Published, Draft, and Obsolete SDV Plan Versions

The Source Data Verification Plan tab includes four links to view the published and draft versions of both patient and forms SDV plans. A fifth link provides access to all obsolete plan versions. A link is inactive if your site doesn't have that type of SDV plan. For example, if you don't have any draft patient plans for the current study site, the Patient Plan: Draft link is inactive.

Below are common workflows that include descriptions of how the links become active and inactive in the course of creating and updating SDV plan versions.

• Updating a Published SDV Plan
  
• Creating a New SDV Plan
  

Updating a Published SDV Plan

Published plans cannot be updated directly. In order to make changes to a published SDV plan, you must first create a draft copy of the current plan, make your changes in the draft version, then publish the new version.

Note:

You may want to make changes soon after the initial SDV plans are published using the Oracle Clinical option to Publish SDV Plans for all Sites. In this case, when you select the Source Data Verification Plan tab in RDC, links for the published versions of both the patient and critical forms plan are enabled. The Draft plan links are disabled.

Follow these steps to update a published SDV plan:

1. Open the published patient or critical forms plan you want to update.
2. Click on Create a New Version to create a draft version of the plan.

   A copy of the published plan is created with an incremented version number.

   RDC navigates to the Draft plan page so that you can edit the draft copy.

   The published plan version remains in effect while you work on the draft version. At this point, both the Published and Draft links for the plan are enabled.

3. In the draft version, make the required updates. You can save the draft version without having to publish it.
4. When you are satisfied with your updates, select the Publish option from the Actions drop-down.
   With publication, the Draft plan link is disabled, and RDC navigates back to the Published plan page where the newly published plan version is displayed. The previously published version of the plan is automatically obsoleted and can be viewed in the Obsolete Plans page.

Creating a New SDV Plan

You may want to create and publish SDV plans for each study site individually, instead of using the Oracle Clinical option to Publish SDV Plans for all Sites. In this case, when you first select the Source Data Verification Plan tab in RDC, the Draft plan links for both Patient and Critical Forms plans are enabled, and the Published and Obsolete plan links are disabled.

Follow these steps to create and publish a new SDV plan:

1. Select the Draft link for either the patient or critical forms plan.
   At this point, the upper right corner of the page displays either No Patient SDV Plan created or No Forms SDV Plan created, depending on the page you have selected. The Draft Patient Plan page shows the default values that have been specified for the study in Oracle Clinical: Number of initial patients, Patient auto-select rate, Exclude batch-loaded CRFs?, and Exclude non-migrated CRFs?. The Draft Critical Forms Plan page identifies the CRFs that were identified in Oracle Clinical as critical for the study.
2. You can save the plan in its current state with the default values in place, override default selections, or make additional selections.
3. When you are satisfied with your plan, select the Publish option from the Actions drop-down.
   With publication, the Draft plan link becomes disabled, and RDC navigates to the Published plan page, where the newly published plan version 1 is displayed.