What this is, and who it is for
Enrolling turns a screened participant, whom the investigator has determined eligible, into a participant of the study. The system issues the subject number, fixes the baseline date, and builds the participant's visit schedule from it. Enrollment is a one-way, audited act.
| You need | To |
|---|---|
subject.write | Enroll (site coordinator, principal investigator) |
subject.read | See the list and who is eligible |
Held by: Principal Investigator, Clinical Research Coordinator (subject.write).
Where to find it
- Sites → your site → Enroll (the site's own participants), or the workspace's Subjects list → Enroll eligible (every site the person may see). A participant must be Screening with eligibility Eligible.
- A participant randomized in an external system is added with External on the site page.
What you can do
Enroll eligible participants
- Choose Enroll eligible. The dialog Enroll eligible subjects lists the screened participants the investigator has determined eligible (No eligible subjects if none), with their Screening ID and demographics. Select all or tick some.
- Give the Baseline date: day 0, from which the schedule is counted.
- In a randomized study (or one with assigned codes), choose the Treatment arm for all selected (All selected subjects get this arm. For mixed-arm batches, run separate selections.). In a study that is not randomized the dialog says the arm is not asked.
- Choose Enroll. A toast says Enrolled N subjects; any that could not be enrolled are counted with the reason.
- Enrolls the ticked participants and dates their visit schedule from the baseline.
Add an externally randomized participant
For a participant randomized in an external IWRS or RTSM: Add externally-randomized subject. The platform records the randomization id as-is and does not re-randomize. The subject number is assigned by the system. Give Consent date, Screening date, ICF version, Birth year, Baseline date, the Randomization ID (external), the IWRS / RTSM system and an optional External screening ID. Informed consent is still required at the site; a pre-screen or external randomization never substitutes for consent. Choose Add & enroll: the participant is screened and enrolled, recording your eligibility determination, in one step; if enrolling fails after screening, the toast says the participant was screened but not enrolled and why.
What happens
- The system issues the subject number (
{study code}-S-0001; in UAT{study code}-UAT-S-0001, so a test participant can never be taken for a real one). - The randomization number is issued by the platform (
RAND-0000001;RAND-UAT-0000001in UAT), or taken from the external system. - The participant's visits are dated: each scheduled visit is baseline plus its day offset, with its window; the visits marked Available during screening already exist from screening (Plan visits).
- The participant becomes Enrolled; in a study that is not randomized they move on to Active from the status menu; in a randomized study the allocation is typed from the randomization system (Not built yet).
Every option
Rules the server applies
- The site must be active: Subject cannot be enrolled — the site is not active.
- The baseline date cannot be in the future (one day of slack for time zones) and cannot be before the participant consented (The baseline date cannot be before the participant consented (consent was on …)).
- Only a participant who has been determined eligible can be enrolled.
- A study that is On hold, Closed to enrolment, Completed, Locked or Archived enrolls no one (Change the state of a study).
Arms and blinding
The arm is recorded as given: there is no allocation list, and no part of the system hides the arm from anyone who may read participants, whatever the study's blinding type says (Not built yet).
What the system records
subject.enrolled with the subject number, the baseline date, the status and (if any) the arm and randomization number; the participant's visits are created in the same transaction. See Audit events.
What you cannot do, and why
- Enroll without the investigator's eligibility determination.
- Enroll at an inactive site, or in a study that no longer enrolls.
- Choose a baseline before consent or after today.
- Change a subject number or enroll the same screening twice.
- Randomize in the system. It issues a number; it does not allocate.
Compliance Q&A
No. Enrollment is refused unless the site is active, the investigator has determined the participant eligible and the baseline date is not before the consent; the study's state must also allow enrollment.
Evidence: server/src/modules/study/subjects/application/commands/enroll-subject.ts (site active, eligible, baseline not before consent)domain/subject.ts
Related
Screen a participant · Run a visit · Change a participant's status · Not built yet