| Oracle® Clinical Remote Data Capture Onsite User's Guide Release 4.6 B31158-04 |
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PDF · Mobi · ePub |
| Oracle® Clinical Remote Data Capture Onsite User's Guide Release 4.6 B31158-04 |
|
|
PDF · Mobi · ePub |
In Oracle Clinical Remote Data Capture Onsite (RDC Onsite), the verification process involves checking the entered data against the source data. Generally, the CRAs and monitors verify the data in a CRF. You can verify CRFs only if you have verification privileges.
You verify CRFs, one at a time, from the Data Entry window. Alternatively, your sponsor can configure RDC Onsite to make a group verification option available.
This chapter includes the following topics:
To review patient CRFs and verify the data against the source data, you can:
Use a customized Activities link on the Home page
Select patients on the Home page and navigate to the Review CRFs page
Select patients on the Home page and navigate to the Casebooks page
By default, the Activities section on the Home page includes a Review non-blank CRFs ready for initial verification link. This link has built-in search criteria that automatically finds only those CRFs that are ready for verification, and then displays those CRFs on the Review CRFs page.
Your sponsor can customize the Activities links. They can choose to create additional links, define different search criteria for links, rename links, or make some links unavailable. The links available to you depends on how your sponsor customized the RDC Onsite application.
To use the default Activities link to find CRFs for verification:
Select the Review non-blank CRFs ready for initial verification link in the Activities section on the Home page.
The Review CRFs page lists all the patients and their CRFs. If the Verified column is blank, then the CRF is not verified.
Expand the Search pane to view the criteria in effect as a result of selecting the activity.
The non-customized activity displays only CRFs with status Entry or Pass 2 Complete that are not verified.
Click Clear to specify different search criteria, if needed.
Click Go to refresh the page according to your new criteria.
You can select specific patients for review on the Home page, and then navigate to the Review CRFs page to view the CRFs ready for verification.
To navigate to the Review CRFs page and view CRFs ready for verification:
Open the Home page and expand the Search pane.
Specify patient search criteria. For example, you can specify a patient range, patients assigned to a particular casebook (study protocol), or patients with no open discrepancies.
Click Go to refresh the patient list according to your criteria.
Select one or more patients for review from the Patients list. Alternatively, you can click Select All to select all the patients displayed.
Click the Select Patients and... field and then select Review Entered CRFs from the list.
Click Go. The Review CRFs page opens, displaying all entered CRFs for the selected patients.
Expand the Search pane to specify CRF-level criteria, such as verification status, entry status, or discrepancy status.
Click Go to refresh the CRF list after selecting additional criteria.
To reset your patient selection entirely and specify a different search, click Clear.
Note:
If the patients are too many to view in one scrollable list, click the Previous and Next buttons to navigate through the entire list. However, you can only select patients from one set at a time. Clicking Previous or Next causes the loss of your current patient selection.You can also select specific patients for review on the Home page, and then navigate to the Casebooks page, instead of the Review CRFs page, to view the CRFs ready for verification. Navigating to the Casebooks page lets you review CRFs in a casebook spreadsheet format instead of a list format.
To navigate to the Casebooks page and view CRFs ready for verification:
Open the Home page and expand the Search pane.
Specify patient search criteria. For example, you can specify a patient range, patients assigned to a particular casebook (study protocol), or patients with no open discrepancies.
Click Go to refresh the patient list according to your criteria.
Select one or more patients for review from the Patients list. Alternatively, you can click Select All to select all the patients displayed.
Click the Select Patients and... field and then select Open Patient Casebooks from the list.
Click Go. The Casebooks page opens, displaying all entered and expected CRFs for the selected patients in spreadsheet format. Each row of icons represents data for a single patient. See "Using the Casebooks Page" for information on navigating in the Casebooks page.
Expand the Search pane to specify CRF-level criteria, such as verification status, entry status, or discrepancy status.
Click Go to refresh the CRF list after selecting additional criteria.
To reset your patient selection entirely and specify a different search, click Clear.
Note:
When you specify CRF-level criteria, the empty CRF icons are not displayed. Ordinarily, these icons represent data that is expected according to the patient's casebook definition.However, when CRF-level search criteria are in effect, cells where data has not been entered are blank. If patients within the current set do not have data for a particular CRF, the column is not displayed. This feature allows for a more compressed view of patient CRFs.
