| Oracle® Clinical Conducting a Study Release 4.6.2 E18821-02 |
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PDF · Mobi · ePub |
| Oracle® Clinical Conducting a Study Release 4.6.2 E18821-02 |
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PDF · Mobi · ePub |
This chapter includes the following topics related to creating and using Data Clarification Forms (DCFs). Information on setting up DCFs is available in the Discrepancy Configuration chapter of the Oracle Clinical Administrator's Guide.
To open the Maintain Data Clarification Forms window, from the Conduct menu, select Data Validation, then select Data Clarification Form. You can also navigate to the window directly from the Maintain Discrepancy Database window. See Chapter 4, "Using the Discrepancy Database".
DCFs enable you to organize discrepancies into groups based on criteria such as Investigator, site, and/or DCM. You specify the criteria and Oracle Clinical creates one DCF for each patient whose records match the criteria. You can create custom header and footer information for the DCF.
A particular discrepancy can appear as ACTIVE on only one DCF. You can manually add and remove discrepancies from DCFs. When a discrepancy's status is updated so that it no longer matches the status criteria for the DCF, the system releases it from the DCF.
Print and Electronic DCFs After you have created a DCF, you can generate a DCF Report printout listing all its discrepancies and send it to an Investigator for review. Oracle Clinical keeps track of each report generated for each DCF and which discrepancies are described on each page. See "Viewing Current Details of Discrepancies on a Page". If you are an Investigator with access to Oracle Clinical, you can view the DCF in the Maintain Data Clarifications Form window, use the link to the Maintain Discrepancy Database window to update discrepancies' status, and use the Update Patient Data link to change incorrectly entered data. Or you can mark your comments on the paper report and send it back for the changes to be entered.
DCF Discrepancy Selection Criteria The criteria you can use to select discrepancies for inclusion on the DCF are:
Discrepancy Status. Specify the status of the discrepancies you want to include in the DCF. You can specify those you want to have appear in the report (such as INV REVIEW) and those you want to include in the DCF but do not want to appear in the report (such as PASSIVE REVIEW). You can also choose to include discrepancies with a resolution status; this may be useful when discrepancies have been resolved internally and need only be checked by the Investigator. You must also choose whether or not to include discrepancies with a status of OBSOLETE.
Any number of the following: Investigator, site, and patient. Oracle Clinical limits your choices to those Investigators, sites, and patients associated with discrepancies that fulfill the status criteria you selected.
One of the following: Patient, Patient Visit, DCM, or Discrepancy. Oracle Clinical limits your choices to those associated with discrepancies that fulfill the status criteria you selected.
This section contains brief descriptions of the fields of the Maintain Data Clarification Forms utility.
Table 5-1 Field Descriptions for the Maintain Data Clarification Forms Utility
| Field | Description |
|---|---|
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DCF Number |
The unique identifier assigned by the system to the DCF record. |
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The DCF's current state in the review process. Click F9 for a list of values. The system assigns a status of CREATED to new DCFs. The default statuses are: Created, Draft, Final, Sent, Received, Reviewed, Closed. You can set the status in the Maintain DCFs window and when you print the DCF Report. After the DCF Report has been sent, the system also sets the DCF status based on the status of its DCF Pages. DCFs also have a Print Status, which is different. See "Viewing Current Details of Discrepancies on a Page", "Changing the DCF Status from the Maintain DCFs Window" and "DCF Print Status". You can change statuses and make them optional in the Installation reference codelists DCF STATUS CODES and DCF OPTIONAL STATUS CODES. |
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Description |
Free text description of the DCF. The creator of the DCF supplies this value. If you have the necessary privileges, you can modify this value. |
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Patient |
Unique identifier of the patient position. DCFs include discrepancies associated with only one patient's data. |
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Investigator |
The code and name of the Investigator. If a single Investigator was specified for the DCF, all of the discrepancies on this DCF are specific to this Investigator. |
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Site |
Name of the site. If a single site was specified for the DCF, all of the discrepancies on this DCF are specific to this site. |
