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# Trials@Home

Centre of Excellence Remote and Decentralised Clinical Trials

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## Posts

- [Webinar: Trials@Home proof-of-concept study RADIAL is ready for patient recruitment](https://trialsathome.com/trialshome-proof-of-concept-study-radial-is-ready-for-patient-recruitment/) - WebinarsTrials@Home proof-of-concept study RADIAL is ready for patient recruitment Wednesday 21 June, 2023 – 15h-16h CET Within Trials@Home we explore the concept of decentralized clinical trial approaches, or DCTs. We are now at the stage of the project that our European proof of concept study, RADIAL, started with activation of the first sites. RADIAL aims to
- [Trials@Home – A Public Call for Proposals to build an end-to-end DCT Tech Package – The RfP explained.](https://trialsathome.com/trialshome-a-public-call-for-proposals-to-build-an-end-to-end-rdct-tech-package-the-rfp-explained/) - WebinarsTrials@Home – A Public Call for Proposals to build an end-to-end RDCT Tech Package – The RfP explained. Wednesday 6 January 2021, 15-16h CET For the project to be able to run a pan-European pilot, we need to build a technology package to run a fully remote trial as explained in the above RfP announcement.
- [Digital Literacy in DCTs. What is asked of trial participants?](https://trialsathome.com/digital-literacy-in-dcts-what-is-asked-of-trial-participants/) - WebinarsTrials@Home – Digital Literacy in DCTs. What is asked of trial participants? 2 March 2023, 15.30-16.45 CET DCTs offer a more patient-centric approach in clinical trials by removing various barriers for participants such as the need for travel. However, increased digital tool use may introduce a new barrier for some groups in the population, due
- [PRESS RELEASE: Study to test innovative decentralised clinical trial model is ready for patient recruitment.](https://trialsathome.com/press-release-study-to-test-innovative-decentralised-clinical-trial-model-is-ready-for-patient-recruitment/) - Study to test innovative decentralised clinical trial model is ready for patient recruitment.Trials@Home proof-of-concept study, RADIAL, has activated its first sites and anticipates patient recruitment this month.Utrecht, June 13, 2023RADIAL, short for Remote And Decentralised Innovative Approaches to CLinical Trials, is a European proof-of-concept study aiming to test out whether future clinical trials can be
- [News](https://trialsathome.com/news/)
- [CLOSING EVENT  Trials@Home, a home run?](https://trialsathome.com/closing-event-trialshome-a-home-run/) - CLOSING EVENTTrials@Home, a home run?Recommendations after leading the way on DCTs in EuropeSCOPE To share learnings from Trials@Home and look to the future of decentralised clinical trials LOCATION The Railway Museum Utrecht, The Netherlands; or online DATE 31 October, 2025 The Trials@Home project has ended with the publication of a set of final recommendations for
- [Layman Poster: What Patients Like and Don’t Like About Decentralised Clinical Trials.](https://trialsathome.com/layman-poster-what-patients-like-and-dont-like-about-decentralised-clinical-trials/) - What Patients Like and Don’t Like About Decentralised Clinical Trials. A group conversation to ask different people what they like?Acknowledgement & Disclaimer This poster is not an original, it has been translated by the Trials@Home Layman Translation Team for purpose of a better understanding by a general audience. The team consists of a diverse group
- [Detailed list of Quality assessment criteria and assessment procedures (D2.2)](https://trialsathome.com/detailed-list-of-quality-assessment-criteria-and-assessment-procedures-d2-2/) - Detailed list of Quality assessment criteria and assessment procedures (D2.2)Lead Contributors: Jaap Trappenburg, Arnela Suman (UMCU)August 25, 2020This report describes the development of the quality criteria and assessment procedures for the quality assessment of the technologies for the pan-European pilot study. The final set of quality criteria and assessment procedures to be used are presented.
- [Criteria for selection of appropriate trials (D1.2)](https://trialsathome.com/criteria-for-selection-of-appropriate-trials-d1-2/) - Criteria for selection of appropriate trials (D1.2)Lead contributors: Giorgia De Paoli / Amy Rogers / Isla Mackenzie (University of Dundee)August 26, 2020Remote decentralised clinical trial (RDCT) methods are increasingly used to answer clinical research questions. However, it is not always possible to use remote methods in clinical trials. Features of the participant population, intervention, outcomes
- [First set of recommendations for RDCTs (D1.1)](https://trialsathome.com/first-set-of-recommendations-for-rdcts-d1-1/) - First set of recommendations for RDCTs (D1.1)Lead contributors: Amy Rogers / Isla Mackenzie (University of Dundee)August 26, 2020Clinical trials are a crucial step in the development and testing of medical treatments. They are essential to ensure that new treatments are safe and effective. Traditionally, clinical trials have taken place in hospitals or other research sites,
- [Research Papers Explained – first paper translated! Experiences of clinical trials in homes and local settings outside of clinics – a research project using interviews.](https://trialsathome.com/research-papers-explained-first-paper-translated/) - Experiences of clinical trials in homes and local settings outside of clinics – a research project using interviewsUtrecht, June 25, 2024Research Papers Explained – first paper translated!WP CODE has recently formed a working group to translate technical/scientific documents into plain language for the general public including patients. It’s intended for those interested in learning more
- [Layman paper: Decentralised, patient-centric, site-less, virtual, and digital clinical trials? From confusion to consensus.](https://trialsathome.com/decentralised-patient-centric-site-less-virtual-and-digital-clinical-trials-from-confusion-to-consensus/) - Decentralised, patient-centric, site-less, virtual, and digital clinical trials? From confusion to consensus.Utrecht, April 2025Acknowledgement & Disclaimer This article is not an original, it has been translated by the Trials@Home Layman Translation Team for purpose of a better understanding by a general audience. The team consists of a diverse group of Trials@Home consortium members and the
- [Layman paper: The experiences of pharmaceutical companies, study doctors and delivery couriers with delivering trial medication directly to participants in Europe](https://trialsathome.com/layman-paper-the-experiences-of-pharmaceutical-companies-study-doctors-and-delivery-couriers-with-delivering-trial-medication-directly-to-participants-in-europe/) - The experiences of pharmaceutical companies, study doctors and delivery couriers with delivering trial medication directly to participants in EuropeUtrecht, March 2025Acknowledgement & Disclaimer This article is not an original, it has been translated by the Trials@Home Layman Translation Team for purpose of a better understanding by a general audience. The team consists of a diverse
- [RADIAL database lock](https://trialsathome.com/radial-database-lock/) - The database lock process has been completed for RADIALUtrecht, February, 2025New RADIAL milestone alert! The database lock process has been completed for RADIAL, the Trials@Home proof-of-concept study on decentralised and hybrid clinical trials. With this significant milestone, we are one step closer to completing RADIAL, consolidating learnings, and producing our final recommendations for DCTs. RADIAL
- [What Happened in Paris? 🗼 Highlights from the Trials@Home Annual Meeting 2024](https://trialsathome.com/what-happened-in-paris-🗼-highlights-from-the-trialshome-annual-meeting-2024/) - What Happened in Paris? 🗼Highlights from the Trials@Home Annual Meeting 2024Paris, 4-6 December 2024Earlier this month, we gathered in Paris for the Trials@Home Annual Meeting, hosted graciously by Natalie Piton, Head of Public-Private Partnerships at Sanofi, at the Sanofi Paris-Gentilly offices. A big thank-you to Sanofi for making us feel so welcome during this insightful
- [100 Patients enrolled in RADIAL!!](https://trialsathome.com/897-2/) - 100 Patients enrolled in RADIAL!!Utrecht, June 17, 2024 This month we reached the end of the recruitment phase in the RADIAL study and have enrolled over 100 patients. RADIAL is the proof-of-concept study conducted as part of Trials@Home The trial is designed to compare a completely decentralized approach (home-based) with both traditional approach (site-based) and a
- [PODCAST: Kim Hawkins - Project Co-Lead of IMI’s Trials@Home](https://trialsathome.com/podcast-kim-hawkins-project-co-lead-of-imis-trialshome/) - Podcast with Kim Hawkins – Project Co-Lead of IMI’s Trials@Home#ClinicalTrialsDay #CTD2024Utrecht, 23 May 2024In the light of International Clinical Trials Day (20 May) and the theme of this year being “Trialblazers among us” we like to focus on the purpose of Trails@Home once more as we are not only running a proof of concept study
- [Summary of the meeting between Trials@Home and the EFPIA ICH (E6) Support Group](https://trialsathome.com/summary-of-the-meeting-between-trialshome-and-the-efpia-ich-e6-support-group/) - Summary of the meeting between Trials@Home and the EFPIA ICH (E6) Support GroupUtrecht, April 12, 2024On 17 January 2024, on behalf of Trials@Home, Mira Zuidgeest (UMCU), Megan Heath (Sanofi), Hamidou Traore (UCB), Helga Gardarsdottir (UU), Solange Rohou (AstraZeneca), and Philippe Bordes (Sanofi) met with members of the EFPIA ICH E6 (R3) Support Group and EC
