| Oracle® Clinical Conducting a Study Release 4.6 Part Number A85201-06 |
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| Oracle® Clinical Conducting a Study Release 4.6 Part Number A85201-06 |
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View PDF |
This chapter contains the following topics:
Patient Data Reports can display clinical data as it would appear in a CRF, and can include Investigator comments, discrepancy information, and an audit history. Alternatively, you can run a report from Oracle Clinical that displays only the audit history.
This section contains the following topics:
The graphic Patient Data Report (PDR) enables you to generate reports that consist of individual or sets of documents, using criteria that you determine. You can use the PDR to print out a set of blank CRFs, which you can then fill in by hand, or you can print out an entire casebook for a particular patient.
You can run the graphic PDR in either Portrait or Landscape format. Launch the Report Submission window for your selected format: from the Conduct menu, select Conduct Reports, then select Data Validation, and choose Graphic Patient Data Report (portrait) or Graphic Patient Data Report (landscape). The format choice affects the non-CRF sections of the report only. Each CRF is presented in the format in which it was designed. This makes it possible, in the case of CRFs with landscape layouts, to have a report with the Audit History Report Section and Audit History Report Section in portrait layout, and the CRFs in landscape.
You can also run the Audit History Report, which prints only the Audit History Report Section of the PDR.
In order to run reports in Oracle Clinical, your system administrator or the sponsor should provide you with the name of a report server to use when you run reports. You should ensure that this name is displayed in the Server/Queue field at the top of the Report Submission window when you initiate the process to run a report.
This section contains the following topics:
In the Patient CRF PDR that is generated in PDF mode, the Audit History, Discrepancy Data, and Deleted CRFs sections are grouped together in an Appendix.
The system provides general information about the report in the header and footer areas of certain pages in the report. Pages that reproduce a CRF display the actual CRF header and footer information.
The information that may be present in non-CRF pages includes:
The CRF number and an abbreviation of the section, with a sub-page number for multipage sections, is displayed in the upper right corner of the End Note pages.
For example, the following may be present in a header:
This indicates that the current page is the second page in the Overflow Section for the fourth CRF in the PDR.
The page number; in the Classic Blank CRF report, all pages in the report are numbered sequentially.
A cover page is generated for each Graphic PDR that Oracle Clinical produces. The purpose of the cover page is to provide information about the PDR. The components that may be included in a PDR cover page are listed and described in Table 10-1.
Table 10-1 PDR Cover Page Components
| Component | PDR Type | Description |
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Title |
Both |
A general description of the contents of the PDR. This may be either:
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Report Run by |
Patient CRF |
The name of the user who initiated the PDR. This is the full name that is associated with the user name. |
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At |
Patient CRF |
The timestamp that the system started to run the report. |
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Book |
Blank Workbook |
The name of the book you designated for the report. |
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Patient |
Blank Workbook for Patient |
The name of the patient whose information is printed in the blank CRFs. Note that in Patient CRFs, this information may be included in the Report Parameters. |
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Filter |
Patient CRF |
A listing of the search criteria when you choose Use Current Selections in the Reports window. |
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Report Parameters |
Patient CRF |
A listing of the parameters you selected in the Report Submission window. |
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Legend |
Patient CRF |
A display of font styles and formatting that is utilized in the current PDR. Its purpose is to provide a reference for reading data and information in the report. |
The cover page for the blank workbook PDR includes:
the name of the study
the name of the book
The blank workbook for a patient also includes the patient number.
The CRF Data section is present in all graphic PDRs.
All CRF header and CRF section header information that is included in the source CRF is included in the PDR. The layout of this section is similar to the layout in the respective PDF or character CRF. The fields that are included in this section are:
| Patient (with initials) | Frozen (if the Patient is frozen) |
| Site Name | Investigator Name |
| CRF Number | Blank Flag Status (Y or N) |
| CRF Status (data entry status) | Visit Date |
| Visit Name (CPE) | Document Number |
| Entry Time | Entered By |
| Latest Modification Time | Locked Status (Y or N) |
| Discrepancy Status | Approval Status |
| Approval Time | Approver Name |
| Verification Status | Verification Time |
| Verifier | Comment Text |
If the CRF is multi-section or single-section with a CRF section header, the PDR includes a section that displays the CRF section information above each section.
| CRF Section Name | CRF Section Number (out of total, if there is more than one section) |
| Blank Flag Status (Y or N) | CRF Section Status |
| Visit Name | Visit Date |
| Visit Time (if supplied) | Entry Time |
| Lock Status (if the section is locked) | Modification Time |
| Lab (if present) | Qualifying Question (if present) |
There are fields at the top of the CRF that provide information about the approval and verification status. If the CRF is verified and/or approved, the PDR lists the user name of the person who performed the action and the timestamp the action occurred in the relevant fields.
All response data is included in the PDR. However, certain aspects of the PDR format may restrict how data values that exceed the width of the data width are presented. Refer to the "Long Data Values" section for further information.
The response values that are displayed in the PDR may be formatted to indicate the presence of discrepancies and/or an audit history.
response values associated with a univariate or manual data discrepancy are printed in bold style font
response values for which an audit history exists are printed in italic style font
response values that are discrepant and possess an audit history are printed in bold and italic style font.
End notes are used to give complete information about response data without interrupting the formatting or flow of the CRF Data Section of the PDR. The End Note section, if present, is placed immediately after the CRF Data Section. There are two types of information that may be included in the end notes of reports that are run: long data values and Investigator comments.
