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.  

eCF Webinar:  Best Practice Recommendations for Changing eCOA Data

Tuesday, 7-Dec-2021

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.

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

  • 19/10/2021 - 28/10/2021
  • Author: Webmaster
  • Number of views: 653
  • 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

eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here

Requirements for Regulated Electronic Data in Clinical Trials and the Site eSource-Readiness Assessment

eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here

This webinar recording provides the same content as was presented to the FDA CDER Health IT Board on 6-April-2021 – on our 2 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials) and eSRA (Site eSource-Readiness Assessment).

eCF "Birds-of-a-Feather" Round-table Discussions and Technology Showcases 2020 to 2021

Select recordings available

eCF "Birds-of-a-Feather" Round-table Discussions and Technology Showcases 2020 to 2021

“Birds-of-a-Feather” Webinars are provided monthly, to get those with similar interests together.  Anyone from an eCF member company (around the globe!) can participate, gratis. All eCF members can suggest a topic and/or lead a discussion.

Recording: Use of eSRA to fulfill Sponsor responsiblity for assessing site systems

Recording: Use of eSRA to fulfill Sponsor responsiblity for assessing site systems

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

January 29 2020; facilitated by Cinzia Piccini of Eli Lilly

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.

 

Webinar on ICH E6 Release2 (GCP) 11Jan17 - An Excellent Event

Event Feedback

Webinar on ICH E6 Release2 (GCP) 11Jan17 - An Excellent Event
We had a fabulous level of participation with well over 140 members online from California to Japan participating in our first webinar of 2017 on the release of the addendum to E6 (Good Clinical Practice), 20 years after its original publication. Some good discussion helped us to understand the changes, opportunities and challenges. Expand the article to read more about the event.

Electronic Informed Consent Technology Showcase - An Excellent Event

Event Feedback

  • 30 November 2016
  • Author: Webmaster
  • Number of views: 14056
  • 0 Comments
Electronic Informed Consent Technology Showcase - An Excellent Event

We had a fabulous level of participation with well over 50 members online from California to Japan participating in our Technology Showcase exploring electronic informed consent and demonstrating Enforme Interactive/Drug Dev’s SecureConsent Application for eICF. Some good discussion helped us to understand the business opportunities and value. Materials are available for download. Expand the article to read more about the event.

Adoption of Cloud Technology in the Regulated Life Sciences Industry

An eCF BoF Webinar presented by PhUSE

  • 27 September 2016
  • Author: Webmaster
  • Number of views: 12130
  • 0 Comments
Adoption of Cloud Technology in the Regulated Life Sciences Industry
PhUSE kindly presented their framework for the adoption of cloud technology in the regulated life sciences industry. The session was attended by 70 members from 24 companies in 14 countries. Expand the article to read more about the topic and discussion

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)
«October 2021»
MonTueWedThuFriSatSun
27282930123
45678910
11121314151617
1819
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
20
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
21
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
22
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
23
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
24
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
25
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
26
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
27
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
28
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
293031
1234567

Upcoming events Events RSSiCalendar export

  • AGENDA AVAILABLE: eClinical Forum Virtual Workshop, 19-28 October 2021 (19/10/2021 - 28/10/2021 (UTC+00:00) Dublin, Edinburgh, Lisbon, London)
    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
  • eCF Webinar: Connecting Clinical Research and Healthcare: The Vulcan HL7 Accelerator Opportunity (17/11/2021 (UTC+00:00) Dublin, Edinburgh, Lisbon, London)
    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.  

    Read more
  • 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