Decentralized Trial Elements (Remote Visits, Home Health, Direct-to-Participant IP)

1. Purpose

This SOP describes how [SITE NAME] conducts trial activities away from the site: telehealth visits, home health visits by site staff or vendors, procedures by local healthcare providers, direct-to-participant shipment of investigational product (IP), and digital health technologies (DHTs). The PI's responsibilities do not change when an activity happens at the participant's home or a local clinic. This SOP sets out how the site keeps oversight, documentation, privacy and participant safety at the same standard as an on-site visit.

2. Scope

This SOP applies to any decentralized element permitted by a protocol and approved by the IRB at [SITE NAME], whether arranged by the sponsor (sponsor-engaged home health, logistics or DHT vendors) or by the site (site staff visits, site-engaged vendors, local providers chosen with the participant).

Out of scope: remote consent and eConsent procedure, including identity verification at consent (SOP-301, section 5.9.4), remote monitoring by sponsors (SOP-600), and remote regulatory assessments (SOP-702). Where the protocol, sponsor or IRB requirement is stricter than this SOP, the site follows the stricter requirement. A decentralized element is used only if the protocol permits it; this SOP does not authorize remote conduct of a visit the protocol requires in person.

3. Responsibilities

4. Definitions

5. Procedure

5.1 Study setup

• who performs it (site staff, sponsor vendor, site vendor, local HCP, participant)
• where it happens and in which states participants may be located
• how data and reports get back to the site and into the source record
• how IP and DHTs reach the participant and come back
• how adverse events found remotely are assessed and managed, including urgent in-person care

5.2 Delegation, Form FDA 1572 and local HCPs

• each report from a local HCP must show the HCP's name and the date the activity was performed
• the PI or delegate communicates any protocol-specific instructions to the local HCP (for example "participant seated and rested 5 minutes before blood pressure")
• the PI or a delegated Sub-I reviews local HCP reports within the result review times in SOP-101, section 5.4.4, follows up abnormal findings, and signs and dates the review

5.3 Identity verification at remote encounters

5.4 Telehealth visits

• The investigator conducting a telehealth assessment generally needs a license to practice in the state where the participant is physically located at the time of the visit, not only the state where the site is located. Nurses and other licensed staff are subject to the same principle. A multistate nurse license under the Nurse Licensure Compact covers only states that participate in the compact. The Interstate Medical Licensure Compact speeds up getting a license in each participating state but does not by itself authorize practice there.
• Before a telehealth visit, the CRC confirms the participant's physical location (state) and checks that the assigned investigator or staff member is licensed there. The location is recorded on F-313-01.
• Prescribing or dispensing controlled substances after a telehealth encounter is subject to DEA telemedicine rules in effect at the time; the PI confirms current requirements before relying on them.

5.5 Home health visits

5.6 Direct-to-participant IP shipment

5.7 Digital health technologies

5.8 Documentation on F-313-01

• participant ID, visit name, date, start and end time
• visit type (telehealth video, telephone, site staff home visit, vendor home visit, local HCP visit)
• participant location (address type and state) and, for telehealth, the location of the staff member
• name and role of the person conducting the visit, and for local HCPs the HCP's name and facility
• identity verification method
• activities performed, findings, adverse events or concerns raised, and actions taken
• privacy confirmation (participant in a private location) for telehealth
• documents received and date reviewed by the PI or Sub-I

5.9 Privacy

• participant data are sent to vendors and local HCPs only as needed for the activity and only as the consent form and HIPAA authorization permit
• communication with local HCPs and vendors uses secure email, secure portal or fax to verified numbers
• staff working remotely use site-managed devices and do not store participant data on personal devices
• participants may choose a location outside the home for visits if they share a residence and want privacy

6. Related Forms and SOPs

• F-313-01 Remote Visit and Home Health Visit Record
• F-302-01 Delegation of Authority Log
• F-304-01 Investigational Product Accountability Log
• F-309-01 Participant Contact and Retention Log
• F-312-01 Equipment Inventory and Calibration Log
• F-105-01 Service Provider Qualification and Oversight Record
• F-103-01 Staff Training Log
• F-400-01 Privacy Incident Report
• F-905-01 Cross-Entity Data Flow Register (Model N only)
• SOP-101 Roles and Responsibilities of the Principal Investigator
• SOP-105 Oversight of Service Providers and Vendors
• SOP-301 Informed Consent Process and Documentation
• SOP-302 Delegation of Authority
• SOP-304 Investigational Product Management
• SOP-306 Source Documentation and Data Integrity (ALCOA+)
• SOP-308 Protocol Deviations and Noncompliance
• SOP-311 Biological Specimen Collection, Processing and Shipping
• SOP-312 Equipment Calibration and Maintenance; Local Laboratory Requirements
• SOP-400 Participant Privacy and HIPAA in Research
• SOP-401 Computerized Systems and Electronic Records
• SOP-500 Adverse Event Identification, Assessment and Recording
• SOP-501 Serious Adverse Event and Expedited Safety Reporting
• SOP-904 Shared Staff, Cross-Site Coverage and Central Services (Model N only)
• Appendix A State Law Worksheet
• Appendix B Central and Site Responsibility Matrix (Model N only)

7. References