- [EU Regulators Told To ‘Normalize’ Decentralized Clinical Trials](https://trialsathome.com/eu-regulators-told-to-normalize-decentralized-clinical-trials/) - EU Regulators Told To ‘Normalize’ Decentralized Clinical TrialsThe Pink Sheet15 January 2024EU drug regulators have received some candid responses from trial sponsors and other stakeholders on the aspects that should be urgently addressed in the next iteration of their guidance on decentralized clinical trials. Mira Zuidgeest, Principal Investigator of the RADIAL trial conducted by the
- [The Future of Medical Research](https://trialsathome.com/the-future-of-medical-research/) - The Future of Medical ResearchA video from The Lancet featuring Trials@HomeSeptember 27, 2023For privacy reasons YouTube needs your permission to be loaded.I AcceptScientists around the world speak to the importance of conducting representative research and show how when people can’t make it to a study, the study needs to come to them. With new technologies
- [Trials@Home Annual Meeting Report](https://trialsathome.com/trialshome-annual-meeting-report/) - Trials@Home Annual Meeting ReportUtrecht, December 5, 2023UCB generously hosted us at their headquarters in Brussels for the 4th Annual Meeting for the Trials@Home project on 24 and 25 October 2023. It was an excellent meeting with plenty of engagement from attendees. We reflected on the achievements of the last year. We ended the meeting with
- [Article: Study on conducting clinical research at home](https://trialsathome.com/study-on-conducting-clinical-research-at-home/) - Study on conducting clinical research at homeUtrecht, November 16, 2023On November 16, 2023, UMCU published an article on their website on the Trials@Home project and RADIAL, the project’s proof-of-concept study. Article is available here (English) Article is available here (Dutch) Related Articles: https://icthealth.nl/nieuws/studie-umc-utrecht-kan-klinisch-onderzoek-ook-remote-en-thuis/ https://zorgkrant.nl/ziekenhuizen/17877-onderzoek-naar-de-uitvoering-klinisch-onderzoek-thuis Project updates Interviews Podcasts Peer reviews & research outputs Research Posters
- [RADIAL -> First Remote Patient is enrolled!](https://trialsathome.com/radial-first-remote-patient-is-enrolled/) - RADIAL has recruited its first remote patientA huge milestone for the project and for the future of clinical trialsUtrecht, November 3, 2023We are very happy to announce that our Clinical Trial RADIAL has enrolled the first patient in the remote arm. This means that we have our first patient that will conduct the clinical trial
- [PARTNERSHIP: Clinical Trials Europe 2023](https://trialsathome.com/cte-2023/) - Clinical Trials Europe 202329-30 November 2023, CCIB, Barcelona, SpainFREE to attend for Pharmaceutical Company, Biotech Company, Medical Device Company, Investigators, Government Body, Patient Advocacy Group and Non-profit representatives, Patients and Academics (free passes not applicable to supplier / vendor / CRO / technology / solution provider companies or consultants). See terms and conditions below*. Now
- [Media: Decentralized Trials: EU Study Explores Different Models For Directly Shipping Drugs To Patients](https://trialsathome.com/media-decentralized-trials-eu-study-explores-different-models-for-directly-shipping-drugs-to-patients/) - Decentralized Trials: EU Study Explores Different Models For Directly Shipping Drugs To Patientsby Vibha Sharma, The PinkSheetAugust 11, 2023Researchers working on behalf of the EU’s public-private Trials@Home project offer insight into practices for direct-to-participant supply of investigational medicinal products in clinical trials. The EU lacks harmonized regulatory requirements on how investigational medicinal products (IMPs) can
- [Uw mening telt – Zou u deelnemen aan klinisch onderzoek vanuit huis?](https://trialsathome.com/uw-mening-telt-zou-u-deelnemen-aan-klinisch-onderzoek-vanuit-huis/) - Uw mening telt – Zou u deelnemen aan klinisch onderzoek vanuit huis?Vrijwilligers gezocht!!!Utrecht, July 21, 2023Doel: Met deze vragenlijst willen we nagaan wat de voorkeuren zijn voor deelname aan verschillende typen klinisch onderzoek bij personen die leven met diabetes mellitus type 2. Wie zoeken we? 1.U bent 18 jaar of ouder 2.U bent minimaal een
- [RADIAL Finger prick demo video](https://trialsathome.com/radial-finger-prick-demo-video/) - RADIAL Finger prick demo videoFor privacy reasons YouTube needs your permission to be loaded.I Accept Project updates Interviews Podcasts Peer reviews & research outputs Research Posters Research Videos This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 831458. This Joint Undertaking receives support from the European Union’s
- [PUBLICATION: Direct-to-Participant Investigational Medicinal Product Supply in Clinical Trials in Europe – Exploring the Experiences of Sponsors, Site Staff, and Couriers](https://trialsathome.com/publication-direct-to-participant-investigational-medicinal-product-supply-in-clinical-trials-in-europe-exploring-the-experiences-of-sponsors-site-staff-and-couriers/) - Direct-to-Participant Investigational Medicinal Product Supply in Clinical Trials in Europe – Exploring the Experiences of Sponsors, Site Staff, and CouriersFirst published: 12 July 2023Authors: Amos J. de Jong, Yared Santa-Ana-Tellez, Mira G. P. Zuidgeest, Renske J. Grupstra, Fatemeh Jami, Anthonius de Boer, Helga Gardarsdottir, on behalf of the Trials@Home Consortium Abstract Aim Insights into the current practice of direct-to-participant (DtP) supply
- [Training: What are Decentralised Clinical Trials (DCTs)?](https://trialsathome.com/training-what-are-decentralised-clinical-trials-dcts/) - What are Decentralised Clinical Trials (DCTs)?Utrecht, May 20, 2023As part of the projects objectives and celebrating Clinical Trials Day on 20th of May 2023, we have developed short videos explaining what are Clinical Trials and what are Decentralised Clinical Trials. You can find those videos, and much more information on the project and clinical trials,
- [Trials@Home – Where are we two years down the road?](https://trialsathome.com/trialshome-where-are-we-two-years-down-the-road/) - WebinarsTrials@Home – Where are we two years down the road? 1 December 2021, 15.00-16.00 CET Two years ago, over 200 people from more than 30 organisations gathered in Paris to launch the IMI Trials@Home project. Ever since, our consortium has only grown, and much work has been done behind the scenes. Today we’re proud that
- [Launch Webinar: Innovative Medicines Initiative Trials@Home A Centre of Excellence in Remote and Decentralised Clinical Trials](https://trialsathome.com/launch-webinar-innovative-medicines-initiative-trialshome-a-centre-of-excellence-in-remote-and-decentralised-clinical-trials/) - WebinarsInnovative Medicines Initiative Trials@Home A Centre of Excellence in Remote and Decentralised Clinical Trials Wednesday 24 June 2020, 11-12 CET Trials@Home aims to reshape clinical trial design, conduct and operations, by developing and piloting standards, recommendations and tools for the definition and operationalisation of remote decentralised clinical trials (RDCTs) in Europe. Given COVID-19’s impact of
- [Article: You can help medical science at the kitchen table (dutch only)](https://trialsathome.com/article-you-can-help-medical-science-at-the-kitchen-table-dutch-only/) - You can help medical science at the kitchen tableUtrecht, April 8, 2023On April 8, 2023, Trials@Home appeared in the Dutch press with an article on how you can help science from the kitchen table. The article was based on an interview with Amos de Jong (UU) and Mira Zuidgeest (UMCU). Volunteers who participate in research
- [Trials@Home Semi-Annual Meeting Valencia](https://trialsathome.com/trialshome-semi-annual-meeting-valencia/) - Trials@Home Semi-Annual MeetingValencia, 30-31 March, 2023From March 30 to 31st, more than 50 consortium members came together in Valencia, Spain, for our Semi-Annual Meeting! The purpose of this meeting was to work together in smaller groups to brainstorm and discuss a variety of topics, from the patient experience to the last preparations for our RADIAL
- [NEW - Research Videos](https://trialsathome.com/new-research-videos/) - NEW – Research VideosUtrecht, April 12, 2023Within Trials@Home we aim to share learnings on implementation of remote technologies and approaches in the context of decentralised clinical trials. Our army of talented young researchers prepared short videos where they share the highlights of their research. These videos were created to share these outputs with the consortium,
- [Decentralized trials getting some attention on the international regulatory front](https://trialsathome.com/decentralized-trials-getting-some-attention-on-the-international-regulatory-front/) - Decentralized trials getting some attention on the international regulatory frontDIA Europe, by Regulatory Focus, 24 March, 2023Work is progressing to overcome the obstacles associated with European decentralized clinical trials and advance their adoption, regulatory and industry officials said during a panel session at DIA Europe 2023. An upcoming guideline from the International Council on Harmonisation
- [ACT EU Recomendations](https://trialsathome.com/act-eu-recomendations/) - ACT EU Recommendations for DCTsUtrecht, March 1, 2023What is ACT EU? The Accelerating Clinical Trials in the EU (ACT EU) initiative, launched in January 2022, aims to develop the EU further as a competitive centre for innovative clinical research. It aims to deliver on the clinical trial innovation recommendations of the European medicines agencies network strategy and the European Commission’s Pharmaceutical strategy for Europe. The initiative builds on the Clinical Trials
