To facilitate centralized monitoring in RDC, you can create custom review types, which are similar to the predefined Verify and Approve review types. By defining custom review types, you enable and can track reviews performed by users with a specific role, such as data manager, safety expert, or adjudicator.
You specify default custom review requirements at the installation, study, or DCI level, which can require that all, none, or some custom review types be performed on CRFs. You can define custom review types in the CUSTOM REVIEW TYPES installation codelist in Oracle Clinical together with a privilege for each, and then assign each privilege to the appropriate reviewer.
This chapter includes the following topics:
Section 5.3, "Finding CRFs with the Review Not Required (RN) Status Set by Users"
Section 5.4, "Viewing Audit History for Changes in Custom Review Requirements"
Section 5.6, "Assign Custom Review Type Privileges to Users"
Each review type you define can have four possible review statuses assigned to CRFs:
Review Required
Review Not Required
Awaiting Re-review
Review Complete
CRF icons also display a review status indicator. See the section "Custom Review Status Icons" in Appendix A of the Oracle Clinical Remote Data Capture Classic Data Entry User's Guide.
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.
The installation-wide requirement applies for all entered CRFs that do not have a review status that was explicitly set by a user.
Log in to Oracle Clinical as an administrator.
Navigate to Admin and then DCI Form Local Database Settings.
At the bottom, expand the Default DCI Custom Review Requirements option by clicking the plus sign.
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.
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.
Click Save.
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.
Log in to Oracle Clinical as an administrator.
Expand the Design node and select DCI Form Local Study Settings.
Select the study or switch to the study for which you want to set the requirement.
At the bottom, expand the Default DCI Custom Review Requirements group of settings by clicking the plus icon to its left.
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.
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.
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.
Log in to Oracle Clinical as an administrator.
Expand the Design node and select DCI Form Local Study Settings.
Select the study or switch to the study for which you want to edit the requirement.
At the bottom, expand the Default DCI Custom Review Requirements group of settings by clicking the plus icon to its left.
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.
For the setting Custom Reviews are Required, select the checkbox Inherit From Local DB Setting. The column Local DB Value shows the inherited value.
Click Save.
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.
Log in to Oracle Clinical as a user with privileges to work in the Glib subsystem.
Expand the Glib node, then expand DCIs DCMs Procedures, and then select DCIs.
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.Query in the DCI Name field for the DCI for which you want to set the custom review requirements.
Click in the Custom Reviews Required field for that DCI to open the Reviews Required dialog box.
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.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).
Click Save.
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.Log in to Oracle Clinical as a user with privileges to work in the Definition subsystem.
Expand the Definition node, then expand DCIs, and then select DCIs.
Select or switch to the study to which the DCI belongs.
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.Query in the DCI Name field for the DCI for which you want to set the custom review requirements.
Click in the Custom Reviews Required field for that DCI to open the Reviews Required dialog box.
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.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).
Click Save.
CRFs for which the review status has been set to Review not Required by users are not affected by changes in the custom review requirements, defined in Oracle Clinical. To find such CRFs and determine if they would require review based on the new requirements you can use:
The option Explicitly set RN status from the Review Status filter in the Search pane.
The metrics for Explicitly set RN status in the Patient Summary, Study Site Summary, or Single Patient Casebooks page.
While it is possible to review audit history for those cases where a user explicitly changes the review status of a CRF, the status of a CRF may also change as a result of changes in Custom Review Requirements at the DCI level will appear in the review status history. Only changes at the installation or study level will not appear in the review status history.
To view audit history for changes in the Custom Review requirements, you can query the columns crt_list and allow_crt_rn in the DCIS and DCIS$JN tables. For details about these columns, see the Oracle Clinical Stable Interface Technical Reference Manual.
