Electronic Clinical Outcome Assessment Consortium

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Overview

Founded in 2011, the Electronic Clinical Outcome Assessment (eCOA) Consortium provides scientific leadership and best practice recommendations surrounding electronic data capture technologies and services that support the collection of patient-focused outcomes data in clinical trials.

The Problem

The critical need for accurately measuring the health status of clinical trial participants directly and without influence continues to rise in importance to both regulators and patients themselves. The ever-expanding use of electronic methods to capture patient-reported outcomes (PRO) and other clinical outcome assessment (COA) data, alongside passive, digitally derived data via digital health technologies (DHTs), has established technology as a powerful and multi-faceted tool in capturing the patient experience in medical and therapeutic development.

Alongside those technologies, there are a range of approaches taken by different stakeholders to justify use, implementation, and oversight of these systems, which introduces inefficiency and instability to the clinical trial process. Singular, siloed approaches that lack standardization, alignment with regulatory expectations, and adherence to established best practices present risks to trial execution and, ultimately, the development of new and effective medicines and treatments. There is a tangible need, recognized by regulators and electronic COA (eCOA) providers alike, to develop the standards, resources, education and best practices to drive efficient use of these systems.

The Solution

The eCOA Consortium is powered by providers of eCOA technologies and allied services who support the collection of COA and DHT-derived data in clinical trials. These industry leaders work in a pre-competitive environment in which a critical mass of experts can collaborate to develop standards, conduct research, design and deliver educational opportunities, and define the best practices for the electronic collection of COA and DHT-derived data. The eCOA Consortium serves the clinical research community as the definitive resource for authoritative, consensus-developed resources to support eCOA usage. The Consortium works closely with other stakeholders, such as clinical trial sponsors from the PRO Consortium and the Rare Disease COA Consortium and regulators, with the overarching aim of enhancing public health by optimizing the quality and value of COA/DHT-derived data in medical evaluation and clinical decision-making.

The Impact

The impact of the eCOA Consortium’s work is improved quality, practicality, and acceptability of electronic capture of clinical trial endpoint data. Since its inception in 2011, the eCOA Consortium members have produced, or collaborated with colleagues to produce, the following educational resources for sponsors and eCOA providers:

Six best practices white papers
21 webinars
20 peer-reviewed publications
10 poster presentations
20 podium presentations

More information about these resources can be found here.

To learn more about eCOA, contact us at ecoac@c-path.org or subscribe to our updates here.

