| Title | Description | Hover Description | Source
| Publication Date | Authors | GBTI
| Link |
| Flexible Approaches to ePROM Data Collection in Clinical Trials: Concerns of Instrument Developers and Copyright Holders | Description | This white paper identifies instrument developer’s/copyright holder’s concerns surrounding electronic implementation, and their willingness to allow for the continued use of flexible approaches permitted during the COVID pandemic. | C-Path | December, 2025 | Anfray C, Eremenco S, Felber B, Mowlem F | Yes | https://media.c-path.org/wp-content/uploads/20251217004554/FlexApp_CopyrightholderDeveloperPerspective_White-Paper_DEC2025_Final.pdf |
| eCOA Lexicon | Description | 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. | C-Path | September, 2025 | GBTI Team | Yes | https://media.c-path.org/wp-content/uploads/20250924215752/GBTI_eCOALexicon_v4-1.pdf |
| eCOA: Process, Workflow, Roles, Responsibilities (Abbreviations Table) | Description | Define an eCOA process and workflow that aligns expectations for successful eCOA strategy development and deployment and clarifies roles and responsibilities. | C-Path | December, 2020 | GBTI Team | Yes | https://media.c-path.org/wp-content/uploads/20240427173146/GBTI_AbbreviationsTable_v1.pdf |
| eCOA: Process, Workflow, Roles, Responsibilities(Roles Table) | Description | Define an eCOA process and workflow that aligns expectations for successful eCOA strategy development and deployment and clarifies roles and responsibilities. | C-Path | December, 2020 | GBTI Team | Yes | https://media.c-path.org/wp-content/uploads/20240427173146/GBTI_Roles_Table_v1.pdf |
| eCOA: Process, Workflow, Roles, Responsibilities(Process Step Table) | Description | Define an eCOA process and workflow that aligns expectations for successful eCOA strategy development and deployment and clarifies roles and responsibilities. | C-Path | December, 2020 | GBTI Team | Yes | https://media.c-path.org/wp-content/uploads/20240427173145/GBTI_Process_StepTable_v1.0.pdf |
| eCOA: Process, Workflow, Roles, Responsibilities(Process Workflow) | Description | Define an eCOA process and workflow that aligns expectations for successful eCOA strategy development and deployment and clarifies roles and responsibilities. | C-Path | December, 2020 | GBTI Team | Yes | https://media.c-path.org/wp-content/uploads/20240427173144/GBTI_eCOA_Process_Workflow_v1.pdf |
| Best Practice Recommendations: User Acceptance Testing for Systems Designed to Collect Clinical Outcome Assessment Data Electronically | Article | 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 | 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
| Yes | https://link.springer.com/article/10.1007/s43441-021-00363-z |
| Best Practice Recommendations for Electronic Patient-Reported Outcome (ePRO) Dataset Structure and Standardization to Support Drug Development | Article | This article discusses best practice recommendations covering the application of CDISC standards for ePRO Datasets, the involvement of key stakeholders, and strategies to manage ePRO dataset content, quality control, and validation. | Value in Health | August 2023 | Hudgens S, Kern S, Barsdorf AI, Cassells S, Rowe A, King-Kallimanis BL, Coon C, Low G, Eremenco S | Yes | https://www.valueinhealthjournal.com/article/S1098-3015(23)00060-8/fulltext?_returnURL=https://linkinghub.elsevier.com/retrieve/pii/S1098301523000608?showall=true |
| Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes | Article | 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. | 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 | Yes | https://www.jscdm.org/article/id/249/ |
| Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes | Webinar | This webinar provides key best practices of electronic clinical outcome assessment data changes that are aligned to the latest health authority guidance. It is based on the article published on December 14, 2023, in the Journal of the Society for Clinical Data Management. | C-Path | February 6, 2024 | Delong P, Humler D, Yeomans A | Yes | https://youtu.be/5PX6sfXPg8U |
| Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes | Post-Webinar Q&A | Provides answers to questions that were received during the Q&A portion of the webinar but not answered due to time limitations. The webinar provided best practices of electronic clinical outcome assessment data changes that are aligned to the latest health authority guidance. It is based on the article published on December 14, 2023, in the Journal of the Society for Clinical Data Management. | C-Path | February 6, 2024 | GBTI Team | Yes | https://media.c-path.org/wp-content/uploads/20240510123257/eCOADataChanges-PostWebinarQA.pdf |
| Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes | Slides | The slide deck presented during the webinar on February 6, 2024. The webinar provided best practices of electronic clinical outcome assessment data changes that are aligned to the latest health authority guidance. It is based on the article published on December 14, 2023, in the Journal of the Society for Clinical Data Management. | C-Path | February 6, 2024 | GBTI Team | Yes | https://media.c-path.org/wp-content/uploads/20240427170529/eCOADataChanges_FINAL-2.pdf |
| Flexible approaches to eCOA administration in clinical trials: The site perspective | Article | This article presents the 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 | 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 | Yes | https://www.sciencedirect.com/science/article/pii/S2451865423001874?via=ihub |
| Bring Your Own Device (BYOD) | Podcast | This podcast provides an exploration of the conceptual challenges around BYOD adoption. | C-Path | April, 2022 | Steele S, Kern S | Yes | https://www.youtube.com/watch?v=OHu6XbKTo9o |