As the name implies, end notes are located at the end of each CRF Data Section in a PDR. There are two sets of numbered end notes:
one set corresponds to the superscripts associated with Investigator Comments
one set corresponds to the subscripts associated with Long Data Values (note that long data values are handled differently in Classic and PDF data entry modes)
PDRs that are run in Classic mode use end notes to display any Investigator comments that are associated with response fields in the preceding CRF. Note that long data values in the Classic PDR are displayed in-place, by wrapping the text.
If an Investigator comment is associated with a datapoint, a superscript is inserted adjacent to the field. The superscripts start at "1" for each CRF and increment regularly for each occurrence of an Investigator comment. The entire content of each Investigator comment is viewable in the Investigator Comments section, which is in the End Notes.
Response data values that exceed the length of the response field in the CRF PDF are marked with a subscript number adjacent to data field. The subscripts start at "1" for each CRF and increment regularly for each long data value in the CRF. The entire contents of the response field is included in a listing of such values in the Overflow section, which is in the End Notes.
The exception is responses to questions of type Extended Text. For these questions, the CRF PDF displays a prefix beginning with the word "ATTACHMENT" in uppercase and including the version number of the attachment that contains the full text of the response, then the beginning of the response text. There is no superscript.
Note:
The version number includes a subversion number following the decimal point; for example, 4.3 where 4 is the number of times a user revised the text and .3 is the number of times the system stored the text, which happens each time the user closes the Show Extended Text dialog box by clicking OK after updating text in RDC Onsite. The subversion number is used for internal auditing only.In addition, for each Extended Text question response there is a separate ancillary page labeled with the name of the CRF and the question. If the text, which can be up to 10,000 characters, does not fit on one page, the report includes additional pages as required. The Extended Text ancillary data pages are not included in the Overflow section.
If a discrepancy is associated with the CRF, the PDR inserts a hyperlink after the End Notes section that allows you to navigate to the Discrepancy Data section. Similarly, if any response value in the CRF contains an audit trail, the PDR inserts a hyperlink at the bottom of the Response Data section that allows you to navigate to the Response History section.
If an Extended Text Question response has one audit history entry, the Extended Text Audit History page displays the full "Changed From" text. The "Changed To" value is displayed as the current data on the Extended Text ancillary page. If there are multiple audit history entries, the Changed From value is in the previous entry. Extended Text ancillary pages are the first ancillary pages displayed after the CRF data page.
The Audit History Report section is present in a Patient CRF PDR if the following two conditions are met:
It has been specified in the PDR definition process, that is, the Report Response History? parameter is set to Y when the report is submitted.
There is an audit history associated with at least one datapoint in the associated CRF.
There is a separate page or set of pages for each CRF in the report that contains an audit trail. The following information is included:
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Note:
If an Extended Text question response has an audit history, the Audit History section displays:ATTACHMENT V<X.Y> where X is the version number of the full text attachment and Y is a number used for internal auditing only; for example, 4.3 where 4 is the number of times a user revised the text and .3 is the number of times the system stored the text, which happens each time the user closes the Show Extended Text dialog box by clicking OK after updating text.
A portion of the response text.
For CRFs entered from RDC Onsite, the CRF creation timestamp is the time the document was first saved, whether saved Complete or Incomplete.
When combined with field-level audit history, the complete history for each field can be constructed, with the caveats noted below.
For responses initially saved as null, while the CRF is in status Pass1 Started or Entry Started, the time a response changed from null to not null is not available. Once the CRF is saved Complete, field-level audit histories include an entry for the change from null to not null.
If optional DCI and DCM header fields like Comment are not entered with initial data entry, the times these fields changed from null to not null values are not available.
If a DCM is marked Blank with the initial save, and responses are subsequently entered, the times these responses were entered after the blank flag is unchecked are not available.
However, the Blank Flag history itself indicates the time the blank flag is unchecked. It can be assumed that at least one, if not all responses would have been entered at that time. Further, assuming the document is saved Complete at this time, subsequent changes of other fields from null to not null values is reported as part of the audit histories for those fields.
The Discrepancy Data section of the PDR lists the discrepancies that are associated with the data that is presented in the CRF Data Section. It is present in the PDR under two conditions:
it has been specified in the PDR definition process, that is, the Report Discrepancies? parameter is set to Y in the Report Submission window, and
there is discrepant data in the associated CRF.
The discrepancies associated with a given CRF are set off in a separate subsection. However, more than one discrepancy record may be present on each page. For each discrepancy, the PDR includes the following information:
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This section lists all CRFs that have been deleted. If the report includes CRFs that have been deleted, they are listed in this section, which is located at the end of the PDR.
The Audit History Report is a subset of the Graphic PDR that includes the Audit History Report Section only.
To run the Audit History Report:
From the Conduct menu, select Conduct Reports, select Data Validation, then choose the report orientation you want to use: Audit History (portrait) or Audit History (landscape).
Choose a site. The Audit History Report returns data from exactly one site.
Enter the starting patient number. This parameter is required.
(Optional) Enter an ending Patient Number. If you leave this parameter blank, the report returns the audit history of the patient in the Starting Patient field only.
(Optional) Choose a date range for which you want to examine audit history. You can choose a starting date, ending date, and qualify whether these dates represent the visit date or the date that data was first entered in the system.
(Optional) Choose an approval status for data included in the report. Approval status choices are: Approved, Not Approved, Undone (for data that was once approved but approval was removed), and Awaiting Reappr (for data that has been modified since approval). You can also choose All Statuses to include data regardless of approval status setting.
(Optional) Choose a verification status for the report data. Verification statuses include: Verified, Not Verified, Awaiting Re-Ver, and Undone. You can also choose All Statuses.
Submit the job, schedule its submission, or click Job Details.
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