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Owning User |
The person responsible for the DCF. The default is the user who logs the DCF. |
These fields are available by clicking the Details button:
| Field | Description |
|---|---|
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Distribution Status |
This field is set when the DCF is created and identifies the review status of discrepancies to include on the DCF report. |
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Non-Distribution Status |
This field is set when the DCF is created and identifies the review status of discrepancies to withhold from the DCF report. |
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Resolved Status |
This field is set when the DCF is created and identifies the resolution status of discrepancies to include in this DCF. This allows a DCF report to be generated that contains only discrepancies that have been resolved internally, and are being forwarded to the Investigator for confirmation. |
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Selection Criteria |
This field contains ranges that were applied when the DCF was created. If the DCF was created from the Discrepancy window using a Group Function, this field is set to "Multi Select". |
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Printed Last |
Timestamp of the last print action. This field is populated for all Print Status codes. |
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Printed By |
Use the name of the last print action. This field is populated for all Print Status codes. |
There are two approaches to creating DCFs. You can create them by specifying criteria for the discrepancies you want the DCF to include, or you can individually select a group of discrepancies with the grouping utility in the Maintain Discrepancy Database window (see "Creating a DCF for a Hand-Selected Group of Discrepancies"). This section describes creating DCFs by specifying criteria for discrepancies and Adding Multivariate Discrepancy's Procedure Variables to a DCF.
Before you can create a DCF, you must set a review status for each of the discrepancies you want to include in it. From the Conduct menu, select Data Validation, then select Maintain Discrepancy Database.
See introductory information at Chapter 5, "Using Data Clarification Forms" and "Description of Fields".
To create a DCF:
Open the Maintain Data Clarification Form window. From the Conduct menu, select Data Validation, then select Data Clarification Forms.
Click the Create DCF button. The Create DCF window dialog box opens.
Specify which discrepancies you want to include in the DCF in terms of their Discrepancy Review Status (see Discrepancy Status Codes):
Discrepancy Status for Distribution. (For example, Investigator REVIEW.) Discrepancies with this status (that also fulfill other selection criteria) appear on printed reports for this DCF as well as the Discrepancies window of the Maintain Data Clarification Forms window.
Discrepancy Status for Non-distribution. (For example, PASSIVE REVIEW.) Discrepancies with this status (that fulfill other selection criteria) do not appear on any printed reports for this DCF, though they do appear in the Discrepancies window of the Maintain Data Clarification Forms window.
Discrepancy Resolution for Resolved Status. (For example, RESOLVED or IRRESOLVABLE.) Normally resolved discrepancies are released from the DCF and do not appear in reports, though they are displayed in the Discrepancies window of the Maintain Data Clarification Forms window. Entering a value in this field allows you to create a DCF Report containing resolved discrepancies for review.
Choose to include or exclude discrepancies of system status OBSOLETE; set the Exclude Obsolete? box. If selected, obsolete discrepancies are excluded from the DCF.
Limit the scope of the DCF by setting specific values. The system limits the lists of values for each field according to the discrepancy statuses you entered. For example, the Specific Investigator field list of values lists only the Investigators identified in discrepancies that match the review and resolution status codes you specified in Step 3. Set at least one of the parameters listed in the substeps a and/or b:
Select a specific Investigator, site, and/or patient position. The system limits the lists of values to Investigators, sites, and patient positions with the same status codes you specified in step 3.
Choose one: Patient, Patient Visit, DCM, or Discrepancy. The system limits the lists of values to patient visits, DCMs, or discrepancies with the same status codes you specified in step 3.
In the Owning User field, enter a user identifier to be responsible for the DCF. The system sets the field to the current user by default, but you can choose any user in the system who has the necessary database privileges.
Describe the DCF in the Description field. The system displays this freeform text in all subsequent displays of the DCF.
