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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.

 

NEWS FROM THE ECF

e-Investigator Site File Questionnaire (eISFQ)

e-Investigator Site File Questionnaire (eISFQ)

There has been a request from our members to develop a questionnaire to assist sites in evaluating their e-Investigator Site File systems against clinical research regulatory regulations and recommendations. This would be similar to what we already offer (for free) to sites around the globe to evaluate their EHR systems or other systems that originate data that may become part of a clinical trial (this questionnaire is called “eSRA” for “e-Source Readiness Assessment” and can be found on our website at eSRA (eclinicalforum.org)).  The team is under the guidance of the eCF REG team, which produces the “eCF Requirements” that the eSRA and future eISF questionnaires are based on.  A Pilot of the eISF Assessment Questionnaire and Handbook was launched in April 2023 and will run through October 2023. We anticipate a public/free release of this product in early 2024.  For more information or to become involved in this team, members should send an email to EISFQ@eclinicalforum.org. 

 

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eCF Birds-of-a-Feather Webinar:  EHR-EDC Integration – Implementation Overview and Learnings

eCF Birds-of-a-Feather Webinar:  EHR-EDC Integration – Implementation Overview and Learnings

Implementing EHR-EDC integrations is an emerging area of focus in the pharma industry.  This presentation will share an overview of implementing an EHR-EDC integration on 2 studies and the associated lessons learned.   Following this overview will be a group discussion on such integrations and prospects for broader adoption within our clinical trials. 

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