| Oracle® Clinical Remote Data Capture Classic Data Entry User's Guide Release 4.6.2 Part Number E18824-01 |
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| Oracle® Clinical Remote Data Capture Classic Data Entry User's Guide Release 4.6.2 Part Number E18824-01 |
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View PDF |
The majority of the functions that you use in RDC Classic affect an individual CRF. Group activities, in contrast, allow you to alter the status of multiple CRFs in a single operation. Using commands in the Group Activities menu, you can change the verification, approval, or lock status of the CRFs that comprise the current workset.
This section outlines the tasks that use group activities, discusses the factors that affect your access to the menu commands, and describes the steps to successfully complete each task. It consists of the following subsections:
This section provides general information about all of the tasks that are available using the Group Activities menu commands and discusses how other RDC Classic components can affect these tasks.
Note:
Refer to "Group Activities" for information about each menu command, including shortcut key designations.The following subsections describe the factors that impact the group activities tasks.
Use the following workflow as a starting point for the commands available through the Group Activities menu.
Use either Search or Activity List to specify a workset that includes the CRFs you want to include in the group activity.
Choose the Group Activities menu command that corresponds to the procedure you want to run.
In the processing window, select those CRFs that you do not want to include in the procedure, if applicable.
Run the procedure.
Review the status window and note the number of CRFs that the procedure updated.
Note:
After a group activity successfully runs and you close the status window, you may notice a slight delay while the system updates the RDC Classic Spreadsheet to display the current status of the CRF icons.Because each group activity evaluates all CRFs in the workset, the tasks that are available from the Group Activities menu may affect a large number of CRFs in a single action. Therefore, use care when employing these commands. In particular, you may want to limit the size of the workset when you use the Group Locking Procedure because, unlike the verification and approval group activities, there is no mechanism to "undo" the lock status of more than one CRF at a time.
A key factor in successfully using any of the commands in the Group Activities menu is to take into account that these functions act upon the entire workset. This includes:
CRFs that have been updated such that they no longer meet the search criteria
unplanned CRFs that are not currently displayed in the RDC Classic Spreadsheet
CRFs for patients that are not in the current patient list
CRFs that are in a RDC Classic Spreadsheet tab that is not currently visible.
This section describes how other RDC Classic components impact a Group Activities task. Each of these factors are listed and briefly described in Table 7-1, and are more fully discussed in the relevant subsections.
Table 7-1 Factors that Affect Group Activities
| Condition | Description | Comment/Recommendation |
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CRFs or CRF sections marked blank are equivalent to entry complete data entry status. |
A CRF that is marked blank or which is at entry complete status but contains one or more sections that are marked blank is eligible for inclusion in a group activity. |
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Only the status of the CRF is pertinent to inclusion/exclusion in Group Activity tasks. |
Each section in a CRF must be at entry complete status for the CRF to be eligible for inclusion in a group activity. |
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The workset displayed in the RDC Classic Spreadsheet maybe out of synch with the criteria used to establish it. |
It is recommended that you refresh the workset to ensure that the required CRFs are available for a group activity. |
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CRFs that are present on other view tabs are available for a group activity. |
If possible, use the Spreadsheet Study view to display all workset CRFs in a single tab. |
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Unplanned CRFs that are present in the workset are eligible for a group activity. |
Use the Hide/Show Unplanned CRFs button to ensure all unplanned CRFs are displayed in the Spreadsheet prior to initiation of a group activity. |
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Eight rows of patient data are displayed in the Spreadsheet, however, the CRFs for all patients in the workset are eligible for group activities. |
Use the navigation tools to inspect the entire set of patients in the workset prior to initiating a group activity. |
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A group activity cannot proceed until all open windows are closed. |
Close all open windows prior to initiating a group activity. |
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A group activity cannot proceed if there are changes pending. |
Process pending changes prior to initiation of a group activity. |
When the blank flag is selected, the associated CRF or CRF section is assigned an entry status of blank. However, for the purpose of processing, RDC Classic treats the blank status as equivalent to entry complete. Therefore:
a multi-section CRF, with some CRF sections that are at entry complete and others that are at blank, is considered entry complete
a CRF that is marked blank is considered entry complete.
In these cases, the CRF is eligible for inclusion in a group activity, subject to its discrepancy, verification, and approval statuses.
