SOP-310
Participant Payments and Reimbursement
- Number
- SOP-310
- Category
- Study Conduct
- Edition
- Reference Edition 1.3
- Approx. pages
- 8
[YELLOW] the site fills in. [DEFAULT: green] a value the site may keep or change.
On this page
1. Purpose
This SOP describes how [SITE NAME] pays trial participants for their time and reimburses their trial-related expenses. It covers payment amounts and schedules approved by the IRB, payment methods, receipts-based reimbursement, travel vendors, tax reporting, protection of payment data and reconciliation with sponsor payments. The aim is that every participant is paid what the IRB-approved consent form says, on time, by an approved method, with a record that a monitor, auditor or tax authority can follow.
2. Scope
This SOP applies to all payments, reimbursements and in-kind items (gift cards, travel, lodging, meals) given to participants, legally authorized representatives (LARs) or caregivers in any study at [SITE NAME], whether funded by the sponsor through the site, paid directly by a sponsor-contracted payment vendor, or paid by the site from its own funds.
Out of scope: negotiation of the participant payment budget line (SOP-201), payments to recruitment vendors and referral sources (SOP-300 and SOP-104; finder's fees, which the site prohibits by default (SOP-300, section 5.6.2)), and research-related injury costs (governed by the clinical trial agreement and the consent form). Where a sponsor, CRO or IRB requirement is stricter than this SOP, the site follows the stricter requirement.
3. Responsibilities
| Role | Responsibilities |
|---|---|
| Principal Investigator (PI) | Confirms that the payment amounts, schedule and method submitted to the IRB are not coercive or unduly influential for the study population. Oversees delegated payment activities. |
| Site Director | Approves the site's payment methods and vendors. Decides how the site handles tax reporting. Approves any payment outside the IRB-approved schedule after IRB approval is obtained. |
| Finance / Contracts Lead | Negotiates the participant payment budget. Sets up and funds reloadable card programs. Collects and secures W-9 forms. Issues Forms 1099-MISC. Reconciles participant payments against sponsor payments and invoices. |
| Regulatory Coordinator | Submits the payment schedule, payment method description and any participant-facing payment materials to the IRB. Files approvals in the Investigator Site File (ISF). |
| Clinical Research Coordinator (CRC) | Explains payment and reimbursement terms during consent. Issues visit payments, processes reimbursement claims and books travel for assigned participants. Records each transaction on F-310-01. |
| Quality Lead | Includes payment records in internal QC reviews (SOP-700). Reviews payment-related deviations and complaints. |
| All Research Staff | Do not give participants cash, gifts or payments that are not in the IRB-approved schedule. |
4. Definitions
| Term | Definition |
|---|---|
| Participant payment (stipend) | Money or equivalent value given to a participant for time, inconvenience or participation. It is taxable income to the participant. |
| Reimbursement | Repayment of actual, documented out-of-pocket expenses the participant incurred because of trial participation (for example mileage, parking, public transit, meals during long visits, lodging). |
| Prorated payment | A payment schedule in which the participant earns payment for each completed visit or segment, so that a participant who withdraws is paid for what they completed. |
| Completion bonus | An additional amount paid for completing the study or a defined part of it. Permitted only in the amount and form the IRB approves. |
| Reloadable card | A prepaid debit card issued to a participant and loaded with payments by the site or a payment vendor (for example a sponsor-provided or site-contracted card platform). |
| Travel vendor | A service provider engaged by the sponsor or the site to book and pay for participant transport, lodging or ride-share directly. |
| Form W-9 | IRS Request for Taxpayer Identification Number and Certification, used to collect the payee's legal name, address and Social Security Number (SSN) or other Taxpayer Identification Number (TIN). |
| Form 1099-MISC | IRS information return used to report other income, including payments to individuals for participating in a medical research study, when the annual total meets the reporting threshold. |
| Payment log | F-310-01, the study-specific record of every payment and reimbursement made to each participant. |
5. Procedure
5.1 Planning and IRB approval
5.1.1
During budget negotiation (SOP-201), the Finance / Contracts Lead confirms with the sponsor:
- the per-visit payment amounts and any completion bonus
- the expense categories the sponsor will reimburse and any caps (for example mileage rate, lodging per night, meal allowance)
- whether payments come from site funds that the sponsor reimburses, or from a sponsor-contracted payment or travel vendor
- who issues tax forms if a sponsor vendor pays participants directly
5.1.2
The Regulatory Coordinator submits to the IRB, as part of the initial submission or an amendment, the payment amounts, schedule and method, and any participant-facing payment material (card instructions, travel vendor letters, reimbursement claim forms). ICH E6(R3) expects the consent form to state any anticipated prorated payment and any anticipated expenses to the participant, and the IRB to review the methods, amounts and schedule of payment (ICH E6(R3) Annex 1, 2.8.10(j) and (k); 1.2.9).
