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)
«May 2022»
MonTueWedThuFriSatSun
252627
eCF BoF Webinar: Principal Investigator's Signature: Best Practices

eCF BoF Webinar: Principal Investigator's Signature: Best Practices

 The eCF’s PI Signature Working Group have updated their 3-year-old document which is released to eCF Members in early April.  They will introduce the 2022 changes to the best practice document for Investigator’s signature on electronic Case Report Forms (eCRFs).  Participants are encouraged to share their thoughts on:

- how to provide continuous monitoring of regulatory expectations;

- sharing members’ experience on implementation and regulatory findings (if any);

- brainstorming for an industry definition of the “meaning” of signature on data reported to sponsors during both traditional and non-traditional clinical trials.

Presenters:   eCF PI Signature Team Leaders:  Cinzia Piccinia (Eli Lilly) and Babette von Hagen (CSL Behring)

Read more
2829301
2345678
9
Japanese translation of eSRA V2022

Japanese translation of eSRA V2022

Version 2022.1JP1 (10-May-2022)

Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)

Read more
101112131415
1617
REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

We are pleased to announce that registration is now open for our next European Workshop at the Crowne Plaza Brussels Airport, Brussels on 17-19 May 2022.
This hybrid workshop is available for face-to-face or remote participation.

  • For those that can come to Brussels, you will benefit from us getting back to the networking and camaraderie of a face-to-face eCF meeting. Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange, contribution to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  
  • For those that prefer to participate virtually, there is a large choice of live streamed and recorded sessions that will be available for you to choose from and to engage with.
Read more
18
REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

We are pleased to announce that registration is now open for our next European Workshop at the Crowne Plaza Brussels Airport, Brussels on 17-19 May 2022.
This hybrid workshop is available for face-to-face or remote participation.

  • For those that can come to Brussels, you will benefit from us getting back to the networking and camaraderie of a face-to-face eCF meeting. Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange, contribution to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  
  • For those that prefer to participate virtually, there is a large choice of live streamed and recorded sessions that will be available for you to choose from and to engage with.
Read more
19
REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

We are pleased to announce that registration is now open for our next European Workshop at the Crowne Plaza Brussels Airport, Brussels on 17-19 May 2022.
This hybrid workshop is available for face-to-face or remote participation.

  • For those that can come to Brussels, you will benefit from us getting back to the networking and camaraderie of a face-to-face eCF meeting. Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange, contribution to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  
  • For those that prefer to participate virtually, there is a large choice of live streamed and recorded sessions that will be available for you to choose from and to engage with.
Read more
202122
23242526272829
303112345

Upcoming events Events RSSiCalendar export