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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.

Last updated: 04/14/2026

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:

FieldDescription
Subject IDThe unique identifier (e.g., 1-016)
StatusCurrent subject status: Available, Locked, etc.
SiteThe site where the subject is enrolled
Date of EnrollmentThe date the subject was officially enrolled
Randomization CodeThe randomization code assigned (if Randomization is enabled)
Randomized OnThe date the subject was randomized
Study GroupThe group assigned — may be blinded (shown as ******)
ButtonDescription
FilesView and manage files attached to this subject
CasebookOpen the subject's full casebook (all CRFs in a printable format)
Audit LogsView the full audit trail for this subject

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

StateDescription
Not startedNo data has been entered for this event
Data entry startedAt least one form has been partially completed
CompletedAll forms are complete
SDVSource Data Verification has been done
LockedThe event is locked

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

FieldDescription
Subject IDAuto-generated, read-only

Personal Data

Field
Full Name
First Name
Middle Name
Last Name
Address
Birthday
Phone Number
Email
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:

  1. Fill in all required fields (marked with *)
  2. Use the Previous / Next buttons to navigate between forms in order
  3. Click Save to save progress at any time
  4. 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:

FieldDescription
DateVisit or administration date
Created ByUser performing the data entry
IPIP address (auto-captured, read-only)
NotesFree-text notes
AttachmentFile attachments

ButtonAction
PreviousGo to the previous form in the sequence
NextGo to the next form in the sequence
SaveSave the current form's data
CasebookView the full casebook for this subject
Audit LogsView subject-level audit trail