Resources

eCOA Consortium Publications/White Papers Library

eCOA Consortium Publications/White Papers Library

Title	Journal	Publication Date	Authors	Link
Conflicting Terminology in Digital Health Space: A Call for Consensus	Applied Clinical Trials	February 15, 2023	eCOA Consortium	https://www.appliedclinicaltrialsonline.com/view/conflicting-terminology-in-digital-health-space-a-call-for-consensus
First-hand Perspectives on Achieving True Digital Health Engagement	Applied Clinical Trials	December 2, 2022	eCOA Consortium	https://www.appliedclinicaltrialsonline.com/view/first-hand-perspectives-on-achieving-true-digital-health-engagement
Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: quantitative study findings	Journal of Patient-Reported Outcomes	November 26, 2022	Stacie Hudgens, Louise Newton, Sonya Eremenco, Mabel Crescioni, Tara Symonds, Philip C. G. Griffiths, David S. Reasner, Bill Byrom, Paul O’Donohoe, Susan Vallow on behalf of the Patient-Reported Outcome (PRO) Consortium and Electronic Clinical Outcome Assessment (eCOA) Consortium	https://jpro.springeropen.com/articles/10.1186/s41687-022-00521-3
Implementing Numeric Rating and Visual Analog Scales in an eCOA Solution	Applied Clinical Trials	November 10, 2022	eCOA Consortium	https://www.appliedclinicaltrialsonline.com/view/implementing-numeric-rating-and-visual-analog-scales-in-an-ecoa-solution
Survey Investigates Backup Solution Adoption for ePRO Systems	Applied Clinical Trials	October 14, 2022	eCOA Consortium	https://www.appliedclinicaltrialsonline.com/view/survey-investigates-backup-solution-adoption-for-epro-systems
Evaluating the Use of Backup Solutions for ePRO Systems	Applied Clinical Trials	September 7, 2022	eCOA Consortium	https://www.appliedclinicaltrialsonline.com/view/evaluating-the-use-of-backup-solutions-for-epro-systems
Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies	Therapeutic Innovation & Regulatory Science	February 10, 2022	Byrom B, Elash CA, Eremenco S, Bodart S, Muehlhausen W, Platko JV, Watson C, Howry C	https://doi.org/10.1007/s43441-022-00376-2
Comparability of a Provisioned Device Versus Bring Your Own Device for Completion of Patient-Reported Outcome Measures by Participants with Chronic Obstructive Pulmonary Disease: Qualitative Interview Findings	Journal of Patient-Reported Outcomes	April 4, 2022	Newton L, Knight-West O, Eremenco S, Hudgens S, Crescioni M, Symonds T, Reasner DS, Byrom B, O’Donohoe P, Vallow S on behalf of the Patient-Reported Outcome Consortium and the Electronic Clinical Outcome Assessment Consortium	https://doi.org/10.1186/s41687-022-00492-5
Progressing BYOD Adoption	Applied Clinical Trials	June 4, 2022	eCOA Consortium	https://www.appliedclinicaltrialsonline.com/view/progressing-byod-adoption
Administering Complex Cognitive Tests Remotely in The Cognitively-Impaired	Applied Clinical Trials	June 7, 2022	eCOA Consortium	https://www.appliedclinicaltrialsonline.com/view/administering-complex-cognitive-tests-remotely-in-the-cognitively-impaired
The Power of Collaboration: Introducing the eCOA Consortium	Applied Clinical Trials	May 12, 2022	eCOA Consortium	https://www.appliedclinicaltrialsonline.com/view/the-power-of-collaboration-introducing-the-ecoa-consortium
Best Practice Recommendations: User Acceptance Testing for Systems Designed to Collect Clinical Outcome Assessment Data Electronically	Therapeutic Innovation & Regulatory Science	March 1, 2022	Gordon S, Crager J, Howry C, Barsdorf AI, Cohen J, Crescioni M, Dahya B, Delong P, Knaus C, Reasner DS, Vallow S, Zarzar K, Eremenco S	https://doi.org/10.1007/s43441-021-00363-z
Recommendations for the Electronic Migration and Implementation of Clinician-reported Outcome Assessments in Clinical Trials	Value in Health	April 1, 2022	Romero H, DeBonis D, O’Donohoe P, Wyrwich K, Arnera V, Platko J, Willgoss T, Harris K, Crescioni M, Steele S, Eremenco S, on behalf of the Electronic Patient-Reported Outcome Consortium and the Patient-Reported Outcome Consortium	https://doi.org/10.1016/j.jval.2022.02.012
Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult than Necessary?	Applied Clinical Trials	August 14, 2020	Gertel A, Raymond S, Vallow S, Arnera V, Crescioni M, Chassany O, Bodart S, Eremenco S	https://www.appliedclinicaltrialsonline.com/view/demystifying-submissions-of-ecoa-documentation-for-ethics-review-are-we-making-submissions-more
Agreement Among Paper and Electronic Modes of the EQ-5D-5L	The Patient – Patient-Centered Outcomes Research	April 28, 2020	Lundy JJ, Coons SJ, Flood E, Patel MJ on behalf of the ePRO Consortium	https://doi.org/10.1007/s40271-020-00419-6
Perceived Burden of Completion of Patient-Reported Outcome Measures in Clinical Trials: Results of a Preliminary Study	Therapeutic Innovation & Regulatory Science	December 23, 2019	Bodart S, Byrom B, Crescioni M, Eremenco S, Flood E, on behalf of the ePRO Consortium	https://doi.org/10.1177%2F2168479018788053
Best Practices for Avoiding Paper Backup When Implementing Electronic Approaches to Patient-Reported Outcome Data Collection in Clinical Trials	Therapeutic Innovation & Regulatory Science	December 23, 2019	Howry C, Elash C, Crescioni M, Eremenco S, O’Donohoe P, Rothrock T, on behalf of the ePRO Consortium	https://doi.org/10.1177%2F2168479018785160
Training on the Use of Technology to Collect Patient-Reported Outcome Data Electronically in Clinical Trials: Best Practice Recommendations from the ePRO Consortium	Therapeutic Innovation & Regulatory Science	December 23, 2019	Ly J, Crescioni M, Eremenco S, Bodart S, Donoso M, Butler A, Dallabrida S, on behalf of the ePRO Consortium	https://link.springer.com/article/10.1177/2168479018796206
Selection of and Evidententiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium	Value in Health	November 7, 2017	Byrom B, Watson C, Doll H, Coons SJ, Eremenco S, Ballinger R, McCarthy M, Crescioni M, O’Donohoe P, Howry C	https://doi.org/10.1016/j.jval.2017.09.012
Optimizing Electronic Capture of Clinical Outcome Assessment Data in Clinical Trials: The Case of Patient-Reported Endpoints	Therapeutic Innovation & Regulatory Science	December 30, 2015	Fleming S, Barsdorf AI, Howry C, O’Gorman H, Coons SJ	https://doi.org/10.1177/2168479015609102
“Bring Your Own Device” (BYOD): The Future of Field-Based Patient-Reported Outcome Data Collection in Clinical Trials	Therapeutic Innovation & Regulatory Science	December 30, 2015	Gwaltney C, Coons SJ, O’Donohoe P, O’Gorman H, Denomey M, Howry C, Ross J	https://doi.org/10.1177/2168479015609104
Considerations for Requiring Subjects to Provide a Response to Electronic Patient-reported Outcome Instruments	Therapeutic Innovation & Regulatory Science	October 13, 2015	Paul O’Donohoe P, Lundy JJ, Gnanasakthy A, Greene A	http://dij.sagepub.com/content/49/6/792.short
Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials	The Patient – Patient-Centered Outcomes Research	October 10, 2014	Coons SJ, Eremenco S, Lundy JJ, O’Donohoe P, O’Gorman H, Malizia W	https://doi.org/10.1007/s40271-014-0090-z
ePRO Systems Validation: Clearly Defining the Roles of Clinical Trials Teams and ePRO System Providers	Value in Health	June, 2013	Coons, SJ	https://doi.org/10.1016/j.jval.2013.04.006
Best Practices for Participant Registration in Clinical Trials Using Bring Your Own Device (BYOD) Technology for Data Collection	White Paper	April, 2021	eCOA Consortium	https://media.c-path.org/wp-content/uploads/20240427170209/BestPractices5_upd-1.pdf
COVID-19: Risk Assessment and Mitigation Strategies for the Collection of Patient-Reported Outcome Data through Clinical Sites	White Paper	June 5, 2020	eCOA Consortium	https://media.c-path.org/wp-content/uploads/20240427170208/COVID-19_CPath_v3.0_2020JUN5-1.pdf
Best Practices for Electronic Implementation of Response Scales for Patient-Reported Outcome Measures	White Paper	September, 2018	eCOA Consortium	https://c-path.org/wp-content/uploads/2022/02/BestPractices2_Response_Scales.pdf
