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

eClinical Forum Europe Meeting in Brussels, Belgium 15-17 May 2019

Better Together

  • 15/05/2019 - 18/05/2019
  • Author: Webmaster1
  • Number of views: 3976
  • 0 Comments
eClinical Forum Europe Meeting in Brussels, Belgium 15-17 May 2019

Our European meeting of the eClinical Forum took place in Brussels 15-17 May 2019, kindly hosted by Janssen.  The rousing meeting was well attended by members from Actelion, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, CRF Bracket, CSL Behring, Eli Lilly, eResearch Technology, Glaxo SmithKline, Idorsia, Janssen Pharmaceuticals, Medidata, Merck KGaA, Munich Technical University, Neptunus Data, Novartis, Novo Nordisk, Oracle, Orion, Servier, Wega Informatik, ZeinCRO ... and guests Association for Innovative Medicines, ECRIN, and European Patients' Forum.  Meeting participants rated this meeting highly successful once again!

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 2019»
MonTueWedThuFriSatSun
293012345
6789101112
1314
eCOA Data Changes

eCOA Data Changes

Best Practices for eCOA Data Changes

Read more
15
eClinical Forum Europe Meeting in Brussels, Belgium 15-17 May 2019

eClinical Forum Europe Meeting in Brussels, Belgium 15-17 May 2019

Our European meeting of the eClinical Forum took place in Brussels 15-17 May 2019, kindly hosted by Janssen.  The rousing meeting was well attended by members from Actelion, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, CRF Bracket, CSL Behring, Eli Lilly, eResearch Technology, Glaxo SmithKline, Idorsia, Janssen Pharmaceuticals, Medidata, Merck KGaA, Munich Technical University, Neptunus Data, Novartis, Novo Nordisk, Oracle, Orion, Servier, Wega Informatik, ZeinCRO ... and guests Association for Innovative Medicines, ECRIN, and European Patients' Forum.  Meeting participants rated this meeting highly successful once again!

Read more
16
eClinical Forum Europe Meeting in Brussels, Belgium 15-17 May 2019

eClinical Forum Europe Meeting in Brussels, Belgium 15-17 May 2019

Our European meeting of the eClinical Forum took place in Brussels 15-17 May 2019, kindly hosted by Janssen.  The rousing meeting was well attended by members from Actelion, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, CRF Bracket, CSL Behring, Eli Lilly, eResearch Technology, Glaxo SmithKline, Idorsia, Janssen Pharmaceuticals, Medidata, Merck KGaA, Munich Technical University, Neptunus Data, Novartis, Novo Nordisk, Oracle, Orion, Servier, Wega Informatik, ZeinCRO ... and guests Association for Innovative Medicines, ECRIN, and European Patients' Forum.  Meeting participants rated this meeting highly successful once again!

Read more
17
eClinical Forum Europe Meeting in Brussels, Belgium 15-17 May 2019

eClinical Forum Europe Meeting in Brussels, Belgium 15-17 May 2019

Our European meeting of the eClinical Forum took place in Brussels 15-17 May 2019, kindly hosted by Janssen.  The rousing meeting was well attended by members from Actelion, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, CRF Bracket, CSL Behring, Eli Lilly, eResearch Technology, Glaxo SmithKline, Idorsia, Janssen Pharmaceuticals, Medidata, Merck KGaA, Munich Technical University, Neptunus Data, Novartis, Novo Nordisk, Oracle, Orion, Servier, Wega Informatik, ZeinCRO ... and guests Association for Innovative Medicines, ECRIN, and European Patients' Forum.  Meeting participants rated this meeting highly successful once again!

Read more
18
eClinical Forum Europe Meeting in Brussels, Belgium 15-17 May 2019

eClinical Forum Europe Meeting in Brussels, Belgium 15-17 May 2019

Our European meeting of the eClinical Forum took place in Brussels 15-17 May 2019, kindly hosted by Janssen.  The rousing meeting was well attended by members from Actelion, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, CRF Bracket, CSL Behring, Eli Lilly, eResearch Technology, Glaxo SmithKline, Idorsia, Janssen Pharmaceuticals, Medidata, Merck KGaA, Munich Technical University, Neptunus Data, Novartis, Novo Nordisk, Oracle, Orion, Servier, Wega Informatik, ZeinCRO ... and guests Association for Innovative Medicines, ECRIN, and European Patients' Forum.  Meeting participants rated this meeting highly successful once again!

Read more
19
20212223242526
272829303112
3456789

Upcoming events Events RSSiCalendar export

  • eCF Webinar:  Best Practice Recommendations for Changing eCOA Data (07/12/2021 (UTC+00:00) Dublin, Edinburgh, Lisbon, London)
    eCF Webinar:  Best Practice Recommendations for Changing eCOA Data

    eCF Webinar:  Best Practice Recommendations for Changing eCOA Data

    Historically, each sponsor, contract research organization (CRO), clinical site, and eCOA service provider has handled eCOA data change request (DCR) processes differently, resulting in the possibility for mixed expectations among the stakeholders and inconsistent results.   In the worst-case scenario, there is the risk of findings from inspections and audits, either because control over source records did not reside as expected with the site, or because there was a lack of oversight over eCOA data changes requested by sites and performed by the eCOA service provider.  There is a need for a well-defined, consistent, and balanced process for handling eCOA data change requests in clinical trials.  The objective of this document is to outline best practices that will result in improved data accuracy and integrity, greater transparency amongst the different stakeholders, increased consistency throughout the clinical trials industry, and adherence to the study protocol, good clinical practices (GCP), and government regulations. The approach to eCOA data changes outlined here is focused on patient-reported outcome (PRO) data but can be applied, where appropriate, to all eCOA data, including clinician-reported data and observer-reported data.   

    A collaborative team comprised of Critical Path Institute’s ePRO Consortium, PRO Consortium and eClinical Forum have been meeting since early 2020 to discuss this topic and produce a best-practice recommendations paper. They will be sharing their discussions during this webinar. The associated paper is anticipated to be published during 1Q 2022.

    Read more
  • eCF Webinar: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials. (11/01/2022 (UTC+00:00) Dublin, Edinburgh, Lisbon, London)
    eCF Webinar: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials.

    eCF Webinar: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials.

    We will be discussing a recent eCF/EUCROF positions paper: 

    The full history of a clinical trial describes the conduct of the trial and the quality of the data produced. Changes in technology and the evolution of regulatory expectations on electronic systems over the past two decades have resulted in a situation where additional supplementary documentation is needed to reconstruct some clinical trial activities. Many of the computerised systems used during a trial are only used during the active trial data collection stage. This period of use is shorter than the retention period required for the archiving of the essential documents of the trial. Furthermore, the documentation that makes up this history is distributed between sponsor, investigators and vendors. Data is stored locally, in the cloud, on patient devices, at vendors, and sub-vendors. Where the data is archived (sponsor, investigator, vendor), in what format (kept live or static), and for how long are issues discussed in the position paper.  You can download the position paper here: Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1 (eclinicalforum.org)

    Read more