Each section in a multi-section CRF is assigned an entry status that is independent of any other sections or the CRF itself. The entry status assigned to the CRF is based on the statuses of its constituent sections.
All of the Group Activity tasks include or exclude workset CRFs based on the data entry status of the CRF. The entry status of individual CRF sections is not a factor in the inclusion or exclusion of the CRF from a given process. Consequently, a CRF that is at entry started status is excluded from Group Activity processes, even if it includes constituent CRF sections at entry complete status. Essentially, each CRF section must be at the entry complete status in order for the CRF to be assigned the entry complete status and be eligible for inclusion in a group activity. Note that, as described in "Blank Flag", RDC Classic treats a CRF section that is marked blank as entry complete.
When you use the Activity List or the Search window to specify a workset, the data in the RDC Classic Spreadsheet is synchronized with the search criteria. However, when you subsequently change data so that the CRF no longer meets the original criteria, it continues to be included in the workset. In this way, the workset may not be synchronized with the criteria.
Each group activity operates on the CRFs that are currently included in the workset, not on those that simply meet the search criteria. Therefore, it is recommended that you update the workset, by choosing Refresh in the File menu, prior to initiating a group activity. This ensures that the appropriate CRFs are included in the procedure that you run.
CRFs that are displayed in view tabs that are not currently displayed in the RDC Classic Spreadsheet are part of the workset and are eligible for inclusion in a group activity. If either the Spreadsheet Visit view or the Phase view is active, there generally will be CRFs present on other view tabs.
If the Spreadsheet View drop-down list is available, you can use the Study view to display all CRFs in the workset (for the current Patient List) on a single tab.
By default, unplanned CRFs in the workset are not displayed in the RDC Classic Spreadsheet. If there are unplanned CRFs associated with the current view tab, RDC Classic displays the Show/Hide Unplanned Pages Button adjacent to the CRF columns. Because all unplanned CRFs are eligible for inclusion in a group activity, it is recommended that you click the Show Unplanned Visits button to inspect unplanned CRFs prior to initiation of a group activity.
The maximum number of patient rows that you can view in the RDC Classic Spreadsheet is eight. However, each group activity acts upon the CRFs associated with all patients in the current Patient List. Refer to "Current Patients" for information on navigating the patient list.
You should ensure that all windows within the RDC Classic Workspace are closed prior to initiating any task that involves the Group Activities menu.
If the Data Entry window is open and there are no pending changes, the menu commands are available; however, RDC Classic closes the Data Entry window when you activate any of the Group Activities menu commands. (Refer to "Pending Changes" for a description of RDC Classic behavior when there are pending changes in the Data Entry window.)
If a "functional" window, such as the Text Editor, is open, the Group Activities menu commands are inactive. You must close these windows in order to access any of the Group Activities commands.
In order to initiate any of the functions that are available through the Group Activities menu, there cannot be pending changes.
If the Data Entry window is open when you select any of the Group Activities menu commands and there are pending changes, RDC Classic prompts you to process those changes – that is, to either save or discard them. After you have handled the pending changes, focus returns to the RDC Classic Workspace; however, you must re-initiate the Group Activities task.
There are several factors that affect the presentation of the Group Activities menu in your RDC Classic session. These factors are related to:
configuration settings defined by your system administrator
the privileges assigned to your user name
the workset that you specify through the Activity List window or the Search window.
Based on these factors, the Group Activities menu may not be present or, if it is, you may not have access to a particular command. When you do not have access to a command, it is said to be "inactive". RDC Classic displays inactive menu commands in light grey font. When you click an inactive menu command, the system does not respond.
Your system administrator can use the RDC Classic Configurator to exclude the Group Activities menu from the RDC Classic Workspace. In this case, the menu and the commands that comprise the menu are unavailable to you. Consequently, you cannot perform any of the group activities that are described in this section.
In order to perform any of the group activities, you must have appropriate access. This means that the privilege necessary to perform the individual function must be assigned to your user name. Table 7-2 lists the privilege that is relevant to each Group Activities menu command.
Table 7-2 Group Activities and Required User Privileges
| Command | Privilege |
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Approve CRFs |
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Undo Approved CRFs |
approve |
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Verify CRFs |
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Undo Verified CRFs |
verify |
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Lock CRFs |
If you do not have the requisite privilege for a particular command, RDC Classic renders that command inactive in the menu.