Best Practices for Maximizing Electronic Data Capture Options during the Development of New Patient-Reported Outcome Measures	White Paper	September, 2018	eCOA Consortium	https://c-path.org/wp-content/uploads/2022/02/BestPractices_Maximizing_Data_Capture.pdf
Best Practices for Migrating Existing Patient-Reported Outcome Measures to a New Data Collection Mode	White Paper	September, 2018	eCOA Consortium	https://c-path.org/wp-content/uploads/2022/02/BestPractices3_Migrating.pdf
eCOA Systems and CE Certification	White Paper	March, 2023	eCOA Consortium	https://media.c-path.org/wp-content/uploads/20240427170207/eCOA-Systems-and-CE-Certification-1.pdf
eCOA Systems and the CE Mark: Navigating the Regulations	Applied Clinical Trials	March 2, 2023	eCOA Consortium	https://www.appliedclinicaltrialsonline.com/view/ecoa-systems-and-the-ce-mark-navigating-the-regulations
Best Practice Recommendations for Electronic Patient-Reported Outcome (ePRO) Dataset Structure and Standardization to Support Drug Development	Value in Health	August, 2023	Hudgens S, Kern S, Barsdorf AI, Cassells S, Rowe A, King-Kallimanis BL, Coon C, Low G, Eremenco S	https://doi.org/10.1016/j.jval.2023.02.011
Data Standards and ePRO Systems: A Road Less Travelled?	Applied Clinical Trials	April 14, 2023	eCOA Consortium	https://www.appliedclinicaltrialsonline.com/view/data-standards-and-epro-systems-a-road-les-travelled
An eCOA Lexicon: The Quest for Single, Trusted Source of Terminology	Applied Clinical Trials	June 7, 2023	eCOA Consortium	https://www.appliedclinicaltrialsonline.com/view/an-ecoa-lexicon-the-quest-for-single-trusted-source-of-terminology
eCOA Systems and Intended Use: Key Considerations	Applied Clinical Trials	September 7, 2023	eCOA Consortium	https://www.appliedclinicaltrialsonline.com/view/ecoa-systems-and-intended-use-key-considerations
Training the Raters: An Important Factor in Clinical Trial Success	Applied Clinical Trials	October 13, 2023	eCOA Consortium	https://www.appliedclinicaltrialsonline.com/view/training-the-raters-an-important-factor-in-clinical-trial-success
The First eCOA Forum Examines BYOD and Item Skipping	Applied Clinical Trials	August 11, 2023	eCOA Consortium	https://www.appliedclinicaltrialsonline.com/view/the-first-ecoa-forum-examines-byod-and-item-skipping
A New and Comprehensive Guide to ePRO Migration and Implementation	Applied Clinical Trials	November 14, 2023	eCOA Consortium	https://www.appliedclinicaltrialsonline.com/view/a-new-and-comprehensive-guide-and-epro-migration-and-implementation
Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes	Journal of the Society for Clinical Data Management	December 14, 2023	Delong P, Humler D, Haag T, Yeomans A, Andrus J, Eremenco S, Finan A, Gable J, Gilfillan D, Howry C, Kern S, Lesniewski S, Simpliciano K, Staunton H, Turnbull J, Workman C, Raymond S.	https://doi.org/10.47912/jscdm.249
Flexible Approaches to eCOA Administration in Clinical Trials: The Site Perspective	Contemporary Clinical Trials Communications	December 7, 2023	Haenel E, Elash C, Garner K, Turner M, Kern S on behalf of the Electronic Clinical Outcome (eCOA) Consortium and the Patient-Reported Outcome (PRO) Consortium	https://doi.org/10.1016/j.conctc.2023.101241
Best Practices for the Electronic Implementation and Migration of Patient-Reported Outcome Measures	Value in Health	October 23, 2023	Mowlem F, Elash CA, Dumais KM, Newara MC, Kern S on behalf of the Electronic Clinical Outcome Assessment Consortium	https://doi.org/10.1016/j.jval.2023.10.007
Unstructured Patient Diaries: To be, or not to be, that is the Question	Applied Clinical Trials	April 18, 2024	eCOA Consortium	https://www.appliedclinicaltrialsonline.com/view/unstructured-patient-diaries-to-be-or-not-to-be-that-is-the-question
Implementing Sensor-based Digital Health Technologies in Clinical Trials: key Considerations from the eCOA Consortium	Clinical and Translational Science	November 3, 2024	eCOA Consortium	http://dx.doi.org/10.1111/cts.70054

