce a list and description of the essential metadata required to be able to reenact the events of the trial. Read more
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) - 3539 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