Select standard header and footer text identifiers from their lists of values. (F9 or the List Values button in the toolbar)
Finish:
Click the Create button to create at least one new DCF with all of the current settings. Oracle Clinical creates one DCF for each patient whose records match the criteria.
Click the Back button to close the Create DCF dialog box without saving the DCF.
Click the Clear button to erase all your settings but remain in the dialog box.
Multivariate discrepancies are created by Validation Procedures that compare multiple question responses as variables. You can choose which responses to display in the DCF.
From the single-record view of the Maintain Discrepancy Database window, select the multivariate discrepancy and click the More... button. The Validation Values window opens, listing the procedure variable (question) names whose responses triggered the discrepancy. Select the DCF Report? boxes of each variable whose response value you want to include in the discrepancy's DCF.
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Note: If you determine that a discrepancy has been triggered by another discrepant response, and that the resolution of the original (or primary) discrepancy would resolve the secondary one, you can mark the secondary discrepancy for passive review, associated with the primary discrepancy. See "Group-Marking for Passive Review". |
This section contains the following topics:
To add and remove a DCF's discrepancies, select a DCF and click the Discrepancies button to open the Maintain DCFs window. Opening the Maintain DCFs window in this manner displays only the discrepancies associated with the selected DCF. You can add and remove discrepancies, maintain question and resolution text, and change the current discrepancy.
When you add discrepancies after you have created the DCF, you can only add discrepancies that match the above criteria and are not already ACTIVE on the current DCF.
You can add a discrepancy to a DCF by clicking the Add button. If this button is grayed out, the current status of the DCF does not permit adding to the DCF. The list of values lists all discrepancies not currently assigned to a DCF that correspond to the criteria specified when the DCF was created. Select a discrepancy from the list of values to add it.
You can remove a discrepancy from a DCF by selecting the discrepancy and clicking the Remove button. If this button is grayed out, the current status of the DCF—either FINAL or SENT—does not permit removing the discrepancy.
If you remove a discrepancy from a DCF that has not yet been SENT, the discrepancy is deleted from the DCF. If the DCF has progressed beyond the SENT status, the discrepancy is still visible in the report, but its status is RELEASED.
Note:
When you remove a discrepancy from a DCF, either before or after the DCF reaches a status of FINAL or SENT, it is available for inclusion in other DCFs. Removing or releasing the discrepancy from a DCF does not change its review status.The system generates resolution (if any) and comment text during DCF creation from information in the Discrepancy Database window. You can modify the resolution and comment text of a discrepancy by clicking the Discrepancies button to display the Discrepancies window, selecting a discrepancy, and clicking the Text button to open the editing window. If the fields are grayed out, the current status of the DCF or the system configuration settings do not permit editing.
From the Maintain Data Clarification Form window (from the Conduct menu, select Validation, then select Data Clarification Forms) click the Details button to view all existing DCFs and their details, including the information from the DCF window and Distribution, Non-distribution, and Resolved statuses; selection criteria, and when and by whom the DCF was last printed. In addition, from this window you can click:
Status History. Displays each DCF Status that has been applied to the DCF, a description of the DCF Status, the date applied and the person who applied the status, as well as their comments.
Print History. Displays a record of each printing of the DCF, including the Print Status at the time of the printing, a description of the Print Status, the date printed and person who printed it.
If you have selected a complex set of discrepancies in a DCF and you want to change some of their discrepancy details, you can open your DCF discrepancy set directly in a version of the Maintain Discrepancy Database window. This feature spares you the necessity of recreating the query in the discrepancy database. From the Conduct menu, select Data Validation, then select Data Clarification Forms, then click the Discrepancies button, and finally, the Discrepancy Maintenance button to open the DCF Discrepancy Query window. This window's functionality is identical to the Maintain Discrepancy Database window, except that you can only access it from the default Master profile for your group.
Oracle Clinical automatically assigns page release numbers to all DCF print jobs. When a final version is initially printed, it is assigned a release number of zero. The system increments the release number whenever you reprint the final version.