5.1.3
The PI reviews the payment plan for undue influence before submission. The PI considers the study population, the burden of each visit and whether any lump sum or completion bonus is large enough to discourage a participant from withdrawing.
5.1.4
The payment schedule should be prorated by visit and must not be wholly contingent on completion of the trial (ICH E6(R3) Annex 1, 1.2.8). A completion bonus is used only in the amount the IRB approves.
5.1.5
No payment, amount, method or schedule is used until the IRB has approved it. A change in any of these (for example raising a visit payment to improve retention, switching from checks to cards) is an amendment and needs IRB approval before use.
5.1.6
The Regulatory Coordinator files the IRB-approved payment schedule in the ISF. The CRC builds the study payment schedule in F-310-01 or the payment system from the approved version only.
5.2 Explaining payment to the participant
5.2.1
During the consent discussion (SOP-301), the CRC explains:
- how much is paid for each visit, when, and by what method
- that payment is earned visit by visit, and what is paid if the participant withdraws or is withdrawn
- which expenses are reimbursed, the receipts needed and the deadline for submitting them
- that payments may be reported to the IRS and that the site will ask for a Social Security Number or TIN for this purpose
- how card fees, card replacement and lost cards are handled, if a card is used
5.2.2
The CRC records in the consent process note (F-301-01) that payment and reimbursement were explained.
5.2.3
Staff do not use payment to persuade a hesitant participant to enroll or to stay in a study. A participant's stated reason for withdrawing is recorded under SOP-309, not argued with.
5.3 Collecting tax information (W-9)
5.3.1
The Finance / Contracts Lead decides, and records here, how the site collects tax information.
5.3.2
The CRC gives the participant Form W-9 (or the payment vendor's equivalent electronic collection) after consent and before the first payment. The CRC does not copy the SSN into the source record, the payment log or any sponsor system.
5.3.3
The completed W-9 is sent to the Finance / Contracts Lead by [SECURE METHOD] and stored in the restricted finance file described in 5.8, not in the ISF or the participant's research chart.
5.3.4
If a participant declines to provide a TIN, the CRC refers the question to the Finance / Contracts Lead before the next payment. Payments to a payee who has not furnished a TIN can be subject to backup withholding. The Finance / Contracts Lead decides with the site's tax advisor whether to withhold, pay by a method that does not require a TIN, or decline the payment, and records the decision.
5.3.5
A participant may decline payment entirely. The CRC records the refusal on F-310-01 and the participant remains eligible.
5.4 Payment methods
5.4.1
The site uses only the payment methods approved by the Site Director and described to the IRB. Acceptable methods include:
- reloadable prepaid card from the site's card program or a sponsor-provided card vendor
- check from the site's operating account
- electronic transfer through an approved payment vendor
- gift card, only where the IRB approves it and the value is tracked like cash
5.4.2
[DEFAULT: Cash is not used.]
5.4.3
Reloadable cards:
- The CRC assigns the card to the participant by participant ID in the card platform and records the card's last four digits on F-310-01.
- The participant signs or electronically acknowledges receipt of the card.
- Unassigned card stock is kept locked and counted [DEFAULT: monthly] by someone other than the person who issues cards.
- Card platform accounts are named user accounts with role-based access (SOP-401). Staff do not share platform logins.
- The CRC loads the card only after the visit is completed and documented in the source record.
5.4.4
Payments are made on the schedule in the consent form. Where the consent form does not specify timing, the CRC issues the payment within [DEFAULT: 5 business days of the completed visit].
5.5 Issuing visit payments
5.5.1
After a visit is completed and documented in source, the CRC issues the payment for that visit in the IRB-approved amount.
5.5.2
The CRC records each payment on F-310-01 at the time of payment: participant ID, visit, date of visit, amount, method, card last four digits or check number, date issued and the initials of the person issuing it.
