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) - 1281 download(s) eCF-Requirements-v2019-Pubilc-Release(.pdf, 1.34 MB) - 1173 download(s) eCF-Requirements-PR2020-Public-Release-V1.1(.pdf, 772.47 KB) - 2301 download(s) eCF-Requirements-PR2021-Public-Release-1.0(.pdf, 1.52 MB) - 2017 download(s) eCF-Requirements-PR2022-Public-Release(.pdf, 1.87 MB) - 1161 download(s) eCF-Requirements-PR2023-Public-Release-V1(.pdf, 1.85 MB) - 1385 download(s) eCF-Requirements-PR2023-Public-Release-V3(.pdf, 1.97 MB) - 8903 download(s) Read more
2Oct2023 AI state-of-play around clinical research 02 October 2023 Read more AI state-of-play around clinical research The regulatory overview presented in this paper shows that while regulations are far from final for all use cases, the US and Europe have made the biggest steps toward monitoring and facilitating the use of AI, and regulations are in development in... Documents to download AI state-of-play around clinical research_15Sep23 _vPR1_Approved by eCF for Release 28Oct23(.pdf, 1.61 MB) - 156 download(s) Read more
1Oct2022 Best Practice Document on Investigator’s Signature 01 October 2022 Read more Best Practice Document on Investigator’s Signature The eClinical Forum is happy to announce the release of the "Investigator’s signature on electronic Case Report Forms (eCRFs), PR2.1" About the Best Practice Document: There is increased scrutiny by regulatory agencies on the... Documents to download eCF_BestPractices_Inv_Signature_version_PR2.1(.pdf, 361.56 KB) - 10153 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) - 10208 download(s) Read more
31Oct2019 RESULTS: Investigator Site Survey 31 October 2019 Read more RESULTS: Investigator Site Survey Voluntary Investigator Site Survey survey concluded with 528 responses. Documents to download Print Version of Online Survey(.pdf, 559.45 KB) - 2017 download(s) Investigational Site Survey - Information(.pdf, 54.15 KB) - 1852 download(s) Site Survey Results_October 2019(.pdf, 3.32 MB) - 1832 download(s) Read more
20Nov2015 eCF Releases Key Documents and Tools 20 November 2015 Read more eCF Releases Key Documents and Tools The eCF is releasing 3 documents via the eCF website “Members” area (un/pw required). Please feel free to download them and share with other members of your company. Read more