- [Trials@Home Annual Meeting #3 Wuppertal 26 & 27 September](https://trialsathome.com/trialshome-annual-meeting-wuppertal-26-27-september/) - Trials@Home Annual Meeting – 26 & 27 September 2022Wuppertal & OnlineThe 2022 Trials@Home Annual Meeting took place in Bayer’s facilities in Wuppertal, where we had two full days of meetings, presentations, and networking. The project thanks Bayer for allowing use of their space for this meeting and for their support in the meeting organisation. The
- [Full steam ahead for RADIAL trial, all CTIS approvals are in, and the UK is on board too](https://trialsathome.com/full-steam-ahead-for-radial-trial-all-ctis-approvals-are-in-and-the-uk-is-on-board-too/) - Full steam ahead for RADIAL trial, all CTIS approvals are in, and the UK is on board too.Utrecht, 29 November 2023 After the good news that the Danish authorities approved our RADIAL study earlier this month, we now have more good news. Germany, Poland, Spain, and Italy have also approved the RADIAL study, and the
- [Decentralized Trial Approaches: How Do They MatchUp To Conventional Studies?](https://trialsathome.com/decentralized-trial-approaches-how-do-they-matchup-to-conventional-studies/) - Decentralized Trial Approaches: How Do They MatchUp To Conventional Studies?The Pink Sheet11 November 2022Mira Zuidgeest is the principal investigator of a key EU study that proposes to compare fully remote, hybridand conventional clinical trial approaches. She talks to the Pink Sheet about how the study might help understand “where we’re heading with decentralized clinical trials.” DECENTRALIZED TRIAL
- [RADIAL is approved in Denmark!](https://trialsathome.com/radial-is-approved-in-denmark/) - RADIAL is approved in Denmark!Utrecht, November 2, 2022 On the 5th of September the team submitted all the necessary documents related to RADIAL for the second part of the CTIS submission and … on the 2nd of November we achieved yet another milestone as the Danish authorities have approved our study. The final preparations are now in full swing to get the last details and
- [PRESS RELEASE: BIOCORP: AARDEX® Group and BIOCORP recruited by Trials@Home - Decentralized Clinical Trial Centre of Excellence](https://trialsathome.com/press-release-biocorp-aardex-group-and-biocorp-recruited-by-trialshome-decentralized-clinical-trial-centre-of-excellence/) - PRESS RELEASEBIOCORP: AARDEX® Group and BIOCORP recruited by Trials@Home – Decentralized Clinical Trial Centre of ExcellenceJuly 21, 2022The AARDEX and BIOCORP teams are outstanding collaborators, who anticipate the nuances of interventional decentralized clinical trials. They go to great lengths to provide the Trials@Home consortium with technology that is the sine qua non for study participants
- [RADIAL CTIS Part I approved & MHRA Submission done!](https://trialsathome.com/radial-ctis-part-i-approved-mhra-submission-done/) - RADIAL CTIS Part I approved & MHRA Submission done!Utrecht, 21 July 2022Very good news: Trials@Home has received approval from the regulators on the CTIS part I submission of the RADIAL trial! The approval was received on the 18th of July. This milestone is a true demonstration of where good teamwork within a consortium can lead to! This was the
- [Public Report Trials@Home Semi-Annual Meeting 7-8 June 2022, Brussels](https://trialsathome.com/public-report-trialshome-semi-annual-meeting-7-8-june-2022-brussels/) - Trials@Home Semi-Annual Meeting Hybrid, 7 & 8 June 2022On June 7 and 8, nearly two and a half years since the kickoff meeting in Paris, Trials@Home hosted a hybrid event with more than 100 delegates from public and private partners and stakeholders coming together in Brussels/Anderlecht (44) and virtually (61). The meeting was hosted by UCB
- [Public Report Trials@Home Annual Meeting – 2 & 3 November 2021](https://trialsathome.com/public-report-trialshome-annual-meeting-2-3-november-2021/) - Trials@Home Annual Meeting Virtual, 2/3 November 2021On November 2 and 3, Trials@Home organised, in virtual format, its major annual event. More than 150 public and private partners and stakeholders came together to move the project forward, contribute to the larger landscape, and improve the access to clinical trials for patients. The meeting was held over two
- [Decentralised Clinical Trials are all about participant centricity](https://trialsathome.com/decentralised-clinical-trials-are-all-about-participant-centricity/) - Decentralised Clinical Trials are all about participant centricityUtrecht, May 20, 2022On 20 May 1747, James Lind started what is often considered the first randomised clinical trial aboard a ship to control an outbreak of scurvy. His approach to ‘compare like with like’, and the design of his trial may have “inspired” and informed future clinical
- [RADIAL Country selection process](https://trialsathome.com/radial-country-selection-process/) - RADIAL Country selection process To select the countries where the pan-EU RADIAL pilot study will be conducted, a multi-step approach was used while considering a good spread across Europe and health care systems, the legal and regulatory framework in those countries and the operational aspects such as potential trial participant recruitment and study start-up timelines.
- [RADIAL submitted in CTIS](https://trialsathome.com/radial-submitted-in-ctis/) - RADIAL submitted in CTISUtrecht, March 28, 2022 We are pleased to inform you that we have submitted the RADIAL study under the new Clinical Trial Regulation using CTIS for the participating EU countries Germany, Poland, Italy, Spain and Denmark on March 28. This is an important milestone achieved for Radial. This application was one of
- [Trials@Home Newsletter - November 2021](https://trialsathome.com/trialshome-newsletter-november-2021/) - Trials@Home NewsletterUtrecht, November 22, 2021Trials@Home – A vision for transforming clinical trials For privacy reasons YouTube needs your permission to be loaded.I Accept RADIAL, a test run for clinical trials of the future The Trials@Home consortium is planning a unique clinical trial, a proof of concept study, called RADIAL to test how clinical trials can
- [Mapping and analysis of the EU legislation on Remote Decentralised Clinical Trials (D4.1)](https://trialsathome.com/mapping-and-analysis-of-the-eu-legislation-on-remote-decentralised-clinical-trials-d4-1/) - Mapping and analysis of the EU legislation on Remote Decentralised Clinical Trials including legal, regulatory, ethical and stakeholder recommendations for the conduct of the pan-EU pilot (D4.1)Lead Contributors: Yared Santa-Ana-Tellez, Utrecht University – Helga Gardarsdottir, Utrecht UniversityFebruary 26, 2021 – updated March 2022The Innovative Medicines Initiative (IMI) Trials@Home project is a large multinational private-public partnership
- [Finalised list of KPI’s to be used to qualify and quantify the flow of activities in the pilot (D3.2)](https://trialsathome.com/d3-2-finalised-list-of-kpis-to-be-used-to-qualify-and-quantify-the-flow-of-activities-in-the-pilot/) - Finalised list of KPI’s to be used to qualify and quantify the flow of activities in the pilot (D3.2)Lead Contributors: UMCU, SanofiJuly 20, 2021Abstract The Trials@Home (T@H) consortium aims to explore opportunities to move clinical trials from the traditional clinic setting into the participants’ local surroundings or even homes. These so-called Remote Decentralised Clinical Trials (RDCTs) make
- [Trials@Home Glossary](https://trialsathome.com/trialshome-glossary/) - GlossaryUnderstanding the key terms that will feature in project outputs (updated April 2021)The aim of the glossary is to establish a common language and to aid understanding of key terms that will feature in project outputs. The glossary itself, presented in the document, may be updated during the Trials@Home project so that important new terms
- [First vendor for RADIAL proof-of-concept-study contracted](https://trialsathome.com/first-vendor-for-radial-proof-of-concept-study-contracted/) - First vendor for RADIAL proof-of-concept-study contractedUtrecht, December 22, 2021 As discussed in our latest webinar, we have selected the full tech package for the RADIAL study and are now contracting the selected vendors. We are excited to announce that the first vendor has been contracted: Signant Health Read the press release from Signant Health here:
- [Fisabio Interview about the Pandemic & Trials@Home](https://trialsathome.com/fisabio-interview-about-the-pandemic-trialshome/) - Virtual clinical trials in times of covid-19 (and beyond)By FISABIOThe pandemic has paved the way for the consolidation of decentralized health studies that facilitate home-based participation and allow researchers to use technology to interact with the volunteers. In 2011 we could not have imagined that just a decade later coronavirus would change our lives. Neither
- [Open call for additional technology partners (D6.5)](https://trialsathome.com/open-call-for-additional-technology-partners-d6-5/) - Open call for additional technology partners (D6.5)Lead Contributors: Nathalie Vigot (UMCU PMO)June 21, 2021The Trials@Home pan-European pilot (pan-EU pilot) study aims at comparing traditional clinical trial approaches to fully and hybrid RDCT approaches; as well as comparatively analyse the components (traditional clinical trial and hybrid and/or fully RDCT) in the pan-EU pilot and present and
- [General Practitioners Survey](https://trialsathome.com/general-practitioners-survey/) - Are you a general practitioner? Do you have 5 minutes for us? Please complete this survey and help us better understand how we can help you better understand what RDCTs are all about. Please click on the image below or scan the QR code to access the survey.