Data can be updated even after a CRF has been verified. When this happens, the CRF automatically acquires a verification status of Awaiting Re-Verification.
To find CRFs that require re-verification:
Follow one of the methods described in "Finding CRFs to Verify" to find CRFs ready for verification.
Expand the Search pane on either the Review CRFs page or the Casebooks page.
Click the Verification field and then select Awaiting Re-Verification from the list.
Click Go to refresh the display.
Continue to "Reviewing Changes since Latest Verification".
Note:
CRFs with an Awaiting Re-Verification status are not retrieved when the Verification field is set to Not Verified.After identifying CRFs that require verification, you can review them to ensure that they meet the requirements for verification. Your review of CRFs can include:
To review entered data for errors:
Open a CRF in a Data Entry window.
Review data in the CRF fields.
Change data as required if you have appropriate privileges.
Save the CRF, if you change data.
Tip:
If reviewing CRFs from the Casebooks page, click the Next CRF link to navigate through all CRFs for a patient visit without having to return to the Casebooks page.As a monitor or CRA, you may need to review discrepancies before you verify a CRF. See Chapter 4, "Managing Discrepancies" for more information.
Before you verify a CRF, RDC Onsite lets you view the CRF's verification history, if any. A CRF that has never been verified does not have a verification history.
To view the verification history of a CRF:
Open the CRF in a Data Entry window.
Click the Verify icon in the toolbar. The Verify CRF dialog box displays the following information about the verification history, if any, for the CRF.
Date — Displays the date and time of the entry in the Verification History table.
Operation — Displays the action that caused a change in verification status: Verify or Undo Verify.
Changed By — Displays the full name of the user who changed the verification status.
Comment — Displays additional information about the Verify or Undo Verify action.
Close the Verify CRF dialog box.
The data in a CRF can undergo change even after the CRF has been verified. When this happens, RDC Onsite automatically changes the status of the CRF to Awaiting Re-Verification.
You should always review the changes in a CRF before you verify it again.
To review the changes to a CRF since the latest verification:
Search for a CRF that needs to be re-verified:
Open the Casebooks page or the Review CRFs page.
Expand the Search pane.
Click the Verification field and then select Awaiting Re-Verification from the list.
Click Go to execute the search and refresh the display.
Note:
If you set the Verification field to Not Verified, the search does not retrieve CRFs with an Awaiting Re-Verification status.Open a CRF in a Data Entry window.
Click the Highlight field in the toolbar, and select Changed since last verified from the list. Fields updated since the last verification are highlighted in blue. Note that fields whose only update is an update to the investigator comment are highlighted.
Right-click a field highlighted in blue, and select View Audit History. The Audit History pane opens at the bottom of the Data Entry window.
Review the history of changes for the selected field.
Continue to review the changes to other fields in the CRF since the last verification.
Finding Non-highlighted Changes in a CRF
When you select Changed since last verified in the Highlight field in the Data Entry window, RDC Onsite does not highlight fields that have undergone the following changes:
If updates were restricted to discrepancies, RDC Onsite does not highlight the associated fields. To locate such cases:
Click the Verify icon in the Data Entry window toolbar to establish the date of the latest verification.
Review the Discrepancy History to identify any updates since the last verification.
If the layout of a CRF was modified, the CRF status reverts to Awaiting Re-Verification, even without any data updates.
Follow your sponsor's instructions for re-verifying CRFs with non-highlighted changes.
As a monitor, you need to review the changes to a CRF, especially the changes made to a CRF that was already verified. The Audit History pane provides comprehensive information on the changes to each field in a CRF.
To view the history of the changes to a field:
Open a CRF in a Data Entry window.
Right-click a field and then select View Audit History. The Audit History pane opens at the bottom of the Data Entry window.
Review the history of changes for the selected field.
Note:
The Audit History pane does not include those changes made to discrepancies or investigator comments. You can, however, view the Discrepancy History and the Investigator Comment History for information on those updates.After identifying CRFs ready for verification as described in "Finding CRFs to Verify", and reviewing CRFs as described in "Reviewing CRFs from the Data Entry Window", you can verify an individual CRF from the Data Entry window. You can use a similar process to undo a verification as well as to redo the verification of a CRF.
Note:
You can verify a CRF only if you have verify privileges and the CRF does not have a status of Received or Entry Started.To verify a CRF:
Open a CRF in a Data Entry window.
