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:  Best Practice Recommendations for Changing eCOA Data

Tues 7-Dec-2021 and Wed 8-Dec-2021

Event date: 07/12/2021 Export event

eCF Webinar:  Best Practice Recommendations for Changing eCOA Data

eCF Webinar:  Best Practice Recommendations for Changing eCOA Data

Date:  Tues 7-Dec-2021 or Wed 8-Dec-21      Duration: One hour

Open to members of the eClinical Forum, C-Path ePRO Consortium, and C-Path PRO Consortium

About This Topic:  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.

 Time:  This webinar will be offered at two times and recorded. We request that you indicate on your registration if you are coming to a live session or would like a link to the recording sent to you the following day.

Webinar A: Wed 8-Dec-2021

Time:  UTC 09:00

Moderator:  Scottie Kern (Critical Path Institute)

Presenters:  Hannah Staunton (Roche) and Alan Yeomans (Viedoc Technologies)

Webinar B: Tues 7-Dec-2021

Time:  UTC 16:00

Moderator:  Scottie Kern (Critical Path Institute)

Presenters:  Trish Delong (J&J), Demian Humler (ERT), and Tom Haag (Cardinal Solutions)

REGISTRATION: Please send a note to webinars@eclinicalforum.or

Print
Tags:
Rate this article:
No rating

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 2022»
MonTueWedThuFriSatSun
252627
eCF BoF Webinar: Principal Investigator's Signature: Best Practices

eCF BoF Webinar: Principal Investigator's Signature: Best Practices

 The eCF’s PI Signature Working Group have updated their 3-year-old document which is released to eCF Members in early April.  They will introduce the 2022 changes to the best practice document for Investigator’s signature on electronic Case Report Forms (eCRFs).  Participants are encouraged to share their thoughts on:

- how to provide continuous monitoring of regulatory expectations;

- sharing members’ experience on implementation and regulatory findings (if any);

- brainstorming for an industry definition of the “meaning” of signature on data reported to sponsors during both traditional and non-traditional clinical trials.

Presenters:   eCF PI Signature Team Leaders:  Cinzia Piccinia (Eli Lilly) and Babette von Hagen (CSL Behring)

Read more
2829301
2345678
9
Japanese translation of eSRA V2022

Japanese translation of eSRA V2022

Version 2022.1JP1 (10-May-2022)

Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)

Read more
101112131415
1617
REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

We are pleased to announce that registration is now open for our next European Workshop at the Crowne Plaza Brussels Airport, Brussels on 17-19 May 2022.
This hybrid workshop is available for face-to-face or remote participation.

  • For those that can come to Brussels, you will benefit from us getting back to the networking and camaraderie of a face-to-face eCF meeting. Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange, contribution to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  
  • For those that prefer to participate virtually, there is a large choice of live streamed and recorded sessions that will be available for you to choose from and to engage with.
Read more
18
REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

We are pleased to announce that registration is now open for our next European Workshop at the Crowne Plaza Brussels Airport, Brussels on 17-19 May 2022.
This hybrid workshop is available for face-to-face or remote participation.

  • For those that can come to Brussels, you will benefit from us getting back to the networking and camaraderie of a face-to-face eCF meeting. Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange, contribution to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  
  • For those that prefer to participate virtually, there is a large choice of live streamed and recorded sessions that will be available for you to choose from and to engage with.
Read more
19
REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

We are pleased to announce that registration is now open for our next European Workshop at the Crowne Plaza Brussels Airport, Brussels on 17-19 May 2022.
This hybrid workshop is available for face-to-face or remote participation.

  • For those that can come to Brussels, you will benefit from us getting back to the networking and camaraderie of a face-to-face eCF meeting. Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange, contribution to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  
  • For those that prefer to participate virtually, there is a large choice of live streamed and recorded sessions that will be available for you to choose from and to engage with.
Read more
202122
23242526272829
303112345

Upcoming events Events RSSiCalendar export