Define Custom Review Type Requirements

You can define a default requirement for custom reviews at the installation, study, GLIB DCI, and study DCI level. The multi-level requirements can specify that all, none, or some custom review types are required by default for CRFs at a particular level. The default applies to entered CRFs with no explicitly set review status.

After you define custom review requirements, RDC users can search for CRFs requiring review and can see indicators on the CRF icon for the review status of CRFs; see Review Statuses for Custom Review Types.

In this section:

• Set Custom Review Requirement for the Installation
  
• Set the Custom CRF Review Requirement for a Study
  
• Set Custom Review Requirement for a GLIB DCI
  
• Set Custom Review Requirement for a Study DCI
  

Set Custom Review Requirement for the Installation

The installation-wide requirement applies for all entered CRFs that do not have a review status that was explicitly set by a user.

1. Log in to Oracle Clinical as an administrator.
2. Navigate to Admin and then DCI Form Local Database Settings.
3. At the bottom, expand the Default DCI Custom Review Requirements option by clicking the plus sign.
4. For the setting Allow CRF status change to RN when review is required?, specify Y or N in the Value column.
   A value of Y allows reviewers to change the CRF review status to Review not Required even when the installation setting, which you set in the next step, is set to require custom reviews.
5. For the setting Custom Reviews are Required, specify Y or N in the Value column.
   A value of Y requires that all custom review types be performed for all CRFs.
6. Click Save.

Set the Custom CRF Review Requirement for a Study

You can set specific custom review requirements for CRFs in a study that are different the installation-wide requirement for a particular study. This requirement applies for all entered CRFs in the study that do not have a review status that was explicitly set by a user.

1. Log in to Oracle Clinical as an administrator.
2. Expand the Design node and select DCI Form Local Study Settings.
3. Select the study or switch to the study for which you want to set the requirement.
4. At the bottom, expand the Default DCI Custom Review Requirements group of settings by clicking the plus icon to its left.
5. For the setting Allow CRF status change to RN when review is required?, specify Y or N in the Value column.

   A value of Y allows reviewers to change the CRF review status to Review not Required even when the study setting, which you set in the next step, is set to require custom reviews.

6. For the setting Custom Reviews are Required, specify Y or N in the Value column.

   A value of Y requires that all custom review types be performed for all CRFs in a study.

7. Click Save.

Note:

If you specify custom review requirements for a study DCI, updates to the study-level custom review requirements will not override the study DCI. If you want to enforce the study-level requirement in such a DCI, you have to manually change the study DCI custom review requirements. See Set Custom Review Requirement for a Study DCI for instructions.

Enforce the Installation-wide Custom Review Requirement for CRFs in a Study

If a study has a custom review requirement defined, the installation-wide default is not enforced for that study. You can apply the installation default to clear the user-defined requirement for the study.

1. Log in to Oracle Clinical as an administrator.
2. Expand the Design node and select DCI Form Local Study Settings.
3. Select the study or switch to the study for which you want to edit the requirement.
4. At the bottom, expand the Default DCI Custom Review Requirements group of settings by clicking the plus icon to its left.
5. For the setting Allow CRF status change to RN when review is required?, select the checkbox Inherit From Local DB Setting. The column Local DB Value shows the inherited value.
6. For the setting Custom Reviews are Required, select the checkbox Inherit From Local DB Setting. The column Local DB Value shows the inherited value.
7. Click Save.

Set Custom Review Requirement for a GLIB DCI

You can set a different custom review requirement than the default that is defined at the installation or study level, which may require all or none of the available review types for all CRFs. At the individual DCI level, you can refine the requirement by setting all, none, or only some custom review types to be required for CRFs of the DCI. This requirement applies for all entered CRFs of the DCI that do not have a review status that was explicitly set by a user.

1. Log in to Oracle Clinical as a user with privileges to work in the Glib subsystem.
2. Expand the Glib node, then expand DCIs DCMs Procedures, and then select DCIs.
3. Select the Review Requirements tab.

   Tip:

   The checkbox Allow CRF status change to RN when review is required? at the top of the tab is read-only and indicates the inherited installation setting. You can specify a different setting for individual custom review types in step 7.
4. Query in the DCI Name field for the DCI for which you want to set the custom review requirements.
5. Click in the Custom Reviews Required field for that DCI to open the Reviews Required dialog box.
6. Select (highlight) all the review types that should be required for CRFs in this DCI.

   Tip:

   Clicking a single review type drops the current selection and selects only that review type. Use Shift+click, Ctrl+click, or the controls below the list to select or deselect multiple review types.
7. Make sure that Allow Override RN Status is checked for only those selected (required) review types for which you want to allow reviewers to set the review status to Review not Required (RN).
8. Click Save.

Set Custom Review Requirement for a Study DCI

You can set a different custom review requirement than the default that is defined for the installation or study DCI. This requirement applies to all entered CRFs in the study DCI that do not have a review status that was explicitly set by a user.

Tip:

You can specify custom review requirements for any DCI, whether active, provisional, or retired. You may want to define requirements even for a retired DCI in case a CRF, entered against the retired DCI, is updated.

1. Log in to Oracle Clinical as a user with privileges to work in the Definition subsystem.
2. Expand the Definition node, then expand DCIs, and then select DCIs.
3. Select or switch to the study to which the DCI belongs.
4. Select the Review Requirements tab.

   Tip:

   The checkbox Allow CRF status change to RN when review is required? at the top of the tab is read-only and indicates the inherited installation or study setting, if one is defined. You can specify a different setting for individual custom review types in step 7.
5. Query in the DCI Name field for the DCI for which you want to set the custom review requirements.
6. Click in the Custom Reviews Required field for that DCI to open the Reviews Required dialog box.
7. Select (highlight) all the review types that should be required for this DCI.

   Tip:

   Clicking a single review type drops the current selection and selects only that review type. Use Shift+click, Ctrl+click, or the controls below the list to select or deselect multiple review types.
8. Make sure that Allow Override RN Status is checked for only those selected (required) review types for which you want to allow reviewers to set the review status to Review not Required (RN).
9. Click Save.