Description

This stop ensures that DHT implementation is treated as a strategic program-level decision rather than a one-off trial gadget. The focus is on aligning technical specifications with the clinical science goals and assessing if the target patient population can successfully interact with the tech.

Substops

Description

The Strategic Operations Plan acts as the foundational roadmap for DHT use. It defines how digital data will be integrated into the broader data lifecycle and ensures that the technology selected supports the required statistical rigor of the program.

Key Considerations

Description

Feasibility assessment involves evaluating the "human side" of the technology. It determines if the intended patients have the technical literacy, infrastructure (Wi-Fi/Cellular), and physical capability to use the device as intended without excessive burden.

Key Considerations

Description

This stop establishes the framework for selecting and managing DHT vendors. Because the technology and the data it generates are regulated as medical devices and electronic records, vendor qualification must be exceptionally rigorous, focusing on stability, security, and compliance.

Substops

Description

Identifying vendors who can meet the technical and regulatory requirements of a clinical trial. Audits must confirm 21 CFR Part 11 compliance, data encryption standards, and a robust Quality Management System (QMS).

Key Considerations

Description

Establishing enforceable agreements that protect the sponsor's data and the participant's privacy. Contracts must clearly define data ownership, service level agreements (SLAs), and the management of firmware or software updates mid-trial.

Key Considerations

Description

This iterative loop is the "Heart" of DHT planning. It ensures that the technology is scientifically sound and regulatory-ready before the protocol is finalized.

Core Requirements: The V3 Framework

• Verification: Bench testing to confirm hardware/software specs.
• Analytical Validation: Confirming the algorithm accurately measures the physiological/behavioral parameter.
• Clinical Validation: Proving the measure is meaningful in the target population.

Description

This stop defines the scientific purpose of the digital data. We must differentiate between objective biomarkers and patient-focused Clinical Outcome Assessments (COAs).

Critical Planning Steps:

• Describe clinical meaningfulness from the patient's perspective.
• Align DHT data (primary vs exploratory) with protocol endpoints.
• Establish sensitivity/specificity targets for the digital measure.

Description

High-frequency DHT data requires a specialized architecture. This stop moves from clinical intent to the "Data Pipeline" design.

Technical Deliverables:

• Data Architecture Diagram: Mapping raw data flow from device to DB.
• Statistical Analysis Plan (SAP): Defining how to handle missing data and "noise".
• Cybersecurity Plan: Encryption at rest/transit per ALCOA+ principles.

Description

The final lock. Here, DHT procedures are hard-coded into the study protocol and ethics submissions.

Key Documentation:

• Intended Use: Defining if DHT data is for safety, primary, or exploratory use.
• Privacy Ethics: Addressing potential for inducement or over-surveillance.
• Informed Consent: Transparent language on data access and technical burden.

Description

Finalizing the technical and statistical documentation required to ensure DHT data meets ALCOA+ standards. This stop bridges the gap between the study protocol and the actual data management workflows.

Substops

Technical Deep Dive

The SAP must handle high-frequency DHT data by defining the algorithms that transform raw sensor signals into clinical endpoints.

• Algorithm version lock and validation status.
• Definition of "Wear Time" compliance (e.g., 10 hrs/day).
• Imputation rules for missing digital data.

Technical Deep Dive

Focuses on data architecture, security, and the path from device to database.

• Encryption at rest (AES-256) and in transit (TLS 1.2).
• Data reconciliation between device and Subject ID.
• Audit trail requirements for automated data transfers.

Description

The physical mobilization of technology. This stop involves procuring devices, verifying they meet technical standards, and managing the global supply chain.

Substops

Technical Deep Dive

Acquisition of hardware models identified in Phase II. Ensures devices are stock-ready for initial site activation.

• Inventory buffering for site replacements.
• Region-specific telecommunication certificates.

Technical Deep Dive

Quality gate to ensure firmware and software pre-loads match technical specifications.

• Firmware version consistency across serial numbers.
• Battery performance baseline testing.

Technical Deep Dive

Global distribution management and reverse logistics for device retrieval or malfunction repair.

• Customs HS Code identification.
• Provisioning of prepaid return shipping kits.

Description

Transforming complex technical requirements into actionable human workflows. Focuses on training clinical staff and providing participant resources.

Substops

Technical Deep Dive

Development of troubleshooting guides and visual manuals for participant success.

