Enrolling a subject

The first step of a coordinator’s (CRC) work in a new study is to enroll a subject: register a participant in the system under a screening number and take them through the statuses from screening to active participation. Everything else — visits, forms, queries — appears around the created subject.

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Enrolling a subject: the Screening → Enrolled status transition, written to the audit

There are no names in the EDC

X7 Insight stores a participant pseudonymously. There are no “surname”, “first name” or “date of birth” fields in the system — a subject is identified only by the subject code (screening number) and the site code. The link “number ↔ a specific person” lives outside the EDC, in the site’s documents.

Do not enter personal data

The screening number is the participant’s only identifier in the system. Do not write a name, a full date of birth or other direct identifiers into text fields, comments or query texts. The participant’s privacy is ensured by the fact that this data simply does not exist in the EDC.

How to enroll a subject

Subject enrollment is open only when the design is published and a site is active. If the design is still a draft, the system will prompt: “Publish the design before enrolling subjects”.

1. Open the study and go to Subjects (the Subject matrix) or to the study overview — there is a “Recent subjects” block there.

2. Click Add subject. The “New subject” dialog opens.

3. Select the Site ID (the activation the participant is enrolled into) and, if needed, specify the Subject code. The code can be left empty — then it is assigned automatically per the “site code-NNN” template.

4. Click Create. The subject appears with the Screening status, and the system offers: “Open casebook →”.

UAT: test subjects

If the study is still in the UAT status (a test run), the subject is created with a TEST mark and will be removed before go-live. In a production (active) study there are no test subjects.

The subject state machine

A subject has its own status axis — the participant’s path through the protocol. The set of statuses and transitions is defined in the study design (it is configurable), but the default platform machine looks like this:

1. Screening
   • failsScreen failed
   enroll
2. Enrolledrandomize
3. Randomizedcomplete
4. Completed

Branches

• Enrolled · Randomizedwithdraws consentWithdrawn
• Enrolled · Randomizedcontact lostLost to follow-up

The platform's default subject status machine (configurable in study design).

Status	What it means
Screening	Being vetted against the eligibility criteria
Enrolled	Enrolled in the study, visits per protocol
Randomized	Randomized to a treatment arm
Completed	Completed participation per protocol
Withdrawn	Withdrew consent / left the study
Lost to follow-up	Contact lost — no further visits
Screen failed	Did not meet the eligibility criteria

The Completed,

Withdrawn,

Lost to follow-up

and Screen failed statuses are terminal: there is no way back from them (unless the design specifies otherwise).

How the status changes

A transition happens in one of two ways, depending on how the machine is configured:

• Automatically. As soon as the transition conditions are met (for example, the eligibility form is filled in, all inclusion criteria = “yes”, exclusion = “no”, there is a valid consent signature), the system moves the subject itself — in the same transaction as the data save.
• Manually. The Change status button on the casebook opens the “Change subject status” dialog: the current status and the available new ones are shown. The system shows only the transitions allowed by the machine and by your permissions.

The system prompts what is possible

If a transition is unavailable, you will see an explanation: “No transitions available from the current status” or exactly which condition is not met. Impossible steps simply do not appear — there is no need to keep the rules in your head. Any status change is recorded in the audit trail.

Randomization (the Enrolled →

Randomized transition) is a distinct status-change act, possible only after the inclusion criteria are confirmed. In the base platform it is performed manually (the Change status button) and recorded in the audit trail as a randomization; a connected RTSM module can automate arm assignment and drug accountability.

What’s next

After enrollment the subject is ready for data collection:

1. Open the subject’s casebook — the “visits × forms” matrix.

2. Fill in the screening forms (demography, inclusion criteria) — see Entering data in a form.

3. When the transition conditions are met, the subject moves to the Enrolled status (automatically or by confirmation) — the scheduled visits per the schedule (SoA) open.

Casebook & visitsThe matrix of visits and forms, tabs, unscheduled visits, repeating forms.

Entering data in a formFilling in forms, the 'not done' marks, keyboard entry.

Status lifecyclesA full reference of the status axes and transition machines.