en-USen-GB
  • Tokyo 3-4 December 2019
    Tokyo 3-4 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.

REPORTS

eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials"
  • 1196
  • Article rating: No rating

eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials"

V2018PR March 2019

The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2018PR”. This is a project the eCF REG team has been working on for a long time and is excited to now be sharing.  

ABOUT THE ECF REQUIREMENTS:  The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents 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. 

To download this file, click on the Downloads tab at the top of this website page.

For more information on the free public webinars, click the title of this article.

eClinical Forum releases eSource-Readiness Assessment (eSRA) V2019
  • 1539
  • Article rating: 2.5

eClinical Forum releases eSource-Readiness Assessment (eSRA) V2019

Investigator Site self-assessment of their healthcare systems against clinical research regulations and guidance

We are happy to announce an updated release of the eSRA (eSource Readiness Assessment) Handbook and Assessment Form. This 2019 version is an update, based on updates to FDA, EMA, PMDA and ICH regulatory documents. We encourage all Sponsors to use this assessment to assist in determining if data that originated in an investigator site system is suitable for inclusion in a clinical trial. We encourage all Investigator Sites to use this assessment tool and provide the resulting report to all Sponsors they are working with, thus avoiding the need to complete different assessments for each Sponsor. Full details of what this valuable tool provides can be found in the eSRA Handbook.

Click on the tab in the top-right of this website (www.eclinicalforum.org) "eSource Readiness Assessment (eSRA)".

Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements" V2019 Members Only
  • 2257
  • Article rating: No rating

Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements" V2019 Members Only

eCF Members Release 25-March-2019

The eClinical Forum is happy to announce the V2019 Members-Only release of the “eCF Requirements”. 

The eCF Requirements are based upon statements in regulatory documents 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.  We have reviewed regulatory documents from the FDA, EMA, PMDA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if data which will become part of a regulated clinical trial are consistent with regulatory requirements. The V2019 Members Release has 21 documents mapped.

Click title for more information

RSS

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)

«September 2019»
MonTueWedThuFriSatSun
2627282930311
2345678
9101112131415
16171819202122
232425
9/25/2019 UTC
87

eCF Birds-of-a-Feather Webinar: Use of eCOA Metadata to Detect Fraud, Develop Risk Indices and More

Electronic solutions for patient-reported and clinician-reported outcomes provide rich metadata that can be mined for additional insights describing trial performance and driving risk-based monitoring. We will explore the use of this eCOA meta data in fraud detection, and other analytics insights and how these data might translate to risk indices to inform risk-based monitoring activities.

Read more
26272829
30123456

Upcoming events Events RSSiCalendar export