Using CRF Page Tracking

Oracle Clinical provides the capability to track each page of a paper CRF online. This capability has three primary benefits. First, it allows you to identify when only a page or two from a document is missing (rather than the entire CRF). The missing page can then either be located or explicitly identified on line as missing. Second, it allows discrepancies to be identified as being on a particular page. This would be helpful if you were discussing a discrepancy with someone by phone. Third, if you are scanning CRFs into the system, the concept of pages (versus documents) becomes very important. Scanners enter documents a page at a time, so it is the concept of a page that is central.

Using this feature requires enabling options at the following Oracle Clinical levels, then the tasks required at each level are described in detail in separate sections:

• Study Definition
• DCI Definition
• DCI Book Definition
• Patient Enrollment or Patient Maintenance
• Data Entry

For more information, see:

• Enabling CRF Page Tracking for a Study
  
• Defining DCIs to Track CRF Pages
  
• Defining DCMs to Track CRF Pages
  
• Defining DCI Books to Track CRF Pages
  

Enabling CRF Page Tracking for a Study

Page tracking must be enabled as part of the definition of a study. You cannot enable page tracking in a study created prior to Oracle Clinical Release 3.1 if data has been entered for that study or if the study is defined as Flexible.

To include page tracking as part of the study definition, you must select the Enable CRF Page Tracking box on the Clinical Study States form. To access the Clinical Study States form, select Conduct, choose Security, then select Clinical Study States.

Defining DCIs to Track CRF Pages

Page tracking actually happens at the DCI level, since the DCI is the equivalent of the CRF. Once CRF page tracking is enabled for the study, complete the following fields for each DCI that you want to track pages for. The fields provide Oracle Clinical with the specifications needed to recognize the information expected on a particular CRF page.

CRF Page Tracking Enabled? specifies whether page tracking is enabled for this DCI. If page tracking was not enabled at the study level, you cannot enable it here.

Page tracking for this DCI is not enabled if this parameter is not selected. However, you may choose to complete the remaining fields in preparation for using page tracking at a future time.

Default Page Numbering Scheme establishes the default page numbering scheme that Oracle Clinical will use for the pages of an expected DCI—a DCI that is specified in the default DCI Book for the specific CPE. This numbering scheme describes how each page of the CRF will be designated in the DCI. This field has a list of values with the following entries:

• SEQUENTIAL – Designate each page by a sequential integer, for example, 1, 2, 3.

• ALPHANUMERIC – Designate each page by an integer plus an alphabetic suffix; for example, 1a, 1b, 1c.

• NUMERIC – Designate each page by an integer plus a numeric suffix; for example, 1.1, 1.2, 1.3.

• USER-DEFINED – A sequence defined by a user-defined database function.

For the user to be able to select the user-defined numbering scheme, its value needs to have been entered in the installation reference codelist CRF PAGE NUMBERING SCHEME.

Unplanned Page Numbering Scheme establishes the default page numbering scheme that Oracle Clinical will use for the pages of an unplanned DCI—a DCI that is unexpected. A DCI is regarded as expected if it is in a DCI Book, has a clinical planned event assigned and an actual event number of zero. Anything else is regarded as unexpected. This numbering scheme describes how each page of the CRF will be designated in the DCI. This field has a list of values with the following entries: SEQUENTIAL, ALPHANUMERIC, NUMERIC.

It is possible to assign an event to a DCM within an unplanned DCI. In this case, the system uses the unplanned scheme for recording pages for that RDCM.

Expected No. of Pages establishes how many physical pages will be in the DCI. This number cannot be changed once production data has been collected with the DCI.

Oracle Clinical does not require you to invoke page tracking for every DCI used in a study with page tracking enabled. You can disable page tracking for an individual DCI. To access the Data Collection Instruments form, from the Definition menu, select DCIs, then choose DCIs.

If your DCI consists of one DCM and is complete on a single page or multiple DCMs all complete on one page, then no further definition is required for CRF page tracking. However, if any DCMs span multiple pages, then you must complete a Page Definition form that describes what Question to expect at the end of each page of each DCM in the DCI. To learn about these definitions, read the next sections.

Defining DCMs to Track CRF Pages

If a DCI spans multiple pages, then Oracle Clinical must be able to determine which page every piece of information falls on. The first step is to specify the pages on which each DCM falls. Use the Data Collection Modules window on the DCI form. The CRF page tracking fields on this form are:

Start Page - The DCI page on which the DCM begins. All pages are given relative to the DCI, and the value entered in this field is validated to check whether this value conforms to the numbering scheme defined for that DCI in the DCI form.

End Page - The DCI page on which the DCM ends. All pages are given relative to the DCI.

To provide the additional information Oracle Clinical requires:

1. From the Definition menu, select DCIs, then choose DCIs.
2. Select the DCI.
3. Click the DCI Modules button.
4. Select the DCM.
5. Scroll the form horizontally until you reach the fields Start Page and End Page.
6. Complete these fields using the descriptions provided above.
7. Save
8. Click the Back button to return to the DCI form.

To expand additional DCIs, repeat Steps 2-7.

For more information, see:

• Defining DCM Pages
  

Defining DCM Pages

When a DCM spans multiple DCI pages, Oracle Clinical must know where on the page the information splits. To do this, specify the final Question on the page on the Data Collection Module Pages window.

