Trusted Resource for Clinical Trials, Protocols & Progress
As clinical trials adopt wearable technologies to collect real-world, continuous, and decentralized data, documentation requirements evolve. Regulatory authorities expect that all trial-related documentation—including wearable-specific protocols—are fully archived within the Trial Master File (TMF).
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As clinical trials expand globally, the adoption of wearable technologies introduces regulatory complexity. While wearables enable continuous data capture and decentralized trial models, regulatory authorities differ significantly in how they define, validate, and approve wearable use.
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Traditional monitoring strategies in clinical trials focus on periodic review of static data—case report forms (CRFs), lab values, and visit summaries. However, wearable technologies introduce continuous, high-frequency data streams that require entirely different oversight models.
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As clinical trials incorporate digital health technologies (DHTs) such as wearables, mobile apps, and sensors, the endpoints derived from these technologies must undergo robust risk assessment. Regulatory agencies require sponsors to proactively identify and mitigate risks related to data integrity, safety, and endpoint reliability.
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As wearables and other digital health technologies (DHTs) become standard tools in clinical trials, regulators require that deviations involving these devices be documented, assessed, and reported with the same rigor as traditional protocol deviations.
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