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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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eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here

Requirements for Regulated Electronic Data in Clinical Trials and the Site eSource-Readiness Assessment

eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here

This webinar recording provides the same content as was presented to the FDA CDER Health IT Board on 6-April-2021 – on our 2 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials) and eSRA (Site eSource-Readiness Assessment).This public webinar was given on 28-April-2021 to over 250 registrants worldwide. 

“eCF Requirements” - The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents (FDA, EMA, PMDA, NMPA and ICH) that pertain to the design, development, implementation, and management of electronic systems that support clinical research data. Each Requirement has, as its basis, one or more statements from one or more of these regulatory documents. The eCF Requirements can be used to determine if systems are consistent with regulatory requirements, and if systems and process that manage these data have the necessary features.  This set of requirements is the result of countless hours of discussion among regulatory experts from the eClinical Forum member organizations over the past 10 years. It is updated annually.

“eSRA” – The eClinical Forum’s free Investigator Site self-assessment, of the readiness of their healthcare systems to originate data that could be used in a regulated clinical trial, is based on the eCF Requirements and thus each question is grounded on one or more regulatory document statements.  It is easy to access and easy to use and has been used by thousands of sites around the globe and many pharmaceutical sponsors and CROs since it’s launch in 2015. It is updated annually. A document, specifically geared to answering Sponsor’s implementation questions, has also been updated and recently released.

 

New versions of both the “eCF Requirements” and “eSRA” have just been released at www.eclinicalforum.org. Please see the Downloads tab and the eSRA tab.

 

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eCF Views & News

eCF Views & News

We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.

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eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials

eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials

Back by popular demand!  Dr. van de Walle presented at the hybrid European eCF workshop in May … and we just ran out of time to answer all the questions! So many requests to ask Viviënne to present again with more time. So, here it is! Not to be missed!  Viviënne is a full-time investigator and founder of an indepenent research site. She has vast site and patient experience and will share her insight into how hybrid trials are going for the sites and the patients.

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