To see DCF page tracking information, click the DCF Pages button from the Maintain Data Clarification Forms window. The following information is displayed:
Page Number. Each page number corresponds to a printed page.
Release Number. The most recent release number for the DCF Report.
Page Status. You can set a status for individual DCF Report pages if they differ from each other. Available page statuses are: Missing, Sent and Received. If you set a page status that is different from other pages in the same DCF, or different from the DCF Status, the system automatically recomputes the DCF Status (see Table 5-3).
Status Date. The status date identifies when the print job was performed.
Reference Number. This field is enterable and its use is determined by your organization.
Table 5-3 DCF Status for DCFs with Pages of Different Statuses
| Page Statuses Manually Entered | DCF Status Computed by System |
|---|---|
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Sent, Missing |
Sent |
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Sent, Received |
Part Received |
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Sent, Missing, Received |
Part Received |
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Missing, Received |
Incomplete |
Viewing Current Details of Discrepancies on a Page
To see information about the discrepancies that appear on a DCF Report page, click the Page Entries button (from the Conduct menu, select Data Validation, then select Data Clarification Forms, then click the DCF Pages button, and finally, the Page Entries button). You cannot change any of the data in this window, but you can see if the discrepancy review status has changed since the report was printed.
This window displays:
the discrepancy ID of each discrepancy printed on this DCF Report page
the status of the discrepancy on the DCF (for example, Active)
the status date
the discrepancy's current review status
This section describes the status of the DCF itself (different from the DCF Print Status) and how to change it, including:
The DCF Status reflects the stage of the DCF in the review process. You can update it either in the Maintain Data Clarification Forms window or when you submit the DCF Report for execution.
Table 5-4 lists the DCF Statuses that are contained as predefined values in the DCF STATUS CODES installation reference codelist, with an explanation of their usage and a list of the statuses the system allows you to assign a DCF immediately following each one. Your organization can choose to make some of these statuses optional or not active in the OPTIONAL DCF STATUS CODES installation reference codelist
| DCF Status | Usage | Valid Subsequent Status(es) |
|---|---|---|
|
Missing |
All DCF pages have a status of Missing. |
N/A; System resets status to Sent or Received when all pages have a status of Sent or Received, respectively. |
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Created |
System gives status of Created to all newly created DCFs |
Draft, Final, Ready, Sent |
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Draft |
User-defined usage |
Final, Ready, Sent |
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Final |
User-defined usage |
Ready, Sent |
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Ready |
User-defined usage |
Sent |
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Sent |
The paper DCF Report has been sent to the person responsible for reviewing the discrepancies in the report; or DCF pages have a status of Sent, or of Sent and Missing |
Received, Reviewed, Verified, Closed; system can set status to Missing, Incomplete or Part Received if individual page statuses are different from each other. |
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Incomplete |
Some pages have status of Missing and some Received |
Received, Reviewed, Verified, Closed; system resets status to Sent or Received when all pages have a status of Sent or Received, respectively. |
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Part Received |
Some pages have status of Sent and some Received; or Sent, Missing and Received |
Received, Reviewed, Verified, Closed; system resets status to Sent or Received when all pages have a status of Sent or Received, respectively. |
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Received |
DCF Report has been received back from the person to whom it was sent and its status updated accordingly; or all DCF pages have status of Received |
Reviewed, Verified, Closed |
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Reviewed |
The data corrections and comments noted on the DCF Report have been reviewed. |
Verified, Closed |
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Verified |
The data corrections and comments noted on the DCF Report have been verified. |
Closed |
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Closed |
The DCF has been closed, either by the system because data or the validation check has been corrected and the discrepancy system status changed to Obsolete; or manually by setting its review status to a status considered closed such as Resolved or Irresolvable (in this case the system status is still Current and you can still revise the discrepancy. |
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You cannot change DCF Status using the Maintain DCFs window if you have used the REPRINT Print Status and the DCF Status is SENT, RECEIVED, INCOMPLETE, or PART RECEIVED.