Example 5-1 Query to find DCIs for which the CRT requirement has changed
column dci_id format 999999999
column allow_crt_rn format a10
column crt_list format a30
set pages 1
set lines 200
select before.dci_id, before.allow_crt_rn, after.allow_crt_rn
from (select row_number () over (order by JN_TIMESTAMP) r_num, dci_id, allow_crt_rn from dcis$jn) before
join (select row_number () over (order by JN_TIMESTAMP) r_num, dci_id, allow_crt_rn from dcis$jn) after
on before.R_NUM = after.R_NUM+1
where before.dci_id = after.dci_id
and before.allow_crt_rn != after.allow_crt_rn;
select before.dci_id, before.crt_list, after.crt_list
from (select row_number () over (order by JN_TIMESTAMP) r_num, dci_id, crt_list from dcis$jn) before
join (select row_number () over (order by JN_TIMESTAMP) r_num, dci_id, crt_list from dcis$jn) after
on before.R_NUM = after.R_NUM+1
where before.dci_id = after.dci_id
and before.crt_list != after.crt_list;
You create custom review types and their corresponding privileges in the CUSTOM REVIEW TYPES installation codelist in Oracle Clinical. This codelist comprises all user-defined review types and the privilege required for each of the review types.
You can define up to 444 custom review types for a DCI.
Log in to Oracle Clinical as an administrator.
Navigate to Admin, Reference Codelists, and select Installation Codelists.
In the Maintain Installation Codelist window, query for the CUSTOM REVIEW TYPES codelist.
In the Reference Codelist Values section, fill in the Long Value field with a name for the new custom review type, such as SAFETY_REVIEW or DM_REVIEW.
Fill in the Short Value field with a name for the privilege required to perform that type of review, such as SAFEREV or DMREV.
Note:
The Short Value field accepts up to 8 characters.To activate the custom review type, select the Active checkbox.
Optionally, you can store details about the custom review type in the Description field.
Repeat steps 4 through 7 to add more custom review types, as necessary.
Click Save after you have finished defining custom review types.
If you deactivate a custom review type from the CUSTOM REVIEW TYPES reference codelist in Oracle Clinical, the change takes effect as follows:
In RDC, the inactive custom review type is available for search but with suffix (inactive). However, the calculation of the CRT icon will not consider the inactive custom review type.
In RDC Data Entry window, reviewers with privileges for the inactive custom review type and one or more active custom review types (so that they can still change review statuses) can view audit history for the inactive custom review type, which appears prefixed by (inactive).
Log in to Oracle Clinical as an administrator.
Navigate to Admin, Reference Codelists, and select Installation Codelists.
In the Maintain Installation Codelist window, query for the CUSTOM REVIEW TYPES codelist.
Under Reference Codelist Values, find the review type that you want to retire and deselect the Active checkbox.
Click Save.
If the custom review type is explicitly required based on the study DCI or GLIB DCI review requirement, the study manager or global librarian must also access the Maintain Study DCIs or Maintain GLIB DCIs form, respectively, at which point the inactive custom review type is removed, and then save changes. If this was the only custom review type that was required for the DCI, the DCI then inherits the study or installation default requirement, as applicable.
A CRF has multiple review statuses at any given time, one for each custom review type. The current review status for a custom review type (see Review Statuses for Custom Review Types) and the corresponding review status indicator on the CRF icon are visible to users who have the privilege for that review type. You define the privilege together with the custom review type; for details, see Add Custom Review Types.
For example, having the custom review types SAFETY_REVIEW and DM_REVIEW, if safety review is complete and DM review is not complete for a CRF, the same CRF appears as having the review status Review Complete (RC on the CRF icon) to users with the privilege for SAFETY_REVIEW, and it appears with the status Review Required (RQ on the CRF icon) to users who have the privilege for DM_REVIEW.
You can assign privileges from Study Security or Site Security in the RDC Administration Tool. See "Assigning Study and Site Security Privileges" for instructions.
You can also assign privileges from Oracle Clinical. See the Oracle Clinical Administrator's Guide for details.
You can leverage custom review types by including them in custom activities. Using the REVIEW_TYPE and REVIEW_STATUS parameters of the rdc_zf_surround_activitiy.setSearchCondition procedure, you can create or edit a procedural activity to search by custom review values. See "Creating and Maintaining Customized Activities" for instructions.
For more information, see:
”Performing Custom Reviews” in the Oracle Clinical Remote Data Capture User's Guide