Monitor and verify data

What this is, and who it is for#

Source data verification (SDV) is a monitor's independent statement that a value in the system matches the site's source document. Trialion is risk-based: the study decides in a plan which forms and fields must be verified, not every value. A verification is evidence, so it names the exact value that was looked at; if that value is later changed, the verification no longer stands and the datapoint must be verified again.

Held by: Clinical Research Associate (sdv.perform).

Held by: Organization Admin, Project Manager, Data Manager (sdv.configure).

Monitoring in the wider sense (reading data, raising queries, looking at the figures) belongs to several roles; this page covers verification, and Work with queries and Use the reports and the dashboard cover the rest.

Where to find it#

Inside a workspace (UAT and Live have their own plans): SDV Plan (what must be verified) and SDV Monitoring (what needs attention). On a participant's form, a Source verification section beside each plan-required field.

What you can do#

Set the plan#

On SDV Plan (Risk-based source-data-verification targeting. Choose which forms and fields a monitor must verify against source — focus on critical safety & efficacy data rather than 100% SDV.): for each active form, Require SDV for the form or for particular fields, optionally Critical; choose whether Requirements apply to All visits or one visit (Toggles below add requirements for this visit only). The page counts Forms targeted, Field rules and Visit-scoped. Requirements are retired, never deleted. The plan needs active forms (Source-verification targeting applies to Active forms).

In UAT the plan can be edited only while the study is in Setup; afterwards it is edited from Live, so a test cycle never changes what is verified in production. When an amendment goes Live the plan is carried to the new version's forms, fields and visits; a requirement that has no counterpart blocks the go-live and is listed (Sign off a version and go live).

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Find what needs attention#

SDV Monitoring (Source-data-verification coverage and the datapoints that need a monitor's attention now) shows Verified, Needs attention, Verified fields, Pending first verification, Need re-verify, Discrepancies and Requirements, and lists the datapoints: Captured, never source-verified, Changed since verified, Discrepancy. It says Nothing needs verification when all is done.

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1. The queue: what has never been verified, what changed after it was verified and what is discrepant.

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Verify#

1. Open the participant's form. Beside a plan-required field the Source verification control says The SDV plan requires this datapoint to be verified and Not yet source-verified.
2. Compare the value with the source document, and choose Verify. It is recorded with your name and the time, against the exact value you looked at.
3. If the value has changed since you opened the page, the dialog says This value changed since you opened it. Nothing was verified. and asks you to verify it as it reads now.
4. If it does not match, choose Log discrepancy and describe what doesn't match the source document. Then raise a query below to send the discrepancy to the site for correction (Work with queries).

After a correction the value is Stale (changed since verified) and is verified again.

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1. Records that the value matches the source document; it stores a hash of the value seen.
2. Records that it does not match.
3. Asks the site about the value.

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Event values#

The values of adverse events and medications are datapoints too; an event's page has its own Source verification card (Field, Value, Verify, Discrepancy, Verify again).

Every option#

Statuses of a datapoint#

The casebook shows the form's verification as none, partial, done or discrepancy.

Separation of duties#

The person who entered a value, or whose save derived it, cannot verify it, with any outcome: the screen says The person who entered a value cannot verify it; a change to a verified value makes it Changed until it is verified again, and the server and database refuse it (clinical.separation_of_duties).

What the system records#

sdv.verified, sdv.discrepancy, sdv.plan_updated, sdv.plan_retired, sdv.plan_carried, each with who and when. Verifications sit in an append-only ledger, each with a hash of the value verified, and are never edited. See Audit events.

What you cannot do, and why#

• Verify your own entry. Independence is the point.
• Verify a value that changed. The system records nothing and tells you.
• Edit a past verification. A new one is added.
• Use the field's own "SDV required" setting in the form builder to drive this. That setting is design information only; the plan on this page decides (Field properties).
• Do central or risk-indicator monitoring, or file a monitoring-visit report. Not built (Not built yet).

Compliance Q&A#

Related#

Work with queries · Use the reports and the dashboard · Close and lock a study · Clinical Research Associate · Site Monitor