If your study uses targeted Source Data Verification (SDV), the SDV strategy ensures that SDV is performed for a specific number of subjects and for either all questions or only critical questions in a study. Any SDV strategy must be associated with a site to become effective.

1. Open the study settings.
2. Below the study name, click the Source Data Verification tab.
3. On the right side pane, click Create SDV Strategy.
4. On the Create Source Data Verification Strategy dialog, fill in the following fields and select Create.

   Field	Description
   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 the total amount of initial subjects that Clinical Research Associates (CRAs) should verify for a site. For example, enter 5 if you want a CRA to verify the data collected for the first 5 added or enrolled subjects at a site. Note: Depending on whether screen failed subjects are included or not (as per the study's general SDV settings), initial subjects are selected differently. When the Include Screen Failures setting is set to Yes, the SDV pool considers subjects for data verification as soon as they have been added to the site. When the Include Screen Failures setting is set to No, the SDV subject pool doesn't consider subjects for data verification until their status is Enrolled or Randomized. Subjects are evaluated in the order that they are added to a site and a subject is not skipped for data verification unless it gets a status of Screen Failed, even if a subject added later is enrolled first.
   Remaining Subjects	Enter the percentage of remaining subjects that CRAs should verify at a site. These are randomly selected after the number of initial subjects is reached and until the specified percentage is reached. The system continuously adjusts to match and maintain the percentage of selected subjects as the total number of subjects increases. For example, enter 10 to randomly select 10% of the remaining subjects at a site (after the initial subjects selection) whose data must be verified by a CRA. Note: Depending on whether screen failed subjects are included or not (as per the study's general SDV settings), the total count of subjects, used to calculate the percentage of remaining subjects to be selected, may be different. When the Include Screen Failures setting is set to Yes screen failed subjects are considered in the total subject count. When the Include Screen Failures setting is set to No, newly added subjects, screen failed subjects, and subjects whose screening is in progress are excluded from the total count of subjects. For more details on how subjects are randomly selected for verification in the system, see How are subjects selected for targeted source data verification?
   SDV Type	For each set of subjects (initial and remaining subjects), you must specify the SDV type: Select 100% SDV if a CRA should perform SDV on all questions in started forms and visits of all the selected subjects, whether they are initial or remaining subjects at a site. Select SDV for All Subjects & Critical Variables if a CRA should perform SDV only on questions marked as SDV for all Subjects and Critical Variables (Targeted SDV) by a study designer. Work with your study designer and refer to Configure source data verification settings for a question.

5. Associate a source data verification strategy with a site:
   1. Navigate to the Sites & Labs tab.
   2. On the top left, select a specific mode:
      • Production Sites
      • Testing Sites
      • Training Sites
   3. From the SDV Strategy drop-down for each site, select a source data verification strategy.
   4. In the upper right, click Apply Changes.

Make sure you create SDV strategies and assign them to sites for other modes in your study, as applicable.

Tip:

Click the Edit icon () next to an SDV strategy to edit it.