Enrol a subject

The coordinator’s first step in a new study is to enrol a subject: register the participant in the system under a screening number and take them through the statuses from screening to active participation.

Who and when

Coordinator — the site coordinator (CRC). You need the permissions to create subjects (subject.create) and to change a subject’s status (subject.status.change) at your site; randomization also needs subject.randomize. The task comes up when a new participant arrives at the site and has signed the informed consent.

Before you start

• The study design version is published and the site is active. While the design is still a draft, the system says: “Publish the design before enrolling subjects”.
• You hold a role at this site.
• The participant’s screening number follows the site’s rules (you may leave it empty — the system will assign one).
• Do not enter names, a date of birth or any other direct identifiers — see below.

Steps

1. Open the study and go to Subjects (or to the study overview — the “Recent subjects” block).

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

3. Choose the Site ID (the activation the participant is enrolled into) and, if needed, enter the Subject code. You can leave the code empty — it is then assigned automatically using the “site code-NNN” pattern.

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

5. Fill in the screening forms (demographics, inclusion criteria) — see Enter data in a form. Once the transition conditions are met, the subject moves to Enrolled — automatically or manually (next section).

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

Change the status manually

1. In the subject’s casebook open the More actions (⋯) menu and choose Change status…. The “Change subject status” dialog opens, showing the current status and the available new ones.

2. Choose the new status and confirm. The system offers only the transitions allowed by the status machine and by your permissions.

Randomize a subject

Randomization (the Enrolled → Randomized transition) is a distinct status-change act, possible only after the inclusion criteria have been confirmed.

1. Open More actions (⋯) → Change status… and choose Randomized.

2. If the statistician has uploaded a randomization list, you do not enter a number: the system takes the next free list number for the subject’s site (in a stratified list — for the chosen stratum).

3. The arm code stays hidden from all blinded roles — the header shows “Randomization R-001 … arm blinded”.

Entering the number by hand (IRT, a paper list) remains a fallback, but the conformance check will flag such a subject as randomized outside the list.

Break the code in an emergency

When the participant’s treatment requires knowing the arm (for example, after a serious adverse event), an investigator holding subject.unblind.emergency proceeds as follows:

1. Open the subject card’s More actions (⋯) menu and choose the separate Emergency code break… item. It is shown only for a randomized subject.

2. In the dialog choose the reason, describe the situation, type the subject code to confirm and enter your password — as when signing.

3. The system shows the arm once and only to you, records the break in the study log and in the audit trail, marks the subject as “code broken” and notifies the sponsor (the medical monitor and the DM).

The sponsor notification cannot be switched off; every break is a separate record.

What happens

• Creating a subject and every status change are written to the audit trail.
• A new subject is in Screening. Once it moves to Enrolled, the scheduled visits per the schedule of activities (SoA) open up.
• In a study in UAT, the subject is created with a TEST mark and will be removed before go-live. A live study has no test subjects.
• Randomization is recorded in the audit trail as a randomization; a list number is counted on the “Randomization” screen.
• An emergency code break is an entry in the emergency break log, in the audit trail and a notification to the sponsor.

If it doesn’t work

• “Publish the design before enrolling subjects” — the design version is still a draft. Ask the data manager to publish the version.
• No “Add subject” button — you lack subject.create at the site, or the site is not activated. Contact the access administrator or the data manager.
• “No transitions available from the current status” — the status machine does not allow the transition (for example, from a terminal status) or a transition condition is not met; the dialog names which one.
• No “Change status…” item — you lack subject.status.change.
• A status was set by mistake (for example, “Withdrawn” instead of “Completed”) — a normal transition cannot fix it. It takes a correction — a separate action under subject.status.correct (a targeted admin grant, not part of any role template). A reason is mandatory; in the audit trail a correction is distinguishable from a regular transition (subject.status_corrected).
• No “Emergency code break…” item — the subject is not randomized yet, or you lack subject.unblind.emergency.

Next

Open a visit and a form in the casebookThe subject casebook: visits, forms, unscheduled visits, repeating forms.

Enter data in a formFilling in forms, “not done” marks, keyboard entry.

Status lifecyclesThe full reference of status axes and transition machines.

More detail

There are no names in the EDC

X7 Insight stores the participant pseudonymously. The system has no “surname”, “first name” or “date of birth” fields — a subject is identified only by the subject code (the screening number) and the site code. The link “number ↔ a particular 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 type names, 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 is not in the EDC.

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 platform’s default machine looks like this:

1. Screening
   • failsScreen failed
   enrol
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	Meaning
Screening	Checking the inclusion criteria
Enrolled	Enrolled in the study, visits per the protocol
Randomized	Randomized to a treatment arm
Completed	Completed participation per the protocol
Withdrawn	Withdrew consent / left the study
Lost to follow-up	Contact lost — no further visits
Screen failed	Did not meet the inclusion criteria

The Completed, Withdrawn, Lost to follow-up and Screen failed statuses are terminal: there is no way back from them (unless the design says 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 complete, all inclusion criteria = “yes”, exclusion criteria = “no”, and there is a valid consent signature), the system moves the subject itself — in the same transaction as the data save.
• Manually. Via Change status… — the dialog shows only the allowed transitions.

The system tells you what is possible

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

Randomization by list

If an unblinded statistician has uploaded a randomization list (the study’s “Randomization” screen), randomization follows the list (steps — above). The “Randomization” screen has three sections:

Section	What it shows
List	File name, its SHA-256, who uploaded it and when; how many numbers are used per site and stratum (without arm codes)
Conformance check	The list was uploaded before the first randomization; all subjects were randomized by the list; numbers were issued in order; every break is documented
Emergency break log	Records of all emergency code breaks

The file format is CSV or XLSX with the randomization_number and arm_code columns and the optional site_code and stratum. File errors are shown all at once, with row numbers. The active list cannot be replaced — it can only be retired with a reason, and a new one uploaded.

Uploading and retiring the list takes randomization.list.manage (the “Unblinded statistician” preset); the counters and the log are visible to holders of randomization.list.read — the DM and the medical monitor. Modules cannot upload a list or break a code.