July 15, 2020
Provides general priniciples helping sponsors prepare and distribute layperson summaries to the general public and study participants to implement the obligations of the European Union Clinical Trial Regulation No. 536/2014.
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July 15, 2020
An engaging and insightful graphic describing key findings from surveys and interviews of patient technology vendors. Includes identification of industry challenges and ways to improve vendor and sponsor working relationships.
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July 15, 2020
A set of considerations developed with vendor insights to assist the facilitation of more routine two-way feedback discussions on the deployment of patient technology. The document is designed to help enable open discussion environments between parties where learnings can be shared, documented and leveraged for future studies.
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July 15, 2020
The Study Participant Feedback Questionnaire (SPFQ) is a survey provided to study participants at the beginning, middle and end of a clinical study. Use of the SPFQ is intended to improve patient centricity in clinical studies.
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July 15, 2020
Developed to capture feedback from sites on their experience on using patient technology in clinical trials. Will help to improve dialogue between sites and sponsors and help improve future study design resulting from direct feedback on what works well.
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July 15, 2020
A summary of key insights and findings from our collection of 81 cases of patient technology use in clinical trials. Intended to drive people to use the Shared Insights Knowledgebase, as well as highlight best practices and common barriers.
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July 15, 2020
Collates U.S., UK, and European regulations and guidances related to digital health technologies and their use in clinical trials through December 2022. Helps organizations by providing critical information for use during regulatory strategy planning and Health Authority interaction planning.
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July 15, 2020
Outlines a possible approach to patient technology implementation to help sponsors develop a holistic approach with patient technology within their own organizations. Shows how companies can use patient technology programs to build towards a unique vision using goals, metrics and important considerations.
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July 15, 2020
For clinical study teams to consider when planning to implement patient technology. Helps organizations realize the full potential value of their implementation of patient technology by guiding them through the various stakeholder discussions and activities.
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July 15, 2020
This paper reveals the results of Patient Advisory Board (PAB) Meetings and a global online survey to obtain insight into the information preferences of people using a clinical trial registry in search for a clinical trial. Based on this data, the paper overviews a representative sample of current ClinicalTrial.gov entries and analyzed the extent to…
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