| Bring Your Own Device (BYOD) | Webinar | This webinar highlights the key recommendations to enable successful BYOD implementation. | C-Path | July 18, 2024 | Dumais K, McEvoy K, Romero H, Barden C | Yes | https://www.youtube.com/watch?v=DILxBKJSJvI |
| Bring Your Own Device (BYOD) | Guide Slides | These guide slides provide a more detailed version of the webinar slides with more granular recommendations. | C-Path | July 18, 2024 | GBTI Team | Yes | https://media.c-path.org/wp-content/uploads/20240726132856/GBTI-BYOD-Webinar-GuideSlides.pdf |
| Conflicting Terminology in Digital Health Space: A Call for Consensus | | | Applied Clinical Trials | February 15, 2023 | eCOA Consortium | No | 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 | No | 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 | No | 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 | No | 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 | No | 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 | No | 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 | No | 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 | No | https://doi.org/10.1186/s41687-022-00492-5 |
| Progressing BYOD Adoption | | | Applied Clinical Trials | June 4, 2022 | eCOA Consortium | No | 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 | No | 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 | No | https://www.appliedclinicaltrialsonline.com/view/the-power-of-collaboration-introducing-the-ecoa-consortium |
| 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 | No | 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 | No | 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 | No | 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 | No | 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 | No | 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 | No | 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 | No | 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 | No | 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 | No | 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 | No | 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 | No | 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 | No | 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 | No | 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 | No | 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 | No | 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 | No | 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 | No | https://c-path.org/wp-content/uploads/2022/02/BestPractices3_Migrating.pdf |
| eCOA Systems and CE Certification | | | White Paper | March, 2023 | eCOA Consortium | No | 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 | No | 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 | No | 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 | No | 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 | No | 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 | No | 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 | No | 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 | No | 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 | No | https://www.appliedclinicaltrialsonline.com/view/a-new-and-comprehensive-guide-and-epro-migration-and-implementation |
| 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 | No | 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 | No | 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 | No | 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 | No | http://dx.doi.org/10.1111/cts.70054 |
| Best Practices for Electronic Migration and Implementation of Patient-Reported Outcome Measures – Condensed Version | Summary | | C-Path | June 17, 2025 | eCOA Consortium | No | https://media.c-path.org/wp-content/uploads/20250714134339/BPforMIofPROMS_Condensed_v1.0_20250617.pdf |
| Best practice recommendations and considerations for designing and electronically implementing event-driven diaries in clinical trials | Article | The collaborative project that delivered this article had its genesis in the synergistic enquiries C-Path received from FDA, an eCOA Consortium Member Representative and a PCE Consortium Member Representative indicating a need for best practices in the use of event-driven electronic diaries (EDeDs). While some other material is available in the public domain that refers to some aspects of EDeD usage, this article serves as both the first and definitive collection of recommendations, and features key contributions from FDA colleagues. | npj | digital medicine | December 15, 2025 | Mowlem F, Trudeau J, Platko J, Bloemers J, Flood E | No | https://www.nature.com/articles/s41746-025-02165-1 |
| Flexible Approaches to ePROM Data Collection in Clinical Trials: Why do we need flexibility in clinical trials? | Description | This white paper, the final product from the Support Flexible Approaches to PRO Data Collection project run under the legacy eCOA: Getting Better Together Initiative, identifies lessons learned during COVID-19 related to flexibility in approaches related to data collection using remote data capture. The authors explore multiple data collection approaches, and highlight their associated benefits and challenges. | White Paper | May 27, 2026 | Yamamoto R, Newara M, Arnera V, Shaw J | Yes | https://media.c-path.org/wp-content/uploads/20260519160210/Commentary_Flexibility-in-Clinical-Trials_2026-FINAL-1.pdf |
| 2026 eCOA Consortium Accomplishments Report | Report | Annual Accomplishments Report | C-Path | September 16, 2026 | C-Path | No | https://media.c-path.org/wp-content/uploads/20260916173312/eCOAC_Accomplishments-Report-2026.pdf |
| ePROM Review Checklist | Checklist | | C-Path | September 23, 2026 | C-Path | No | https://media.c-path.org/wp-content/uploads/20260923182046/Electronic-Patient-Reported-Outcome-Measure-Review-Checklist.docx |