The casebook is the read-only record of one subject: the subject information, the screening record, and every event of the subject with its CRFs, randomization and IMP data. A Monitor reviews it before a monitoring visit; a CRC or Investigator exports it to PDF when the complete record of a subject is required, for example at the end of the study.
Path: Study Name → Subjects → open a subject → Casebook in the subject header. The casebook opens in a new browser tab. The Casebook link is not shown on mobile screens.
Who can open a casebook: users who can view subjects —
Available to 14 roles
Clinical Research CoordinatorInvestigatorProject ManagerSite MonitorStudy AdministratorStudy CoderStudy MonitorStudy SponsorSystem AdministratorUnblinded Supply ManagerUnblinded RTSM AdminSponsor Supply ManagerSponsor Data ManagerSponsor Manager(default roles — your study may differ)The casebook shows the current data of the subject. The change history of a subject is in Study Audit Logs.
Study casebook list
Casebook in the breadcrumb of a subject's casebook opens the casebook list of the study, with one row per subject.
| Column | Description |
|---|---|
| Subject ID | The subject identifier, under the label the study sets for its subjects. Click it to open the subject's casebook |
| Status | The subject status |
| Site Name | The subject's site. Shown when you work at study level |
| Created On | Date and time the subject was created |
| Created By | The user who created the subject |
| Last Updated On | Date and time of the last change to the subject. Hidden by default; turn it on in the column settings |
Filters: Subject ID, Status (Available, SDV, Signed, Removed, Auto Removed, Locked) and Created On (date range).
Row action: View opens the subject's casebook.
What this should show: the Casebook list of a study with subjects at Bach Mai Hospital and Cho Ray Hospital, the Subject ID links, the Status and Site Name columns, and the View action.
Read a subject's casebook
The casebook header shows the subject information. Below it, a row of tabs selects what the page shows:
- Information — the subject record.
- One tab per event of the subject, with the event status icon. A repeating event shows one tab per occurrence, for example Follow-up Visit #2.
Information tab
| Section | Content |
|---|---|
| Screening | The screening record of the participant. Shown on studies with Pre-Screen & eConsent installed |
| Subject → Information | Subject ID, Status, Date of Enrollment (when the study uses it), the dynamic group class and its events (when the study uses dynamic groups), and the personal data fields the study collects |
| Subject → Subject Group Class | One row per subject group class: Question, Answer, Notes |
| Subject → Attachments | Files attached to the subject: File Name, Status, File Size, Content Type, Uploaded Date |
Event tabs
An event tab lists every form of the event. An event without forms shows No forms.
| Form | Content |
|---|---|
| CRF | The CRF name, version and status, followed by the CRF content read-only, section by section. A CRF without data shows This form has not been started. |
| Randomization | Randomized information (Randomization Code, Status, Randomized On, Randomized By, Study Group, Has Un-blind Request, Has Un-randomize Request), Stratification, and the answers to the inclusion, exclusion and open questions |
| IMP | The IMP form with its status, a Dispense Summary (Subject ID, Visit, Kit Number, Product, Expiry Date, Current Status, Requested Date, Created By, Note) and an Audit History of the kit (Kit Number, Status, Kit Assigned Date, Dispensed Date, Dispensed By, Note) |
| Survey | The survey name with a Survey tag. Survey answers are not shown in the casebook |
Show CRFs only
The Control Bar on the right of the page holds the display options. Turn on CRF only to hide the screening record, the randomization, IMP and survey forms, and the events that have no CRF.
What this should show: the casebook of a subject at Tam Duc Heart Hospital on a Baseline Visit event tab, with the subject header, the Information and event tabs, a completed CRF shown read-only, and the Control Bar with the CRF only switch and the Export button.
Export a casebook to PDF
- Open the subject's casebook.
- Set the CRF only option in the Control Bar if the PDF should contain CRFs only.
- Click Export in the Control Bar.
- In the Export Casebook dialog, check the preview and change the Casebook name if needed.
- Click Export.
The PDF contains the Information content and every event of the subject, whichever tab is open. Casebook name is filled in with the study code, the subject ID and the current date and time, for example NEURO-01 - BMH-0012 - 2026-10-12 14-30-05; the file is saved as Casebook name.pdf. Each A4 page carries a CASEBOOK header with the Study, Site and Subject, and the page number in the footer.
What this should show: the Export Casebook dialog for a subject at Bach Mai Hospital, with the Casebook name field filled in by default, the preview of the casebook, and the Export button.
Related
- Subject Detail
- Study Audit Logs
- Datasets — extract study data across subjects