eCOA: Getting Better Together Initiative

eCOA: Getting Better Together Initiative This initiative is a pre-competitive collaboration among Critical Path Institute, clinical trial sponsors from the Patient-Reported Outcome (PRO) Consortium, providers of electronic data collection technologies and services from the Electronic Clinical Outcome Assessment (eCOA) Consortium, contract research organizations, and regulators. The initiative was launched in 2019 to identify and address the root cause of challenges with the implementation of clinical outcome assessments collected electronically in clinical trials, elevate eCOA improvement efforts to the clinical trial industry level, and drive positive and lasting change in the eCOA ecosystem.

Quarterly Update

Please click here to view the most recent quarterly update, which includes the status of current and future areas of focus.

eCOA: Getting Better Together Initiative

Resources

Name	Description	Links
eCOA Lexicon	Without a common lexicon among eCOA vendors, sponsors, and regulators, the chance for miscommunication, errors, and inefficiencies increases. The objective of this team is to review the terminology and create an aligned eCOA Lexicon for use by stakeholders across the eCOA ecosystem.	eCOA Lexicon
eCOA: Process/Workflow and Roles/Responsibilities	Define an eCOA process and workflow that aligns expectations for successful eCOA strategy development and deployment and clarifies roles and responsibilities.	Abbreviations Table Roles Table Process Step Table Process Workflow
Best Practice Recommendations: User Acceptance Testing for Systems Designed to Collect Clinical Outcome Assessment Data Electronically	This article provides best practice recommendations for user acceptance testing to support a high quality eCOA system and ensure reliable and more complete data are collected during the study.	Therapeutic Innovation & Regulatory Science
Best Practice Recommendations for Electronic Patient-Reported Outcome (ePRO) Dataset Structure and Standardization to Support Drug Development	This article discusses best practice recommendations covering the application of CDISC standards for ePRO Datasets, involvement of key stakeholders, and strategies to manage ePRO dataset content, quality control, and validation.	Value in Health
Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes	This article presents key best practices that are aligned to the latest health authority guidance. From 2018 to 2022, 45 representatives of C-Path’s Patient-Reported Outcome Consortium, eCOA Consortium, and the eClinical Forum collaborated to develop guidelines on changes to eCOA data. The resulting core principles can become the foundation upon which sponsors, investigators, and eCOA providers can evaluate and manage data change requests.	Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes Webinar Post-Webinar Q&A Slides
Flexible approaches to eCOA administration in clinical trials: The site perspective	This article presents results of a survey of eCOA-experienced clinical trial sites to understand their challenges and gather suggestions for simplification that may result in a more flexible, participant- and site-centric approach to ePRO implementation in clinical trials.	Contemporary Clinical Trials Communications
Bring Your Own Device (BYOD)	These resources developed during our BYOD project provide an in-depth look at the key considerations around the use of BYOD approaches to collect eCOA data. Podcast: An exploration of the conceptual challenges around BYOD adoption Webinar: Highlighting the key recommendations to enable successful BYOD implementation Guide Slides: A more detailed version of the webinar slides with more granular recommendations	Podcast Webinar Guide Slides

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Q3 2024

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Q1 2024

Webinars

eCOA Exchange – Is there any point in eCOA Libraries? (December 4, 2024)

eCOA libraries can be valuable assets in clinical research, offering ready-to-use, validated and pre-translated COA measures for collecting the trial participant’s voice. However, uptake varies hugely, and for a range of reasons. Do they really streamline the process and reduce costs? Join our expert panel as they identify and discuss the pros and cons of eCOA libraries, and whether we as an industry are deriving the true dividend that eCOA libraries claim to deliver.

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To access the eCOA Educational Series, please provide your email address

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Moderator: Scottie Kern (C-Path)

Presenters: Cindy Howry (Medable), Christian Knaus (Evinova), Jonathan Norman (YPrime), and Shelly Steele (WCG Clinical)

eCOA Clinic #2 – BYOD – The Sequel! (September 25, 2024)

Revisiting the lively topic of Bring Your Own Device (BYOD), this event offered attendees a further chance to pose any questions to the experts that were unaddressed at the 1st eCOA Clinic or the recent collaborative webinar delivered by the eCOA Consortium and PRO Consortium entitled “BYOD: A Guide for Successful Implementation.”

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To access the eCOA Educational Series, please provide your email address

By providing your email address, you’re agreeing to receive communications from C-Path.

BYOD: A Guide for Successful Implementation (July 18, 2024)

This webinar presents an in-depth look at the key considerations around the use of Bring Your Own Device (BYOD) approaches to electronic clinical outcome assessment data collection in clinical trials, developed and presented by members of the BYOD Project Team as part of the eCOA Consortium and PRO Consortium’s eCOA: Getting Better Together Initiative.

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Moderator: Scottie Kern

Presenters: Kelly Dumais (Clario), Karl McEvoy (YPrime), Heather Romero (Takeda), Chris Barden (Kayentis)

eCOA Masterclass #1: The Road to Best Practice Consensus: Electronic Migration and Implementation of PRO Measures (June 5, 2024)

This 1st Masterclass — the fourth installment of our eCOA Educational Series — takes a deep dive into current best practices for the electronic migration and implementation of patient-reported outcome (PRO) measures, as featured in the published article in Value in Health.

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To access the eCOA Educational Series, please provide your email address

By providing your email address, you’re agreeing to receive communications from C-Path.

Moderator: Scottie Kern (C-Path)

Presenters: Florence Mowlem (ObvioHealth), Ben James (uMotif), and Melissa Newara (Medrio)

eCOA Clinic #1: BYOD (Bring Your Own Device) (December 12, 2023)

This 1^st eCOA Clinic — the third installment of our eCOA Educational Series — offered attendees the chance to bring their own questions on the topic of BYOD to be addressed by experts from across the eCOA Consortium’s membership, with matters ranging from the impact of BYOD on study timelines to the regulatory perspective on BYOD.

