Monitoring, SDV and the data manager's approval

SDV of every form or of critical fields only, the data manager's approval after SDV, the SDV and approval list, the monitor's routine.

Source data verification (SDV) means comparing the values in the forms with the source documents: the outpatient record, the medical history, laboratory reports. In YouEDC Capture the monitor verifies form by form.

The monitor’s routine

1. On the study overview, look at Verified (SDV) and at the sites table: which sites lag behind.
2. Open SDV and approval, tab Waiting for SDV: the complete forms of your sites that wait for you. You can also open a patient in Patients: forms marked Complete are waiting for SDV.
3. Open a form and compare the values with the source documents, critical fields first.
4. If a value does not match, raise a query on that field with an explanation (New query).
5. If everything matches, click Data verified: the form becomes SDV verified, with your name and the date.

Critical fields

In the eCRF builder a field can be marked as critical, for example the primary endpoint or a serious adverse event. In the form such fields have a red line on the left: verify them first.

Every form or critical fields only

On the SDV and approval page the project administrator chooses what the monitor verifies in this study:

• Every complete form (the default): the monitor compares every field of every complete form with the source documents. Any change of the data takes the SDV mark off.
• Critical fields only: only forms with critical fields need SDV, and only those fields. The SDV panel of the form lists them, and the button reads Critical fields verified. A change of another field keeps the SDV mark; a change of a critical field takes it off. A form without critical fields says that it needs no SDV.

ICH E6(R3) asks for monitoring in proportion to the risks: verifying the critical data rather than every value is the usual risk-based choice. Mark the critical fields in the eCRF builder before you switch to it.

SDV plan by visit and form

For partial SDV the project manager opens SDV and approval → SDV plan by visit and form: a table of the forms against the visits, and for each form at each visit one of three levels:

• 100% SDV: the page of every patient is verified (screening, eligibility, adverse events, the primary endpoint);
• Partial SDV: only the pages of the patients in the site's sample are verified;
• No SDV: a complete page counts as done.

Until someone edits the plan, every cell follows the choice above (every form, or the forms with critical fields), so a running study does not change. Every change of a cell and of the share is in the audit trail.

The sample. At each site the patients are taken in the order they were registered in the portal. With a share of P% the step is k = round(100 / P): the 1st patient of the site, then the (1 + k)-th, the (1 + 2k)-th and so on are in the sample (50% — patients 1, 3, 5…; 25% — 1, 5, 9…). The rule gives the same sample every time, and an auditor can check it by hand. When the monitoring plan of YouEDC Trials is on, the share of each site is the SDV share of its risk level (high, medium, low); otherwise the study's own share set under the table. The page lists the sample of each of your sites; a change of a site's risk can change its sample, and pages already verified stay verified.

The plan drives everything that counts SDV: the Waiting for SDV tab, the SDV panel of the form (it says whether the patient is in the sample), the visit states in the patient list and card (the card also shows Partial SDV: in the sample), the study overview, and the counts of YouEDC Trials (with partial SDV the pool of a site is its sample, so the monitoring plan expects all of it verified). Excel for the TMF downloads the plan and the sample of each site with the rule. A blinded reader does not see the forms for the unblinded team, and a site team member sees only their sites.

Data manager approval

After the SDV the data manager looks at the form once more: the values, the queries and the history. When the form is clean, they click Approve the data in the Data manager approval panel. A form can be approved when:

• it is complete;
• its SDV is done, when the form needs one;
• it has no open or answered queries.

Any change of the data withdraws the approval, and so does taking the SDV mark off. The audit trail keeps every approval and withdrawal with who, when and why. The data manager can also take an approval back by hand (Take the approval back). The investigator sees who approved the form. The project administrator can switch approval off for the study on the same page.

The SDV and approval list

The SDV and approval page lists the complete forms of your sites by what they wait for: Waiting for SDV (the monitors’ tab), Waiting for approval (the data managers’ tab) and Approved forms. A form held by queries says so: close the queries first. The study overview shows how many forms are approved, and before the database lock the forms not yet approved are counted as open work (see Closing a study).

Example from the demo

Igor Smirnov, monitor of REG-DIAB-01, opens the Month 3 Vital signs form of REGDIA-01-0004. The form is Complete; Systolic blood pressure is a critical field with a red line. The values match the outpatient record, so he clicks Data verified. On the study overview, Verified (SDV) shows the share of complete forms already verified: in the demo, 62 of 124.