9May2022 Japanese translation of eSRA V2022 09 May 2022 Read more Japanese translation of eSRA V2022 Version 2022.1JP1 (10-May-2022) Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳) Documents to download Handbook+Site Form V2022.1JP1(.pdf, 899.47 KB) - 74 download(s) Read more
7Apr2022 Members Release: Best Practice Document on Investigator’s Signature 07 April 2022 Read more Members Release: 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), MR2022”. About the Best Practice Document: There is increased scrutiny by regulatory agencies on the... Documents to download eCF_BestPractices_Inv_Signature_version_MR2(.pdf, 364.68 KB) - 76 download(s) Read more
4Apr2022 Member Release: "Requirements for Electronic Data for Regulated Clinical Trials" MR2022 04 April 2022 Read more Member Release: "Requirements for Electronic Data for Regulated Clinical Trials" MR2022 ABOUT THE ECF REQUIREMENTSThe eClinical Forum has updated their set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support... Documents to download eCF Reqs MR2022 Members Release(.pdf, 1.32 MB) - 35 download(s) Read more
31Mar2022 eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire 31 March 2022 Read more eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire Version 2022 (31-March-2022) This is the ONE FILE that you need to perform an eSRA Assessment. Documents to download Handbook+Site Form V2022.1(.pdf, 1023.14 KB) - 577 download(s) Read more
31Mar2022 Implementing eSRA: Sponsor Perspective 31 March 2022 Read more Implementing eSRA: Sponsor Perspective How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2022) Documents to download eCF eSRA Sponsor Guide V2022(.pdf, 756 KB) - 108 download(s) Read more
30Mar2022 Difference between eSRA V2022 and eSRA V2021 30 March 2022 Read more Difference between eSRA V2022 and eSRA V2021 Documents to download Comparison of eSRA V2022 question text with eSRA V2021 question text(.pdf, 140.12 KB) - 97 download(s) Read more