- [Public Report Semi-Annual Meeting April 2021](https://trialsathome.com/public-report-semi-annual-meeting-april-2021/) - Trials@Home celebrated its annual meeting’s extra spring editionVirtual, 23 June 2021After nearly 2 years of intense work and study in the field of decentralised clinical trials, more than 120 Trials@Home colleagues met up in a virtual semi-annual meeting in April 2021 to reflect on all the progress made in the project until now. The meeting
- [Patient Survey](https://trialsathome.com/patient-survey/) - This survey is now closed. If you like to know the results or participate in future surveys, please contact Petra Naster
- [Request for Proposal](https://trialsathome.com/request-for-proposal/) - Request for ProposalSubmit your technology to Trials@HomeTrials@Home (EU/EFPIA Innovative Medicines Initiative – Joint Undertaking (H2020-JTI-IMI2) Trials@Home grant n° 831458) aims to reshape clinical trial design, conduct and operations, by developing and piloting standards, recommendations and tools for the definition and operationalisation of remote decentralised clinical trials (RDCTs) in Europe. Request for Proposals (RfP) In a
- [Trials@Home Annual General Meeting  5-6 October 2020 - Public Report](https://trialsathome.com/trialshome-annual-general-meeting-5-6-october-2020-public-report/) - Trials@Home Annual General MeetingPublic Report5-6 October 2020September 2019, the great and grand kick-off meeting for the Trials@Home project in Paris. A big project, a large group of people, some have left us, some have joined us in the meantime, but what a fun two days. We all went home feeling part of the group and
- [Ethics D1a, GEN-Requirement: Independent Ethics Advisor appointed to participate in the independent external expert panel (D6.9)](https://trialsathome.com/ethics-d1a-gen-requirement-independent-ethics-advisor-appointed-to-participate-in-the-independent-external-expert-panel-d6-9/) - Ethics D1a, GEN-Requirement: Independent Ethics Advisor appointed to participate in the independent external expert panel (D6.9)Lead Contributor: Mira Zuidgeest (UMCU)November 11, 2019Ethical guidance for the Trials@Home project is built into the project in several manners. One request from the IMI during the grant negotiation phase was to include the appointment of an independent Ethics Advisor,
- [First version of Data management plan (D6.3)](https://trialsathome.com/first-version-of-data-management-plan-d6-3/) - First version of Data management plan (D6.3)Lead Contributor: Herman Verheij (Lygature)June 8, 2020Data Management Plan (DMP) provides a description of the data management that will be applied in the Trials@Home project including: A description of the data repositories, who is able to access the data, and who owns the data. The main DMP elements for
- [EU Remote Trials Project Gets Moving](https://trialsathome.com/eu-remote-trials-project-gets-moving/) - EU Remote Trials Project Gets MovingDiabetes Pilot Will Compare Conventional & Remote Trial ApproachesBy Vibha Sharma, Pink Sheet, 29 June 2020REMOTE TRIALS CAN IMPROVE PATIENT RECRUITMENT AND RETENTION An EU project that is looking to develop standards and tools for remote decentralized clinical trials (RDCTs) has decided on diabetes as the ideal therapeutic area for a
- [Request for information](https://trialsathome.com/request-for-information/) - Request for informationSubmit your technology to Trials@HomeTrials@Home (EU/EFPIA Innovative Medicines Initiative – Joint Undertaking (H2020-JTI-IMI2) Trials@Home grant n° 831458) aims to reshape clinical trial design, conduct and operations, by developing and piloting standards, recommendations and tools for the definition and operationalisation of remote decentralised clinical trials (RDCTs) in Europe. Identifying existing RCDT solutions In this
- [Innovative Medicines Initiative Launches ‘Trials@Home’](https://trialsathome.com/innovative-medicines-initiative-launches-trialshome/) - Innovative Medicines Initiative Launches ‘Trials@Home’A major European project to bring clinical trials to the participant’s homeUtrecht, October 7, 2019The Trials@Home consortium will explore the opportunities of moving clinical trials from the traditional clinic setting to the participant›s immediate surroundings. These so-called Remote Decentralised Clinical Trials (RDCTs) make use of new – digital – innovations and
- [Remote Decentralized Clinical Trials Could Solve RCT Problems](https://trialsathome.com/remote-decentralized-clinical-trials-could-solve-rct-problems/) - Remote Decentralized Clinical Trials Could Solve RCT ProblemsThe Pink Sheet21 November 2019Europe’s Innovative Medicines Initiative has launched a new project, Trials@Home, to evaluate how remote decentralized clinical trials (RDCTs), which use new technologies to allow bigger, more diverse and remote populations to take part in clinical trials, could become the gold standard for clinical research.

## Pages

- [Recommendations for DCTs](https://trialsathome.com/) - Recommendations for decentralised clinical trial approachesActivities & OperationsExploreImpact & KPIsExplorePatient Considerations & InvolvementExploreAssessment & ApprovalExploreOversight & Clinical ManagementExploreTechnology & SupportExploreAbout Trials@Home The Trials@Home consortium explored the opportunities of moving clinical trials from the traditional clinic setting to the participant’s immediate surroundings. These so-called Decentralised Clinical Trials (DCTs) make use of new, digital innovations and enable
- [Events](https://trialsathome.com/events/) - Events Events Click to see where Trials@Home will be represented or what events we’re planning Or subscribe to our newsletter to be kept informed about upcoming events. More Webinars Trials@Home proof-of-concept study RADIAL is ready for patient recruitment, 21 June 2023 More Podcasts Want to hear what people have to say about Trials@Home or DCTs?
- [Webinars](https://trialsathome.com/webinars/) - WebinarsSign up to our newsletter to receive the invitation. Upcoming Webinar more webinars will be announced soon Previous Webinars trialshome2023-06-22T13:40:08+00:00Webinar: Trials@Home proof-of-concept study RADIAL is ready for patient recruitmenttrialshome2023-06-22T13:40:08+00:00June 7th, 2023|trialshome2023-06-19T13:55:41+00:00Digital Literacy in DCTs. What is asked of trial participants?trialshome2023-06-19T13:55:41+00:00March 2nd, 2023|trialshome2023-05-10T13:32:35+00:00Trials@Home – Where are we two years down the road?trialshome2023-05-10T13:32:35+00:00December 1st, 2022|trialshome2023-06-19T13:56:57+00:00Trials@Home – A
- [About DCTs](https://trialsathome.com/about-rdcts/) - About DCTsClinical trials are, and will remain, crucial in drug development and improving patient health. However, (s)low patient recruitment and low retention puts pressure on the efficiency, generalisability and validity of traditional, clinical site-centred trials. Decentralised Clinical Trials (DCTs) hold the promise of solving this problem. The DCT approach is an operational strategy for technology-enhanced
- [publications deliverables and other outputs](https://trialsathome.com/publications-deliverables-and-other-outputs/) - Project outputsPublications A Systematic Approach to Quality Requirement Management in Medical Software Messer-Misak, et al dHealth 2020 – Biomedical Informatics for Health and Care 2020 Read now COVID‐19 and the Emerging Regulatory Guidance for Ongoing Clinical Trials in the European Union de Jong, et al Clinical Pharmacology & Therapeutics 2021 Read now Learning from remote
- [webinars](https://trialsathome.com/webinars-2/) - WebinarsTrials@Home Interest Network Webinars Trials@Home Webinar: Patient views on decentralisation of clinical trials Wednesday, 10 June, 3:00 pm About the webinarVideoSlides Trials@Home webinar: Operational Learnings from the RADIAL Trial March 30, 2026 About the webinarVideoSlides
- [Participant experience](https://trialsathome.com/participant-experience/) - Patient Considerations & InvolvementParticipant experienceWhen introducing a different way of doing clinical trials to participants, the impact on participant experiences is an important component to evaluate. While DCTs promise to reduce the burden on trial participants and make participation more compatible with everyday life responsibilities, there is little knowledge about how moving trial activities to
- [Participant preferences](https://trialsathome.com/participant-preferences/) - Patient Considerations & InvolvementPatient preferencesDCTs may be less burdensome for participants than conventional trials, as travel to the research site is reduced or eliminated and trial visits can be carried out from the participant’s home or immediate vicinity by applying digital technologies and operational innovations. To tailor DCT elements to patients and lower the participation
- [Site staff readiness and training](https://trialsathome.com/site-staff-readiness-and-training/) - Oversight & Clinical ManagementSite staff readiness and trainingIn conventional trials, sites traditionally serve as central locations for patient recruitment, monitoring and data collection, and regulatory compliance. In a DCT these traditional roles change, shifting some trial activities away from sites to remote settings. The perspective of sites is vital for the successful implementation of DCT
- [DCT approaches](https://trialsathome.com/dct-approaches/) - Activities & OperationsDCT approachesSeveral approaches have been used in DCTs to move trial activities towards participants’ homes. A selection of these, which were used in RADIAL, are shown in the figure below. Others include postal or telephone contact, shipment of study materials to participants, use of local healthcare services and routine care, use of centralised