Access to the Group Activities menu commands may be dependent on the Site criterion that was used to generate the workset.
In order to perform tasks that use the commands that affect the verification and the approval status of CRFs, the workset that is displayed in the RDC Classic Spreadsheet must be based on an individual site and the appropriate privilege must be assigned to your user name for that site. The verification and approval Group Activities menu commands are rendered inactive if the Site criterion is set to All Sites (either in the Search window or by the scope of the task selected in the Activity List window). If this situation occurs, you must limit the site criteria to an individual site to which you have the required privilege. You do this either by:
Changing the Site Criterion in the Search Window to a single site
Selecting a task in the Activity List Window that is a constituent of either:
a Site node to which you have access, or
a Patient node within such a site.
The lock privilege can be assigned to your user name on a site-by-site basis or on a study basis.
If it is assigned for the current study, the value of the Site criterion that is used to generate the workset is irrelevant – the Lock CRFs menu command is always accessible.
If it is assigned at the site level, the Lock CRFs menu command is inactive in each of the following circumstances:
the Site criterion is set to All Sites, and
the Site criterion is set to a site to which you do not have Lock privilege.
You use the following commands in the Group Activities to change the verification status of the CRFs displayed in the RDC Classic Spreadsheet:
These commands are functionally equivalent to the Verify and Undo Verify tasks for an individual CRF.
Because group activities have the potential to affect a large number of CRFs through a single user action, it is important to understand the rules that RDC Classic uses as the basis to take action on a particular CRF in the RDC Classic Spreadsheet. The following sections describe which CRFs RDC Classic automatically includes or excludes when a group verification procedure runs. Also, "Optionally Excluded CRFs" describes how you can choose to exclude certain CRFs from the verify/undo verification group procedures.
CRFs that meet the following criteria are automatically included in group verification procedures:
Present in the RDC Classic Spreadsheet
CRF entry status of entry complete, or equivalent Oracle Clinical designation (for example, Pass 2 Complete)
Verification status other than Verified for the Verify a Group of CRFs procedure, specifically:
Verification status of verified for the Undo Verification for a Group of CRFs procedure
Discrepancy status of either none or closed
Certain CRFs in the workset are not, by definition, included in the set that is eligible for group verification procedures. CRFs that meet the following criteria are automatically excluded from group verification procedures:
CRF entry status that is less than entry complete
Verification status of Verified for the Verify a Group of CRFs procedure
Verification status other than Verified for the Undo Verification for a Group of CRFs procedure, specifically:
In addition to those CRFs that are never included in a group verification procedure, the Verify CRFs procedure allows you to exclude CRFs that have open discrepancies. If you choose this option, any CRF in the workset that has one or more active or other discrepancies is not processed.
In contrast, the Undo Verified CRFs procedure does not provide the option to exclude CRFs. All CRFs that meet the inclusion criteria, as described in "Automatically Included CRFs", are immediately processed.
This section describes the procedure to change the status of the workset CRFs to verified.
The following conditions must be present in order to initiate this procedure:
Your user name is assigned the verify privilege.
At least one CRF in the RDC Classic Spreadsheet is a candidate for verification, that is, its verification status is:
The Group Activity menu is present in the RDC Classic Workspace.
To change the verification status of unverified CRFs in the current RDC Classic Spreadsheet:
In the Group Activities menu, select Verify CRFs. The Group Verification Processing Window displays.
In the Group Verification Processing window, ensure that the search criteria is correct. You also have the option to:
Select the Skip CRFs with discrepancies check box to exclude discrepant CRFs from the procedure
Type a comment in the Comment text box that you want to associate with each CRF that is verified
Click the OK button to close the Verify CRFs window and initiate the verification procedure.
When the procedure completes, the Group Verify Update Complete message window displays, which describes the status of the procedure. The message lists the number of eligible CRFs and the number of CRFs that were processed.
Click OK to close the window.
When you close the message window, the system updates the RDC Classic Spreadsheet to reflect the change in verification status of those CRFs that were processed.
This section describes the procedure to change the verification status of a group of CRFs to verification undone.