This procedure is only required for DCMs that span multiple pages. Note that you do not provide information about the last page of the DCM. The system assumes that Questions coming after the last Question on the previous page are on the last page.

The CRF page tracking fields on this form are:

Field	Usage
Page Relative to DCI	The DCI page for which you are providing information. All pages are given relative to the DCI and are defaulted by the system.
Question Name	The name of the Question that appears last on the page.
Question Occurrence Sn	The Question Group occurrence sequence number that appears last on the page.
Last Repeat on Page	If this Question belongs to a repeating Question Group, that is the last repeat instance that appears on the page. Leave this space blank if the Question is not repeating.
Repeat?	Indicates whether this Question belongs to a repeating Question Group; defaulted by the system.

To provide the additional information Oracle Clinical requires:

1. In the Data Collection Modules window of the DCI form, place the cursor in the row of the DCM you need to expand.
2. Click the DCM Module Pages button.
3. Place the cursor in the first row of the page.
4. Scroll the form horizontally until you reach the final fields on the form.
5. Complete these fields using the field descriptions above.
6. Repeat Steps 3-5 for each page.
7. Click the Back button to return to the DCM form.

Defining DCI Books to Track CRF Pages

The DCI Book is the vehicle for applying the page tracking features of Oracle Clinical to data entry. Once you establish the page tracking criteria for each DCI, group them in study-specific DCI Books. Each study has a default DCI Book. Each patient is also linked to a DCI Book. If you do not explicitly assign a patient to a DCI Book, Oracle Clinical assigns that patient to the default DCI Book for the study. You can change to a different DCI Book in data entry. Defining a Traditional DCI Book further describes defining DCI Books without page tracking.

For more information, see:

• Creating the DCI Book
  
• Defining DCI Book Pages
  
• Describing Each DCI Page
  

Creating the DCI Book

DCI Books are flexible and allow you to truly match your physical CRF book to your online DCIs. As with the DCI definition, you must complete a series of drill-down forms to describe the configuration of the DCI Book to Oracle Clinical. Begin with the Maintain DCI Book form.

To create a DCI Book definition:

1. From the Definition menu, select DCIs, then choose DCI Books.
2. Complete the fields:

   • Status – Database status for the DCI Book; controls the usage and attributes. Choices are P for Provisional, A for Active, or R for Retired. P is the default value for a newly created DCI Book. Since DCI Books are now definitional elements—accurate page tracking is dependent on them—you cannot delete them once you use them to enter production data.

   • Status Comment – Optional field allowing you to comment on changes made to the Status field.

   • Retirement Reason – Optional field allowing you to comment if you retire a DCI Book.

3. Save. To exit the form without specifying CRF page tracking information, select Exit.

Defining DCI Book Pages

If you plan to utilize CRF page tracking, you must now provide additional information about each DCI Book page. Use the following field descriptions to understand how the entry in each field relates to CRF page tracking:

Field	Relationship to CRF page tracking
Display #	Number that represents the DCI's place in the sequence of the DCI Book. The list does not have to be sequential; you can rearrange it so that DCI #4 precedes #2.
Start Page #	Page number assigned to the first page of the physical CRF. Since this number matches the actual number on the physical CRF, the format of this number can be different for each DCI in the book. It is also editable. The only restriction is that there cannot be two identical entries within the column.
DCI Name	Name of the DCI.
Clinical Planned Event	Clinical planned event with which this DCI is to be used.

To define DCI Book pages:

1. In the DCI Book form, place the cursor in the row of the DCI Book you need to expand.
2. Click the DCI Book Pages button.
3. Add a row to this form for each DCI that should be part of this book. Use the field descriptions above and field help to complete each field.

It is important to understand the relationship between the Display # and the Start Page # fields. The display number describes the relative position of the DCI within the book. It is always an integer, but integers in this column do not have to be sequential. The Start Page Number is specific to the DCI. It describes the actual first page of the physical CRF, and each entry in this column can be based on a unique page numbering format.

When you enter a new DCI, if you are using a sequential, numeric, alphanumeric, or user-defined format, Oracle Clinical also calculates how many pages were in the previous DCI and generates an entry in the Start # field. You can change this entry, but you can only use the numbering scheme defined for that DCI; if the Start Page Number is in a different format from the DCI's numbering scheme, the system gives a warning message.

Note:

Do not use identical characters twice within the column. For example, do not define two DCIs that start on page 2a. This can result in missing pages in the patient data and blank casebook reports.

For each DCI you add to this form, complete the steps in the next section.

Describing Each DCI Page

For each DCI described using the previous section, Oracle Clinical provides a DCI Book Physical Pages form. The previous form describes the overall parameters of each DCI within the book—how many pages and the page number of the first page. This form follows up with specific details about each physical page in the DCI. The information in this form is system generated, but you can overwrite fields, as required.

The fields on this form are:

Field	Definition
Seq within DCI	Number that identifies the position of the page within the DCI.
Book Page #	Page number assigned to the individual page that aligns with the number displayed in the first column. This field is editable so you can explicitly match it to its physical counterpart.
Description	Optional field describing the individual page.