You cannot change discrepancy status back to UNREVIEWED.
When you change the DCF Status from the Maintain Data Clarification Forms window, you are restricted to entering one of the following:
the next mandatory status
a status between the current status and the next mandatory status
See codelist DCF OPTIONAL STATUS CODES to determine which status values are optional. By default, any values not listed in optional status codes are required and should exist in the DCF Status Codes Codelist.
You cannot change DCF status from the Maintain DCFs window if you have used the REPRINT print status and the status is SENT, RECEIVED, INCOMPLETE, or PART RECEIVED.
You cannot change discrepancy status back to UNREVIEWED.
To change the DCF status here, enter a value from the list of values for the parameter New DCF Status to Assign. After the system prints the report, it changes the DCF Status to the value you set here. See "About the Parameter New DCF Status to Assign" and Table 5-4, "DCF Statuses".
If you update the status of the DCF's pages individually, the system automatically recomputes the DCF status to Missing, Part Received, or Incomplete when the pages have different statuses, or Sent Or Received after you have set all page statuses to either Sent or Received (see Table 5-4). Until the system has reset the DCF status to Sent Or Received, you cannot reset the DCF status manually.
This section includes the following topics:
Use the DCF Report to print one or more DCFs.
Oracle Clinical keeps track of each printing of a DCF, including the page content of each printing (see "Tracking DCF Pages" and "DCF Print Status").
You can submit the report in three locations:
From the Conduct menu, select Data Validation, and then select DCF Report (portrait)—for a vertical paper orientation
From the Conduct menu, select Data Validation, and then select DCF Report (landscape)—for a horizontal paper orientation)
From the Conduct menu, select Data Validation, then select Data Clarification Forms, and click the Print DCF button. (This produces a horizontal paper orientation.)
From any location, you can print one or more DCFs. The submission form is the same. It is possible to enter invalid criteria combinations. If you do so, the job will not work. Enter submission information as follows:
Single DCF ID If you only want to print a single DCF, enter its ID here. A list of values is available.
If you want to print more than one DCF in the same DCF Report, you can use the next four fields in any combination to set criteria for the DCFs to include.
Batch Status for DCFs If you want to print multiple DCFs with the same DCF status, choose the status from the list of values.
DCF Site If you want to print multiple DCFs with the same site, choose the site from the list of values.
DCF Investigators If you want to print multiple DCFs assigned to the same Investigator, choose the Investigator from the list of values.
Owning User If you want to print multiple DCFs with the same owning user, choose the user from the list of values.
The rest of the report parameters apply to all DCFs included in the report:
DCF Print Status for This Run (Mandatory) Enter the DCF Print Status to assign to this run of the DCF Report. A list of values is available. See "DCF Print Status".
New DCF Status to Assign Enter the DCF Status (different from the DCF Print Status) to assign to the DCF(s) following the execution of the DCF Report. For further information, see "About the Parameter New DCF Status to Assign".
Print Released Discrepancies Y/N (Mandatory) Discrepancies are "released" from a DCF in two ways:
when they are resolved
when the user explicitly removes them from a DCF (the DCF must have a status of SENT or higher). In this case, they are then available for inclusion in another DCF.
When you print a DCF Report, you may want to include discrepancies that have been released from the DCF, especially those that have been resolved.
If you want to print a closed DCF or a DCF from which all discrepancies have been released, you must set this parameter to Yes. No is the default value.
Print Header Page Y/N (Mandatory) If Yes, the system prints the DCF Report with a leading header page that contains the selection criteria. Yes is the default value.
Start at Page 1 for each DCF Y/N (Mandatory) If multiple DCFs are included in the report, you can choose to print them continuously or have each one start on a new page. This setting has no effect for reports on only one DCF.
In addition to the DCF Status, which reflects the DCF's stage in the discrepancy review process, DCFs also have a Print Status. Each time you print the DCF, you enter the Print Status for the current run.
