| 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 |
Reports in RDC Classic allow you to generate output that incorporates the patient data for your current workset or a different workset that you specify and collates it into a single document. Alternatively, you can produce a CRF report that includes the blank CRFs that comprise a particular workbook.
This section describes each type of report that you can run in RDC Classic, explains the different sections that can be included, and discusses how the different parameters you set can affect the report that is produced.
This section consists of the following topics:
The 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.
This section consists of the following topics:
You use the Reports window to select the type of PDR you want to run. By selecting different options in this window, you can run several different reports.
When you run reports, you have the option to either generate a blank workbook, a blank workbook with patient information, or a report with data for a set of patients that you specify. The primary difference between these reports is that the latter includes response data. The blank workbook report either includes no data or, if you choose the Patient Workbook option, it includes only patient information in each CRF header.
These are the types of reports that you can generate in RDC Classic:
Workbook Report - this type of report does not include response data.
Blank Workbook – this option generates a Blank Case Report Form PDR that consists of all planned CRFs in the Book that you specify. It does not contain response data or CRF header information. To run this report, select Print Blank Workbook in the Reports window.
Patient data CRFs - this type of report includes the header data and the response data currently saved for all selected patients; when you run the report you have the option to:
Use current selections – this option uses the search criteria that is the basis for the current workset. In this PDR, you can set parameters that display the Audit History Report Section and/or the Discrepancy Detail Report Section; set a time period that restricts the CRFs that are included; limit the time period to the last verification or approval operations; and specify the date format that is used in the report. All other aspects of the PDR are controlled by the current search criteria.
To run this report, select Patient Data Reports and the "Use current selections" option.
Specify Report parameters – this option gives you extensive control over the information that is included in the PDR; it allows you make selections that limit the data presented in the PDR based on a variety of parameters that are similar to those offered in the Search Window.
To run this report, select Patient Data Reports and the "Specify report parameters" option.
Note:
When you run a PDR, it only includes those CRFs to which your assigned privileges allow you to view in the RDC Classic Workspace.This section describes the requirements for running reports in RDC Classic.
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.
Each CRF is the same as the version that displays in the Data Entry window; the report simply combines multiple CRFs into a single PDF document. When you run reports, each CRF in the report is representative of the form that the system presents in the Data Entry window.
In addition, you have the option to set the page layout of the report to either portrait, which is the default selection, or landscape format. 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 Discrepancy Detail and Audit History sections in portrait layout, and the CRFs in landscape.
This section describes the components that may comprise a PDR. Certain components are part of every report, while others are only present in specific types of reports or when certain conditions, such as long data values, are present.
This section consists of the following topics:
Each PDR contains a Cover Page, which lists basic information about the report. The PDR may contain the following sections:
Blank CRFs section
CRF Data section
Audit History section
Discrepancy Data section
Deleted CRFs section
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 upper right-hand corner of the pages that are not part of the CRF, such as 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 Blank CRF report, all pages in the report are numbered sequentially.
A cover page is generated for each PDR that RDC Classic produces. The purpose of the cover page is to provide information about the PDR. Table 4-1 describes the components that may be included in a PDR cover page.
Table 4-1 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 fullname 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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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 are used in the current PDR. Its purpose is to provide a reference for reading data and information in the report. |
You have the option to include CRF Data section in the PDR.
All CRF header and CRF section header information that is included in the source CRF is included in the PDR. 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 the following information:
| 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 "Long data values" 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, if placed immediately after the CRF data section.
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 endnotes:
One set corresponds to the superscripts associated with Investigator comments
One set corresponds to the subscripts associated with Long data values
PDRs use endnotes to display any investigator comments that are associated with response fields in the preceding CRF. Note that long data values in the 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 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.
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.
The Audit History Report section is present in a Patient CRF PDR under two conditions:
It has been specified in the PDR definition process, and the parameter is set to "Y" in the Report Submission Window.
An audit history is 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 for each CRF:
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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, and the parameter is set to "Y" in the Report Submission Window.
Discrepant data is 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.
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