- [Technical Support System](https://trialsathome.com/technical-support-system/) - Technology & SupportTechnical support systemDCTs use a variety of digital tools to facilitate at-home data collection, enhance participant convenience, and enable remote monitoring. However, the use of multiple tools—often sourced from different vendors—can create challenges for both participants and support teams. It was recognized that site staff and CRAs may not have the technical expertise
- [Trials@Home Interest Network](https://trialsathome.com/trialshome-interest-network/) - About usTrials@Home Interest NetworkTo stimulate short-term and long-term uptake of the recommendations and to leverage the network, expertise and experience gained during the project to continue the advancement of the field of DCTs, the Trials@Home project continues as the Trials@Home Interest Network. The Trials@Home Interest Network is a voluntary community of individuals interested in the
- [DCT course - chapter 3](https://trialsathome.com/dct-course-chapter-3/) - The Trials@Home DCT courseCHAPTER 3: Tackling challenges in DCTsDCTs have many potential benefits when it comes to bringing clinical trials closer to the patient’s home, but this also means that there are potential challenges that can be encountered along the way. This chapter covers some of those challenges and how they can be anticipated and
- [About Trials@Home](https://trialsathome.com/about-trialshome/) - About Trials@HomeThe Trials@Home consortium explored the opportunities of moving clinical trials from the traditional clinic setting to the participant’s immediate surroundings. These so-called Decentralised Clinical Trials (DCTs) make use of new, digital innovations and enable participants to visit a clinical trial centre less frequently, if at all. To stimulate short-term and long-term uptake of the
- [What is Trials@Home?](https://trialsathome.com/what-is-trials-at-home/) - About usWhat is Trials@Home?Centre of Excellence for Decentralised Clinical Trial Approaches The Trials@Home consortium explored the opportunities of moving clinical trials from the traditional clinic setting to the participant’s immediate surroundings. These Decentralised Clinical Trials (DCTs) make use of digital and operational innovations, enabling participants to visit a clinical trial centre less frequently, if at
- [Impact & KPIs](https://trialsathome.com/impact-kpis/) - Recommendations onImpact & KPIsThe potential benefits of DCTs are often highlighted: improved participant retention, greater representativeness, reduced costs, and a smaller carbon footprint. What did we find as drivers for these KPIs? Participant accessibility and representativeness Participant accessibility and representativeness DCTs have significant potential to reduce logistical barriers and improve accessibility. This can enable the
- [Technology & Support](https://trialsathome.com/technology-and-support/) - Recommendations onTechnology & SupportDigital tools enable decentralisation, but their selection and implementation are critical. We review the technologies assessed and used during the project and share lessons learned from providing technical support throughout the proof-of-concept trial. Technology components Technology components Digital tools in DCTs can improve real-world data collection, reduce participant travel, and offer more
- [Activities & Operations](https://trialsathome.com/activities-operations/) - Recommendations onActivities & OperationsWe gathered practical insights on trial set-up and conduct throughout our proof-of-concept DCT. What are best practices for recruitment, screening and consent? And how should decentralised activities during the trial be managed, such as sample collection and home nursing visits? Best practices for DCT approachesBest practices for DCT approaches Many of the
- [Oversight & Clinical Management](https://trialsathome.com/oversight-and-clinical-management/) - Recommendations onOversight & Clinical ManagementEnsuring robust oversight in a decentralized model requires careful planning. This theme covers site staff readiness and training, privacy and data handling, and the responsibilities of principal investigators, including safety reporting and overall trial governance. Site staff readiness and trainingSite staff readiness and training In conventional trials, sites traditionally serve as
- [Patient Considerations & Involvement](https://trialsathome.com/patient-considerations-and-involvement/) - Recommendations onPatient Considerations & InvolvementPutting participants at the centre has long been a priority in clinical research, and DCTs are expected to reduce burden compared to traditional trials. But what do participants really think? We explore their experiences and perspectives on DCTs. Patient preferencesPatient preferences DCTs may be less burdensome for participants than conventional trials,
- [Assessment & Approval](https://trialsathome.com/assessment-approval/) - Recommendations onAssessment & ApprovalRegulatory and ethical engagement was a cornerstone of Trials@Home, given the implications of this innovative model. In this theme, we examine ethical considerations, the regulatory landscape, and the level of awareness among HTAs across Europe. Overarching ethical considerationsOverarching ethical considerations All clinical trials require ethical review, including DCTs. However, the regulatory and
- [What are decentralised clinical trials?](https://trialsathome.com/what-are-dcts/) - About usWhat are decentralised clinical trials?Clinical trials are essential to prove the safety and efficacy of new medicines. They remain challenging to deliver due to low participation rates. Decentralised Clinical Trial (DCTs) approaches hold the potential to address some of these challenges. Decentralised clinical trials are trials in which activities are designed to take place
- [What are clinical trials?](https://trialsathome.com/what-are-clinical-trials/) - About usWhat are clinical trials?Clinical research is the ‘backbone’ of progress in healthcare. Behind every modern medical treatment are people who took part in clinical trials to find out if the medicine was safe and if it worked. Clinical trials are research studies in which people volunteer to receive medical interventions including medicines, cells, or
- [Introductory course on DCTs](https://trialsathome.com/introductory-course-on-dcts/) - Introductory course on DCTsThe Trials@Home consortium developed a training for patients and patient organisations to optimise understanding of Decentralised Clinical Trial approaches (DCTs) in Europe. This online training has been created to introduce the concept of DCTs, and to explain how to design and run such trials and which technologies can be used for which
- [Technology components](https://trialsathome.com/technology-and-support/technology-components/) - Technology & SupportTechnology componentsDigital tools in DCTs can improve real-world data collection, reduce participant travel, and offer more flexible engagement. However, there are challenges that come from integrating technology into trials: (1) reliance on cutting-edge yet immature technologies, (2) increased trial complexity, and (3) potential overload for clinical sites and participants. Recommendations Advocate for robust
- [What is RADIAL?](https://trialsathome.com/what-is-radial/) - About usWhat is RADIAL?The RADIAL (Remote And Decentralized Innovative Approach to cLinical trials) trial is a pan-European phase IV proof-of-concept trial designed to evaluate the feasibility, acceptability, and quality of decentralised clinical trial (DCT) approaches compared to conventional site-based models. Conducted across six European countries, the trial involved adults with Type 2 Diabetes Mellitus (T2DM)
- [Remote consent](https://trialsathome.com/remote-consent/) - Activities & OperationsRemote consentRemote consent is a key decentralised element in DCTs that enables participants to give their consent to participate in a trial without a visit to the trial centre. In a DCT, the process usually take place online (eConsent) through identification online (eIdentification) and digitally signing documents (eSignature). Yet implementation of eConsent faces
- [Terms & Privacy](https://trialsathome.com/terms-privacy/) - Terms & privacyWelcome to the Trials@Home website. Disclaimer The consortium members make no warranties or representations of any kind as to the content’s accuracy, currency or completeness. Neither the consortium members nor any party involved in creating, producing or delivering this website shall be liable for any damages, including without limitation, direct, incidental, consequential, indirect
- [Peer reviews & research outputs](https://trialsathome.com/peer-reviews-and-research-outputs/) - Peer reviews & research outputsAll papers published as a result of the work done in the Trials@Home can be found on this page. When posters or layman articles of papers are available, they have been added below, other posters can be found here. Some papers also have a short summary video, you can find these
- [Deliverables](https://trialsathome.com/deliverables/) - Objectives and key deliverablesThe six work packages (WPs) of Trials@Home and their interdependencies. 1. BEST2. TECH3. PILOT4. EAGLE5. CODE6. PROMS1. BEST 1. Best practices in DCTs WP1 BEST had three objectives: To collect and analyse prior and ongoing experiences with DCTs; To provide best practices, selection criteria and recommendations for implementation into the WP3 PILOT.
