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) - 63 download(s) eCF-Requirements-v2019-Pubilc-Release(.pdf, 1.34 MB) - 53 download(s) eCF-Requirements-PR2020-Public-Release-V1.1(.pdf, 772.47 KB) - 58 download(s) eCF-Requirements-PR2021-Public-Release-1.0(.pdf, 1.52 MB) - 56 download(s) eCF-Requirements-PR2022-Public-Release(.pdf, 1.87 MB) - 59 download(s) eCF-Requirements-PR2023-Public-Release-V1(.pdf, 1.85 MB) - 52 download(s) eCF-Requirements-PR2023-Public-Release-V3(.pdf, 1.97 MB) - 70 download(s) Read more
15Jul2024 Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”) 15 July 2024 Read more Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”) The eClinical Forum is releasing its 7th public version of the “eCF Requirements” which takes all of the requirements and guidance directions that pertain to electronic data and electronic systems that support clinical research, from FDA,... Documents to download eCF-Requirements-PR2023-Public-Release-V3(.pdf, 1.97 MB) - 209 download(s) Read more
5Jul2024 2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”) 05 July 2024 Read more 2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”) The "eCF Requirements" Members Release V2024 has been released. This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over many years to... Read more
20May2024 Japanese translation of eSRA V2024 20 May 2024 Read more Japanese translation of eSRA V2024 Version 2024JP1 (20-May-2024) Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳) Documents to download Handbook+Site-Form-V2024JP1(.pdf, 1010.78 KB) - 689 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) - 5382 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) - 2751 download(s) Read more