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To access the eCOA Educational Series, please provide your email address

By providing your email address, you’re agreeing to receive communications from C-Path.

Moderator: Scottie Kern (C-Path)

Presenters: Chris Barden (Kayentis), Lisa Charlton (Science 37), Kelly Dumais (Clario), Karl McEvoy (YPrime), and Flo Mowlem (ObvioHealth)

eCOA Exchange #2: What is (and What is Not) an Appropriate Wearable Device for Use in Clinical Trials? (October 19, 2023)

This eCOA Exchange — the second in our eCOA Educational Series — identifies and examines the key considerations around the selection and implementation of sensor-based wearable technologies in clinical trials. An expert panel with deep experience in the field and formed from our eCOA Consortium members ActiGraph, Koneksa, Parexel, and uMotif share their perspectives on how successful use of these powerful tools can be achieved.

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To access the eCOA Educational Series, please provide your email address

By providing your email address, you’re agreeing to receive communications from C-Path.

Moderator: Scottie Kern (C-Path)

Presenters: Julia Kling (Koneksa), Julia Lakeland (uMotif), Ian Pallett (Parexel), Sylvain Zorman (ActiGraph)

eCOA Exchange #1: How to Succeed with Global eCOA Implementations (September 27, 2023)

This eCOA Exchange session examines what clinical operations teams should be prepared for, from an eCOA translations and licensing perspective, when running multi-country trials. Translations and licensing experts from eCOA Consortium members Mapi Research Trust, RWS, and TransPerfect Life Sciences share key considerations and experience-based recommendations to reduce the risk to study start-up for global eCOA trials.

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To access the eCOA Educational Series, please provide your email address

By providing your email address, you’re agreeing to receive communications from C-Path.

Moderator: Scottie Kern (C-Path)

Presenters: Elsa Lindstrom (TransPerfect Life Sciences), Shawn McKown (RWS), and Foteini Sakellaropoulou (Mapi Research Trust)

PDF Version

eCOA: Getting Better Together Initiative – An Update from C-Path’s PRO Consortium and ePRO Consortium (February 17, 2021)

This webinar provides an overview of the eCOA: Getting Better Together Initiative. This collaborative, pre-competitive initiative was launched in 2019 to identify and address the root cause of issues with eCOA implementation in clinical trials and to drive positive and lasting change in the eCOA ecosystem for the benefit of all stakeholders. This webinar discusses the achievements and future goals of the initiative, in addition to recent highlights from each consortium.

Moderator: Keith Wenzel (Parexel)

Presenters: Sonya Eremenco, MA (C-Path) and Paul O’Donohoe, MSc (Medidata Solutions)

PDF Version

COVID-19: Risk Assessment and Mitigation Strategies for the Collection of PRO Data through Clinical Sites – Lessons Learned (October 29, 2020)

This webinar provides an update from sponsors and eCOA providers as they discuss lessons learned from managing clinical trials that originally planned for in-person collection of ePRO data through clinical sites. Due to public health concerns, many patients are either unable or unwilling to travel to sites for scheduled visits or sites have had to close. In March 2020, ePRO Consortium and PRO Consortium member representatives collaborated on risk assessment and mitigation strategies for clinical trials in response to COVID-19. This webinar discusses lessons learned, how the initial recommendations performed, and how sponsors and eCOA providers are applying these learnings to future trials.

Moderator: Sonya Eremenco, MA (C-Path)

Presenters: Patricia (Trish) Delong, MS (Janssen Global Services, LLC); Gena Gough, MBA, PMP (Clinical Ink); Cindy Howry, MS (.assisTek); Paul O’Donohoe, MSc (Medidata Solutions); and, Megan Turner (GlaxoSmithKline)

PDF Version

Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult Than Necessary? (September 18, 2019)

This webinar presents an overview of Good Clinical Practice (GCP)/ethics review guidelines (ICH E6 R2), which indicate that written information provided to the patient must be submitted for ethical review. Many have broadly interpreted the GCP requirement concerning “written information” to mean that screenshots for every proposed patient-facing image must be provided for review, approval, and filing prior to study information. The presenters question whether requests from ethics review bodies for eCOA screenshots is warranted and will propose a new path forward.

