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A Decentralized Clinical Trial of a Digital Intervention with Multiple Health Trackers for Heart Failure: Early Learnings and Practical Considerations Rachel Tunis1(B), Tom Baranowski2, Angelica Rangel3,

How to fill out a decentralized clinical trial

How to fill out a decentralized clinical trial

1. Identify the decentralized clinical trial protocol and study design.
2. Determine the decentralized trial technology and platform to be used for data collection and monitoring.
3. Recruit study participants and provide necessary training and support for remote data collection.
4. Monitor and manage data quality and ensure compliance with regulatory requirements.
5. Analyze and interpret the data collected from the decentralized clinical trial.
6. Prepare and submit final study results for publication and regulatory approval.

Who needs a decentralized clinical trial?

1. Researchers conducting clinical trials in remote or underserved areas.
2. Patients who cannot easily travel to a traditional clinical trial site.
3. Companies looking to streamline the clinical trial process and reduce costs.

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What is a decentralized clinical trial?

A decentralized clinical trial is a type of clinical trial where the majority of study activities are conducted remotely, minimizing the need for physical visits to study sites.

Who is required to file a decentralized clinical trial?

Any organization or individual conducting a clinical trial that meets the criteria for a decentralized trial may file for one.

How to fill out a decentralized clinical trial?

To fill out a decentralized clinical trial, the study protocol must outline how the trial will be conducted remotely, including details on remote monitoring, data collection methods, and patient engagement strategies.

What is the purpose of a decentralized clinical trial?

The purpose of a decentralized clinical trial is to increase patient access and participation, reduce burdens on study sites, and improve the efficiency of data collection.

What information must be reported on a decentralized clinical trial?

Information on study protocol, remote monitoring procedures, data collection methods, patient engagement strategies, and any deviations from the original protocol must be reported.