- [Overarching ethical considerations](https://trialsathome.com/overarching-ethical-considerations/) - Assessment & ApprovalOverarching ethical considerationsAll clinical trials require ethical review, including DCTs. However, the regulatory and ethical review system was designed for conventional (site-based) trials. To fully realise the promises of DCT approaches, the ethical context needs to be aligned with the practice of DCTs to safeguard responsible conduct. Recommendations Consider positive outcomes beyond direct
- [EU Regulatory landscape](https://trialsathome.com/eu-regulatory-landscape/) - Assessment & ApprovalEU regulatory landscapePrior to the implementation of the Clinical Trials Regulation (EU No. 536/2014), clinical trials in the EU were governed by EU directives (2001/20/EC, 2005/28/EC) and national laws, with variability across Member States (MS). In 2022, the Clinical Trials Regulation (CTR) became mandatory in all MS, repealing the Clinical Trials Directive (CTD)
- [DCT course - chapter 5](https://trialsathome.com/dct-course-chapter-5/) - The Trials@Home DCT courseCHAPTER 5: RADIAL, the Trials@Home proof-of-concept trial, as an example of a trial using decentralised elementsThe RADIAL trial is a proof-of-concept clinical trial exploring how clinical trial activities can be moved from hospitals to participants’ homes. It involved people with Type 2 diabetes across six European countries and compared three different trial
- [DCT course - Chapter 1](https://trialsathome.com/dct-course-chapter-1/) - The Trials@Home course on DCTsCHAPTER 1: Why do decentralised clinical trials?Decentralised clinical trials (DCTs) are a way of conducting research that allows participants to participate from the comfort of their own homes, rather than having to travel to a clinic or hospital. Here are some potential benefits for participants and trial sites when conducting DCTs:
- [DCT course - Introduction](https://trialsathome.com/dct-course-introduction/) - The Trials@Home course on DCTsIntroductionThe IMI Trials@Home consortium has developed this training for patients and patient organisations. Nowadays, it is possible to participate in a clinical trial from the comfort of your home instead of visiting your doctor regularly, and such trials are called Decentralised Clinical Trials (DCTs) or trials with decentralised elements. These trials with
- [DCT course - chapter 4](https://trialsathome.com/dct-course-chapter-4/) - The Trials@Home DCT courseCHAPTER 4: Co-creating DCTs – engaging with the target participant group to design the study tailored to the potential participantMany stakeholders are involved in the design and conduct of clinical trials, including (but not limited to) researchers, regulators, funding bodies, patient organisations and patients. This last group has gained more of a
- [DCT course - chapter 2](https://trialsathome.com/dct-course-chapter-2/) - The Trials&Home DCT courseCHAPTER 2: Know the most common DCT elementsA DCT can either be fully remote or merely contain DCT elements. Trials that only contain some DCT elements are considered hybrid clinical trials. DCT approaches are quite common in clinical trials, although fully remote DCTs are less common. To fully explore which elements are
- [quiz](https://trialsathome.com/quiz/) - Question 2: Which of the following are potential benefits of decentralised clinical trials for study centres? (Select the answers you think are true) Expanded participant recruitment beyond geographic limitations Correct! Increased workload and operational burden on site staff. Incorrect! This is because DCTs can potentially reduce operational burden by minimising in-person visits and automating data
- [Health technology assessment awareness](https://trialsathome.com/health-technology-assessment-awareness/) - Assessment & ApprovalHealth technology assessment awarenessHealth technology assessment (HTA) bodies are responsible for evaluating new health technologies to support reimbursement decision-making in Europe. As data from DCTs may be used for clinical or economic evaluation (for reimbursement purpose), it is important to investigate the opportunities and challenges for DCT approaches from an HTA perspective. Recommendations
- [Participant accessibility and representativeness](https://trialsathome.com/participant-accessibility-and-representativeness/) - Impact & KPIsParticipant accessibility and representativenessDCTs have significant potential to reduce logistical barriers and improve accessibility. This can enable the participation of traditionally underserved populations, ensuring that findings are applicable to more segments of the population. However, challenges persist in effectively reaching diverse populations due to varying levels of digital literacy, accessibility constraints, and operational
- [Home nursing in DCTs](https://trialsathome.com/home-nursing-in-dcts/) - Activities & OperationsHome nursing in DCTsOne way of decentralising a study visit in a clinical trial is for a nurse or other healthcare professional (HCP) to visit a participant at their home or another community location (for example, their workplace) to perform trial related activities. Such home nurse visits could either be conducted by nurses
- [Course Materials](https://trialsathome.com/course-materials/) - Course MaterialsThe Trials@Home consortium developed a training for patients and patient organisations to optimise understanding of Decentralised Clinical Trial approaches (DCTs) in Europe. This online training has been created to introduce the concept of DCTs, and to explain how to design and run such trials and which technologies can be used for which decentralised activities.
- [Research Videos](https://trialsathome.com/news-publications/research-videos/) - Research VideosWithin Trials@Home we aim to share learnings on implementation of remote technologies and approaches in the context of decentralised clinical trials. Our army of talented young researchers prepared short videos where they share the highlights of their research. These videos were created to share these outputs with the consortium, but we think they are
- [POSTERS](https://trialsathome.com/posters/) - Research PostersMany of the research papers that are produced for the Trials@Home project get translated into posters that are presented at various conferences. You can find all Trials@Home related posters here. RADIAL Study: A European Innovative Medicines Initiative Assessing a Decentralized Clinical Trial Approach in People with Type 2 Diabetes Treated with Basal Insulin Presented
- [Economic insights](https://trialsathome.com/economic-insights/) - Impact & KPIsEconomic insightsSetting up and conducting clinical trials is costly, and some have raised concerns that expenditures may increase. Introducing DCT elements could further increase clinical trial costs, particularly for technology set-up and online recruitment methods. However, DCTs also have the potential to achieve cost-savings, if they can accelerate patient recruitment and improve retention,
- [Home shipment and collection](https://trialsathome.com/home-shipment-and-collection/) - Activities & OperationsHome shipment and collectionDirect-to-participant (DtP) shipment of investigational medicinal products (IMPs) and study materials, combined with remote biological sample collection, can reduce participant burden and improve accessibility in DCTs. However, these processes introduce operational complexity, including balancing the number of shipments against assembling comprehensive kits, and managing challenges at initiation (IoT) and end-of-trial
- [Remote recruitment and (pre-)screening](https://trialsathome.com/remote-recruitment-and-pre-screening/) - Activities & OperationsRemote recruitment and (pre-)screeningDCTs minimise or eliminate the need for travel to research sites, enabling broader accessibility for participants who are not in convenient proximity to a trial site. This enables broader outreach to potential participants through online recruitment methods such as social media ads, search engine advertisement and recruitment websites, replacing, or
- [Best practices](https://trialsathome.com/best-practices/) - Activities & OperationsBest practices for DCT approachesMany of the best practices for DCTs are the same as in more conventional trial designs. However, some areas of DCT design and planning need additional attention to make the trial successful and to improve the participant experience. Recommendations Answer an important research questionAll clinical trials should aim to
- [Carbon Footprint](https://trialsathome.com/carbon-footprint/) - Impact & KPIsCarbon footprintIt has been reported that the pharmaceutical industry is among the highest producers of greenhouse gas emissions. Carbon footprinting can be used to identify which elements of DCTs have the greatest impact on greenhouse gas emissions and can support future decision making in Europe to reduce carbon emissions in clinical trials. However,
- [Retention](https://trialsathome.com/retention/) - Impact & KPIsRetentionRetention in a clinical trial refers to the number or proportion of participants who complete the study through to the end. The ease of participation in a DCT may improve retention as continued participation may be more flexibly managed around a participant’s work and personal commitments or changing circumstances. However, with minimal or
- [Privacy & data protection](https://trialsathome.com/privacy-data-protection/) - Oversight & Clinical ManagementPrivacy & data protectionThe successful and sustainable adoption of DCTs hinges on robust data privacy and protection measures. Moving trial activities outside traditional research sites significantly increases the complexity of data flows and amplifies privacy and data protection challenges, such as participant personal data being shared to third party service providers. Unlike
- [flip-box-home](https://trialsathome.com/flip-box-home/) - Activites & Operations Lorem ipsum dolor sit amet, consetetur sadipscing elitr, sed diam nonumy eirmod tempor invidunt ut labore et dolore magna aliquyam erat MoreActivites & Operations Lorem ipsum dolor sit amet, consetetur sadipscing elitr, sed diam nonumy eirmod tempor invidunt ut labore et dolore magna aliquyam erat MoreActivites & Operations Lorem ipsum dolor sit
- [Public events](https://trialsathome.com/public-events/) - EventsEvents & Speaking Engagements 5th International Conference WE! Are Clinical Research in Warsaw (8–10 October 2025) at Kozminski University. Bart Lagerwaard will discuss key findings from RADIAL, our decentralised proof-of-concept trial, and reflect on what they mean for reshaping the future of clinical research. Poland played a central role in RADIAL, and we gained valuable
- [Glossary](https://trialsathome.com/glossary/) - GlossaryUnderstanding the key terms that will feature in project outputs (updated April 2021)The aim of the glossary is to establish a common language and to aid understanding of key terms that will feature in project outputs. The glossary itself, presented in the document, may be updated during the Trials@Home project so that important new terms
- [Template Recommendations Content](https://trialsathome.com/template-recommendations-content/) - Section titleSection recommendation headingIntroduction text lorem ipsum dolor sit amet, consetetur sadipscing elitr, sed diam nonumy eirmod tempor invidunt ut labore et dolore magna aliquyam erat, sed diam voluptua. At vero eos et accusam et justo duo dolores et ea rebum. Stet clita kasd gubergren, no sea takimata sanctus est Lorem ipsum dolor sit amet.
