SOP-10
Participant Retention, Withdrawal and Payments
- Number
- SOP-10
- Category
- Core
- Edition
- Lean Edition 2.0
- Approx. pages
- 6
[YELLOW] the site fills in. [DEFAULT: green] a value the site may keep or change.
On this page
1. Purpose
[SITE NAME] uses this SOP to keep enrolled participants engaged to the end of a study, handle discontinuation and withdrawal, document attempts to reach participants who stop attending, and pay and reimburse participants as the IRB approved, with records a monitor, auditor or tax authority can follow.
2. Scope
All enrolled participants in every study at [SITE NAME], from enrollment to the protocol-defined end of participation, and all payments, reimbursements and in-kind items (cards, travel, lodging, meals) given to participants, legally authorized representatives (LARs) or caregivers, whether paid by the site or by a sponsor's payment or travel vendor.
Out of scope: recruitment (SOP-05 for pre-screening; SOP-M3, if adopted), the consent process (SOP-04), negotiation of the participant payment budget (SOP-M2, if adopted), remote visits (SOP-M4, if adopted), and research-injury costs (clinical trial agreement and consent form). Follow the protocol, sponsor or IRB requirement wherever it is stricter than this SOP.
3. Responsibilities
| Role | Responsibilities |
|---|---|
| Principal Investigator (PI) | Approves the retention plan. Decides on investigator-initiated withdrawal and IP discontinuation, arranges safety follow-up, and confirms lost to follow-up status. Reviews the payment plan for undue influence. |
| Lead CRC | Prepares the retention plan and reports retention risks to the PI. |
| Clinical Research Coordinator (CRC) | Schedules and reminds visits, keeps F-309-01, documents withdrawal discussions and contact attempts, updates EDC and IRT, issues payments and processes reimbursements on F-310-01. |
| Regulatory Coordinator | Submits retention materials and the payment schedule, method and participant-facing payment materials to the IRB and files approvals in the ISF. |
| Finance / Contracts Lead | Runs the card program, collects and secures W-9 forms, issues Forms 1099-MISC, and reconciles participant payments with sponsor payments. |
| Site Director | Approves payment methods and vendors, and approves any payment outside the schedule after IRB approval. |
| All Research Staff | Do not give participants cash, gifts or payments outside the IRB-approved schedule. |
4. Definitions
| Term | Definition |
|---|---|
| Discontinuation of IP | The participant stops the IP but stays in the study for follow-up. |
| Withdrawal of consent | The participant tells the site they no longer wish to take part, in all or some study activities. |
| Investigator-initiated withdrawal | The investigator removes a participant from IP or the study (for example for safety, noncompliance, pregnancy or a protocol stopping rule). |
| Lost to follow-up | Status given when a participant stops attending and cannot be reached after the documented attempts in 5.5. |
| Participant payment | Money or equivalent value for time, inconvenience or participation. Taxable income to the participant. |
| Reimbursement | Repayment of actual, documented out-of-pocket expenses caused by participation (for example mileage, parking, meals, lodging). |
| Prorated payment | Payment earned per completed visit or segment, so a participant who withdraws is paid for what they completed. |
| Restricted finance file | The access-limited file holding W-9 forms, card enrollment data, check copies and receipts with identifiers. |
5. Procedure
5.1 Retention plan and contact details
5.1.1
Before first enrollment, the Lead CRC prepares a retention plan, approved by the PI and filed in the ISF, stating the visit schedule and reminder method, contact methods participants may choose, retention materials, transport and reimbursement arrangements, remote visit options the protocol allows, and expected retention risks with planned actions.
5.1.2
Retention materials participants will see (appointment cards, newsletters, text templates with study content) are used only after IRB approval, unless the IRB's policy exempts them.
5.1.3
At enrollment, the CRC records the participant's contact details, preferred methods and times, and at least one alternate contact where the participant agrees and the consent allows. The CRC confirms the details at each visit.
