Workflow for defining SDV in your study

Depending on the level of SDV required in your study, the process to configure SDV may involve the following tasks:

SDV configuration for different use cases

When no SDV is required in a study

In some cases, your study may not require any level of SDV. For example, when you use Oracle Clinical One Platform primarily for randomization and trial supply management. In this use case, the study manager configures the study-level SDV settings to not allow SDV. Given that SDV is not allowed, any SDV strategy or question-level SDV settings are not applied, so you don't need to define them. As a result, the Clinical Research Associate (CRA) doesn't need to verify any data in the study.

Note:

When SDV is turned off in a study, the Verify Data button to perform SDV is not available, even if the user has the appropriate permissions to verify data.

SDV settings (in the SDV tab of the study settings)	SDV strategy	Question-level SDV settings (in form design)
Allow SDV in Study: No	Not required.	Not required.

When full SDV is required in a study

If your study requires verification of all data entered for all subjects, without exception, you need to configure a full SDV. To enable a full SDV, the study manager configures study-level SDV settings for it. In this use case, CRAs must verify all questions (that are not Read-only) for all subjects, so the study manager doesn't need to create any specific SDV strategies, nor is the study designer required to select any specific questions for data verification.

SDV settings (in the SDV tab of the study settings)	SDV strategy	Question-level SDV settings (in form design)
Allow SDV in Study: Yes Amount of SDV: 100% Include Screen Failures: Select Yes to consider screen failed subjects for data verification. Select No to make screen failed subjects to not require any data verification.	Not required.	Not required.

When targeted SDV is required in a study

If your study requires partial SDV, for a targeted amount of subjects or for specific questions only, you need to configure a targeted SDV. A targeted SDV involves the three tasks described in the workflow section: specify study-level settings for SDV, create an SDV strategy and assign it to a site, and configure question-level SDV settings.

1. The study manager must configure a Targeted SDV in the study-level SDV settings. Additionally, with the Include Screen Failures and the Allow SDV Overrides settings, you can control the SDV definition at a more granular level.
2. Next, study managers must define an SDV strategy and assign it to sites. This is required to determine the amount of subjects that will require verification and the amount of data that needs to be verified for the subjects that require SDV.

   The numbers set in the SDV strategy associated to a site define the targeted SDV subject pool, which consists of the selected subjects that will require verification for that site. For each set of subjects in the SDV strategy, you must specify the SDV type: whether they require verification for all data (100% SDV) or only for a specific set of questions (SDV for All Subjects & Critical Variables).

3. To complement SDV strategies, study designers can define question-level SDV settings in form design to mark specific questions for SDV. This is required if your SDV strategy uses the SDV for All Subjects & Critical Variables option, but you can also define questions that require verification for all subjects (even for those not selected for the targeted SDV subject pool), regardless of the SDV type used in the SDV strategy.

   Caution:

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

CRAs will then be required to verify the questions for the subjects according to these SDV settings.

• If 100% SDV is selected for any of the subject subsets in the SDV strategy (defined initial subjects or percentage of remaining subjects), CRAs must verify all answered questions for those subjects. Read-only questions are excluded.
• If SDV for All Subjects & Critical Variables is selected for any of the subject subsets in the SDV strategy (defined initial subjects or percentage of remaining subjects), CRAs must only verify the questions marked by study designers with the given toggles.
• For all remaining subjects that were not selected for SDV, CRAs must only verify the questions marked by study designers with the SDV for All Subjects toggle.
• Only if your study settings Allow SDV Overrides, will CRAs have the ability to also verify non-required questions. These include questions that were not marked with the SDV toggles by study designers, and questions for subjects that were not selected for the SDV subject pool, as per the SDV strategy (including screen failed subjects when excluded from SDV).

  Note:

  Questions set as critical variables in form design, are marked with a bullseye icon() for subjects not selected for the targeted SDV subject pool.

SDV settings (in the SDV tab of the study settings)	SDV strategy	Question-level SDV settings (in form design)
Allow SDV in Study: Yes Amount of SDV: Targeted SDV Include Screen Failures: Select Yes to consider screen failed subjects for data verification. Select No to exclude screen failed subjects from the targeted SDV subject pool. Allow SDV Overrides: Select Yes to allow CRAs to verify all data for all subjects. Select No to restrict CRAs to only verify SDV required questions.	Required. Refer to Create a source data verification strategy and assign it to a site to set up an SDV strategy that meets your study's needs. Besides creating the SDV strategy, you must assign it to sites for it to be applied.	If your SDV strategy uses SDV for All Subjects & Critical Variables, question-level SDV settings are required. You have the option to activate the following toggles for the questions that require SDV: SDV for All Subjects for questions that must be verified for all subjects (regardless of whether they were seleted for the targeted SDV subject pool). Critical Variables (Targeted SDV) for questions that must be verified only for the selected subjects as per the SDV strategy.