5.5.3
Partial or missed visits are paid as the IRB-approved schedule states. If the schedule does not address the situation (for example a visit stopped for an adverse event), the CRC asks the PI, who decides in favor of the participant where the schedule is silent, and records the decision on F-310-01 or a note to file (F-306-01). If the gap is likely to recur, the Regulatory Coordinator asks the IRB to approve a clarified schedule.
5.5.4
A payment in an amount or at a time other than the IRB-approved schedule (overpayment, underpayment, unapproved bonus) is a protocol deviation, recorded and assessed under SOP-308. An underpayment is corrected within [DEFAULT: 5 business days] of discovery. An overpayment is not recovered from the participant without the PI's and Site Director's agreement.
5.5.5
Payments for unscheduled visits, screen-fail visits and early termination visits are made only if the IRB-approved schedule includes them.
5.6 Reimbursement of expenses
5.6.1
Reimbursement covers actual, documented expenses in categories the IRB approved. The participant submits receipts (paper or photo) with a reimbursement claim within [DEFAULT: 60 days of the expense].
5.6.2
The CRC checks each claim against the study's approved categories and caps, verifies that the date matches a study visit or approved study activity, and records the reimbursement on F-310-01 separately from visit payments, with the expense category.
5.6.3
Mileage is calculated using [MILEAGE METHOD: e.g., MAPPED ROUND-TRIP DISTANCE FROM HOME ADDRESS ON FILE TIMES THE APPROVED RATE], not the participant's own estimate.
5.6.4
Receipts are stored with the payment records (5.8). Receipts that show diagnosis, medication or card numbers are stored in the restricted finance file.
5.6.5
A flat travel allowance paid without receipts is a payment, not a reimbursement, for tax purposes. The Finance / Contracts Lead decides with the site's tax advisor how reimbursements and flat allowances are treated for 1099 reporting and records that decision in the site's finance procedures.
5.7 Travel vendors and sponsor payment vendors
5.7.1
When the sponsor provides a travel or payment vendor, the CRC follows the vendor's study instructions as approved by the IRB. The site does not enter participant data into a vendor platform until the consent form or HIPAA authorization covers that disclosure (SOP-400).
5.7.2
The CRC enters only the data the vendor needs to deliver the service (for example name, contact details, pickup address, travel dates). The CRC does not enter diagnosis, eligibility or medical details.
5.7.3
When the site engages its own travel or payment vendor, the Site Director qualifies and oversees the vendor under SOP-105 (F-105-01), including a business associate agreement or data protection terms where the vendor receives protected health information.
5.7.4
The CRC records vendor-paid travel and vendor-issued payments on F-310-01 (or files the vendor's participant-level report with F-310-01) so that the site has a complete record of what each participant received.
5.7.5
The CRC confirms the transport or lodging booking with the participant before the visit and records any failed pickup or booking problem in the participant contact log (F-309-01). Repeated vendor failures are reported to the sponsor and handled under SOP-105.
5.8 Privacy and security of payment records
5.8.1
Payment records contain identifiers (name, address, SSN, card numbers) and link a person to a study, which itself can reveal a health condition. The site keeps two sets of records:
- F-310-01 payment log, identified by participant ID and kept in the study file
- the restricted finance file (W-9 forms, card enrollment data, check copies, receipts with identifiers), held by the Finance / Contracts Lead with access limited to [ROLES]
5.8.2
SSNs are never written on F-310-01, source documents, CRFs, sponsor portals or email. W-9 forms are transmitted only by [SECURE METHOD] and stored encrypted or locked.
5.8.3
Payment records are not sent to the sponsor with participant names unless the sponsor requires it for its own payment process and the consent form or authorization covers that disclosure.
5.8.4
Loss or misdirection of payment records with participant identifiers is a privacy incident, reported under SOP-400 on F-400-01.
5.9 Tax reporting
5.9.1
The site reports payments to participants on Form 1099-MISC, Box 3 (Other income), when the total paid by [SITE LEGAL NAME] to one individual in a calendar year meets the reporting threshold. For payments made in calendar year 2026 the threshold is $2,000 (raised from $600 for payments made after 31 December 2025, with inflation adjustment possible from 2027). The Finance / Contracts Lead confirms the threshold each January from the current IRS Instructions for Forms 1099-MISC and 1099-NEC.
