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

Wednesday, 17-Nov-2021

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.  

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

  • 19/10/2021 - 28/10/2021
  • Author: Webmaster1
  • Number of views: 840
  • 0 Comments
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

BoF Round-Table Discussion: "eClinical Standards - Best practices for implementing"

Tuesday, 21 September 2021

BoF Round-Table Discussion: "eClinical Standards - Best practices for implementing"

This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. We will be discussing: “Can we develop best practices for implementing standards across sponsors and CROs of all sizes to drive efficiencies that result in medical advancements getting to patients faster?”

  • Can we facilitate a mechanism to share standards across organizations to avoid process changes from one trial to the next?
  • Can we track standard utilization across organizations to be data driven about when and how updates are needed?
  • With the increase in digital trials, what additional standards should we be considering?
  • What does an optimal standards committee look like? 

eCF Focus Session:  Audit Trail Review in Practice

Wednesday, 18-August-2021

eCF Focus Session:  Audit Trail Review in Practice

The eClinical Forum published a joint paper with SCDM in April 2021, titled “Audit Trail Review: Key Tool to Ensure Data Integrity”.  (If you missed it, you can download it here: Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0 (eclinicalforum.org) )  Now that members have had time to review the paper and perhaps discuss with colleagues, we thought it is a good time to hear what different members are doing, or are planning to do, regarding audit trail review. This focus session will not be discussing the paper, but rather will be discussing what practices around audit trail review our members are taking.

This is a two-hour focus session. The first hour will be presentations of case-studies from eClinical Forum members. The second hour will be a round-table discussion.

eCF Webinar:  FDA OneSource and Common Data Model Harmonization (CDMH)

Wed, 14-July-2021

eCF Webinar:  FDA OneSource and Common Data Model Harmonization (CDMH)

eCF Webinar:  FDA OneSource and Common Data Model Harmonization (CDMH) - Use of Real World Data in Clinical Research

Presenter:   Mitra Rocca, FDA CDER Health Information Technology Technical Lead

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

eCF BoF Round-table: Utilization of Scribes for eCOA

15-June-2021

eCF BoF Round-table: Utilization of Scribes for eCOA

This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. We will be discussing “The utilization of scribes is needed for the conduct of clinical assessments within eCOA.  Therefore, eCOA needs to be built in a manner that meets the regulatory requirements for scribing, to ensure all individuals participating in the assessment are audit trailed.”

eCF Free Public Webinar: Requirements for Electronic Data for Regulated Clinical Trials, and associated Investigator Site eSource-Readiness Assessment

Wed, 28-April-2021 -- webinar offered at 2 times

eCF Free Public Webinar: Requirements for Electronic Data for Regulated Clinical Trials, and associated Investigator Site eSource-Readiness Assessment

The eClinical Forum is pleased to offer a free public webinar – the same as was presented to the FDA CDER Health IT Board on 6-April-2021 – to provide information on our 2 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials) and eSRA (Site eSource-Readiness Assessment).

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

  • 04/05/2021 - 18/05/2021
  • Author: Webmaster1
  • Number of views: 2085
  • 0 Comments
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

Birds-of-a-Feather Round Table Discussion: “When does audit trail begin?”

Tuesday, 16-March-2021 at UTC 08:00 and UTC 16:00

Birds-of-a-Feather Round Table Discussion:  “When does audit trail begin?”

Audit trails create a step-by-step record of data back to its source. It is utilized when the integrity and confidence of the datapoint has critical/legal significance. It is important to determine and declare when data entry becomes “real” data. In legacy paper, data is manually recorded, but only becomes “real” when it is signed, submitted, or completed. Signatures and confirmations also exist to add additional credibility to the source. If a paper form is being filled, it is considered draft until it is declared complete by the originator. The originator has the option to crumple up the “draft” paper and start another without question. The same should hold true with electronic data entry as this webinar will discuss.

Birds-of-a-Feather Webinar: Practical Considerations when implementing eConsent

Wed, 10-March-2021 at UTC 09:00 and UTC 16:00

Birds-of-a-Feather Webinar: Practical Considerations when implementing eConsent

This webinar introduces the NEW "Practical Guide to eConsent" which addresses key themes and hots topics and provides a view on the modernization of the clinical trials informed consenting process, including the current perception shift of eConsent adoption in light of the COVID-19 pandemic.  This is a joint work by the eClinical Forum and EUCROF.

 

BoF Round-table Discussion: Considerations and challenges for electronic research data archival at sites using direct download

Wed, 24-Feb-2021 at UTC 0800 or UTC 1600

BoF Round-table Discussion: Considerations and challenges for electronic research data archival at sites using direct download

The implementation of new solutions to share electronically the eCRF PDFs with sites have brought up new considerations and challenges to this process.

We would like everyone to share their experiences on how the process has been implemented, as well as the challenges experienced. This will be a group discussion on the recommendations to make this process as straight forward as possible for Sites and Sponsors, while complying with requirements.

Facilitated by Carmen Jiménez, Eli Lilly

Birds-of-a-Feather Round Table Discussion: New recommendations from EMA on the frequency of investigators’ signature collection on eCRF data

Tues 26-January-2020 at UTC 08:00 or 16:00

Birds-of-a-Feather Round Table Discussion:  New recommendations from EMA on the frequency of investigators’ signature collection on eCRF data

In July 2020, EMA released a new Q&A to provide further expectations on continuous oversight and frequency of investigators’ signature collection on eCRF data reported to the sponsor. Prior to filing a marketing authorization application, all eCRF data should be signed and dated. But also important data such as that related to reporting of SAEs, adjudication of important events and endpoint data, DSMB review, should be signed off in a timely manner. In addition, a timely review and sign-off of data that are entered directly into the CRF as source is particularly important.

The intent of this webinar is to identify if there are new challenges, and if any – to proceed with an update to the eCF best practices on investigator signatures document that was released in 2017.

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«November 2021»
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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

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

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

Read more
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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)

    Read more