What this is, and who it is for
Consent is recorded twice in a participant's life. The first consent is recorded when the participant is screened (the consent date and the version of the consent form). A re-consent is recorded when an amendment to the protocol asks participants to agree again. The re-consent decides whether a participant moves to the new version of the study's design.
| You need | To |
|---|---|
clinical.consent.write (site coordinator, principal investigator) | Record a participant's first consent and each answer to an amendment |
subject.read | See the consent section |
Held by: Principal Investigator, Clinical Research Coordinator (clinical.consent.write).
Where to find it
On a participant's page, Consent (the section titled What this subject agreed to, and when). The first consent is also on the participant's details. For the study as a whole, the amendment's Version details page shows how many participants follow it, are ready, are waiting for consent or declined (Amend a live study).
What you can do
The first consent
It is part of screening: Consent date, ICF version and Signed (Screen a participant and record eligibility). The participant's details show them. It cannot be left out and cannot be after the screening date or in the future.
Re-consent to an amendment
When an amendment asks for it, each participant who is still in the study (Screening, Enrolled or Active) is asked again.
- On the participant's Consent section choose Record a new answer (or Record re-consent).
- In the dialog Record re-consent: Asked about (choose the amendment's version), Their answer (Consented again or Declined), Date signed and ICF version (a consent only, such as
v2.0; a decline carries neither, and a decline sent with a date is refused), and an optional Note (Anything the site wants kept with the answer, up to 1,000 characters). - Save. The answer is added to the participant's history of answers: the section lists each with Version, Answer, Date signed, ICF version, Recorded by and Note.
What the answer does:
| Answer | Effect |
|---|---|
| Consented again | The participant can follow the new version. If the amendment is Live, they are moved at once: their visits that never took place are replaced by the new version's and later forms follow it. If the amendment is only approved, they move when it goes Live. A failure to move never undoes the consent; the move is retried |
| Declined | Recorded. The participant stays on the version they follow. The platform withdraws nobody; the site decides what the protocol requires |
A later answer for the same amendment replaces the earlier one in effect (the latest answer is what counts), and every answer is kept.
Every option
Rules
- Re-consent is recorded in the Live workspace only: a test participant is never moved to another version.
- The amendment must ask for re-consent and be Approved or Live.
- The participant must still be in the study, and must not already follow the version.
- A site person can record answers only for their own site's participants.
- The signing date is a real calendar day and cannot be in the future (one day of tolerance for time zones).
What a site can see
The amendment's move panel lists, by site and status, who is ready to move, waiting for their consent and declined (counts, or names for those who may read participants).
What the system records
subject.screened (the first consent), subject.reconsented or subject.reconsent_declined (the version, the date, the ICF version, the recorder and the note), and subject.version_transitioned when the participant moves. The answers are append-only. See Audit events.
What you cannot do, and why
- Record an answer to an amendment that does not ask for consent again. There is nothing to answer.
- Record an answer in UAT. Test participants are not moved.
- Delete or edit an answer. Add a newer one.
- Move a participant who has not consented when consent is required.
- Withdraw a participant by recording a decline. That is a separate act (Change a participant's status).
Compliance Q&A
Yes. The first consent is required to screen; each answer to an amendment is a row of its own with the date, the form version and the person who recorded it, never overwritten; and a participant moves to the amended design only when their latest answer is consented.
Limits: the system records that consent was given and which version; it does not hold the signed document or check the signature (Not built yet).
Evidence: server/src/modules/study/subjects/application/commands/record-reconsent.tsappend-only subject_reconsentsdatabase gate on moving a participant (P0031)audit events subject.reconsented, subject.reconsent_declined
Related
Amend a live study · Screen a participant · Change a participant's status · Clinical Research Coordinator