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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.
Investigators are frequently asked to complete sponsor-specific assessments of their EHR systems to enable sponsors to evaluate clinical trial data that will be sourced from these systems. The eClinical Forum has developed a free, standard tool that can help sites to do this quickly, easily, and once for all sponsors.
This presentation provides an overview of the assessment tool and information on access and use.
Key points:
It is important that electronic health record systems (EHRS) that will supply source data for clinical research be designed and maintained to meet regulatory requirements. Sponsors bear the responsibility for ensuring that data sourced from these systems are acceptable. As a result investigators are frequently being asked to complete sponsor-specific assessments of their EHR systems.
The eClinical Forum, a non-commercial, global organization has developed a free and standard self-assessment tool that can help sites to do this quickly, easily, and once for all sponsors. With the aid of information provided by their EHR vendor, the site can quickly identify if its system and/or processes are compliant with research regulations or if additional processes need to be put into place.
Using this assessment tool will enable sponsors to evaluate and manage risk. Regulators and sponsors should feel confident in the quality of eSource coming from assessed sites.
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New eCF ISF System Assessment!
eClinical Forum now has 2 FREE assessment forms for sites to self-assess their systems for use in regulated clinical trials. We are excited to release the first version of the “ISF System Assessment”. This assessment form is very similar to our eSource-Readiness Assessment (eSRA) and is, like eSRA, based on regulatory documents from regulators around the globe.
(16/04/2024 - 18/04/2024)
eCF Spring Workshop in Ridgefield, Connecticut USA
Registration is open for the eCF Spring Workshop, kindly hosted by Boehringer Ingelheim at their Ridgefield, Connecticut campus on April 30 to May 3, 2024.