What this is, and who it is for
A form of a visit is filled in on the participant's form screen. This page is how entering works: the controls, what the checks do as you type and when you save, how to leave a comment, and the one rule people ask about most: once a form is saved, its values can be changed only through a query. Changing a saved value is Correct data.
| You need | To |
|---|---|
form.write (site coordinator, principal investigator) | Enter and save a form |
form.write_dispensing (pharmacist) | Enter dispensing forms only |
form.read | Read forms |
Held by: Principal Investigator, Clinical Research Coordinator (form.write).
Held by: Pharmacy (form.write_dispensing).
Data entry belongs to the people at a site: no study-team role (not the Data Manager, the Medical Officer, the Clinical Research Associate) can enter or change a site's data. The Pharmacy role writes only forms whose CDISC domain is EX or CM.
Where to find it
A participant's page → the visit → Open on a form (or Record event here for an event form). The screen has a header (the participant, the visit and how it was held, the form and its version) and, when the participant is not in a state that takes data, a notice saying why.
What you can do
Fill in the form
- Each field shows its label, a required mark (*), its help text and unit, and the controls of its type (Field types). A calculated field is tagged Calculated and cannot be typed; a field set by a rule is tagged Auto-assigned.
- Fields that depend on others appear and disappear as you answer; a hidden field is greyed with its message and is neither checked nor required.
- Comments: where a field allows them, the comment icon opens a box (up to 500 characters) kept with the value.
- Raise a query on a field with the flag icon, and read or answer queries on it (Work with queries).
- A message under a field tells you when a value fails a check, in red for a check that blocks and amber for one that only asks.
- Saves the whole form: the checks of the design run and every changed value is audited.
Submit
The one button, Submit form, saves the form and marks it complete. If a required field is empty the screen lists the problems and nothing is saved; if a check set to Block fails, the server refuses and each field is named under the form.
When the save succeeds a toast says Saved {form} for {participant}. If a check set to Warn fired, it says Saved — with warnings and the message stays under the form. A save that fails a check set to Query still succeeds, and the auto-query appears on the field.
Until you submit, what you typed is not saved: the rail marks the form Unsaved — saved on Submit, and leaving asks you first.
If someone else saved while you were editing
A dialog says This record changed while you were editing and lists Changed by someone else, already updated for you and Your changes that nobody else touched. Choose Keep editing, or Review and save; for a value you both changed, Keep mine or Keep current. Keeping a value that replaces an earlier one asks for a reason on the next step.
Every option
What is open to change after a save
Once a record is saved, every value in it is read-only except:
- a field nobody has entered yet (filling it is a first entry);
- a field with a live query (open, answered, reopened or escalated) that somebody else raised, or that the edit-check engine raised. A query you raised yourself never lets you change the value, because you could flag your own entry, change it and close it.
Changing a saved value asks for a reason for change (Correct data). After the form is signed and locked its values are read-only in the same way, and changing one withdraws the signature (Sign records).
Participants who no longer take data
For a participant who is completed, withdrawn or lost to follow-up, the screen says Data capture is not allowed for a {status} subject. A saved value of the record can be corrected only by answering a query on it. A correction through a live query is the only way.
Event forms
An adverse event, serious adverse event or medication is entered on its own form, not on a visit (Record an adverse event).
Where the checks run
The browser checks as you type (required, limits, pattern, dates, normal range) and the server checks again at save, including formats, code lists and file type, recalculates calculated fields and decides the outcome of every check. Value assignment and auto-populate are applied in the browser only (Conditional logic). See Validation, edit checks and their severities.
- The field says how many decimals it takes.
What the system records
Every value entered is an item with its field's variable, the person, the time and the form version; every change keeps the earlier value with the reason (form.field_entered, form.field_modified), each completion is record.completed, and calculated values the server replaced are form.derived_value_overridden. See Audit events.
What you cannot do, and why
- Change a saved value without a query. The rule exists so that a correction is always asked for and answered.
- Enter as a study-team role, or enter forms the Pharmacy role may not.
- Save a form with a required field empty (the Submit button marks it complete).
- Enter for a participant at another site, or for a Live participant from the UAT workspace.
- Enter in a study that is Locked or Archived, or after Completed except through a query.
Compliance Q&A
Yes. Each value is stored with who entered it and when; a later change adds a new value with a reason and keeps the earlier one; and a saved value can change only where a query raised by someone else authorizes it.
Evidence: server/src/modules/study/data-capture (field-level audit in the same transactionreason for changequery-authorized corrections)client correction-gate.ts
Yes. The server runs the field checks on every save and decides what blocks, warns or opens a query, whatever program saved. See Validation, edit checks and their severities.
Evidence: server data-capture validation-engine.tssave-responses.ts
Related
Run a visit · Correct data · Work with queries · Sign records · Validation, edit checks and their severities