6 Monitor Data

Monitors have read-only access to data. See Review and Manage Data for information on reviewing data using the Subject Matrix or Queries pages. This topic focuses on using the Source Data Verification page to review and verify data against source records.

To perform source data verification, from the Tasks menu, select Source Data Verification.

The Source Data Verification page displays. Only records that have been marked "complete" are listed.

You have options to show more columns (Show More), show more rows, or filter based on any column that includes a gray filter box below the column heading.

SDV requirements are defined for each form when the study was designed. If you are not sure what "Partial Required" means for your study, refer to your study's Monitoring Plan.

To perform Source Data Verification

  1. Click on the view icon in the CRF Status column to view the completed form.

  2. Compare the data entered in the form against the source record.
  3. If there are any discrepancies between the source record and the data on the form, click the query bubble for the item in question and create a query for the site to address.

  4. Complete the review of the data and close the form.
  5. To mark a form as source data verified, click the SDV icon in the Actions column.

    The SDV Status box changes to a double check, indicating that SDV is complete for that form.

If you inadvertently marked a record as source data verified, you can reset its status by clicking the double-check icon in the SDV status column. You are prompted to confirm resetting the status.

Alternatively, you can view each form and click the SDV Status checkbox to indicate review is complete. You can continue to view and check each form and, when finished, click the SDV All Checked button at the bottom of the SDV table.

 


Functional approval by Laura Keita (lkeita), Director of Training and Compliance. Signed on 2018-04-23 2:39PM

Approved for publication by Benjamin Baumann (bbaumann), Principal. Signed on 2018-05-07 10:47AM

Not valid unless obtained from the OpenClinica document management system on the day of use.