Create a source data verification strategy and assign it to a site

Your source data verification strategy ensures that partial source data verification is performed for a specific number of subjects and for either all subjects or only critical questions in a study. Source data verification strategies must be associated with a site to become effective. This procedure also applies to rollover studies.

These steps are for Testing mode. Need to perform this task for a production study?

Want to see how to perform this task? Watch the video below.

  1. On the Home page, click the study settings button (settings button) on the study you want to edit, and select Open Settings.
  2. Below the study name, click the Source Data Verification tab.
  3. Along the top, make sure Testing Settings is selected.
  4. On the right, click Create SDV Strategy.
  5. On the Create Source Data Verification Strategy dialog, fill in the following fields and click Create.
    • SDV Strategy Title: Enter the name of the source data verification strategy. If you create multiple source data verification strategies, consider using names that will indicate the type of SDV performed for each strategy.
    • Initial Subjects: Enter a number of initial subjects that Clinical Research Associates (CRAs) should verify. For example, enter 5 if you only want a CRA to verify the data collected from the first 5 enrolled subjects at a site
    • Remaining Subjects: Enter the percentage of remaining subjects that Clinical Research Associates (CRAs) should verify at a site. For example, enter a percentage of 10% of randomly selected subjects at a site whose data must be verified by a CRA. For more details on how subjects are randomly selected for verification in the system, see How are subjects randomly selected for targeted source data verification?
    • SDV Type: Select 100% SDV if a CRA should perform source data verification on all completed questions, forms, and visits of all the subjects specified in the Subject Count column, whether they are initial or remaining subjects at a site. Select SDV for All Subjects & Critical Variables if a CRA should perform source data verification only on questions marked as SDV for all Subjects and Critical Variables (Targeted SDV) by a study designer.
  6. Associate a source data verification strategy with a site:
    1. On the Sites & Labs tab, on the left, select Testing.
    2. From the SDV Strategy drop-down for each site, select a source data verification strategy.
    3. In the upper right, click Apply Changes.
Tips:
  • Click the Edit icon (The edit icon is a pencil) next to a source data verification strategy to edit it.