Publish Source Data Verification Plans for All Sites

After you have made default selections for partial source data verification, you can use this job to simultaneously create and publish SDV plans for each site in the study based on those default values.

To run the job, select Conduct, then select Security, and then select Publish SDV for all sites. Click Submit.

Default settings for the patient SDV plan are set in the DCI Form Local Study Settings window. DCIs are marked as critical for SDV in the Study DCI window. For more information see Setting Up Partial Source Data Verification.

You can then modify the plan for each site as necessary using the SDV Plans tab in RDC. Alternatively, you can create and publish an SDV plan for each site individually in RDC, as described in the Oracle Clinical Remote Data Capture User's Guide.

The log file for this job includes warning, error, or success messages for each site in the study.

If the job returns an error, it does not generate a plan. Error conditions include:

• No SDV defaults have been specified, that is, patient auto-select rate = 0%, SDV Initial patients = 0, and no active, critical DCIs have been selected.
• The site already has a draft or published SDV plan. This utility is intended only for initial creation of SDV plans for all sites. It cannot be used to make updates to existing plans.
• Critical DCIs are specified at the study level, but one or more of the selected DCIs are provisional. (No critical forms SDV plan is generated, but a patient plan may be generated.)

If the job returns a warning, it generates a plan anyway. Warning conditions include:

• The patient automatic selection rate and initial patients are both 0, though Critical DCIs are specified. An empty patient SDV plan is created for each site to indicate that no patients require 100% SDV.

  Having an empty patient SDV plan for a site means that a user with some type of verify privileges in RDC will be able to search for patients requiring 100% SDV. This results in a consistent user interface across all sites, even if some sites have some patients requiring 100% SDV and other sites have none.

• No Critical DCIs have been selected, though Patient auto-select rate and/or Initial patients are non-zero. A critical forms SDV plan is created for each site with no forms specified, meaning no forms require SDV across all patients.

  Note:

  Creating empty plans under these Warning conditions produce different system behavior than having no critical forms or patient SDV Plan at all. The absence of a critical forms SDV plan for a study site means that all CRFs require SDV. If you create a patient SDV plan for a site without an accompanying forms plan the patient SDV plan loses its meaning. For a site like this, if an RDC user searches for all patients requiring 100% SDV, the patients are retrieved as expected. However, if the RDC user searches for all CRFs requiring SDV, all CRFs for all patients will be retrieved. Having an empty critical forms SDV plan to accompany the patient plan ensures that a search for CRFs requiring SDV will retrieve only CRFs for patients requiring 100% SDV.

  Conversely, if a critical forms SDV plan is specified with no accompanying patient plan, results will be correct for both searches: no patients require 100% SDV, but the specified forms require SDV for all patients. Without a patients SDV plan in place for a site, an RDC user is simply prevented from searching for patients requiring 100% SDV.