Using Empty SDV Plans

RDC allows you to publish a patient SDV plan without a critical forms SDV plan, and the other way around. This might produce unintended consequences that you can avoid by using empty SDV plans. An empty patient SDV plan is one in which both the initial patient count and the auto-select rate are zero and no individual patients are manually selected or imported. An empty critical forms SDV plan is one in which no forms are selected.

Consider using empty SDV plans in the following circumstances:

• If you want to be explicit about not having SDV requirements, you can publish a blank patient SDV plan, a blank critical forms SDV plan, or both. Publishing empty plans ensures that search is available in the RDC search pane and that the appropriate review data is displayed in the Single Patient Casebook Page, even if these values are zero.
• If you do not require 100% patient SDV and do not have a patient SDV plan, but want to exclude batch-loaded or non-migrated CRFs from the critical forms SDV plan, you can create an empty patient plan to set the CRF exclusion options. See Review Exclusion Options for details.
• If no patients require 100% SDV, but critical forms do require SDV across all patients, publish an empty patient plan to maintain consistency in the RDC search pane from one site to the next. Otherwise, the option to search for Patients requiring 100% SDV is not available for the site, but is available for other sites where a patient plan is published.
• If none of your sites require a selection of patients for 100% SDV, you can publish a critical forms SDV plan for each site with no accompanying patient SDV plan. This means that no patients require 100% SDV at any site, and RDC users will not have the option to search for Patients requiring 100% SDV at any site.