Track monitoring progress

The Monitoring screen is one summary of study progress: enrollment, data entry, queries, SDV progress, signature coverage, locks, a table by site and audit trail review. It shows which site is falling behind and where to go to work.

Who and when

Monitor Data manager — and the auditor: they see the Monitoring menu item. A site row is shown when you may read that site’s data (data.read); the Audit trail column — with the audit trail read permission (audit.read); recording a trail review takes the “document audit trail review” permission (audit.review); exporting the verification report takes the export permission (export.run).

Look at the summary before and after a monitoring visit, when preparing a report for the sponsor, and regularly — so the audit trail review does not pile up.

Before you start

• You hold a role on the study or on the sites you need.
• Keep in mind: counts cover only the data you can access; zero does not prove there are no issues outside your permissions.

Steps

1. Open Monitoring in the study menu. Above the summary you see when the data was computed (“Data as of …”).

2. Look over the study total tiles — they lead into the working screens: the subject matrix, queries and SDV.

3. In the Summary by site table, find sites that fall behind: unclosed and overdue queries, fields awaiting SDV, medical review and coding. What each column counts is under Summary columns.

4. Follow a number into its worklist and work it through: queries, SDV.

Export the verification report

Verification progress by site and form is available as a file, without entering the SDV queue.

1. Open the Export menu in the screen header.

2. Choose SDV report — XLSX or SDV report — PDF — the report for the whole study. To narrow it, choose SDV report with filters…, set the Site, Verification status and Form, and export the file.

3. Wait for the document to be prepared — the file downloads.

Record an audit trail review

1. In the Audit trail column of the site (or in the Study row — events without a site), click the “Not reviewed: N” link.

2. The audit trail opens on exactly the events the review will confirm. Review them under your SOP. It usually pays to start with the ones listed under the link (“Including: …”): cleared values, signatures invalidated by an edit, lock releases, emergency code breaks.

3. Return to Monitoring and click Record review. Enter the outcome and a reference to the SOP check (the reason is required) and confirm.

What happens

• Viewing the summary changes no data and does not assess risk.
• A verification report export lands in the Exports journal with its checksum; every download is recorded in the audit trail.
• The trail review is written to the audit trail (“Review recorded in the audit trail”): the reviewer, time, reason and the reviewed boundary. The cell shows “Reviewed: …” with the date; events arriving later remain unreviewed.

If it doesn’t work

• No Monitoring item — the item is shown with any one of data.sdv.verify, audit.review, audit.verify, lock.apply.soft or lock.apply.hard. Your role holds none of them.
• “No sites with data you can access” or a site row is missing — you lack the right to read that site’s data.
• No Audit trail column — you do not hold audit.read.
• No Record review button — you do not hold audit.review, or you cannot see every event of the area: if part of a site’s trail is closed to you, the site cannot be confirmed as a whole.
• No Export menu — you do not hold export.run.

Next

Manage queriesQuery age and SLA, the worklist and bulk actions.

Verify source data (SDV)The verification queue against the site's source documents.

Audit trailWhat the trail records and how to read “before → after” entries.

More detail

What the screen shows and what it doesn’t do

The screen changes no data and does not assess risk: there are no KRIs, QTL thresholds or automatic site ratings. The former Reports address leads here.

Summary columns

Each column of the “Summary by site” table uses the same formula as the queue of that work:

Column	What is counted
Subjects	Subjects of the site
Forms complete	Completed forms out of all created
Unclosed queries	Open and answered queries; how many of them are overdue
Awaiting SDV	SDV plan fields not yet verified
Awaiting medical review	Filled fields without medical review (blinded ones excluded)
Uncoded	Terms awaiting coding

Query aging breaks unclosed queries down into buckets of days since opening:

Bucket	Query age
0–3	Opened 0–3 days ago
4–7	Opened 4–7 days ago
8–14	Opened 8–14 days ago
15+	Opened 15 days ago or longer

Verification report

The server builds the document: the XLSX with a first “About this export” sheet (filters, who built it and when), a site × form summary and a field register with who verified each field and when — printing pre-configured (landscape, the header repeats); the PDF — a printable copy for a visit. The same report can be exported from the SDV queue.

Audit trail review

Trail review is a process separate from data cleaning: the mark records that the area’s new events have been reviewed. A separate Study row covers events without a site: design versions, access, exports.

The “Not reviewed: N” link opens the area’s events after the previous review up to the latest event inclusive — exactly what the mark will confirm. The reviewer, time, reason and the reviewed boundary are retained; later events remain unreviewed. A review mark is not a signature of clinical data and does not replace the SOP check.

Review marks recorded before this screen

Earlier audit review marks (before the screens were merged) covered site events only: study-level events without a site were not included, and the link to view the events did not work. Those marks remain in the immutable trail as they are; study-level events are reviewed afresh in the “Study” row.