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WHO WE ARE
The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
How to assess site's systems for appropriateness of use for regulated clinical research. (Applies to both eSRA and ISF Assessment 2024.)
What has changed?
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Essential Metadata
The goal is to produce a list and description of the essential metadata required to be able to reenact the events of the trial.
Questions from eSRA Users
This is a categorised list of questions sent in from eSRA users (sites, sponsors, CROs) with the response from the eClinical Forum eSRA Team.
eClinical Forum has released the 2024 version of their “eSource Readiness Assessment” – eSRA
It is a response to the growing expectation by regulatory agencies for clinical trial sponsors to verify that clinical research site systems (e.g., EHRs) comply with requirements to protect confidentiality and provide accurate and reliable data for the use in a regulated research environment. V2024 includes updates based on the EMA Guideline on computerised systems and electronic data in clinical trials.