Configure source data verification settings for a question

If your study requires a targeted Source Data Verification (SDV) strategy, you must work with your study manager to configure these two settings for certain or all questions in the study.

To learn more about source data verification, see Understand source data verification.

Note:

In order for these question-level SDV settings to be applied, your study must be configured to have targeted SDV, create an SDV strategy and assign it to sites. Work with your study manager and refer to Specify settings for source data verification and Create a source data verification strategy and assign it to a site.

Caution:

Unblinded data may be inferred by blinded users during the verification process, even when a question is hidden. Take this into consideration when specifying the questions that require SDV.

To configure source data verification settings at a question level:

Access the Draft version of a study as described in Open a study's design.
Make sure you are on the Data Collection tab.
On your form, select a question.
On the right, expand the Details pane.
Turn on one or both of the following toggles ():
- SDV for All Subjects: To require CRAs to verify this question for all subjects in a study, regardless of the SDV settings and whether the subject is part of the targeted SDV subject pool or not. This also applies to screen failed subjects, even if they are excluded from SDV.
- Critical Variables (Targeted SDV): To mark the questions that CRAs are required to verify for studies with Targeted SDV when the SDV strategy is set as SDV for all subjects and critical variables. These questions only need to be verified for subjects in the targeted SDV subject pool, determined according to the SDV strategy, see How are subjects randomly selected for targeted source data verification?.
Figure 8-3 Source data verification (SDV) toggles

Related Topics

Parent topic: Question types and settings