Sensor Data Glossary

Whether you’re a data producer, data processor, data consumer, or just getting started, language matters. Access the glossary to master the terms needed to successfully collaborate in this interdisciplinary ecosystem.

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Clinical Trials, Digital Measures Development Projects in Practice

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Sensor Data Glossary

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Workbook: Inclusive Support for End Users

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Verification, Analytical Validation, and Clinical Validation (V3) framework

Vendor selection considerations for clinical trial design utilizing digital measurement of nocturnal scratch

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Value of Regulations for Digital Health Products in the U.S.

Value of a Successful Measure: Translating Patient Value to Commercial Value

Value of a Successful Measure: Modeling Potential Increases in Drug Utilization

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V3+: An extension to the V3 framework to ensure user-centricity and scalability of sensor-based digital health technologies

Utilizing a modified Delphi approach to select digital measures of physical activity

Using evidence from digital endpoints to demonstrate the value of a new drug: Considerations and recommendations

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Use Real-World Data and Real-World Evidence

U.S. RegPath flowchart

Tidepool’s Regulatory Journey Case Study

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The Primer on Digital Health Measurement

The Playbook: Digital Healthcare Edition

The Library of Evidence

The Framework for Inclusive Development

The Digital Health Measurement Product Development Process

The Conceptual Model: A core set of digital measures for physical activity

Terminology and ontology: “scratch”

Terminology and ontology: “nocturnal”

Technology performance considerations for selection of devices measuring nocturnal scratch

Systematic Literature Review of Qualitative Evidence of Sleep Disturbance

Support and train clinical trial site staff

Study population considerations for clinical trial design utilizing digital measurement of nocturnal scratch

Strategies to optimize site and investigator experience in clinical trial design utilizing digital measurement of nocturnal scratch

Strategies to optimize atopic dermatitis patient experience in clinical trial design utilizing digital measurement of nocturnal scratch

Standardized Rationale for the Use of the Core Digital Measures of Sleep

Specific Actions – Diversity Plan

Snapshot of Sleep Library of Digital Measurement Products

Sensor Data Glossary

Sensor Data Design Flow Tool

Scientific Figures of Sleep Disturbance

Sample End User License Agreement

Risk Assessment Model for Digital Health Product Lifecycle

Reimbursement for Clinicians: Getting paid for caring for your patients using digital measures of sleep

Regulatory Strategy for Digital Health Products in the U.S.

Regulatory Engagement Pathways Map for Digital Health Product

Reference Data Architecture

Recommendations for subject privacy assurance, data collection and study monitoring in clinical studies utilizing digital measurement of nocturnal scratch

Recommendations for pharma at-a-glance

Recommendations for pharma

Recommendations for payers at-a-glance

Recommendations for payers

Recognize the Need for Diversity

Quickstart Guide: V3+ Use-Related Risk Analysis

Quickstart Guide: V3+ Use Specification

Quick Start Guide: Inclusive Engagement Plan

Quick Start Guide: Community Partnerships

Quick start guide to drug reimbursement – U.S.

Quick start guide to drug reimbursement – Europe

Quick Guide on Intended Use and Indication for Use for Digital Health Products

Questions to Ask – Patient/Participant Perspective

Quantitative Survey Results Dataset

Project charter template for clinical studies utilizing digital measurement of nocturnal scratch

PMA Request Review Process

PMA Preparation Guide

PMA Checklist

PMA At-a-Glance

Plan for Diverse, Equitable, and Inclusive Engagement

Patient usability form for uniform usability testing of devices measuring nocturnal scratch

Patient research: A systematic review to uncover meaningful concepts of physical activity for patients

Opportunities and challenges to using digital clinical measures to inform reimbursement decisions in drug development

Ontology: Walking speed

Ontology: Walking bout at specified bout durations

Ontology: Time spent in moderate to vigorous physical activity

Ontology: Step count

Ontology: Postural sway

Narrative Review Objective Clinical Measures of Sleep in Real-World Settings

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Mapping the Steps Forward: Decision tree for endpoint strategy for digital measures of physical activity

Logical Data Architecture