Click the Verify icon in the toolbar to open the Verify CRF dialog box.
The Verify CRF dialog box includes the verification history of the CRF, if any.
The verification actions available in the Verify CRF dialog box depends on the current status of the CRF. Based on the status of the CRF, you can:
Click Verify to verify the CRF.
Click UnVerify to undo the verification if the CRF was already verified.
Click Re-Verify to redo the verification of a CRF. A CRF needs to be re-verified if data is updated or added since the last verification.
Save your changes.
See "Reviewing Verification History" if you want to review the verification changes to the CRF.
RDC Onsite assigns Awaiting Re-Verification status to a CRF, if data is updated, new data collected or discrepancies added/updated, after the CRF was verified.
To redo the verification of a CRF:
Search for CRFs that need to be re-verified, as described in "Finding CRFs Requiring Re-verification".
Review changes in the CRF after verification, as described in "Reviewing Changes since Latest Verification".
Review the audit history of changes in the CRF, as described in "Reviewing Audit History", if you want.
Redo the verification of an individual CRF, as described in "Verifying CRFs from the Data Entry Window".
Redo the verification of a group of CRFs, as described in "Verifying Multiple CRFs".
You can verify multiple CRFs simultaneously from the Casebooks page or the Review CRFs page. The group verification option is available only if you have verify privileges, and if your sponsor has configured RDC Onsite to allow it.
To verify multiple CRFs:
Open the Casebooks page or the Review CRFs page.
From the Casebooks page, select one or more patients whose CRFs you need to verify. Click the Select Patients and... field and select Verify from the list.
From the Review CRFs page, select one or more CRFs to verify. Click the Select CRFs and... field and select Verify from the list.
Note:
If the Verify option does not appear in the list, either you do not have appropriate privileges, or your sponsor has not configured RDC Onsite for group verification.Click Go. The Group Verification dialog box opens and displays the following information:
The number of CRFs selected
The number of selected CRFs with open discrepancies
The number of patients you selected (if you started with a patient selection on the Casebooks page)
Enter a comment in the Verification Comment field, if you want.
Clear the Skip CRFs with discrepancies check box if you want to verify such CRFs. The check box is selected by default.
Click Continue to proceed with the group verification. RDC Onsite prompts for confirmation before continuing.
Click Yes. RDC Onsite verifies all the selected CRFs. A dialog box reports when the verification is complete, and displays the total number of CRFs that were verified.
Click Close to close the dialog box.
RDC Onsite automatically refreshes the page and updates the verification status of the affected CRF icons.
Note:
The number of CRFs verified may be less than the number of CRFs selected for any of the following reasons:The Skip CRFs with discrepancies check box is selected.
The CRF is already verified.
The CRF has a database lock (another user or a validation procedure is updating the CRF).
The CRF has an Oracle Clinical lock.
The CRF is entered from another site.
The CRF is at status Received or Entry Started.
If you unintentionally verify a group of CRFs, you can reverse the action with the Undo Group Verification option. You can undo verification of multiple CRFs simultaneously from the Casebooks page or the Review CRFs page.
The Undo Group Verification option is available only if you have the appropriate privileges, and your sponsor has configured RDC Onsite to allow it.
To undo the verification of a group of CRFs:
Open the Casebooks page or the Review CRFs page.
From the Casebooks page, select the patients that you need to undo the verification of their CRFs. Click the Select Patients and... field and select UnVerify from the list.
From the Review CRFs page, select one or more CRFs for which you need to undo the verification. Click the Select CRFs and... field and select UnVerify from the list.
Note:
If the UnVerify option does not appear in the list, either you do not have appropriate privileges, or your sponsor has not configured RDC Onsite for the undo group verification.Click Go. The UnVerify CRFs dialog box opens and displays the following information:
The number of CRFs selected
The number of patients you selected (if you started with a patient selection on the Casebooks page)
Enter the user name and password that you specify when you log in to the RDC Onsite application.
Enter a comment, if you want.
Click Continue to proceed with undoing the group verification. RDC Onsite prompts you for confirmation before continuing.
Click Yes. RDC Onsite undoes the verification of the selected CRFs. A dialog box reports when the unverify operation is complete, and displays the total number of CRFs that were unverified.
Click Close to close the dialog box.
RDC Onsite automatically refreshes the page and updates the verification status of the affected CRF icons.
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