Documenting Wearable Protocols in the TMF
Documenting Wearable Protocols in the TMF How to Document Wearable Protocols in the Trial Master File (TMF) Introduction: The Rise of Wearables in Clinical Trials 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…