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

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.

 

Documents to download

Print

NOT A MEMBER?

Visit the Membership page to learn 
How To Become a Member
(Join the eClinical Forum and learn how to leverage existing and emerging technologies for electronic clinical trials. Access an eClinical community, member-only knowledge, events and forums)
«August 2022»
MonTueWedThuFriSatSun
2526
HOLD THE DATES: eClinical Forum Hybrid Workshops, Sweden, Japan and United States October/November 2022

HOLD THE DATES: eClinical Forum Hybrid Workshops, Sweden, Japan and United States October/November 2022

We are pleased to announce our next Workshops:

- Europe: Uppsala, Sweden on 4-6 October 2022 kindly hosted by Viedoc Technologies

- Asia-Pacific: Tokyo, Japan on 25-26 October 2022 kindly hosted by Bristol-Myers Squibb

- Americas: North Wales, Pennsylvania on 14-16 November 2022 kindly hosted by Merck & Co.

The workshops will be available for face-to-face and remote participation. We will soon be in touch with registration details but in the meantime please save the dates in your calendar.

We are building exciting agendas for the meetings. If you can contribute or have topics to propose, then please get in touch.

Read more
2728293031
12
Views & News -- August 2022

Views & News -- August 2022

We send a monthly email newsletter to our members to keep them abreast of eCF Views (items on our online members-only discussion board) and eCF News (upcoming events, activities of our project teams, etc). If you would like to be included in the monthly e-newsletter mailing, please send a note to Webmaster3@eclinicalforum.org.   Click "Read More" to see this month's "Views & News"!

Read more
345
eClinical Forum APAC Workshop

eClinical Forum APAC Workshop

This meeting is kindly hosted by Bristol Myers Squibb and held in a facility near the Tokyo Station.  We are currently accepting suggestions for agenda topics and/or presenters in the areas of  Decentralized Clinical Trials, Digital Health Technologies, Trends in Clinical Research, AI/ML case studies, Regulatory Updates, and Emerging Roles/Responsibilities.

Read more
67
8910
Birds-of-a-Feather Round Table Discussion:  Measuring Clinical Trial Data Quality

Birds-of-a-Feather Round Table Discussion: Measuring Clinical Trial Data Quality

We will be discussing the general GCP expectations to perform “Quality control” to each stage of trial data handling to ensure that all data are reliable and has been processed correctly. This single statement has very broad interpretations and in this session we can enable the discuss focused the application over Clinical Data Management.

Read more
11121314
15161718192021
22232425262728
2930311234

Upcoming events Events RSSiCalendar export