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

AGENDA AVAILABLE: eClinical Forum Virtual Workshop, 19-28 October 2021

  • 19/10/2021 - 28/10/2021
  • Author: Webmaster1
  • Number of views: 840
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AGENDA AVAILABLE: eClinical Forum Virtual Workshop, 19-28 October 2021

We are pleased to announce the details of our next Virtual Global Workshop on 19-28 October 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops have been a great success and this one will be even better! The sessions have been optimised to accommodate our members from around the world by spreading the meeting over 6 days (19-21 October and 26-28 October), limiting the duration of each meeting day to 2 hours and by offering 2 sessions a day (at 8:00 UTC and 16:00 UTC). Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange through breakout groups to contribute to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  Of course, nothing can replace the networking and camaraderie of a face-to-face eCF meeting, but we will come close! REGISTER HERE

Public Release: Electronic Informed Consent Implementation Guide Practical Considerations Version 1.0

Better Together

  • 18 March 2021
  • Author: Webmaster1
  • Number of views: 2311
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Public Release: Electronic Informed Consent Implementation Guide  Practical Considerations  Version 1.0

The EUCROF and eClinical Forum Electronic Informed Consent (eConsent) Joint Task Force are pleased to announce the publication of the eConsent Implementation Guide (version 1). The joint task force was formed in 2019 with a view to look at some of the barriers to adoption of eConsent considering the benefits to stakeholders.

eConsent offers remote electronic options for informing and consenting trial participants of a clinical trial, this being a particularly useful capability especially during the pandemic period when site visits are reduced.

eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire

  • 15 March 2021
  • Author: Webmaster1
  • Number of views: 23370
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eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire

Version 2021

This is the ONE FILE that you need to perform an eSRA Assessment.

Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

Release 2021

  • 1 March 2021
  • Author: Webmaster1
  • Number of views: 6975
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Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

  • 04/05/2021 - 18/05/2021
  • Author: Webmaster1
  • Number of views: 2085
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REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

We wish you a Happy New Year 2021

Better Together

  • 14 January 2021
  • Author: Webmaster1
  • Number of views: 1492
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Ransomware Attack at Hosting Company Took Website Offline

Site Under Maintenance

  • 8 December 2020
  • Author: Webmaster1
  • Number of views: 917
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Ransomware Attack at Hosting Company Took Website Offline

The eClinical Forum website was disabled for a while because of a ransomware attack at our hosting company. We apologise for any inconvenience that this might have caused.

We have succeeded in restoring the site to a new server and it is now available again for general use. We are still in the process of testing and reconfiguring the site and so some aspects may not work at expected. We ask for your patience while we bring everything back online. 

If you do encounter problems and need to contact us, then we are always available at...

esra@eclinicalforum.org for eSRA related questions

webinars@eclinicalforum.org for webinar registrations and questions

info@eclinicalforum.org for membership and general enquiries

ECF Newsletter 2020/21

Better Together

  • 23 October 2020
  • Author: Webmaster1
  • Number of views: 1605
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ECF Newsletter 2020/21

The eClinical Forum is a peer networking group run by its members for its members. Our newsletter provides important information and facts about the eClinical Forum. Read about the philosophy and objectives of the group, the eCF community and the work it has done, the teams that are active and what our members say. There is nothing quite like the eClinical Forum.

 

Fraud Alert!

Fraudulent Emails sent out with eclinicalforum.org addresses in April and May 2020

  • 8 May 2020
  • Author: Webmaster1
  • Number of views: 2453
  • 0 Comments
Fraud Alert!

We have recently learnt that fraudulent Emails have been sent out with eclinicalforum.org addresses. The security issue has now been fixed, however, please be vigilant if you have received Emails during April and May purportedly from the eClinical Forum if they are asking for payment or personal information.

Please don’t hesitate to contact us at webmaster3@eclinicalforum.org if you have any questions or concerns.

Success! eClinical Forum 2020 Spring Meetings replaced with Virtual Global Workshop 11-13 May 2020

  • 11/05/2020 - 14/05/2020
  • Author: Webmaster1
  • Number of views: 4796
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Success! eClinical Forum 2020 Spring Meetings replaced with Virtual Global Workshop 11-13 May 2020

The Virtual Workshop on May 11-13 that replaced the planned face-to-face Spring Workshops in Helsinki, Finland and Princeton, NJ was a huge success.  It was attended by over 130 members from around the globe, representing 46 member companies -- many of whom would not have been able to attend a face-to-face meeting and this was their first eCF workshop. 4 EMA inspectors and several guests also attended. Evaluations gave the workshop a 4.3/5.0 which is lower than our face-to-face workshops, but for our first virtual workshop we are happy with this grade!  A few comments from the evaluations: "Always an excellent group with many real experts.  The interactions are very good."  "Congratulations on an excellent event.  Everything worked well.  Sure, we missed the networking and evening events, but this worked well."  "eClinical Forum is a fantastic source of information about the landscape of eClinical today."  "eCF continues to be incredible value for money"

We are planning for another Virtual Workshop in Autumn 2020 (the week of October 12-16) and hoping to return to face-to-face workshops for Spring 2021. We now have a lot of good ideas for improvements for our 2nd Virtual Workshop! If anyone wants to make suggestions, please send to info@eclinicalforum.org. Thanks!!

eCF Requirements for Electronic Data for Regulated Clinical Trials V2019PR

  • 12 March 2020
  • Author: Webmaster1
  • Number of views: 1530
  • 0 Comments
eCF Requirements for Electronic Data for Regulated Clinical Trials  V2019PR

The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2019PR” 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.

