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