Status lifecycles and axes

In X7 Insight, a single record has several independent axes of status at once — they do not merge into one “overall status” but are shown as separate badges. Below is a cheat sheet for all axes and lifecycles: their states and the transitions between them, in plain language.

How to read the transitions

The notation “A → B” means “from state A you can move to B.” In parentheses is what that requires (a permission and, where needed, a reason). Many reverse transitions are made by the system automatically — for example, editing data resets SDV and breaks the signature.

Field: completion

What happens to a single value as it is entered.

Status	Meaning
Empty	the value has not been entered yet
Entered	the value has been entered
Not done	the procedure/measurement was deliberately not performed (with a reason)
Unavailable	the value cannot be obtained — lost or unavailable (with a reason)

Transitions: empty → entered (initial entry, no reason needed); entered → entered (edit, an RfC reason is required); entered → empty (clearing; the value remains in the audit). “Not done” is not “empty”: a “required” rule should not fire on a deliberate “not done.”

Field: source data verification (SDV)

Reconciliation of data against source documents (the monitor’s (CRA) workspace).

Status	Meaning
not required	the field is not in the SDV sample
pending	awaiting the monitor’s check
verified	the monitor has checked it against source

Transitions: pending → verified (the monitor has checked); verified → pending automatically if the data changed after the check; verified → pending manually if the monitor removed the mark (with a reason). See Monitoring & cleaning.

Field: medical review

Status	Meaning
not reviewed	awaiting the medical monitor
reviewed	review completed
reviewed with a flag	review completed, a flag was left

Editing data after review automatically returns the field to “not reviewed” (re-review).

Field: coding

Status	Meaning
not applicable	not_applicable: the field is not subject to coding
awaiting code	uncoded: the term awaits medical coding — holds database lock
Coded	coded: the term has been coded

Editing the value after coding automatically returns the field to “awaiting code”. The assigned code itself (MedDRA, WHODrug) lives with the coding module — the core keeps the axis and a reference to the coding act in the audit trail. See Coding.

Field: computed axes

These axes are not stored on the value but computed from related objects:

• Signature — Signed / Not signed: whether a valid signature covering the value exists.
• Lock — Locked / Not locked: whether an active lock exists on the path.
• Queries — whether there are open queries on this value.

Form: entry status

Status	Meaning
Not started	no value has been entered yet
In progress	some values are entered, but it is not complete
Complete	marked complete (required fields are not empty)

The first value automatically moves the form to “in progress.” “Complete” is set manually (the form.mark_complete permission). Editing data after completion automatically returns the form to “in progress” — and, if the form was signed, breaks the signature.

Subject

The subject state machine is configured at the design-version level; the platform default is:

Status	Meaning
Screening	checking inclusion criteria
Screen failed	did not meet the criteria (terminal)
Enrolled	enrolled in the study, visits per protocol
Randomized	assigned to a treatment arm (usually done by the RTSM module)
Completed	completed per protocol (terminal)
Withdrawn	withdrew consent / dropped out (terminal, with a reason)
Lost to follow-up	contact lost (terminal, with a reason)

A “terminal” status does not forbid data entry — forbidding entry is a separate axis (the lock).

Visit (study event)

Status	Meaning
planned	planned: the date has not been recorded yet
occurred	occurred: the date (and moment, if needed) recorded
missed	missed: the window closed without a date, or marked manually

A missed visit is reversible: a late date entry moves it to “occurred” (out of window — with a reason). See Casebook and visits.

Study

The status axis for the whole study. It is created as a draft and is not active until it is explicitly moved forward.

Status	Meaning
Draft	design assembly; no subjects and no data entry
UAT	a run on test data; test subjects do not appear in production exports
Active	production enrollment and entry; test subjects do not exist
Enrollment closed	no new subjects may be enrolled; visits and entry continue
Closed	collection finished; final cleaning before the lock is underway
Archived	terminal; all mutations are forbidden (after hard lock)

Moving to “active” and go-live require gates (a published version, an active site, no test subjects) and a deliberate reason. Archiving happens only through the database close-out procedure (F10), not by an ordinary transition.

Design version (StudyVersion)

Status	Meaning
Draft	being edited; definitions can be changed only here
In review	submitted for review
Approved	approved (the approver ≠ the author of the edits — an SoD rule)
Published	in effect; for a multilingual design, translations of the declared languages are approved
Superseded	automatically, when the next version is published
Retired	withdrawn from any non-published stage

A published version is immutable. Data does not migrate on its own — only through an explicit migration operation. See Study design.

Query

Status	Meaning
Open	the question has been raised, awaiting an answer
Answered	the query has been answered
Closed	the question is resolved
Reopened	a closed query was reopened (with a reason)
Cancelled	the query was cancelled (with a reason)

Transitions: open → answered → closed (accepted) or reopened (the answer was rejected, with a reason). An auto-query from an edit check closes itself when the data is corrected. See Monitoring & cleaning.

Signature

Status	Meaning
Signed (valid)	a valid signature over a snapshot of the data
Invalidated (invalidated)	the signature was broken: a covered value was changed

Invalidation is terminal and cannot be turned off. Re-signing is a new record; the old one remains in the history. See Electronic signatures.

Lock

Status	Meaning
Soft lock	active: warns and holds back changes
Hard lock	active: a full prohibition on changes
Released	the lock has been released (the lock.release permission + a reason)

Writing into a locked scope is impossible. The database close-out procedure follows a chain: study “Closed” → pre-lock report → soft lock → tidying up loose ends → hard lock → export snapshot → “Archived.” See Signatures, locks, export.

What happens when data is edited (the order)

Changing a value triggers a fixed chain of reactions: rejection if there is an active lock → a required reason (RfC) → a blocking edit check → resetting SDV to “pending” → resetting medical review to “not reviewed” → returning the form to “in progress” → invalidating the covering signatures → auto-queries → a record in the audit trail. All of this is captured in the audit.

GlossaryThe terms behind the statuses.

Permission catalogWhich permissions the transitions require.

Audit trailWhere all transitions are recorded.

Electronic signaturesMore on the signature status and invalidation.