5.1.4
The CRC records every retention contact and attempt on F-309-01 or in source, with date, method, initials and outcome. Texts and emails carry no diagnosis, study drug or other sensitive information unless the participant agreed in writing and the IRB approved the content (SOP-12).
5.2 Visits and reminders
5.2.1
The CRC schedules the next visit within the protocol window before the participant leaves and gives the date in writing, and sends a reminder [DEFAULT: 1 to 3 days before the visit, by the participant's preferred method], recorded on F-309-01.
5.2.2
After a missed visit, the CRC contacts the participant [DEFAULT: by the next business day] to reschedule within the window. A visit that cannot be held in window is a deviation (SOP-08).
5.2.3
When preparing for each monitoring visit, the Lead CRC reviews missed and out-of-window visits, discontinuations and withdrawals with their reasons. The PI and Lead CRC change the retention plan where a pattern appears; participant-facing changes go to the IRB first.
5.3 Discontinuation and withdrawal
5.3.1
When a participant says they want to stop, the CRC or investigator asks, without pressure, whether they want to stop the IP only, stop visits but allow follow-up by phone or medical records, or stop all participation including contact and data collection. The staff member records the exact choice in source. Unless the participant clearly withdraws from everything, the site offers continued follow-up as the protocol describes.
5.3.2
Before the participant leaves, the investigator explains the safety follow-up the protocol recommends (for example an end-of-treatment visit, tapering, return of IP or devices) and options for medical care. The participant may decline.
5.3.3
An investigator may discontinue IP or withdraw a participant for protocol reasons or to protect the participant, records the reason in source and tells the participant. Where possible, the participant continues follow-up off IP.
5.3.4
A participant need not give a reason. Staff may make a reasonable effort to learn it and may discuss concerns that could be addressed (visit timing, transport, side effects), but do not pressure, repeat the request after a refusal, or link payment or care to staying. Staff record the reason as given, or "participant declined to give a reason".
5.3.5
For each discontinuation or withdrawal, the CRC records the date, who initiated it, its scope, the reason, safety follow-up offered and accepted, and IP and device returns; completes the end-of-treatment or end-of-study EDC pages; updates IRT and F-303-01; recovers IP (SOP-06); notifies the sponsor as the protocol requires; and, where the participant agrees, sends written confirmation of their choices. Withdrawal caused by an AE, pregnancy or deviation is also handled under SOP-09 or SOP-08.
5.4 Data after withdrawal
5.4.1
Data collected before withdrawal stay in the study database; staff do not offer removal of data already collected (FDA guidance, Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials, 2008).
5.4.2
If the participant agrees to continued follow-up, the CRC records what may be collected (for example phone contact, medical records) and uses a new consent or addendum where the IRB or sponsor requires.
5.4.3
After full withdrawal, staff do not contact the participant for study purposes or access their medical or other confidential records for the study. A revocation of HIPAA authorization must be in writing; the site stops new uses and disclosures but may use PHI already obtained to the extent needed to protect the integrity of the research (45 CFR 164.508(b)(5)).
5.4.4
[DEFAULT: When the sponsor or protocol asks for vital status after full withdrawal, the CRC may search public records (for example death records), as FDA's 2008 guidance permits, unless the consent form, the IRB or the participant's documented choices restrict it.] The CRC records each search, its date and source.
5.4.5
Use, destruction or retention of samples already collected follows the consent, the protocol and the participant's wishes; the CRC tells the sponsor of any request to destroy samples (SOP-11). Safety information learned after withdrawal is still assessed and reported (SOP-09).
5.5 Lost to follow-up
5.5.1
The CRC makes the first attempt to reach a participant who missed a visit within [DEFAULT: 1 business day], and before a participant is declared lost makes [DEFAULT: at least 3 documented attempts by at least 2 methods on different days and times, then a certified letter with return receipt to the last known address], or more where the protocol requires. Each attempt is recorded on F-309-01.
5.5.2
Contact with alternate contacts stays within what the participant authorized. Where the consent allows, the CRC may check the site's or affiliated practices' medical records for recent contact, hospitalization or death.
