SOP-M4
Decentralized Trial Elements
- Number
- SOP-M4
- Category
- Module
- Edition
- Lean Edition 2.0
- Approx. pages
- 5
- Reference Edition source
- 313
[YELLOW] the site fills in. [DEFAULT: green] a value the site may keep or change.
On this page
1. Purpose
This module describes how [SITE NAME] conducts trial activities away from the site: telehealth visits, home visits by site staff or vendors, procedures by local healthcare providers and direct-to-participant shipment of investigational product (IP).
2. Scope
Adopt this module only if [SITE NAME] runs any study in which the protocol permits or requires telehealth visits, home visits, local healthcare provider procedures or direct-to-participant IP shipment, whether the sponsor or the site arranges them.
ePRO devices, wearables and other digital health technologies, whether issued at the site or used on the participant's own device, do not by themselves trigger this module. They are handled by the core SOPs: source, participant training and data review in SOP-07 (5.4 and 5.6) and device records in SOP-11 (5.8.3).
A decentralized element is used only if the protocol permits it and the IRB has approved it. This module does not authorize remote conduct of a visit the protocol requires in person. Remote consent and identity verification at consent are in SOP-04. Follow the protocol, sponsor or IRB requirement where it is stricter than this module.
3. Responsibilities
| Role | Responsibilities |
|---|---|
| Principal Investigator (PI) | Remains responsible for all trial activities wherever performed. Reviews home visit and local provider reports. Confirms before each direct-to-participant shipment that the participant may receive the IP. Holds a license in each state where they see participants by telehealth, or arranges an investigator who does. |
| Sub-Investigator (Sub-I) | Conducts telehealth assessments and reviews reports as delegated, under the same licensure conditions as the PI. |
| Site Director | Approves the telehealth platform and any site-engaged home health or logistics vendor. Confirms licensure and insurance cover remote activities. |
| Clinical Research Coordinator (CRC) or Lead CRC | Plans and documents remote and home encounters on F-313-01. Verifies identity and participant location. Tracks shipments. |
| Research Pharmacist or IP Manager | Authorizes release of each shipment against the investigator's confirmation and the prescription or IRT assignment, and reconciles accountability. |
| Regulatory Coordinator | Submits decentralized elements and participant materials to the IRB. Updates the 1572 and delegation records for remote staff. |
4. Definitions
| Term | Definition |
|---|---|
| Decentralized element | A trial-related activity performed somewhere other than the trial site, such as the participant's home, a local healthcare facility or a pharmacy. |
| Telehealth visit | A trial visit by real-time audio and video (or audio only, where the protocol allows) between trial personnel and a participant at another location. |
| Local healthcare provider (local HCP) | A licensed provider near the participant who performs trial activities that do not differ from their clinical practice and need no detailed knowledge of the protocol, investigator's brochure or IP (for example vital signs or a routine blood draw). |
| Direct-to-participant (DtP) shipment | Shipment of IP from the site, a sponsor depot or a distributor to the participant's location or a local HCP. |
5. Procedure
5.1 Study setup
5.1.1
At start-up, the Lead CRC records for each decentralized element the protocol permits or requires:
- who performs it (site staff, sponsor vendor, site vendor, local HCP, participant)
- where it happens and in which states participants may be located
- how reports and data reach the site and the source record
- how IP and supplies reach the participant and come back
- how adverse events found remotely are assessed, including urgent in-person care
5.1.2
The Regulatory Coordinator confirms the IRB has approved the decentralized elements and every participant-facing material (telehealth instructions, home visit letters, IP shipping instructions).
5.1.3
The Site Director confirms that the site's professional liability insurance covers remote and home activities by site staff, and that sponsor vendors carry their own insurance.
5.1.4
Site-engaged vendors (home health, courier, telehealth platform) are qualified and overseen under SOP-M1. For sponsor-engaged vendors, the CRC confirms their staff received protocol training for their tasks and reports performance problems to the sponsor.
5.1.5
Staff who conduct remote or home visits are trained on the protocol, this module, the telehealth platform and, for home visits, safety and emergency procedures for working alone. Training is recorded on F-103-01 Staff Training Log.
