en-USen-GB
  • Tokyo 2-3 December 2019
    Tokyo 2-3 December 2019
  • Zurich 28-30 October 2019
    Zurich 28-30 October 2019
  • Peapack 14-16 October 2019
    Peapack 14-16 October 2019
  • Brussels 15-17 May 2019
    Brussels 15-17 May 2019
  • Danbury 8-10 April 2019
    Danbury 8-10 April 2019
  • Tokyo 5-6 November 2018
    Tokyo 5-6 November 2018
  • Paris, France 23-25 October 2018
    Paris, France 23-25 October 2018
  • Philadelphia, USA 2-4 October 2018
    Philadelphia, USA 2-4 October 2018
  • Princeton 1-3 May 2018
    Princeton 1-3 May 2018
  • Darmstadt, 15-17 May 2018
    Darmstadt, 15-17 May 2018

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

Login to also view news for Members.

Applied Clinical Trials publishes article on eCF Requirements

Applied Clinical Trials publishes article on eCF Requirements

Applied Clinical Trials has published an article highlighting the eClinical Forum “Requirements for Electronic Data for Regulated Clinical Trials” (or simply, “eCF Requirements”: http://www.appliedclinicaltrialsonline.com/keeping-regulatory-expectations .

This set of requirements can be downloaded for free from the eCF website and can be of great assistance when developing system specifications, test suites, evaluation checklists and RFIs for systems that are/will be managing data for clinical research. They are based upon statements in regulatory documents (from the FDA, EMA, PMDA and ICH) that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial … and thus, through using the eCF Requirements you can save countless hours studying all the different regulatory documents.

This work is a result of the vast experience of the eCF REG members who come from a variety of different eCF Member companies. They have spent hours debating each regulation or guidance and how to word the eCF Requirements to correctly meet the needs in the regulatory document. 

The eCF Requirements V2018PR document (mapped to 14 regulatory documents) can be downloaded from www.eclinicalforum.org in the “Downloads” tab.

The eCF has also produced a free assessment tool, based on the eCF Requirements, that can be used for sites to assess if their EHR/EMR systems are suitable for originating data that could be used in a regulated clinical trial. This tool is called “eSRA” for “eSource-Readiness Assessment” and can be downloaded from the eClinical Forum website in the eSRA tab.  

At this time, the 2019 Version (mapped to an additional 9 documents) is reserved for eClinical Forum members only.  For information on becoming an eClinical Forum member (and thus having access to the eCF Requirements V2019), please see membership details at www.eclinicalforum.org/membership or send us a note at info@eclinicalforum.org and we will be happy to set up a phone meeting to discuss all the benefits that come to an organization through membership.

 

Print
Tags:
Rate this article:
No rating

Theme picker

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)

«November 2019»
MonTueWedThuFriSatSun
28293031123
45678910
11121314
11/14/2019 UTC
88

Birds-of-a-Feather Round-Table Webinar Discussion: Subject Status Calculations

Facilitator: Lisa Jones-Moore, Clinical Systems & Supplies Planning, Eli Lilly & Co.

Open To: Staff from eClinical Forum member companies  (If you are not an eCF member, please review our website www.eclinicalforum.org for membership information or contact info@eclinicalforum.org )

Background: eClinical Forum webinar sessions focus on the details of a specific topic.  All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.

Read more
151617
18192021222324
2526272829301
2
12/2/2019 - 12/3/2019 UTC
83

Asia Pacific Meeting in Tokyo to be hosted by Eli Lilly

The eClinical Forum offers a unique, non-commercial networking environment to learn, exchange information and ideas, collaborate on shared initiatives and to influence the future. The following areas will be discussed.

  • The evolving landscape of the Pharma/Clinical Research industry
  • Clinical Trial Operations
  • Regulatory / Compliance
  • Emerging Technologies/Processes
  • Trial of the Future
  • eCF Project Teams: Progressing shared initiatives
Read more
3
12/2/2019 - 12/3/2019 UTC
83

Asia Pacific Meeting in Tokyo to be hosted by Eli Lilly

The eClinical Forum offers a unique, non-commercial networking environment to learn, exchange information and ideas, collaborate on shared initiatives and to influence the future. The following areas will be discussed.

  • The evolving landscape of the Pharma/Clinical Research industry
  • Clinical Trial Operations
  • Regulatory / Compliance
  • Emerging Technologies/Processes
  • Trial of the Future
  • eCF Project Teams: Progressing shared initiatives
Read more
45678

Upcoming events Events RSSiCalendar export