Subject Detail
The Subject Detail page provides a complete view of a single subject — their information, enrolled events, and the CRFs within each event. This is the primary data entry interface for clinical coordinators and investigators.
Path: Study Name → Subjects → Subject ID
Subject Header
The top bar displays key subject metadata:
| Field | Description |
|---|---|
| Subject ID | The unique identifier (e.g., 1-016) |
| Status | Current subject status: Available, Locked, etc. |
| Site | The site where the subject is enrolled |
| Date of Enrollment | The date the subject was officially enrolled |
| Randomization Code | The randomization code assigned (if Randomization is enabled) |
| Randomized On | The date the subject was randomized |
| Study Group | The group assigned — may be blinded (shown as ******) |
Quick Links
| Button | Description |
|---|---|
| Files | View and manage files attached to this subject |
| Casebook | Open the subject's full casebook (all CRFs in a printable format) |
| Audit Logs | View the full audit trail for this subject |
Left Sidebar — Events and CRFs
The sidebar displays the subject's event navigation:
- Subject Information — Link to the subject's personal data form (with status badge)
- Events and CRFs — Collapsible list of all events and their CRFs
Event Status Icons
| State | Description |
|---|---|
| Not started | No data has been entered for this event |
| Data entry started | At least one form has been partially completed |
| Completed | All forms are complete |
| SDV | Source Data Verification has been done |
| Locked | The event is locked |
CRF Links within Events
Each event expands to show its assigned CRFs with:
- CRF name and version
- Current status (e.g., Not started, Available, Completed)
- Last updated timestamp
Clicking a CRF opens it for data entry.
Subject Information Form
The Subject Information section captures core subject data in two subsections:
Basic Information
| Field | Description |
|---|---|
| Subject ID | Auto-generated, read-only |
Personal Data
| Field |
|---|
| Full Name |
| First Name |
| Middle Name |
| Last Name |
| Address |
| Birthday |
| Phone Number |
| Fax Number |
| Sex (Male / Female / Other) |
| Ethnicity |
| Education Level |
| Medical Record Number |
| Identity Number |
| Citizen Identity Number |
| Social Security Number |
| Health Plan Beneficiary Number |
| Passport Number |
| Bank Account Number |
| Certificate or License Number |
Note: Personal data fields are governed by the study's privacy settings and may be masked for blinded roles.
CRF Data Entry
When a CRF is open for data entry:
- Fill in all required fields (marked with
*) - Use the Previous / Next buttons to navigate between forms in order
- Click Save to save progress at any time
- The Issues panel on the right shows validation errors and warnings
IMP Form (Investigational Medicinal Product)
If the study uses IMP, a special IMP form appears within the event. It includes:
| Field | Description |
|---|---|
| Date | Visit or administration date |
| Created By | User performing the data entry |
| IP | IP address (auto-captured, read-only) |
| Notes | Free-text notes |
| Attachment | File attachments |
Navigation
| Button | Action |
|---|---|
| Previous | Go to the previous form in the sequence |
| Next | Go to the next form in the sequence |
| Save | Save the current form's data |
| Casebook | View the full casebook for this subject |
| Audit Logs | View subject-level audit trail |