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The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
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Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)
Member Release: "Requirements for Electronic Data for Regulated Clinical Trials" MR2023
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 clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial. We have reviewed regulatory documents from the FDA, EMA, PMDA, MHRA, NMPA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if systems that data which will become part of a regulated clinical trial are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.
eCF Technology Showcase: eClinical Solutions - "Leveraging a Digital Accelerator
eClinical Solutions Technology Showcase: As the volume, variety and velocity of data sources available for use in clinical research have grown, the need has arisen for a modern data infrastructure that automates data processes from ingestion through submissions. 75% of Life Sciences companies are still using Excel and SAS to integrate data sources slowing time to insight for data review teams, reducing collaboration and extending traditional cycle time metrics like LPLV to DBL.
eClinical Solutions, and eClinical Forum Member company, offer elluminate Clinical Data Cloud as a foundation of modern digital trials. This session will demonstrate the numerous capabilities in the platform that replace manual processes in the data lifecycle. They will share frequent uses cases and the business outcomes data management, medical monitoring, statistical analysis and clinical programming and clinical operations teams experience when using the elluminate Clinical Data Cloud.
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 collection of investigator’s signatures as evidence of the overall oversight on the eCRF is reported to the sponsor. eClinical Forum PI Signature Working Group was formed in March 2021 to update the best practice document originally issued in 2017 by identifying best practices that are based on compliance to regulatory requirements and on risks such as reputation, credibility, legal liability of the data being used by the sponsor.
eCF BoF Webinar: Principal Investigator's Signature: Best Practices
The eCF’s PI Signature Working Group have updated their 3-year-old document which is released to eCF Members in early April. They will introduce the 2022 changes to the best practice document for Investigator’s signature on electronic Case Report Forms (eCRFs). Participants are encouraged to share their thoughts on:
- how to provide continuous monitoring of regulatory expectations;
- sharing members’ experience on implementation and regulatory findings (if any);
- brainstorming for an industry definition of the “meaning” of signature on data reported to sponsors during both traditional and non-traditional clinical trials.
Presenters: eCF PI Signature Team Leaders: Cinzia Piccinia (Eli Lilly) and Babette von Hagen (CSL Behring)
eCF Technology Showcase: Veeva Systems “End-to-End Clinical Data: Connecting Patients, Sites, and Sponsors”
This is an eClinical Forum Technology Showcase. Our Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services. Veeva Systems, an eClinical Forum member company, will showcase their end-to-end solution for patients, sites, and sponsors. The eClinical Forum does not promote nor endorse any particular technology vendors.