Maintaining Clinical Study States

You can set or review several study-level settings that control data definition and collection in the Maintain Study States window. From the Conduct menu, select Security, then select Clinical Study States. These are the settings:

• Enable Data Entry? This box must be selected to enable data entry for the selected study.

• Allow 1st Pass from Login? Select this box to enable data entry operators to directly access the first-pass data entry window after completing a CRF's login information.

• Frozen? Indicates if the study is frozen at the data level. You perform this operation by running a batch job. (From the Conduct menu, select Security, then select Freeze Study.) This is a view-only field.

• Second Pass Required? Select this box to force a study to complete second-pass data entry to complete data collection.

• Enable CRF Page Tracking? Select this box to use Oracle Clinical's Page Tracking utility in a paper-based study. See Using CRF Page Tracking.

  You cannot select both Enable CRF Page Tracking? and Flex Study Enabled?.

• VB Enabled? Select this box to enable the Data Extract subsystem's View Builder utility. (See The View Builder's Structure.)

• DCI Forms Definition Enabled? Select this box to enable DCI Forms definition for the selected study in the Definition subsystem. (See Enabling DCI Forms.)

• DCI Forms Entry Enabled? Select this box to enable collecting data in RDC Onsite.

• Flex Study Enabled? Select this box if your study has an adaptive (or flexible) protocol. If you check this box, you can use the Enhanced DCI Books window to define rules that make specified CRFs and Intervals expected for a particular patient based on data collected for that patient at specified points in the trial. You cannot select both Enable CRF Page Tracking? and Flex Study Enabled?.

  You can change this setting for an existing study if no Test or Production data exists (test data can have been entered and then deleted). If you change a study from flexible to nonflexible, the system ignores any rules defined for its DCI Book and you can no longer see them because the rules button in the Maintain Enhanced DCI Book window is inactive.

  Note:

  The Enhanced DCI Books window includes Start Page renumbering, copying, and navigational enhancements that are helpful in any study. Studies with Enabled CRF Page Tracking? checked cannot use the Enhanced DCI Books window; they must use the original DCI Books window.

  Studies with neither Enable CRF Page Tracking? nor Flex Study Enabled? checked can use Enhanced DCI Books, but the rule definition required for a flexible protocol is available only for studies with Flex Study Enabled? checked. See Traditional and Enhanced DCI Books for further information.

• Key Template Specifies a key template for the Data Extract View Builder.

• Template Domain Specifies the Key Template's Domain.

• Surrogate Key Enabled? To use Data Reload from Oracle Health Sciences Life Sciences Data Hub for Data Extract views in Oracle Clinical, activate this setting. This setting is available only if View Builder is enabled for the study. The surrogate key adds a field to your views that is guaranteed to be unique across all RDCM repeats in a given view and which does not change with data updates. After activating this setting, the new surrogate key appears in Data Extract view after you regenerate them.

  Note:

  The new surrogate key does not appear in SAS views.

  Also the OC function vb.getViewColumnsTable, which returns the columns in a Data Extract view, does not return the surrogate key column (which includes the Y or N value for this setting) in order to avoid possible impact on activities that use the function with SAS views.

You can also set a number of default study-level data entry settings from the Maintain Study Configuration window. From the Maintain Study States window, choose Special, then select DE Config. local database. The database-level settings are in effect unless you change them here; explicitly defined study-level settings override local settings, and user-level settings override both study and local settings. For many of these options, you can choose to enable them, disable them, or leave them in a "Not Set" state. In the Not Set state, the settings at the local database override settings here at the study level. These settings include:

• Second Pass Comparison Failure Alert

• Manual Discrepancy in Browse

• Resolve Discrepancies in Data Entry

• Privileged Update

• List of Values for Thesaurus Questions

• Univariate Failure Alert

• Initiate DE Session Using DCI Book

• Unhonored Patient Alert

• Prevent Second-pass Entry by First-pass Operator

• Browse Accessible Data Only

• DCI and DCM Date Required

• Default Height for Data Entry Page in DCM (character-based system)

• Default Width for Data Entry Page in DCM (character-based system)

For more information on managing data entry configuration and user preferences, see the Oracle Clinical Administrator's Guide.