Source Data Verification (SDV)

Source Data Verification (SDV) is the checking of entered data against the site’s source documentation. It is one of a monitor’s (CRA) key tasks. In X7 Insight, SDV is a status axis of a specific value rather than a separate entity, so verification is always tied precisely to what was checked.

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SDV Workbench: the Pending queue, checking a value against the source, and marking it verified — all audited

SDV status axis

Mark	Meaning
not required	The field is not in the SDV scope
awaiting	Requires checking against source data
verified	The value has been verified against the source

1. not requiredfield in SDV scope
2. awaitingverified against source
3. verified
   • value editawaiting

A value's SDV axis. Editing a verified value synchronously resets it back to “awaiting”.

SDV Workbench

The SDV Workbench is the monitor’s workspace: a selection of fields awaiting verification, with filters by site, visit, and form. Two tabs:

• Awaiting — the queue of fields with status awaiting;
• Verified (this session) — what you marked in the current browser session (the list survives a page refresh). The full verification history is in the audit trail and on the form pages.

The table shows the subject, visit, form, field, value, and time of last update.

1. Open the SDV Workbench and the Awaiting tab.

2. Verify the field’s value against the site’s source document.

3. Click Verify — the field moves awaiting →

   verified.

4. If the value differs from the source — instead of verifying, open a query; the field stays in the “awaiting” status.

You can also verify inside the form: the field has an “SDV ✓” action (verify against source data). Verification is unavailable for an empty field — there is nothing to check there.

Un-verification

If a mark was set by mistake, the monitor can remove it: the “Unverify” action returns the field to awaiting. Un-verification requires a reason and is audited.

Bulk verification

When many fields of one form or selection are being verified, select them and click Verify selected. Each field is verified and audited individually; in the end you will see “Verified N of M”.

Automatic reset on value edit

This is SDV’s most important property: verification does not survive a data change.

Editing a value removes verification

As soon as a coordinator changes a value previously marked as verified, the system synchronously returns it from verified to awaiting. The field resurfaces in the SDV Workbench for re-verification. This cannot be turned off: “verified” always means “this exact value has been verified”.

The coordinator sees this at the moment of the edit — the reason for change dialog explicitly warns that the SDV mark will be removed and the monitor will have to re-check the value.

Someone edits the field while you verify it

Verification checks a value’s version. If the value changed just before your mark, the system shows the new value and the verification is not applied — you only ever verify current data.

Risk-based SDV

Verifying 100% of fields by hand is expensive and not always necessary. The SDV scope is set by risk and comes from two sources:

• fields marked in the design as required for SDV;
• the targeted-SDV plan — a percentage of forms/sites configured at the study level.

Hence three typical modes:

Mode	What is checked
Full	All data is verified against the source
Targeted	A set percentage/subset per the plan
Selective / none	Only critical fields or no positional verification

If the plan is tightened (the percentage is raised), previously not-required fields move from “not required” to “awaiting”; already-verified fields are left untouched. A plan change is recorded as a configuration change.

SDV and locks

• Under a soft lock, SDV verification is allowed: the lock freezes values, and verification does not change values.
• Under a hard lock, SDV is forbidden, like any change to the data axes — this is the final state before export.

SDV progress by site and study is visible in reports: “Verified X of Y, awaiting Z”.

QueriesOpen a query when a value differs from the source.

Reason for change (RfC)Why editing a value resets the SDV verification.

Signatures, locks, exportHow soft and hard locks affect the ability to verify.

Status lifecyclesThe SDV axis and its reactions to data changes.