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.

 

NEWS FROM THE ECF

eSRA V2024 (eSource-Readiness Assessment) Handbook and Questionnaire

eSRA V2024 (eSource-Readiness Assessment) Handbook and Questionnaire

This is the ONE FILE that you need to perform an eSRA Assessment.

Implementing eSRA - Sponsor Perspective

V2024

Implementing eSRA - Sponsor Perspective

How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2024)

Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

V2024

Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

Differences between eSRA V2024 to eSRA V2023

Differences between eSRA V2024 to eSRA V2023

What has changed?

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Essential Metadata

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.

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Questions from eSRA Users

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.

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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.

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