- [buttons](https://trialsathome.com/buttons/)
- [About RADIAL](https://trialsathome.com/about-radial/) - About RADIAL, the Trials@Home proof-of-concept studyThe RADIAL trial is testing out whether future clinical trials can be successfully run from participants’ homes rather than hospitals or clinics – and the best way to do this. The trial is open to people living with type 2 diabetes who are on long-acting basal insulin. About the RADIAL
- [Trials at Home - a home run?](https://trialsathome.com/trials-at-home-a-home-run/) - CLOSING EVENTTrials@Home, a home run?Recommendations after leading the way on DCTs in EuropeSCOPE To share learnings from Trials@Home and look to the future of decentralised clinical trials LOCATION The Railway Museum Utrecht, The Netherlands; or online DATE 09.00 – 17.30 CET 31 October, 2025 The Trials@Home project is coming to its end with the publication
- [Training Materials](https://trialsathome.com/training-sessions-and-kits/) - Training MaterialsIn order to support future implementation of DCTs in Europe we will design online training and education to introduce the concept of DCTs, how to design and run them and which technologies are most suitable. These trainings will also target patients and patient organisations in order to make them familiar with the concept of
- [About us](https://trialsathome.com/about-us/) - About usThe Trials@Home consortium explores the opportunities of moving clinical trials from the traditional clinic setting to the participant’s immediate surroundings. These so-called Decentralised Clinical Trials (DCTs) make use of new, digital innovations and enable participants to visit a clinical trial centre less frequently, if at all. This makes it easier for larger, more diverse
- [Home](https://trialsathome.com/home/) - Centre of Excellence for Decentralised Clinical TrialsTrials@Home aims to reshape clinical trial design, conduct and operations, by developing and piloting standards, recommendations and tools for the definition and operationalisation of decentralised clinical trials (DCTs) in Europe. Centre of Excellence Decentralised Clinical TrialsTrials@Home aims to reshape clinical trial design, conduct and operations, by developing and piloting
- [Contact](https://trialsathome.com/contact/) - Contact usFor further details about our project please contact us today. Annemarijn Douwes Trials@Home Project Manager Tel: +316 3111 7756 Email: trialsathome@umcutrecht.nl Lucas Pagnier Trials@Home Project Manager Tel: +33 6 83 91 50 25 Email: lucas.pagnier@sanofi.com
- [Podcasts](https://trialsathome.com/podcasts/) - PodcastsWelcome to the Trials@Home podcast page. In our series “10 Minutes with Trials@Home” we invite a variety of guests for a quick chat. For privacy reasons SoundCloud needs your permission to be loaded.I AcceptFor privacy reasons SoundCloud needs your permission to be loaded.I AcceptEvents Webinars Podcasts
- [radial_es](https://trialsathome.com/radial_es/) - ¿Qué es RADIAL?RADIAL es un estudio de investigación científica. El objetivo de RADIAL es probar una nueva forma de investigación científica que pueda reducir la carga que supone participar en estudios clínicos. Queremos comprobar si los llamados ensayos clínicos descentralizados funcionan igual de bien que los ensayos clínicos tradicionales. Los ensayos tradicionales se llevan a
- [News & publications](https://trialsathome.com/news-publications/) - News & publications Project updates Featured article RADIAL is approved in Denmark! The Danish authorities have approved our study Read More … November 2022 Read all Interviews Featured interview The Future of Medical Research The Lancet 27 September 2023 Read all Peer reviews & research outputs A secondary qualitative analysis of stakeholder views about participant recruitment, retention,
- [Training](https://trialsathome.com/training/) - Training Training materials In order to support future implementation of DCTs in Europe we will design online training and education to introduce the concept of DCTs, how to design and run them and which technologies are most suitable. More DCT check list Coming soon. More
- [FAQs](https://trialsathome.com/faqs/) - Frequently asked questionsWhat are DCTs? See page: About DCTs. What is the ESP? See page: About the ESP. Can I join the consortium? For more information on the terms and conditions to join the Trials@Home consortium, please contact: Annemarijn Douwes trialsathome@umcutrecht.nl She will happily explain you the procedure. Glossary with terminology used within the project
- [DCT checklist](https://trialsathome.com/rdct-check-list/) - DCT checklistComing soon. At the end of the project Trials@Home will produce recommendations on how to best run a DCT or when it’s appropriate to opt for a DCT. A checklist will be developed based on these recommendations. Training Materials Research Videos DCT checklist
- [About the ESP](https://trialsathome.com/about-the-esp/) - About the ESP & PEPThroughout the project, we engage in frequent and in-depth dialogue with various stakeholders, also outside of the Trials@Home consortium. This allows us to incorporate the views and knowledge of such stakeholders including patients, (clinical) researchers, healthcare providers, regulators, payers, Health Technology Assessment (HTA) groups, and ethics bodies. Representatives of these stakeholder
- [interviews](https://trialsathome.com/interviews/) - Interviewstrialshome2024-02-09T14:11:08+00:00EU Regulators Told To ‘Normalize’ Decentralized Clinical Trials EU Regulators Told To ‘Normalize’ Decentralized Clinical Trials The Pink Sheet 15 January 2024 EU drug regulators have received some candid responses from trial sponsors and other stakeholders [...]trialshome2024-02-09T14:05:32+00:00The Future of Medical Research The Future of Medical Research A video from The Lancet featuring Trials@Home September 27,
- [About](https://trialsathome.com/about/) - About Trials@Home About us The Trials@Home consortium will explore the opportunities of moving clinical trials from the traditional clinic setting to the participant’s immediate surroundings. These so-called Decentralised Clinical Trials (DCTs) make use of new – digital – innovations and enable participants to visit a clinical trial centre less frequently, if at all. More About
- [Request for Proposals](https://trialsathome.com/request-for-proposals/) - Submit your technology to Trials@HomeAll fields marked * are mandatory. By submitting your application you acknowledge that your information will be transferred to Trailas@Home for processing. See our terms and privacy here. Email Address* First Name* Last Name* Company* Job Title* Telephone Address Name of solution* Which RCT phase is supported by your proposal?* RCT
- [form test](https://trialsathome.com/form-test/)
- [Request for information form](https://trialsathome.com/request-for-information-form/) - Submit your technology to Trials@HomeAll fields marked * are mandatory. By submitting your application you acknowledge that your information will be transferred to Trailas@Home for processing. See our terms and privacy here. Email Address* First Name* Last Name* Company* Job Title* Telephone Address Name of solution* Which RCT phase is supported by your solution?* —Please
- [Project updates](https://trialsathome.com/project-updates/) - Project Updatestrialshome2025-11-27T11:03:30+00:00Layman Poster: What Patients Like and Don’t Like About Decentralised Clinical Trials.What Patients Like and Don’t Like About Decentralised Clinical Trials. A group conversation to ask different people what they like? Acknowledgement & Disclaimer This poster is not an original, it has [...]trialshome2025-12-05T16:38:33+00:00CLOSING EVENT Trials@Home, a home run? CLOSING EVENT Trials@Home, a home run?
- [Request (old)](https://trialsathome.com/request-old/) - Request for informationSubmit your technology to Trials@HomeTrials@Home (EU/EFPIA Innovative Medicines Initiative – Joint Undertaking (H2020-JTI-IMI2) Trials@Home grant n° 831458) aims to reshape clinical trial design, conduct and operations, by developing and piloting standards, recommendations and tools for the definition and operationalisation of remote decentralised clinical trials (RDCTs) in Europe. Identifying existing RCDT solutions In this

## CM Tooltip Glossary

- [Decentralised clinical trials](https://trialsathome.com/glossary/decentralised-clinical-trials/) - Abbreviation: DCT Decentralised clinical trials, or DCTs, is an operational model of clinical trials in which some or all trial activities are designed to take place at, or in the vicinity of, the participant's home, rather than at a traditional clinical site. This approach can make use of technologies and other innovative operational approaches to facilitate data
- [RADIAL](https://trialsathome.com/glossary/radial/) - The RADIAL (Remote And Decentralized Innovative Approach to cLinical trials) trial is a pan-European phase IV proof-of-concept trial designed to evaluate the feasibility, acceptability, and quality of decentralised clinical trial (DCT) approaches compared to conventional site-based models. more info -> About Trials@Home -> What is RADIAL?
- [Decentralised Clinical Trial](https://trialsathome.com/glossary/decentralised-clinical-trial/) - Abbreviation: DCT Decentralised clinical trials, or DCTs, is an operational model of clinical trials in which some or all trial activities are designed to take place at, or in the vicinity of, the participant's home, rather than at a traditional clinical site. This approach can make use of technologies and other innovative operational approaches to facilitate data
- [DCTs](https://trialsathome.com/glossary/dct/) - Decentralised clinical trials, or DCTs, is an operational model of clinical trials in which some or all trial activities are designed to take place at, or in the vicinity of, the participant's home, rather than at a traditional clinical site. This approach can make use of technologies and other innovative operational approaches to facilitate data collection. source:
- [Wearables](https://trialsathome.com/glossary/wearables/) - Portable devices, especially those incorporating microprocessor technology, designed to be worn on one's person to collect, store and/or transmit healthcare data in real-time. Original source: OEDxxvi
- [Trial site](https://trialsathome.com/glossary/trial-site/) - The location(s) where trial-related activities are conducted. This would typically be a healthcare or research facility in a non-DCT. Adapted from: ICH GCPxxv
- [Trial building block](https://trialsathome.com/glossary/trial-building-block/) - A framework developed for use in the Trials@Home project to facilitate the mapping of the set of related and coordinated services and solutions that supports one or more activities within a clinical trial across site-based, hybrid and fully DCT. Source: Trials@Home
- [Telemedicine](https://trialsathome.com/glossary/telemedicine/) - The delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing
- [Subject](https://trialsathome.com/glossary/subject/) - An individual who participates in a clinical trial either as a recipient of the investigational product(s) or as a control. The term “subject” is part of the federal regulation and may be used interchangeably with participant in some situations. This is not a preferred term within Trials@Home. Original Source: FDAxxiii
- [Study consent](https://trialsathome.com/glossary/study-consent/) - A subject's free and voluntary expression of his or her willingness to participate in a particular clinical trial, after having been informed of all aspects of the clinical trial that are relevant to the subject's decision to participate or, in case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated
- [Siteless trial](https://trialsathome.com/glossary/siteless-trial/) - See “Decentralised clinical trial (DCT)”.