5.5.3
If there is no response [DEFAULT: 30 days after the certified letter], the PI reviews the attempts and confirms lost to follow-up status in source. The CRC records the last contact date, updates EDC and F-303-01, and notifies the sponsor. If the participant later makes contact, the CRC informs the PI and sponsor, and follow-up resumes as the protocol allows.
5.6 Payment approval and explanation
5.6.1
The Regulatory Coordinator submits the payment amounts, schedule and method, and any participant-facing payment material, to the IRB. No payment, amount, method or schedule is used, or changed, until the IRB approves it.
5.6.2
Before submission, the PI reviews the plan for undue influence, considering the population, visit burden and any completion bonus. Payment is prorated by visit and is not wholly contingent on completing the trial; a completion bonus is used only in the amount the IRB approves (ICH E6(R3) Annex 1, 1.2.8).
5.6.3
The CRC builds the study payment schedule in F-310-01 or the payment system from the approved version only.
5.6.4
During consent, the CRC explains the amount, timing and method per visit, what is paid on withdrawal, reimbursable expenses and the receipt deadline, that payments may be reported to the IRS and a Social Security Number (SSN) or Taxpayer Identification Number (TIN) is requested, and card fee and replacement rules. The CRC records on F-301-01 that payment was explained. Staff do not use payment to persuade a hesitant participant to enroll or stay.
5.7 Tax information
5.7.1
Where the Site decision below requires it, the CRC gives the participant Form W-9 (or the vendor's electronic equivalent) after consent and before the first payment (or the next payment, once the Site decision first applies to that participant), sends it to the Finance / Contracts Lead by [SECURE METHOD], and never copies the SSN into source, F-310-01, CRFs, sponsor systems or email.
5.7.2
If a participant declines to give a TIN, the CRC refers it to the Finance / Contracts Lead before the next payment, who decides with the site's tax advisor whether to apply backup withholding, use a method that needs no TIN, or decline the payment, and records the decision. A participant may decline payment entirely and stays eligible; the CRC records the refusal on F-310-01.
5.8 Issuing payments and reimbursements
5.8.1
The site uses only methods the Site Director approved and the IRB reviewed: reloadable prepaid card, check, electronic transfer through an approved vendor, or gift card where the IRB approves it and its value is tracked like cash. [DEFAULT: Cash is not used.]
5.8.2
For cards, the CRC assigns the card by participant ID in the platform, records the last four digits on F-310-01, and obtains the participant's acknowledgment of receipt. Unassigned card stock is locked and counted at each restock and at closeout by someone other than the person who issues cards; where only one person handles cards, the Site Director or Quality Lead initials the count. Platform accounts are named, role-based and never shared (SOP-12).
5.8.3
After a visit is completed and documented in source, the CRC issues the IRB-approved payment on the consent form schedule or, where the form sets no timing, [DEFAULT: within 5 business days of the visit], and records on F-310-01 the participant ID, visit, visit date, amount, method, card digits or check number, date issued and initials.
5.8.4
Partial, unscheduled, screen-fail and early termination visits are paid only as the approved schedule states. Where the schedule is silent, the PI decides in the participant's favor and records it on F-310-01 or F-306-01; the Regulatory Coordinator asks the IRB to clarify the schedule if the gap may recur.
5.8.5
A payment outside the approved schedule (over, under or unapproved bonus) is a deviation (SOP-08). An underpayment is corrected [DEFAULT: within 5 business days of discovery]. An overpayment is not recovered without the PI's and Site Director's agreement.
5.8.6
The participant submits receipts with a claim [DEFAULT: within 60 days of the expense]. The CRC checks each claim against the approved categories and caps and a matching study visit, calculates mileage by [MILEAGE METHOD], and records the reimbursement on F-310-01 separately from visit payments. The Finance / Contracts Lead records the tax advisor's written position on reimbursements and flat allowances once and applies it consistently.
