Casebook & visits

Casebook (the subject’s casebook) is the participant’s main screen. It is a matrix where the rows are forms (CRFs) and the columns are visits. Each cell is either a form instance for a specific visit, or a dash if the study schedule (SoA) has no such form on that visit. From here you reach any form and see the status of all the subject’s data at a glance.

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A subject's casebook: the visits × forms matrix and adding an unscheduled visit

Subject tabs

In the subject header are three tabs:

Tab	What it shows
Casebook	The “visits × forms” matrix — the data-entry workplace
Queries	All queries for this subject in a single list
Audit	The subject’s change history — who changed what and when

In the header, next to the subject number, are its status and status badges (form completion, SDV, queries, signatures). The Change status button leads to changing the participant’s status.

The visits × forms matrix

The matrix columns are visits in chronological order; the rows are forms. Scheduled visits are created automatically from the visit schedule (SoA) as soon as the subject moves to an active status.

Each cell carries icons along independent status axes — they do not blend into one “overall” color. A legend right below the matrix explains the marks:

• (n) — the number of instances of a repeating (log) form;
• ⚑ — an unscheduled visit;
• a red “missed” — the visit window elapsed without a recorded date;
• a digit by the amber icon — the number of open queries;
• a lock — the visit is locked;
• a calendar — the visit date can be recorded;
• a highlighted cell — the next unfilled form.

The casebook itself prompts what comes next

The first unfilled form in schedule order is highlighted, and the “Next form to fill” link takes you straight to it. Clicking a cell opens the form at the right visit.

Form statuses

A form (FormInstance) has its own completion status, managed by the coordinator:

1. Not startedfirst value
2. In progressmark complete
3. Complete
   • data editIn progress

The form's completion status; editing after 'Complete' automatically returns it to 'In progress'.

Status	Icon	What it means
Not started	○	The form has not been opened yet, there are no values
In progress	◐	At least one value has been entered, filling in continues
Complete	●	The coordinator has explicitly marked the form as finished

A form instance is created “lazily” — at the moment it is first opened. As soon as you enter the first value, the form moves from Not started →

In progress itself. The Complete mark is set by a person with the “Mark complete” button — a deliberate step, not automatic.

Note

If someone changes the form data after the “Complete” mark, it automatically returns to the In progress status — the status always honestly reflects the real state of the data.

Unscheduled visits

Not everything happens on schedule: an unplanned visit, a repeat draw, a safety visit. “Unscheduled” does not mean “outside the structure” — the forms allowed for it are declared in the design in advance.

1. In the casebook click + Unscheduled visit.

2. Choose the visit definition (an unscheduled/common event) and specify the visit date.

3. The unscheduled visit is woven into the matrix by its actual date with a ⚑ mark and numbering within the subject.

If the design has no available unscheduled or common events, the system will say so directly: scheduled visits are created automatically, and only unscheduled and common ones are created by hand.

Repeating (log) forms

Some forms are repeating by nature: adverse events (AE), concomitant therapy (ConMeds). There can be several instances of them for a single visit.

• In the matrix such a form is collapsed with a counter, for example (3) — three instances.
• The + instance button creates another record of this log form in the visit.
• Each instance is a standalone record with its own status, queries and history.

The visit date and missed windows

A visit has a window per protocol. The calendar icon in the cell lets you record the visit date. A visit’s status can be “planned”, “occurred” or “missed”.

A date out of the window is recorded as a deviation

If the recorded date falls outside the visit window (or you edit an already-saved date), the system will ask for a reason, and the deviation is captured in the audit trail.

If the subject remains on an outdated design version (after an amendment), the casebook will show a “version outdated” mark — moving to the new version is done via the “Amendments” page.

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

Reason for Change (RfC)Editing a saved value and its consequences for SDV and the signature.

Status lifecyclesAll the form, subject and data status axes in one place.