2020 is our 20th Anniversary Year!

  • 12 December 2019
  • Author: Webmaster1
  • Number of views: 3457
  • 0 Comments
2020 is our 20th Anniversary Year!

A lot has happened in electronic support for clinical research in the last 20 years ... and eClinical Forum has been there discussing it all!  We are pleased to be celebrating our 20th anniversary year, stronger than ever with 45+ member companies (and growing), meetings on 3 continents, global webinars that have been attended by members in over 25 countries, very active project teams, meetings with regulators, and freely adding to the knowledge base of the industry. Any organization working in this space is welcome to join. Please see the membership tab on our website (www.eclinicalforum.org) or contact us for more information!  info@eclinicalforum.org

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AGENDA AVAILABLE: eClinical Forum Virtual Workshop, 19-28 October 2021

AGENDA AVAILABLE: eClinical Forum Virtual Workshop, 19-28 October 2021

We are pleased to announce the details of our next Virtual Global Workshop on 19-28 October 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops have been a great success and this one will be even better! The sessions have been optimised to accommodate our members from around the world by spreading the meeting over 6 days (19-21 October and 26-28 October), limiting the duration of each meeting day to 2 hours and by offering 2 sessions a day (at 8:00 UTC and 16:00 UTC). Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange through breakout groups to contribute to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  Of course, nothing can replace the networking and camaraderie of a face-to-face eCF meeting, but we will come close! REGISTER HERE

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AGENDA AVAILABLE: eClinical Forum Virtual Workshop, 19-28 October 2021

AGENDA AVAILABLE: eClinical Forum Virtual Workshop, 19-28 October 2021

We are pleased to announce the details of our next Virtual Global Workshop on 19-28 October 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops have been a great success and this one will be even better! The sessions have been optimised to accommodate our members from around the world by spreading the meeting over 6 days (19-21 October and 26-28 October), limiting the duration of each meeting day to 2 hours and by offering 2 sessions a day (at 8:00 UTC and 16:00 UTC). Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange through breakout groups to contribute to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  Of course, nothing can replace the networking and camaraderie of a face-to-face eCF meeting, but we will come close! REGISTER HERE

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AGENDA AVAILABLE: eClinical Forum Virtual Workshop, 19-28 October 2021

AGENDA AVAILABLE: eClinical Forum Virtual Workshop, 19-28 October 2021

We are pleased to announce the details of our next Virtual Global Workshop on 19-28 October 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops have been a great success and this one will be even better! The sessions have been optimised to accommodate our members from around the world by spreading the meeting over 6 days (19-21 October and 26-28 October), limiting the duration of each meeting day to 2 hours and by offering 2 sessions a day (at 8:00 UTC and 16:00 UTC). Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange through breakout groups to contribute to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  Of course, nothing can replace the networking and camaraderie of a face-to-face eCF meeting, but we will come close! REGISTER HERE

Read more
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AGENDA AVAILABLE: eClinical Forum Virtual Workshop, 19-28 October 2021

AGENDA AVAILABLE: eClinical Forum Virtual Workshop, 19-28 October 2021

We are pleased to announce the details of our next Virtual Global Workshop on 19-28 October 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops have been a great success and this one will be even better! The sessions have been optimised to accommodate our members from around the world by spreading the meeting over 6 days (19-21 October and 26-28 October), limiting the duration of each meeting day to 2 hours and by offering 2 sessions a day (at 8:00 UTC and 16:00 UTC). Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange through breakout groups to contribute to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  Of course, nothing can replace the networking and camaraderie of a face-to-face eCF meeting, but we will come close! REGISTER HERE

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eCF Webinar: Connecting Clinical Research and Healthcare: The Vulcan HL7 Accelerator Opportunity

eCF Webinar: Connecting Clinical Research and Healthcare: The Vulcan HL7 Accelerator Opportunity

HL7 FHIR (Fast Healthcare Interoperability Resources) is a standard describing data formats and elements and an application programming interface for exchanging electronic health records. The standard was created by the Health Level Seven International health-care standards organization.  Vulcan is an HL7 FHIR Accelerator that brings together stakeholders from across the translational and clinical research communities in order to bridge existing gaps between clinical care and clinical research, strategically connect industry collaboratives, maximize collective resources, and deliver integrated tools and resources.  HL7 FHIR is the path forward to bridge clinical care and clinical research. A global collaboration between all translational and clinical research stakeholders to co-develop out the standard, it will allow for a reproducible, scalable process for data exchange. The presenters will share not only the conclusions drawn from use cases developed up to this point, but will also provide insight into the future direction and priorities of Vulcan.  

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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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