The following conditions must be present in order to initiate this procedure:
Your user name is assigned the verify privilege.
At least one CRF in the Spreadsheet is assigned the verification status verified.
The Group Activity menu is present in the RDC Classic Workspace.
To undo verification of the verified CRFs in the RDC Classic Spreadsheet:
In Group Activities menu, select Undo Verified CRFs. The Group Undo Verification Processing displays.
In the Group Verification Processing window:
Ensure that the search criteria are correct
Type an optional comment in the Comment text box that you want to associate with each CRF that is processed
Click OK to close the Group Verification Processing window and initiate the verification procedure.
When the procedure completes, the Group UNDO VERIFY Update Completed message window displays, which describes the status of the procedure. The message lists the number of eligible CRFs and the number of CRFs that were processed.
Click OK to close the message window.
When you close the message window, the system updates the RDC Classic Spreadsheet to reflect the change in verification status of those CRFs that were processed.
You can use the commands in the Group Activities to change the approval status of the CRFs displayed in the RDC Classic Spreadsheet. There are two commands that you can use to change the approval status:
These commands are functionally equivalent to the approve and undo approval tasks for an individual CRF.
Because group activities can potentially affect a large number of CRFs through a single user action, it is important to understand the rules that RDC Classic uses as the basis to take action on a particular CRF in the RDC Classic Spreadsheet. The following sections describe which CRFs RDC Classic automatically includes or excludes when the group approval procedures run. Also, the Optionally excluded CRFs section describes how you can choose to exclude certain CRFs from the Approve CRFs procedure.
CRFs that meet the following criteria are automatically included in group approval procedures:
Present in the RDC Classic Spreadsheet
CRF entry status of entry complete, or equivalent Oracle Clinical designation (for example, pass 2 complete)
Approval status other than approved, for the Approve a Group of CRFs procedure, specifically:
Approval status of Approved, for the Undo Approval for a Group of CRFs procedure
Discrepancy status of either None or Closed.
Certain CRFs in the workset are not, by definition, included in the set that is eligible for group approval procedures. CRFs that meet the following criteria are automatically excluded from group approval procedures:
CRF entry status that is less than entry complete
Approval status of approved for the Approve CRFs procedure
Approval status other than approved for the Undo Approved CRFs procedure, specifically:
In addition to those CRFs that are automatically excluded from a group approval procedure, the Approve CRFs procedure allows you to exclude CRFs based on:
Discrepancies
Verification status
The discrepancies option affects CRFs that have one or more open discrepancies. If you choose this option, any CRF in the workset that has one or more Active or Other discrepancies is not processed.
The verification option affects CRFs that are not verified. If you choose this option, any CRF in the workset that is not assigned a status of Verified is not processed.
In contrast, the Undo Approved CRFs procedure does not provide the option to exclude CRFs. All CRFs that meet the inclusion criteria, as described in "Automatically Included CRFs", are immediately processed.
Both group approval procedures require user confirmation, which consists of typing your user name and password in a Password confirmation window. This step is required for each group approval procedure that you run.
Note that the system allows three attempts to type the correct user name/password combination. After a third unsuccessful attempt, RDC Classic closes the session.
This section describes the procedure to approve currently unapproved CRFs in the RDC Classic Spreadsheet.
The following conditions must be present in order to initiate this procedure:
Your user name is assigned the approve privilege.
One or more CRFs in the Spreadsheet are assigned an approval status other than approved.
The Group Activity menu is present in the RDC Classic Workspace.
To change the approval status of the CRFs that are currently not approved in the current RDC Classic Spreadsheet:
In the Group Activities menu, select Approve CRFs. The Password Confirmation window displays.
In the Password confirmation window:
Type your user name in the Username text box
Type the password associated with your user name in the Password text box.
Click OK to proceed to the Approve CRFs window.
In the Group Approval Processing window, ensure that the search criteria is correct. You also have the option to:
Select the Skip CRFs with discrepancies check box to exclude discrepant CRFs from the procedure
Select the Skip Un-verified CRFs check box to exclude CRFs that are not verified
Type a comment in the Comment text box that you want to associate with each CRF that is processed
In the Group Approval Processing window, click OK to close the window and initiate the approval procedure.