• Step-by-step syncing and charging guides.
• 6th-8th grade reading level health literacy review.

Technical Deep Dive

Site Initiation visits including hands-on tech workshops for study coordinators.

• Coordinator certification on device setup.
• Site-facing technical manual distribution.

Technical Deep Dive

Ensuring the Informed Consent Form covers digital privacy, data encryption, and device expectations.

• Clear language on data de-identification.
• Indication if device provides real-time medical alerts.

Description

Active support for participants and sites to ensure continuous data capture. This stop involves maintaining the technical helpdesk and responding to physiological alerts triggered by DHT data.

Substops

Technical Deep Dive

Maintenance of the 24/7 technical support structure. Effective troubleshooting minimizes "Data Gaps" which can compromise statistical powering.

• Tiered support desk SLAs (Response within 2-4 hours).
• Knowledge Base (FAQ) updates based on live participant feedback.
• Device sync status monitoring.

Technical Deep Dive

Managing the flow of replacement devices. Ensures participants receive new hardware within 24-48 hours of a reported failure.

• Monitoring of "Buffer Stock" levels at sites or central hubs.
• Refurbishment process for returned faulty hardware.

Technical Deep Dive

The workflow for triaging real-time physiological alerts. This stop bridges the gap between digital "noise" and Serious Adverse Events (SAEs).

• Validation of alert thresholds in the software.
• Immediate escalation path to the Medical Monitor for "Red Flags."

Description

Oversight of the incoming data stream quality and participant adherence. This stop also manages mid-study technical changes, such as security patches or OS updates.

Substops

Technical Deep Dive

Oversight of automated data transfers. Ensuring that "raw" sensor data is being correctly transformed into "metrics" per the SAP.

• Audit trail review for data transfers.
• Cleaning of artifacts or technical noise from the data stream.

Technical Deep Dive

Identifying participants who are not meeting "Wear Time" or "Sync" requirements. Allows for proactive intervention from the site.

• Review of "Compliance Dashboards."
• Automated notifications to participants (SMS/Push) for missed syncs.

Technical Deep Dive

Governance of mid-trial technology changes. Security patches must be deployed without disrupting data collection.

• Impact assessment for every firmware/app update.
• Coordination with IRB for updates requiring re-consent.

Description

This stop manages the "Reverse Logistics" of the DHT lifecycle. It involves the physical retrieval of devices from sites and participants and the reconciliation of inventory against enrollment data.

Substops

Technical Deep Dive

Closing the financial and technical loops with the vendor. For DHTs, this involves "Data Destruction" or "Sanitization" of returned hardware to protect patient privacy (GDPR/HIPAA).

• Certificate of Data Destruction for every returned device serial number.
• Final vendor payment reconciliation based on device loss/theft rates.
• Archive of cloud data portals into the Trial Master File (TMF).

Technical Deep Dive

Physical accounting of all DHT assets. Reconciliation must match the "Procured Amount" vs. "Enrollment Use" vs. "Broken/Lost" units.

• Reconciliation of site-level inventory logs against central shipping logs.
• Documentation of "Lost to Follow-up" devices for financial write-off.
• Shipping confirmation for bulk device returns to refurbish/recycle center.

Technical Deep Dive

Crucial for future DHT selection. Gathering insights on "Technical Burden"—was the device comfortable, easy to sync, and non-stigmatizing?

• Analysis of participant satisfaction surveys.
• Correlation of participant feedback with actual compliance (wear-time) data.
• Closing the loop with participants: Thank you letters and study result summaries.

Description

The transition from "Clean Data" to "Clinical Evidence." This stop involves the final statistical processing of digital endpoints and the formal documentation of what went right (and wrong) operationally.

Substops

Technical Deep Dive

Execution of the "Algorithm Lock." Processing the full longitudinal digital dataset to determine treatment effect on the digital primary/secondary endpoints.

• Final imputation of missing data per the SAP.
• Validation of algorithm performance against any "gold standard" used in Phase II.
• Preparation of digital data for regulatory submission (SDTM/ADaM datasets).

Technical Deep Dive

Evaluating the "Tubestop" process. Did the technology choice, logistics provider, and training program meet the study goals? This feeds into the next program-level planning cycle.

• Analysis of technical support tickets (identifying common device failure points).
• Vendor Performance Review (SLA adherence).
• Operational post-mortem report for the Digital Strategy team.