- [Scientific advisory board](https://trialsathome.com/glossary/scientific-advisory-board/) - Abbreviation: SAB A selective group of stakeholders that will review the trial and project design and is not involved in the shaping of outputs. It consists of independent, sovereign thought leaders in the field of DCTs who serve in a private capacity. The SAB will provide a scientific review of the project and will report
- [Remote source data verification](https://trialsathome.com/glossary/remote-source-data-verification/) - Abbreviation: rSDV Review of source data by clinical trial Monitors using digital platforms. May include review of digital copies of paper-based materials, or direct review of electronic source data such as electronic records. Source: Clinical Research Newsxxii
- [Remote site monitoring](https://trialsathome.com/glossary/remote-site-monitoring/) - Abbreviation: RSM Review of trial documentation and drug accountability by clinical trial Monitors using digital platforms and without physically visiting a research site. This may also be referred to as virtual trial monitoring. Source: Clinical Research Newsxxii
- [Real world evidence](https://trialsathome.com/glossary/real-world-evidence/) - Abbreviation: RWE Results derived from the analysis and/or synthesis of real-world data. Adapted from: IMI GetRealxx
- [Real world data](https://trialsathome.com/glossary/real-world-data/) - Abbreviation: RWD Data collected in a manner that reflects how interventions would be used in routine clinical practice or secondary research data derived from routinely collected data. Adapted from: IMI GetRealxx
- [Randomisation and trial supply management](https://trialsathome.com/glossary/randomisation-and-trial-supply-management/) - Abbreviation: RTSM Comprehensive solution that manages randomisation and clinical trial supplies in complex studies. Advanced version of Randomisation and Trial Supply Management systems commonly known as Interactive Voice Response Systems (IVRS), Interactive Web Response Systems (IWRS), and Interactive Responsive Technology (IRT). Adapted from: Parexelxix
- [Pseudonymisation](https://trialsathome.com/glossary/pseudonymisation/) - The processing of personal data in such a manner that the personal data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organisational measures to ensure that the personal data are not attributed to
- [Processor](https://trialsathome.com/glossary/processor/) - A natural or legal person, public authority, agency, or other body that processes personal data on behalf of the controller. Original source: GDPRv
- [Personalised medicine](https://trialsathome.com/glossary/personalised-medicine/) - Medicine that is targeted to individual patients or stratified population of patients with specific characteristics. Personalised medicine can also be interpreted more narrowly to mean targeted treatment according to genetic variations only or to mean a unique treatment for the individual patient rather than groups of patients. Original source: IMI ADAPT/SMARTxviii
- [Personal data](https://trialsathome.com/glossary/personal-data/) - Any information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological,
- [Person identifiable data](https://trialsathome.com/glossary/person-identifiable-data/) - Abbreviation: PID Person (or patient) identifiable data: See "Personal data".
- [Patient-centric trial design](https://trialsathome.com/glossary/patient-centric-trial-design/) - A study design principle where the needs and wishes of the patient are considered as much as possible. Source: Trials@Home
- [Participant](https://trialsathome.com/glossary/participant/) - A person taking part in a clinical trial. This term is preferred within Trials@Home. Source: Trials@Home
- [Patient](https://trialsathome.com/glossary/patient/) - A person receiving or registered to receive medical treatment or (para)medical care. This is not a preferred term in Trials@Home when referring to a trial participant. Original Source: Oxford English Dictionaryxvii
- [Non-investigational medicinal product](https://trialsathome.com/glossary/non-investigational-medicinal-product/) - Abbreviation: Non-IMP, NIMP See "Auxiliary medicinal product".
- [Mobile health](https://trialsathome.com/glossary/mobile-health/) - Abbreviation: m-Health, mHealth Medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants, and other wireless devices. Original source: WHOxvi
- [Investigational medicinal product](https://trialsathome.com/glossary/investigational-medicinal-product/) - Abbreviation: IMP A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorized form, or when used for an unauthorized indication, or when used to
- [Informed consent](https://trialsathome.com/glossary/informed-consent/) - Abbreviation: ICF Informed consent (trial participation): See “Study consent”.
- [Hybrid trial](https://trialsathome.com/glossary/hybrid-trial/) - Trial model that involves both remote/decentralised and traditional site-based trial elements. Source: Trials@Home
- [Home trial support](https://trialsathome.com/glossary/home-trial-support/) - Services required to allow the conduct of trial activities in a participant’s home instead of at a trial site. May include home nursing (IMP administration, phlebotomy and other sample collection, physiological observations, etc.) as well as supportive logistics and pharmacy. Original Source: MRNxiv
- [Health technology assessment](https://trialsathome.com/glossary/health-technology-assessment/) - Abbreviation: HTA The systematic evaluation of the properties and effects of a health technology, addressing the direct intended effects of this technology, as well as its indirect unintended consequences, and aimed mainly at informing decision-making regarding health technologies. Original source: WHOxiii
- [External stakeholder platform](https://trialsathome.com/glossary/external-stakeholder-platform/) - Abbreviation: ESP External stakeholder platform (Trials@Home): A consultation group that is actively involved in the Trials@Home project. It consists of representatives from relevant stakeholder groups and expertise fields to provide expert views, insights and knowledge about DCT approaches. They also serve as ambassadors of the project. Source: Trials@Home
- [Electronic participant reported outcome](https://trialsathome.com/glossary/electronic-participant-reported-outcome/) - Abbreviation: ePRO See “Electronic Patient Reported Outcome”. An ePRO used to collect data entered actively by participants in a clinical trial.
- [Electronic health](https://trialsathome.com/glossary/electronic-health/) - Abbreviation: e-Health, eHealth Activities that use electronic means to deliver health-related information, resources, and services: it is the use of information and communication technologies (ICT) for health. Original source: WHOxi
- [Electronic consent](https://trialsathome.com/glossary/electronic-consent/) - Abbreviation: eConsent eConsent includes multimedia components which can be used to develop an interactive and engaging informed consent experience, offering flexibility for diverse learning styles (e.g., auditory, visual). Original Source: TransCeleratex
- [Electronic clinical outcome assessment](https://trialsathome.com/glossary/electronic-clinical-outcome-assessment/) - Abbreviation: eCOA An electronically collected clinical outcome assessment is a measure that describes or reflects how a patient feels, functions, or survives. Original Source: FDAix
- [Electronic case report form](https://trialsathome.com/glossary/electronic-case-report-form/) - Abbreviation: eCRF An auditable electronic record of information that generally is reported to the sponsor on each trial subject, according to a clinical investigation protocol. The eCRF enables clinical investigation data to be systematically captured, reviewed, managed, stored, analysed, and reported. Original Source: FDAviii
- [Direct-to-participant](https://trialsathome.com/glossary/direct-to-participant/) - Abbreviation: DTP Direct-to-participant (IMP delivery): Any method of IMP delivery directly to a trial participant. Two strategies are common: site-to- participant IMP delivery and depot-to-participant IMP delivery; each requires different regulatory approaches. Trials@Home
- [Digital trial](https://trialsathome.com/glossary/digital-trial/) - A trial that uses digital technologies (such as electronic data, mobile communications, sensors, and devices). Original Source: Steinhubl et al., 2019vii
- [Digital biomarker](https://trialsathome.com/glossary/digital-biomarker/) - Objective, quantifiable physiological and behavioural data that are collected and measured by means of digital devices such as portables, wearables, implantables or digestibles. Original source: Digital Biomarkersvi
- [Data consent](https://trialsathome.com/glossary/data-consent/) - Any freely given, specific, informed, and unambiguous indication of the data subject’s wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to him or her. Original source: GDPRv
- [Controller](https://trialsathome.com/glossary/controller/) - Controller (of data): The natural or legal person, public authority, agency, or other body which alone, or jointly with others, determines the purposes and means of the processing of personal data. Original source: GDPRv
- [Clinical trial](https://trialsathome.com/glossary/clinical-trial/) - Abbreviation: CT Clinical trial (interventional): A clinical study which fulfils any of the following conditions:(a) the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned;(b) the decision to prescribe the investigational medicinal products is taken together with the
- [Central monitoring](https://trialsathome.com/glossary/central-monitoring/) - Central monitoring (of data): A remote evaluation of accumulating data, performed in a timely manner, supported by appropriately qualified and trained persons (e.g., data managers, biostatisticians). See also Remote Site Monitoring and Remote Source Data Verification. Original source: ICH GCPiv
- [Auxiliary medicinal product](https://trialsathome.com/glossary/auxiliary-medicinal-product/) - Abbreviation: AMP A medicinal product used for the needs of a clinical trial as described in the protocol, but not as an investigational medicinal product (e.g., rescue medication, challenge agents, medicinal products used to assess clinical trial end-points, or medicinal products used for background treatment). Original source: CTRii
- [Big data](https://trialsathome.com/glossary/big-data/) - Data of a very large size, typically to the extent that its manipulation and management present significant logistical challenges; (also) the branch of computing involving such data. Original source: OEDiii
- [Basic building block](https://trialsathome.com/glossary/basic-building-block/) - Abbreviation: BBB See "Trial building block".
- [Clinical study](https://trialsathome.com/glossary/clinical-study/) - Abbreviation: CS Any investigation in relation to humans intended: (a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products; (b) to identify any adverse reactions to one or more medicinal products; or (c) to study the absorption, distribution, metabolism and excretion of one or more medicinal products; Abbreviation: CS Any investigation in relation to humans intended: (a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products; (b) to identify any adverse reactions to one or more medicinal products; or (c) to study the absorption, distribution, metabolism and excretion of one or more medicinal products; with the objective of ascertaining the safety and/or efficacy of those medicinal products. Original source: CTRii
- [Adaptive trial design](https://trialsathome.com/glossary/adaptive-trial-design/) - A clinical trial design that allows for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial. Original source: FDAi
- [Electronic patient reported outcome](https://trialsathome.com/glossary/electronic-patient-reported-outcome/) - Abbreviation: ePRO An outcome that is measured using electronic data supplied actively and directly by a patient. Examples include online or tablet-based questionnaires collecting quality of life or symptom data. Adapted from: FDAxii

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