Presenters: Steve Raymond, PhD (ERT); Art Gertel (MedSciCom, LLC); Olivier Chassany, MD, PhD (Paris-Diderot University and INSERM); and, David Forster, JD, MA, CIP (WIRB-Copernicus Group)

PDF Version

Note: Audio is not available for this webinar.

Best Practices for Avoiding Paper Backup When Implementing Electronic Approaches to Patient-Reported Outcome Data Collection in Clinical Trials (May 16, 2019)

This webinar provides an overview of the issues related to the use of paper backups in studies for which PRO data is collected electronically. Viable strategies to eliminate the necessity of a paper-backup system are provided.

Presenters: Cindy Howry, MS (.assisTek) and Paul O’Donohoe, MSc (Medidata Solutions)

PDF Version

Training on the Use of Technology to Collect Patient-Reported Outcome Data Electronically in Clinical Trials: Best Practice Recommendations from the ePRO Consortium (May 10, 2018)

This webinar provides a recommended framework for training end users, including site staff and study participants, on the use of ePRO technology in clinical trials. The goal of the webinar is to promote consistent and sufficient training prior to initiating data collection.

Presenters: Jenny J. Ly, PhD (ERT) and Serge Bodart, MSc (Bracket)

PDF Version

Selection of and Evidentiary Considerations for Wearable Devices and their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium (May 18, 2017)

This webinar provides a recommended framework for the selection and evaluation of wearable devices and their measurements for use in regulatory trials to support labeling claims. The webinar will also address the essential properties of fit-for-purpose wearables and the activities required to establish clinical endpoints derived from data collected with wearable devices.

Presenters: Bill Byrom, PhD (ICON) and Chris Watson, PhD (ERT)

PDF Version

Considerations for Requiring Subjects to Respond to PRO Instruments Collected Electronically (February 28, 2017)

This webinar provides an overview of specific considerations related to allowing subjects to opt out of responding to individual items when PRO data collection is electronic as well as the relevance to other types of electronic clinical outcome assessments.

Presenter: Paul O’Donohoe, MS (CRF Health)

PDF Version

Ensuring Equivalence of Electronic and Paper Administration of Patient-Reported Outcome Measures (September 29, 2016)

This webinar provides an overview of scientific and regulatory considerations when migrating paper-based patient-reported outcome (PRO) measures to electronic modes of data collection.

Presenters: Paul O’Donohoe, MS (CRF Health) and Willie Muehlhausen, DVM (ICON)

PDF Version

Bring Your Own Device (BYOD) (March 10, 2016)

This webinar provides an overview of scientific, logistical, and regulatory considerations when using a BYOD approach to collect patient-reported outcome data in clinical trials.

Presenters: Jennifer Crager (YPrime) and Paul O’Donohoe, MS (CRF Health)

PDF Version

Best Practices for ePRO Implementation in Clinical Trials (December 3, 2015)

This webinar provides an overview of considerations in selecting the optimal ePRO modes, review best practices related to the deployment of ePRO systems, and discuss key items for ePRO deployment in clinical trials.

Presenters: Serge Bodart, MS (Biomedical Systems) and Elisa Holzbaur, BS, PMP (Almac)

PDF Version

Migrating a PRO Instrument (May 6, 2015)

This webinar provides a detailed description of the process for conducting paper to ePRO migration, mode-specific migrations, usability, feasibility and user acceptance testing as well as case studies of successful migrations.

Presenters: Serge Bodart, MSc (Biomedical Systems) Alisandra Johnson, BS (Bracket)

PDF Version

Intro to ePRO – Part II (April 13, 2015)

This webinar provides an overview of current ePRO data collection modes, the mode selection process, key considerations for selecting the most appropriate mode for a study and considerations for migrating an existing PRO instrument to an electronic mode.

Presenters: Cindy Howry, MS (YPrime) and Jennifer Ross, MPhilEd (Almac)

PDF Version

Intro to ePRO – Part I (January 12, 2015)

This webinar provides an overview of the ePRO Consortium, describes the various modes of PRO data capture, and discusses the trends in the collection of clinical data electronically.

Presenters: J. Jason Lundy, PhD (C-Path) and Valdo Arnera, MD (PHT Corp)

PDF Version