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Standard Operating Procedure for Wearables/Digital Biomarkers Acquisition and Validation

Purpose

The purpose of this SOP is to define procedures for acquiring, managing, and validating data collected from wearable devices and digital biomarkers in clinical trials. It ensures subject safety, data reliability, and compliance with international regulations for decentralized and hybrid trial designs.

Scope

This SOP applies to sponsors, investigators, CROs, site staff, data managers, and technology vendors involved in the implementation of wearables and digital biomarkers in clinical trials. It covers device calibration, subject training, data transmission, validation, audit trails, cybersecurity, and regulatory compliance.

Responsibilities

• Sponsor: Ensures validated wearable technologies and regulatory compliance.
• Investigator: Provides oversight of wearable device use at the site.
• Site Staff: Train subjects on proper device use and maintain accountability logs.
• CRO: Monitors wearable data quality and compliance across sites.
• Technology Vendor: Provides validated, secure, and reliable wearable systems.
• QA: Audits wearable workflows and ensures inspection readiness.

Accountability

The Sponsor’s Digital Health Lead is accountable for wearable and digital biomarker validation processes. Principal Investigators are accountable for subject-level wearable use and data accuracy.

Procedure

1. Device Qualification
1.1 Select devices with regulatory approvals or CE/FDA marking where applicable.
1.2 Validate devices for accuracy and reproducibility.
1.3 Document in Device Qualification Log (Annexure-1).

2. Subject Training
2.1 Train subjects on wearable use, charging, and data syncing.
2.2 Provide training materials in local languages.
2.3 Record in Subject Training Log (Annexure-2).

3. Data Acquisition
3.1 Collect real-time data via secure cloud or site-based systems.
3.2 Ensure redundancy for data continuity.
3.3 Record in Data Acquisition Log (Annexure-3).

4. Data Transmission and Storage
4.1 Transmit data via encrypted channels.
4.2 Store in validated EDC or eSource systems.
4.3 Record in Data Transmission Log (Annexure-4).

5. Data Validation
5.1 Validate data against clinical endpoints.
5.2 Use algorithms for quality checks.
5.3 Document in Data Validation Log (Annexure-5).

6. Device Accountability
6.1 Maintain logs for device issuance and returns.
6.2 Record in Device Accountability Log (Annexure-6).

7. Cybersecurity
7.1 Ensure devices comply with cybersecurity standards.
7.2 Regularly update firmware/software.
7.3 Document in Cybersecurity Log (Annexure-7).

8. Archiving
8.1 Archive raw data, validation records, and accountability logs in TMF and ISF.
8.2 Retain as per regulatory requirements.

Abbreviations

• SOP: Standard Operating Procedure
• CRO: Contract Research Organization
• QA: Quality Assurance
• EDC: Electronic Data Capture
• ISF: Investigator Site File
• TMF: Trial Master File
• FDA: Food and Drug Administration
• EMA: European Medicines Agency
• CDSCO: Central Drugs Standard Control Organization
• WHO: World Health Organization

Documents

1. Device Qualification Log (Annexure-1)
2. Subject Training Log (Annexure-2)
3. Data Acquisition Log (Annexure-3)
4. Data Transmission Log (Annexure-4)
5. Data Validation Log (Annexure-5)
6. Device Accountability Log (Annexure-6)
7. Cybersecurity Log (Annexure-7)

References

• FDA – Digital Health Guidance
• EMA – Digital Biomarker and Wearable Guidance
• CDSCO – Medical Device Rules
• ICH GCP – Data Validation Standards
• WHO – Digital Health Recommendations

Version: 1.0

Approval Section

Annexures

Annexure-1: Device Qualification Log

Annexure-2: Subject Training Log

Annexure-3: Data Acquisition Log

Annexure-4: Data Transmission Log

Annexure-5: Data Validation Log

Annexure-6: Device Accountability Log

Annexure-7: Cybersecurity Log

Revision History

For more SOPs visit: Pharma SOP