When the procedure completes, a message window, entitled, "Group Approval Update Complete", is displayed that describes the status of the procedure. The message lists the number of eligible CRFs and the number of CRFs that were processed.
Click OK to close the message window.
When you close the message window, the system updates the RDC Classic Spreadsheet to reflect the change in verification status of those CRFs that were processed.
If this procedure causes a CRF to be inadvertently approved, refer to "Undo CRF Approval" to change it to an unapproved status.
This section describes the procedure to change the approval status of the CRFs that are currently approved in the workset. In order to initiate this procedure, the following conditions must be present:
Your user name is assigned the approve privilege.
One or more CRFs in the Spreadsheet are assigned an approval status of approved.
The Group Activity menu is present in the RDC Classic Workspace.
To change the approval status of the CRFs that are currently approved in the current RDC Classic Spreadsheet:
In the Group Activities menu, select Undo Approved CRFs. The Undo Approved CRFs window displays.
In the Undo Approved CRFs window:
Ensure that the search criteria is correct.
Type an optional comment in the Comment text box that you want to associate with each CRF that is processed.
Type your user name in the Username text box.
Type the password associated with your user name in the Password text box.
Click OK to close the Undo Approved CRFs window and initiate the procedure
When the procedure completes, the Group Undo Approval Complete message window displays, which describes the status of the procedure. The message lists the number of eligible CRFs and the number of CRFs that were processed.
Click OK to close the message window.
When you close the message window, the system updates the RDC Classic Spreadsheet to reflect the change in verification status of those CRFs that were processed.
You can use the Lock CRFs command to change the lock status of CRFs displayed in the RDC Classic Spreadsheet.
In contrast to the group verification and approval procedures, which provide a mechanism to undo the verify and approve procedures, respectively, there is not an analogous "undo lock" procedure for a group of CRFs. Therefore, the Lock CRFs procedure should be used carefully. The only mechanism in RDC Classic to change the status of a locked CRF so that it can be updated is the Unlock a CRF task, which acts on a single CRF (refer to "Unlock a CRF").
Refer to "Lock an Individual CRF" which describes the procedure to lock a single CRF.
CRFs that meet the following criteria are automatically included in the Lock CRFs procedure:
Present in the RDC Classic Spreadsheet
CRF entry status of entry complete, or equivalent Oracle Clinical designation (for example, Pass 2 Complete)
Status other than locked
CRF entry status that is less than entry complete
Status of Locked
Certain CRFs in the workset are not, by definition, included in the set that is affected by group verification procedures. These are CRFs with an:
In addition to those CRFs that are automatically excluded from the Lock CRFs procedure, you may choose to exclude CRFs based on:
Discrepancies
Verification status
Approval status
The discrepancies option affects CRFs that have one or more open discrepancies. If you choose this option, any CRF in the workset that has one or more Active or Other discrepancies is not processed.
The verification option affects CRFs that are not verified. If you choose this option, any CRF in the workset that is not assigned a status of Verified is not processed.
The approval option affects CRFs that are not approved. If you choose this option, any CRF in the workset that is not assigned a status of Approved is not processed.
RDC Classic does not permit multiple CRFs to be unlocked via a group activity. You can only unlock CRFs one at a time. Consequently, there is not an "Unlock CRFs" command in the Group Activities menu.
Refer to "Unlock a CRF" for a description of this procedure.
The following conditions must present in order to initiate the process of locking a group of CRFs:
Your user name is assigned the lock privilege.
One or more CRFs in the workset is not locked.
The Group Activity menu is present in the RDC Classic Workspace.
To lock the CRFs that are unlocked in the workset:
In the Group Activities menu, select Lock CRFs. The Group Lock Processing window is displayed.
In the Group Lock Processing window, ensure that the search criteria are correct. Also, you have the option to:
Select the Skip CRFs with Discrepancies check box to exclude discrepant CRFs
Select the Skip Un-verified CRFs check box to exclude CRFs that are not verified
Select the Skip Un-approved CRFs check box to exclude CRFs that are not approved
Click OK to initiate the locking procedure
When the procedure completes, a message window is displayed that describes the status of the procedure. If the procedure was successful, the number of CRFs processed is also displayed.
Click OK to close the message window.
When you close the message window, the system updates the workset to reflect the change in lock status of the CRFs that were processed.
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