This is a ready-to-use form for the moment a participant withdraws from a trial, in whole or in part. “Withdrawn” is not one state: a participant can mean stop the study drug, stop collecting anything new from me, or stop using what you already have, and each one triggers a different set of actions across a decentralized trial’s eConsent, ePRO, EDC, sensor, and vendor systems. Open this form the same day a withdrawal request is received. Replace every <<FILL: ...>> placeholder. A filled specimen follows. This content is general educational reference, not legal or regulatory advice.
Document control header
| Field | Entry |
|---|---|
| Form title | Consent Withdrawal Scope and Downstream Data-Handling Record |
| Form number | <<FILL: FORM-ID, e.g. FRM-CL-019>> |
| Linked SOP | <<FILL: SOP-ID for informed consent process>> |
| Participant ID / site | <<FILL>> |
| Version | <<FILL>> |
1. Event identification
| Field | Entry |
|---|---|
| Date and time of withdrawal request | <<FILL>> |
| Received by (name, role) | <<FILL>> |
| How communicated | In person / phone / televisit / written / through the app |
| Participant’s own stated reason, in their words (optional, not required) | <<FILL>> |
2. Scope clarification
This is the field that most often gets skipped under the assumption that “withdrawn” needs no further detail. Clarify it directly with the participant and record which applies, not a guess.
| Scope | Applies? | Participant’s own words |
|---|---|---|
| Stop study treatment/drug; continue safety follow-up and keep using data already collected | Yes / No | <<FILL>> |
| Stop all future data collection (ePRO, sensors, visits); data already collected is retained | Yes / No | <<FILL>> |
| Full withdrawal, including a request about data already collected | Yes / No | <<FILL>> |
| Other / mixed scope (describe) | Yes / No | <<FILL>> |
Per 21 CFR 50.25(a)(8), the right to discontinue at any time without penalty is a consent element the participant already holds; this form documents how that right was exercised, not whether it exists.
3. Systems and vendors notified
List every system or vendor in scope for this study and confirm each one actually received and acted on the withdrawal, not only the system that first recorded it.
| System / vendor | Notified (Y/N) | Date | Action taken | Confirmation received from owner |
|---|---|---|---|---|
| eConsent platform | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| ePRO / eCOA vendor | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| EDC | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Wearable / sensor platform | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Home-health / courier vendor | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Biobank / sample repository | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL: other>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Action taken is one of: access revoked, collection stopped, record flagged withdrawn (not deleted), samples held pending the determination in section 4, or no action needed (scope does not apply to this system).
4. Determination on data already collected
Complete this section only where section 2 indicates a request about data already collected.
| Field | Entry |
|---|---|
| What the participant requested regarding existing data | <<FILL>> |
| What the applicable regulation and the signed ICF actually permit to be removed | <<FILL>> |
| Data or samples that will be retained regardless (e.g., already tied to a reported safety event, already locked into an analysis) | <<FILL>> |
| Data or samples that will be removed or destroyed, and by when | <<FILL>> |
| Determination made by (name, role) | <<FILL>> |
| Rationale | <<FILL>> |
| Participant notified of the determination (date, method) | <<FILL>> |
5. Continuing safety obligations
Complete where section 2 indicates safety follow-up continues.
| Field | Entry |
|---|---|
| Safety follow-up plan | <<FILL>> |
| AE/SAE reporting continuation | <<FILL>> |
| Next scheduled safety contact | <<FILL>> |
6. Acceptance criteria
This record is complete when: the scope was clarified directly with the participant rather than assumed; every system or vendor holding this participant’s data was notified with the action taken and a confirmation on file; a determination on already-collected data is documented wherever the scope called for one, with a named owner and rationale; and continuing safety obligations, where applicable, are explicit rather than left to informal memory.
7. References
21 CFR 50.25(a)(8), right to discontinue participation at any time without penalty, as a required consent element. ICH E6(R2)/E6(R3), Good Clinical Practice, investigator and sponsor obligations following a participant’s withdrawal.
Confirm the current version and clause numbers before issue.
Filled specimen
The following shows the form completed for an example participant in a decentralized hypertension trial who asked to stop the study drug but is willing to continue safety contact. Illustrative only.
1. Event identification. Request received 2026-08-11, 14:20, by phone, by the site coordinator. Participant’s stated reason: “the medication is upsetting my stomach, I don’t want to keep taking it.”
2. Scope clarification. Stop treatment, continue safety follow-up and keep using data already collected: Yes. Full withdrawal: No. Participant’s words: “I just want to stop the pills, I don’t mind if you check in on me or keep what you’ve already got.”
3. Systems and vendors notified.
| System / vendor | Notified | Date | Action taken | Confirmation |
|---|---|---|---|---|
| eConsent platform | Y | 2026-08-11 | Record updated to “treatment withdrawn, follow-up continues” | Platform admin, same day |
| ePRO vendor | Y | 2026-08-11 | Diary schedule changed from daily symptom diary to monthly safety check-in | Vendor support ticket #44192, closed 2026-08-12 |
| EDC | Y | 2026-08-12 | Disposition field updated | Data management, 2026-08-12 |
| Wearable platform | Y | 2026-08-11 | Device access revoked; prior data retained | IT confirmed de-provisioning per the device SOP, 2026-08-13 |
| Biobank | N | n/a | No action, this scope does not request removal of samples | n/a |
4. Determination on data already collected. Not applicable; the participant did not request removal of existing data.
5. Continuing safety obligations. Monthly safety check-in by phone through <<FILL: end of study>>; any new adverse event reported per the standard AE pathway. Next scheduled contact: 2026-09-11.
What made this withdrawal defensible on review was not the decision itself but the paper trail: the scope was captured in the participant’s own words, every system that previously collected data from this participant was individually confirmed, not assumed, to have acted, and the safety follow-up kept running rather than quietly stopping along with everything else.
Common inspection findings this form prevents
- A withdrawal recorded in one system (commonly the EDC) while another (commonly the ePRO vendor) kept collecting or prompting, because nothing confirmed the withdrawal reached every system.
- “Withdrawn” treated as a single undifferentiated status, so safety follow-up stops when the participant never asked for that.
- A participant’s request about already-collected data acted on informally, with no documented determination of what the regulation and the ICF actually permit.
- No record of who decided what to retain versus remove, leaving the decision unreconstructable later.
How to adapt this form
- Set your form number and link it to your consent-process SOP in the header.
- Adjust the system/vendor list in section 3 to the actual platforms used in your program; add rows rather than leaving an unused system blank.
- Point section 4’s regulatory determination to your actual data retention and sample-destruction procedures.
- Confirm the cited regulations against the current published version before issue.