25Nov2024 Japanese translation of Inv Site File Assessment V2024 25 November 2024 Read more Japanese translation of Inv Site File Assessment V2024 Version 2024JP1: 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) - 929 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) - 623 download(s) eCF-Requirements-v2019-Pubilc-Release(.pdf, 1.34 MB) - 552 download(s) eCF-Requirements-PR2020-Public-Release-V1.1(.pdf, 772.47 KB) - 740 download(s) eCF-Requirements-PR2021-Public-Release-1.0(.pdf, 1.52 MB) - 751 download(s) eCF-Requirements-PR2022-Public-Release(.pdf, 1.87 MB) - 588 download(s) eCF-Requirements-PR2023-Public-Release-V1(.pdf, 1.85 MB) - 588 download(s) eCF-Requirements-PR2023-Public-Release-V3(.pdf, 1.97 MB) - 2080 download(s) Read more
20May2024 Japanese translation of eSRA V2024 20 May 2024 Read more Japanese translation of eSRA V2024 Version 2024JP1: Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳) Documents to download Handbook+Site-Form-V2024JP1(.pdf, 1010.78 KB) - 1570 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) - 8159 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) - 9546 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) - 1658 download(s) Investigational Site Survey - Information(.pdf, 54.15 KB) - 1538 download(s) Site Survey Results_October 2019(.pdf, 3.32 MB) - 1506 download(s) Read more