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Digital Study Design
Last Updated: 2026-06-03 00:14:08
Abstract
Digital Health Technology (DHT) enables new study designs, including better evidence generation for value-based health care. This module focuses on the preparation of a study synopsis incorporating a digital technology and/or modern study concept.
Objective
Participants will be able 1. to define and explain all components of a clinical trial using Digital Health Technology (DHT) 2. to discuss the advantages and challenges of digital trial design in human research 3. to describe risks in the feasibility of a digital clinical study and define countermeasures 4. to apply the knowledge acquired during the CAS Digital Clinical Trials to design their own digital trial 5. to explain how results can be returned to participants 6. to understand how gamification can help to engage and motivate patients
Content
Digital trial design represents a new approach to conducting clinical studies by integrating digital tools and technologies. This method reduces reliance on traditional, paper-based processes and physical site visits, thereby streamlining recruitment, data collection, and patient engagement. By leveraging technologies such as wearable devices, and remote monitoring systems, digital trials can enhance efficiency, reduce costs, and improve patient experience. Throughout this module, students will use their knowledge acquired in the previous modules of the CAS Digital Clinical Trials to develop a digital trial design for a clinical study. The students will integrate Digital Health Technology and/or novel study design for different research purposes. They understand the most critical aspects of data management and respect the ethics of data. During a power workshop, they will have the opportunity to clarify any open questions regarding their final project from a regulatory, statistical, and content-related perspective. At the end of this module and thus the CAS Digital Clinical Trials students write a study synopsis and present and discuss their study concept with fellow students and faculty.
General Information
- Language
- English
- Levels
- WBZ , NDS
- Frequency
- Yearly recurring
Examination
- Type
- ungraded semester performance
Registration & Places
Course Components
| Type | Title | Time & Place | Hours |
|---|---|---|---|
| lecture with exercise | Digital Study Design |
|
15 h semesterly |