5.2 Delegation, the 1572 and local HCPs
5.2.1
Site and vendor staff who perform trial-specific activities are trial personnel. The PI delegates their tasks on F-302-01 Delegation of Authority Log after qualification and protocol training are recorded (SOP-02).
5.2.2
For IND studies, trial personnel who contribute directly and significantly to trial data or need detailed protocol, investigator's brochure or IP knowledge are listed as Sub-Is on the 1572 (SOP-02).
5.2.3
Local HCPs who perform only routine activities within normal practice are not trial personnel, are not Sub-Is and are not placed on the delegation log. For their work:
- each report shows the HCP's name and the date of the activity
- the PI or delegate gives the HCP any protocol-specific instructions in writing
- the PI or a delegated Sub-I reviews each report within the result review times in SOP-02, follows up abnormal findings, and signs and dates the review
5.2.4
Local HCPs do not obtain informed consent.
5.2.5
The Lead CRC keeps [DEFAULT: a study-level list of local HCPs and facilities used (name, address, activities, dates)]. The list supports monitoring and does not imply delegation.
5.2.6
Local laboratories used for protocol tests follow SOP-11.
5.3 Identity and location at remote encounters
5.3.1
At the start of every telehealth visit, the person conducting it confirms identity using [DEFAULT: full name and date of birth, plus visual comparison with the photo identification viewed at consent or screening]. Home visit staff verify identity on arrival by the same method.
5.3.2
The first remote contact, and any remote consent, uses the identity rule in SOP-04.
5.3.3
If identity cannot be verified, the encounter does not proceed as a trial visit. The CRC records the attempt on F-313-01 Remote Visit and Home Health Visit Record and reschedules.
5.3.4
Where a legally authorized representative or caregiver takes part, the CRC verifies their identity and relationship as documented at consent.
5.4 Telehealth visits
5.4.1
The protocol decides which visits may be telehealth. The CRC does not convert a visit to telehealth on the site's own initiative. If a participant cannot attend an in-person visit, the CRC asks the PI and records any deviation under SOP-08.
5.4.2
Telehealth uses only the platform the Site Director approved (SOP-12), with encryption and a business associate agreement where HIPAA applies. Unapproved consumer video applications are not used.
5.4.3
Staff work from a private space. At the start, the staff member asks whether the participant is in a private location and whether anyone else is present, and offers to reschedule or move if the participant wants more privacy.
5.4.4
Sessions are not recorded unless the protocol requires it and the consent form discloses it. The visit is documented in source (visit note, eSource form or F-313-01) under SOP-07.
5.4.5
Before each telehealth visit, the CRC confirms the state where the participant is physically located and checks that the assigned investigator or staff member is licensed there. The location is recorded on F-313-01. A license is generally needed in the participant's state at the time of the visit; a Nurse Licensure Compact privilege covers only compact states, and the Interstate Medical Licensure Compact does not by itself authorize practice.
5.4.6
Before prescribing or dispensing a controlled substance after a telehealth encounter, the PI confirms the DEA telemedicine rules then in force (Regulatory Currency Note).
5.4.7
If the participant reports a symptom that needs urgent in-person assessment, the staff member directs the participant to emergency care or arranges an in-person visit as the protocol's safety plan describes, and notifies the PI the same day. Adverse events found remotely are handled under SOP-09.
5.5 Home visits
5.5.1
The CRC confirms each home visit with the participant in advance and sends the visiting staff member or vendor the procedures, kits, any IP and the protocol instructions.
5.5.2
The visiting staff member follows the protocol and laboratory manual, handles specimens under SOP-11, and documents the visit on the vendor form or F-313-01: date, start and end time, location, procedures, findings, adverse events or concerns, name and signature.
5.5.3
Vendor visit documentation reaches the site within [DEFAULT: 2 business days of the visit, or the vendor agreement timeline if shorter]. The CRC chases late reports, records the date received, and logs late reports as a vendor issue (SOP-M1, or to the sponsor for sponsor vendors).
5.5.4
The PI or a delegated Sub-I reviews each home visit report, assesses abnormal findings and adverse events, and signs and dates the review. Visit reports are source and are filed in the participant's research record.