5.8.7
For a sponsor-provided travel or payment vendor, the CRC follows the IRB-approved vendor instructions, enters only the data the vendor needs (no diagnosis or medical details) and only once the consent or authorization covers the disclosure, records vendor payments and travel on F-310-01 (or files the vendor's participant report with it), and records failed bookings on F-309-01. A site-engaged vendor has a business associate agreement or data protection terms before it receives participant data (SOP-M1, if adopted).
5.9 Payment records and tax reporting
5.9.1
F-310-01 is identified by participant ID and kept in the study file. W-9 forms, card enrollment data, check copies and receipts showing identifiers are kept in the restricted finance file, encrypted or locked, with access limited to [ROLES]. Payment records with names go to the sponsor only when its payment process requires it and the consent or authorization covers it. Loss or misdirection of payment records is a privacy incident (SOP-12).
5.9.2
The Finance / Contracts Lead reports payments on Form 1099-MISC, Box 3, when the total paid by [SITE LEGAL NAME] to one individual in a calendar year, across all studies, meets the IRS threshold ($2,000 for payments made in 2026), and confirms the threshold each January from the current IRS instructions. Payments made directly by a sponsor's vendor are reported by the vendor or sponsor as the agreement states; the Finance / Contracts Lead confirms who reports at study start. Forms are filed and furnished by the IRS deadlines.
5.9.3
Staff do not give tax advice; they tell participants that payments are taxable whether or not a form is issued.
5.10 Reconciliation and closeout
5.10.1
Before each sponsor invoice for participant costs, and at closeout, the Finance / Contracts Lead reconciles F-310-01 against card load reports or bank records, sponsor payments received and completed visits in EDC, and invoices with participant ID, visit and amount only. The person who approves a study's payments does not reconcile them; where one person does both, the Site Director or Quality Lead reviews and initials the reconciliation.
5.10.2
A payment without a supporting visit, or a card load without an F-310-01 entry, goes to the Site Director, and to the independent reviewer named under SOP-02 where it suggests misuse of funds (SOP-M5, if adopted).
5.10.3
At closeout (SOP-15), the Finance / Contracts Lead confirms all earned amounts are paid, claims are closed and unassigned study cards are deactivated or reassigned, and signs and files the final reconciliation.
5.10.4
F-310-01, IRB-approved payment documents and reconciliations are essential records retained under SOP-12. W-9 and 1099 records are kept for the period the tax advisor sets, and at least as long as the IRS requires.
6. Related Forms and SOPs
- F-309-01 Participant Contact and Retention Log
- F-310-01 Participant Payment Log
- F-303-01 Screening and Enrollment Log
- F-301-01 Informed Consent Process Note
- F-306-01 Note to File
- SOP-02 Roles, PI Oversight, Delegation and Conflicts of Interest
- SOP-04 Informed Consent
- SOP-05 Pre-Screening, Screening, Eligibility, Randomization and Blinding
- SOP-06 Investigational Product Management
- 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-15 Study Closeout
- SOP-M1 Service Providers and Vendors, if adopted
- SOP-M2 Feasibility, Contracts, Budgets and Research Billing, if adopted
- SOP-M3 Recruitment and Advertising, if adopted
- SOP-M4 Decentralized Trial Elements, if adopted
- SOP-M5 Research Integrity and Misconduct Reporting, if adopted
7. References
| Reference | Title |
|---|---|
| 21 CFR 50.20 | General requirements for informed consent (coercion and undue influence) |
| 21 CFR 50.25(a)(8), (b)(4) | Consent elements: right to discontinue; consequences of withdrawal |
| 45 CFR 164.508(b)(5) | HIPAA authorization: revocation |
| ICH E6(R3) Annex 1, 1.2.8, 1.2.9 | IRB/IEC review of participant payment |
| ICH E6(R3) Annex 1, 2.8.10(j), (k) | Consent information on prorated payment and anticipated expenses |
| ICH E6(R3) Annex 1, 2.9 | End of Participation in a Clinical Trial |
| FDA Guidance (Oct 2008) | Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials |
| 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; $2,000 threshold for payments made after 2025 |
| Reference Edition SOP-309, SOP-310 | Background and full wording |
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