What this is, and who it is for
Screening is the first thing the system knows about a person: they have consented, and the site records who they are in the minimum needed to assess them. Eligibility is then decided by the principal investigator, never by the coordinator and never by the system. A participant is enrolled only after the investigator has determined them eligible.
| You need | To |
|---|---|
subject.write and clinical.consent.write (site coordinator, principal investigator) | Screen a participant |
subject.eligibility (principal investigator only) | Confirm eligible, or mark ineligible |
subject.read | See participants |
Held by: Principal Investigator, Clinical Research Coordinator (subject.write).
Held by: Principal Investigator (subject.eligibility).
A participant belongs to one site and to one workspace. A person at a site sees only their own site's participants; study-level roles read across sites; Live and UAT participants never mix.
Where to find it
Inside a workspace: Sites → your site → Screen; or the workspace's Subjects list. A participant's page has tabs (overview, Consent, details, timeline, casebook, queries, events, deviations, signatures, reports). The page named Eligibility (the Consent screen) holds the eligibility card.
What you can do
Screen
- Choose Screen on the site's page. The dialog collects:
| Field | Notes |
|---|---|
| Site | Required; the site you are at |
| Screening ID | Issued by the system (Auto), like SCR-01-0003 |
| Sex | Male, Female or Other. Required; used by normal ranges that differ by sex |
| Birth year | Required (YYYY); used for age-based normal ranges |
| Screening date | Required; not in the future |
| Treatment arm | Only in a randomized study, and only for roles that may set it |
| Informed consent (ICF): Consent date, ICF version, Signed | Required on every screening. The consent date cannot be in the future or after the screening date |
| Screening notes | Optional |
- Choose Screen. The participant is created in Screening with an eligibility of Pending. The visits marked Available during screening appear in the casebook now (Plan visits).
Date problems are said beside the field: The consent date cannot be in the future., The screening date cannot be in the future., Consent comes first: it cannot be after the screening date. The server refuses the same.
- Disabled until sex, birth year, the screening date, the consent date and the ICF version are given.
- Records the participant as Screening; the screening identifier carries the site.
Screen many (import)
Import on the site page reads a CSV (a template can be downloaded). Consent date and version are required on every row. A row with an eligibility verdict or a randomization identifier can be imported only by someone who may determine eligibility; the system infers the stage from the columns (a randomization identifier enters the participant as Enrolled, an Ineligible verdict as Screen Failed, otherwise Screening). Invalid rows are listed and only valid rows are committed.
Record eligibility (principal investigator)
On the participant's Eligibility page the card says The Principal Investigator must confirm the subject meets all inclusion & exclusion criteria before enrollment. The investigator chooses:
- Mark eligible: tick I confirm this subject meets all inclusion and exclusion criteria per the protocol, give the Determination date (the day you determined it, kept beside the time it is recorded) and an optional Note, and confirm. Recording an eligibility determination is an investigator responsibility (ICH E6(R2) §4.3). Once confirmed, enrollment is unlocked for this subject.
- Mark ineligible: give the Reason, the Specific criterion (such as
Inc-3,Exc-7) and Detail; the participant becomes Screen Failed (a final status; the screening data is kept).
Every option
Status after screening
| Eligibility | Status | Next |
|---|---|---|
| Pending | Screening | Waits for the investigator |
| Eligible | Screening | Can be enrolled (Enroll a participant) |
| Ineligible | Screen Failed | Final |
The coordinator has no eligibility control: a coordinator cannot mark a participant eligible, and the generic status menu does not offer Enrolled until the investigator has confirmed.
What the system records
subject.screened (the consent and screening dates and the consent version), subject.eligibility_determined (the investigator, the verdict, the criterion and the time), subject.transitioned for a screen failure with its reason. See Audit events.
What you cannot do, and why
- Screen without consent. The consent date and ICF version are required: consent precedes any study procedure, and a pre-screen or external randomization never substitutes for it.
- Enter a consent or screening date in the future, or a consent after screening.
- Decide eligibility as a coordinator or a study-team role. Only the investigator can.
- Screen at a site that is not active (Site is not active — subjects can only be screened at an active site), or at a site that is not yours (You can only screen subjects at your assigned site).
- Delete a participant through screening. A participant who should not proceed is screen-failed, and kept.
Compliance Q&A
Yes. A participant cannot be screened without a consent date and ICF version, the dates must be sensible, and only the principal investigator can determine eligibility; enrollment is refused until they have.
Limits: the system records the consent date and ICF version; it holds no image of the signed form (Not built yet).
Evidence: server/src/modules/study/subjects (screen-subject: consent date and ICF version required, dates validateddetermine-eligibility: permission subject.eligibility)client screening-dates.ts
Related
Enroll a participant · Record consent and re-consent · Run a visit · Clinical Research Coordinator · Principal Investigator