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 European Autumn Meeting in Zurich Switzerland to be hosted by BSI

28-30 October 2019

  • 28/10/2019 - 30/10/2019
  • Author: Webmaster1
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eCF European Autumn Meeting in Zurich Switzerland to be hosted by BSI

Networking with peers has never been more important in order to stay current, collaborate on shared challenges and influence the future. The eClinical Forum offers a unique, non-commercial networking environment to learn, exchange information and ideas, collaborate on shared initiatives.

This meeting will be of relevance to those with an interest in advancing clinical research from:

  • Clinical Trial sponsor organisations
  • Healthcare institutions
  • Technology providers
  • Service providers
  • Academia
  • Stakeholder groups and associations
  • Government

North America Autumn Meeting to be hosted by Pfizer in Peapack NJ

Oct 14-16 2019

North America Autumn Meeting to be hosted by Pfizer in Peapack NJ

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.  A comment from our Spring 2019 meeting: “Great Forum again! Relevant topics and participants are SMEs or at least willing to share experiences.” 

The meeting starts at 1pm on Mon Oct 14 2019 and finishes at 3pm on Wed Oct 16 2019. Each evening there will be networking social events included as part of your meeting registration.

Announcing Autumn 2019 Meeting Dates

  • 14/10/2019 - 17/10/2019
  • Author: Webmaster1
  • Number of views: 4995
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Announcing Autumn 2019 Meeting Dates

Save the date!!

Oct 14-16 2019 in Peapack, New Jersey USA. Kindly hosted by Pfizer

Oct 28-30 2019 in Zurich, Switzerland EU. Kindly hosted by Business Systems Integration (BSI)

Dec 2-3 2019 in Tokyo, Japan. Kindly hosted by Eli Lilly

Announcing Autumn 2019 Meeting Dates

  • 28/10/2019 - 31/10/2019
  • Author: Webmaster1
  • Number of views: 4995
  • 0 Comments
Announcing Autumn 2019 Meeting Dates

Save the date!!

Oct 14-16 2019 in Peapack, New Jersey USA. Kindly hosted by Pfizer

Oct 28-30 2019 in Zurich, Switzerland EU. Kindly hosted by Business Systems Integration (BSI)

Dec 2-3 2019 in Tokyo, Japan. Kindly hosted by Eli Lilly

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Birds-of-a-Feather Webinar & Discussion:  Investigator Oversight on eCOA data - what is a good evidence?

Birds-of-a-Feather Webinar & Discussion: Investigator Oversight on eCOA data - what is a good evidence?

As there are no regulatory detailed expectations on oversight by investigators on eCOA data, multiple approaches have been adopted across the industry (from log-in as evidence to notification/alerts or investigator signature on eCOA data). In general, as per other data sources, oversight for eCOA data should be continual and not once at the end of the study. In addition, oversight activities should be right-sized according to the criticality of the data and protocol requirements for compliance. Evidence of the oversight should be available during the conduct of the trial and enduring for the entire retention period.  The aim of this webinar is to allow participants to share different approaches and any knowledge of current expectations by regulatory inspectors.

 

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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.

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  • 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)

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