Oracle Clinical enforces the sequence of the DCF Print Status as follows:
Table 5-5 DCF Print Status Sequence
| DCF's Print Status | Valid Subsequent Print Status |
|---|---|
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(DCF not printed) |
DRAFT, FINAL |
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DRAFT |
DRAFT, FINAL |
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FINAL |
REPRINT, COPY |
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REPRINT |
REPRINT, COPY |
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COPY |
REPRINT, COPY |
If the DCF has not been printed or has been printed using Print Status of DRAFT, then the only valid Print Status is DRAFT or FINAL. You can run a DRAFT report for a DCF as many times as you want, but you can run a FINAL report only once.
When you print a DCF Report with a print status of FINAL, the system assigns a release number of zero to that printing, and creates a page release number of zero for each page.
If the DCF has been printed using Print Status of FINAL and another DCF needs to be printed, you must select a Print Status of REPRINT or COPY:
Setting the Print Status to REPRINT creates a new release with a new release number (incremented by one). If discrepancies have been resolved or released since the last time the DCF Report was run, the content of the report will differ, and pages may change.
Setting the Print Status to COPY results in an exact copy of the last run of the report. Even if individual discrepancy statuses have changed, the report is exactly the same as it was at the last run, and has the same release number.
You can see the page-specific contents of a specific version of a DCF Report in the DCF Pages window (see "Tracking DCF Pages").
When you submit the DCF Report for printing, you must specify the status (DCF Status, not DCF Print Status; see "Setting the DCF Status") that you want the DCF itself to have after it is printed. If you are printing more than one DCF in the report, they are all assigned the same status. If you are printing a DRAFT or FINAL DCF, you must enter a value.
The following constraints apply:
You must choose a DCF Status that comes after the DCF Status of the DCF(s) being printed or that status will not be assigned to the DCF. To see the order of statuses, look at the DCF STATUS CODES installation reference codelist.
You cannot enter a status that comes after the next required status. To see which statuses are required, look at the DCF OPTIONAL STATUS CODES installation reference codelist. By default, the required statuses are: Created, Sent, and Closed.
You can also change a DCF's status in the Maintain Data Clarification Forms window (see "Changing the DCF Status from the Maintain DCFs Window") or by changing the status of a DCF's pages.
If you are unable to print a DCF Report, check the following:
If you are printing a DRAFT or FINAL DCF, you must enter a value for New DCF Status to Assign parameter.
If a FINAL report has been printed, the DCF print status must be REPRINT or COPY. Otherwise the DCF print status must be DRAFT or FINAL. You can tell if a FINAL report has been printed by clicking the DCF Pages button. If there are any pages listed, a FINAL report has been printed.
The DCF owning user may not be entered in Oracle Accounts. To check this, use one of the methods below.
You can find the owning user and check their account through the UI.
Query for the DCF in the Maintaining Data Clarification Forms window.
Highlight the DCF and click the Details button. The DCF Details window opens.
Read the Owning User field and make a note of the user ID.
From the Admin menu, select Users, then select Oracle Accounts, and query for the user ID.
If it is not listed, add it.
You can use SQL to check the owning user information.
To find the owning user of the DCF, enter this SQL query:
select owning_user from data_clarification_forms where dcf_id=xxxxx;
If the owning_user query in the above step returns a value, execute this query, substituting the value for returned_value, to check if the owning user has an Oracle user account:
select count(*) from oracle_accounts oa where ORACLE_ACCOUNT_NAME='returned_value';
If the count is zero, the owning user does not have an account.
From the Admin menu, select Users, then select Oracle Accounts, and add the account.
If you entered the wrong criteria for the information you wanted to include in the DCF, you can delete the DCF and create a new one. You can delete a DCF only when its DCF Status is CREATED, DRAFT, CLOSED or FINAL. To delete a DCF, select it in the Maintain Data Clarification Forms form and perform a delete operation. If the operation fails, the current status of the DCF does not permit deletion.
Note:
When you delete a DCF, the system releases all discrepancies associated with it.
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