13 Using Source Data Verification

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.

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.

3. • 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.

4. In the draft version, make the required updates. You can save the draft version without having to publish it.

5. 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.

Patient Plan Draft

You use the draft patient plan page to create the initial patient SDV plan for a site or to make changes to the published plan version. You can perform the following actions in a draft patient SDV plan:

• Change the initial patient count and the auto-selection rate, or both — If no patients require 100% SDV for this site, set both the auto-select rate and initial number of patients selected to 0. This is an empty plan. See "Using Empty SDV Plans" for more details.

• Choose between CRF options — You can exclude batch-loaded or non-migrated CRFs from the SDV requirement even for patients requiring 100% SDV.

• Patient selection actions — You can manually select patients for SDV using the Patient Selection table. To do so, first select a patient by clicking anywhere in the patient row. You can use Shift+click or Ctrl+click to select multiple patient rows. Then choose Select from the Actions drop-down list for this table. Your selection, if valid, is saved in the Pending Action column for each patient affected. If the action was not valid for one or more patients, you are notified to go to the action log to view the error message(s). Other actions are available and valid for a selected patient as follows:

  • Select is valid for any patient with a selection status of null or excluded.

  • Exclude is valid for a patient having any status except excluded.

  • Undo select is valid for a manually selected or imported patient.

  • Undo exclude is valid for an excluded patient.

  Other patient selection actions are also available. The Clear Pending action can be used to undo a previous action. This has an effect only for patients which have a value in the Pending Action column. View Action Log allows you to view any errors resulting from the last action.

• Plan actions — You can validate the changes and publish the plan after changing the plan parameters using the Validate and Publish actions, respectively. If the validation returns error messages, they are added to the Validation log. You can view the log by selecting View Validation Log. When you publish the plan without getting any errors, the Published plan page comes into focus.

  In addition to the Refresh, Save and Cancel actions, if you have the ADMIN_SDVPLAN privilege for the study or site, you can also Unlock an SDV plan. This situation can occur if several users simultaneously open a Draft plan for update.

• Review current patient SDV status — In the Patient Selection table, the columns Selection Status, SDV Eligibility, Proc Vers, and Active SDV? all provide you with information about the current SDV status of each patient.

  The Selection Status column can contain any of the values listed below:

• • null — The patient is not selected for 100% SDV.

  • Initial — The patient was auto-selected for SDV as one of the first n patients to become SDV-eligible for this site, where n was specified in a published patient SDV plan.

  • Auto-Selected — The patient was auto-selected for SDV based on the auto-select rate specified in the published patient SDV plan.

  • Selected — You manually selected the patient for SDV using this page.

  • Imported — The patient was selected for SDV as part of a patient list imported using Oracle Clinical's Load Patient SDV Attributes job.

  • Excluded — You manually excluded the patient for SDV using this page.

  • Import Excluded — The patient was excluded from SDV as part of a patient list imported using Oracle Clinical's Load Patient SDV Attributes job.

  The SDV Eligibility column can be null, show an eligibility date, or specify failed plus the date when the patient became ineligible for SDV.

  The Active SDV? column can contain the following:

  • Active — The patient is both eligible and selected for SDV. These are the patients that are retrieved when an RDC user searches for patients requiring 100% SDV.

  • Not eligible yet — Indicates that the patient was manually selected or imported for SDV, but is not yet eligible for SDV. Patients with this status are not retrieved when an RDC user searches for patients requiring 100% SDV.

  • Failed eligibility — Indicates that the patient was manually selected or imported for SDV, but failed SDV eligibility. Patients with this status are not retrieved when an RDC user searches for patients requiring 100% SDV.

Patient Plan Published

The published version of the plan cannot be edited, so neither the Action drop-down list or Pending Action column are visible. You can press the Create a New Version button to copy the plan and create a draft version which you can edit. See "Updating a Published SDV Plan" for more information on how to do this. If you already have a draft version, you have the option to overwrite it.

Critical Forms Plan Draft

You use the draft critical forms plan page to create the initial forms SDV plan for a site or to make modifications to the current published plan version.

Select Critical Forms for SDV

You can select critical forms that require SDV across all patients for the site using the Form Selection table. First select a CRF by clicking anywhere in the CRF row, then Shift+click or Ctrl+click to select multiple CRF rows. Then choose Select (or Undo select) from the Actions drop-down list for this table. Your selection is saved in the Pending Action column for each CRF you selected. If you want to renounce the selection, use the Clear Pending action. This only affects CRFs with a value in the Pending Action column.

Description of the illustration ''cfdr_sdvplan.gif''

Critical Forms Plan Published

In the published version of the critical forms plan, the Action drop-down list and Pending Action column are not available because this is a read-only version. You can press the Create a New Version button to copy the plan and create a draft version which you can edit. See "Updating a Published SDV Plan" for more information. If you already have a draft version, you have the option to overwrite it.