5.9.2
The total is calculated per individual across all studies at [SITE LEGAL NAME], not per study. The Finance / Contracts Lead runs a cross-study total by TIN before year end.
5.9.3
Payments issued directly by a sponsor's payment vendor are the vendor's or sponsor's to report, as the vendor agreement states. The Finance / Contracts Lead confirms who reports at study start and records it on F-201-01 or the study budget file.
5.9.4
The Finance / Contracts Lead files Forms 1099-MISC and furnishes participant copies by the IRS deadlines for the tax year. Participants whose address on file is outdated are contacted through the CRC.
5.9.5
Staff do not give participants tax advice. They tell participants that payments are taxable income whether or not a form is issued, and that questions go to the participant's own tax advisor.
5.10 Reconciliation with sponsor payments
5.10.1
For site-funded payments that the sponsor reimburses, the Finance / Contracts Lead invoices the sponsor for participant payments and reimbursements as the clinical trial agreement allows, with supporting detail from F-310-01 (participant ID, visit, amount; no names or SSNs).
5.10.2
At least [DEFAULT: quarterly], the Finance / Contracts Lead reconciles:
- payments recorded on F-310-01
- card platform load reports or bank records
- sponsor payments received for participant costs
- completed visits in EDC or the sponsor's payment report
5.10.3
Differences are investigated and resolved. A payment recorded on F-310-01 with no supporting visit, or a card load with no F-310-01 entry, is escalated to the Site Director and, if it suggests misuse of funds, handled under SOP-704. The person who approves participant payments for a study does not also perform that study's reconciliation; at a site too small to separate these duties, the Site Director or Quality Lead reviews and initials each reconciliation.
5.10.4
At study closeout (SOP-601), the Finance / Contracts Lead confirms that every participant has been paid all earned amounts, all reimbursement claims are closed, unassigned cards for the study are deactivated or reassigned, and the final reconciliation is signed and filed.
5.11 Records
5.11.1
F-310-01, IRB-approved payment documents and reconciliation records are essential records, kept with the study file and retained under SOP-402.
5.11.2
W-9 forms and 1099 records are kept in the restricted finance file for the period the site's tax advisor sets, and at least as long as the IRS requires for information returns.
6. Related Forms and SOPs
- F-310-01 Participant Payment Log
- F-301-01 Informed Consent Process Note
- F-306-01 Note to File
- F-309-01 Participant Contact and Retention Log
- F-105-01 Service Provider Qualification and Oversight Record
- F-201-01 Contract and Budget Review Checklist
- F-400-01 Privacy Incident Report
- F-905-01 Cross-Entity Data Flow Register (Model N only)
- SOP-105 Oversight of Service Providers and Vendors
- SOP-201 Confidentiality Agreements, Clinical Trial Agreements and Budgets
- SOP-203 IRB Submissions, Approval and Continuing Oversight
- SOP-301 Informed Consent Process and Documentation
- SOP-308 Protocol Deviations and Noncompliance
- SOP-309 Participant Retention, Withdrawal and Lost to Follow-Up
- SOP-400 Participant Privacy and HIPAA in Research
- SOP-402 Record Retention, Archiving and Destruction
- SOP-601 Study Closeout
- SOP-704 Research Misconduct and Fraud Reporting
- Appendix B Central and Site Responsibility Matrix (Model N only)
7. References
| Reference | Title |
|---|---|
| ICH E6(R3) Annex 1, 1.2.8 and 1.2.9 | IRB/IEC review of participant payment |
| ICH E6(R3) Annex 1, 2.8.10(j) and (k) | Consent information on prorated compensation and anticipated expenses |
| 21 CFR 50.20 | General requirements for informed consent (minimize coercion or undue influence) |
| 21 CFR 56.111(a)(3) and (b) | IRB criteria for approval: equitable selection and protection of vulnerable participants |
| FDA guidance (Jan 2018) | Payment and Reimbursement to Research Subjects |
| IRS Instructions for Forms 1099-MISC and 1099-NEC (current revision) | Box 3 Other income: payments for participation in a medical research study; $2,000 threshold for payments made after 2025 |
| IRS Form W-9 | Request for Taxpayer Identification Number and Certification |
| 45 CFR 164.508 | HIPAA authorization (disclosure of participant data to payment and travel vendors) |
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