5.5.5
Home visit staff carry the minimum participant information needed, in a locked bag or encrypted device, and leave no trial documents at the home other than IRB-approved participant materials.
5.6 Direct-to-participant IP shipment
5.6.1
DtP shipment is used only when the protocol and sponsor permit it for that IP, and only through the sponsor's approved courier or distributor.
5.6.2
Before each shipment, an investigator (the PI or a Sub-I listed for the study) confirms the participant may receive that IP at that visit (for example safety results reviewed and no dose-hold criterion met) and records the confirmation in source. The IP Manager then authorizes release in the sponsor's system or on the shipment request after checking the shipment matches the prescription or IRT assignment. The IP Manager does not make the medical decision.
5.6.3
The CRC confirms receipt intact and within temperature, using the courier's proof of delivery and a contact with the participant, and records the receipt date on F-304-04 Participant IP Dispensing and Return Log. Shipment and temperature records are kept with IP accountability records, and transit excursions are handled under SOP-06.
5.6.4
The CRC confirms the participant has the IP instructions and knows how to store, take or use, and return the IP and packaging.
5.6.5
Returns and destruction follow the sponsor's direction and are reconciled on F-304-04 and the site inventory ledger F-304-01 (SOP-06).
5.7 Documentation and privacy
5.7.1
For every remote or home encounter, the person conducting or arranging it completes F-313-01 (or an equivalent eSource template): participant ID, visit, date and times, visit type, participant state and location type, staff location for telehealth, who conducted it (and the local HCP and facility), identity method, activities, findings, adverse events and actions, privacy confirmation for telehealth, and documents received with the date of investigator review. F-313-01 and attached reports are source (SOP-07).
5.7.2
Participant data go to vendors and local HCPs only as needed for the activity and as the consent form and HIPAA authorization permit, by secure email, secure portal or fax to a verified number. Remote staff use site-managed devices only.
5.7.3
A lost device, a misdirected shipment carrying participant information, or an unauthorized person present at a telehealth visit is reported as a privacy incident on F-400-01 Privacy Incident Report the same business day (SOP-12).
6. Related Forms and SOPs
- F-313-01 Remote Visit and Home Health Visit Record
- F-302-01 Delegation of Authority Log
- F-103-01 Staff Training Log
- F-304-01 Investigational Product Accountability Log
- F-304-04 Participant IP Dispensing and Return Log
- F-400-01 Privacy Incident Report
- SOP-02 Roles, PI Oversight, Delegation and Conflicts of Interest
- SOP-04 Informed Consent
- SOP-06 Investigational Product Management
- SOP-07 Source Documentation and EDC
- SOP-08 Protocol Deviations and CAPA
- SOP-09 Safety Reporting (AEs, SAEs, IRB-Reportable Events, Pregnancy)
- SOP-11 Specimens, Equipment and Laboratories
- SOP-12 Privacy, Electronic Systems and Record Retention
- SOP-M1 Service Providers and Vendors
- Appendix A State Law Worksheet
7. References
| Reference | Title |
|---|---|
| FDA Guidance (Sept 2024) | Conducting Clinical Trials With Decentralized Elements |
| FDA Guidance (Oct 2024) | Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers |
| ICH E6(R3) Annex 1, 2.3 | Investigator responsibilities (delegation and oversight) |
| ICH E6(R3) Annex 1, 2.10.8 | IP shipped to the participant's location |
| ICH E6(R3) Annex 1, 2.12.10 | Computerised systems at the investigator site |
| ICH E6(R3) Annex 2 (ICH Step 4, June 2026) | Decentralised elements, pragmatic trials and real-world data |
| 21 CFR 312.53(c) and 312.60 to 312.62 | Form FDA 1572; investigator responsibilities, IP control and records |
| 21 CFR 812.100, 812.110 and 812.140 | Device investigator responsibilities and records |
| 45 CFR 164 Subparts C and E | HIPAA Security and Privacy Rules |
Independent Site SOP Library. Licensed CC BY-NC 4.0 by the American Institute for Medical Research (AIMR), with added permission for any site's internal use (license terms). Not legal advice: each adopting site confirms state law, IRB and sponsor requirements with its own counsel and owns every step it approves.