| Oracle® Clinical Remote Data Capture Onsite User's Guide Release 5.1 E53567-01 |
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PDF · Mobi · ePub |
| Oracle® Clinical Remote Data Capture Onsite User's Guide Release 5.1 E53567-01 |
|
|
PDF · Mobi · ePub |
The Home page of Oracle Clinical Remote Data Capture Onsite (RDC Onsite) lists all the patients in a selected study and site. You work with this data to create, update, review, and maintain patient data.
This chapter includes the following topics:
The general process for entering patient data involves the following tasks:
The studies and sites available to you depend on the studies you are participating in, your user role, and the privileges assigned to you by the study sponsor.
Before you enter or update patient data in a CRF, you should always check that you are using the correct study and site.
At the top-left of the Home page and the Patient Casebooks page, RDC Onsite displays the name of the study and site that you are currently using. For example:
Description of the illustration study_site01.gif
You can click the Study and Site fields to select from those available to you. Note that:
When you log in the first time, RDC Onsite accesses and displays the first study and site available to you.
When you log in again, RDC Onsite accesses and displays the study you last visited.
Most users work exclusively on a single site in a study. If that is the case for you, the study and site you work on are your only choices. You do not need to select the study and site. However, if you work on more than one study or more than one site, always check that you are using the correct study and site before you add or modify any data.
The lists displayed in the Study and Site fields include only valid sites and studies. A valid site must have an investigator and at least one patient assigned. A valid study must have at least one valid site assigned. If the study or site you need is unavailable, contact your Help Desk.
To select the study and site you want to access:
Open the Home page.
Click the Study field and then select a study from the list. Note that RDC Onsite inserts a --Select Site-- message into the Site field and updates the list of sites based on the study you selected: 
Description of the illustration study_site02.gif
Click the Site field and then select a site from the list. RDC Onsite accesses the selected study and site, and then updates the list of patients for the selected study and site.
Caution:
Always make sure you select the site when changing studies in order to refresh the screen with current data.You can similarly change your study and site from the Patient Casebooks page. After you select your study and site, you enter search criteria and click Search to display patient data in the casebook spreadsheet.
When you need to enter data for a patient for the first time, you do not actually add a patient to the study. Instead, you select an unused patient number (ID) from the Home or the Patient Casebooks page. Some sponsors pre-assign patient numbers, so you may know exactly which one to use. In other cases, you are instructed to select the next available patient number.
Unused patient numbers have grayed-out patient icons with a question mark symbol.
Depending on your sponsor's instructions, you can locate a new patient number (ID) in various ways.
To find a patient without entered data, you can:
Scroll through the patients list on the Home page to find the next available patient number
Filter the patient list to show only patients without data entered
Search for a particular patient number, or a range of patient numbers
If your sponsor instructs you to use the next available patient number (ID) for a new patient, select one or more unused patient numbers from the list of patients on the Home page and then proceed to the Patient Casebooks page. Alternatively, you can filter the list to display only those patients without data entered.
You can use the search options to filter the patients list and display only those patient that have no data entered. These patient numbers are available for you to use for data entry.
To filter the patients list to find unused patient numbers (IDs):
Open the Home page.
Click the 
button to expand the Patient Search pane.
Click the Show for status field and then select Patients with no data entered from the list.
Click Search to display only unused patient numbers (IDs).
If at your site, patient numbers are pre-assigned to specific patients, you need to find specific patient numbers or ranges before starting data entry.
To find one patient or a range of patients:
Open the Home page.
Click the button to expand the Patient Search pane.
Enter your search criteria in the Range field to find either a single patient or a range of patients.
You can also click the down arrow to access the list of values for all the patients in the site, together with the respective Casebook. Here you can choose one patient, or click on the More... link at the bottom of the list that opens a separate window called Search and Select: Patient. Pick the patient or perform a search by entering the patient number in the text box at the top of the window and press the Enter key. Once the patient is selected, click Ok.
Click Search to retrieve and display the patients that satisfy your search criteria.
On the Home page, you select the patient numbers (IDs) to start data entry, and then drill down to the Patient Casebooks page to enter data against those patients.
Alternatively, you can select the Patient Casebooks tab, and then search for the patient numbers (IDs) on that page instead. By default, you see the multiple patients view. You can view all the visits for a single patient by choosing Single from the View drop-down list. The single view displays the first patient in the multi-view, then you can navigate through the list to see each patient in turn.
To enter data for one or more patients:
Open the Home page.
Click the row or rows to select one or more patients.
Click the Action menu and then select Multi-Patient View from the list.
The Patient Casebooks page opens and displays the selected patients in the Casebook Spreadsheet. Note that:
The Search pane is collapsed, and the title in the Search pane indicates the number of patients you selected from the Home page. For example:
The breadcrumb displays Home > to indicate your navigation path to the Patient Casebooks page.
By default, the Patient Casebooks page displays in the multiple patients view all the CRFs expected for Visit 1 for the selected patients. You can select another visit, search for a different set of patients, or enter data into a CRF.
See "Using the Patient Casebooks Page" for more information on selecting visits, selecting patients, navigating around the page, and opening CRFs.
After you select one or more patients on the Home page and drill down to the Patient Casebooks page, you click an empty CRF icon (a gray square with a green arrow) to open the CRF in a Data Entry window. You can now enter patient data into the selected CRF.
For more information on opening CRFs, using the tools in the Data Entry window, and entering patient data, see the following sections:
This section contains the following topics:
Searching and filtering in Single Patient Casebook Spreadsheet
You can use the Patient Casebooks page in two alternate views: Single Patient and Multi-Patient. In the Patient Casebooks tab, on top of the page, you can select your view from the drop-down list next to the View button: 
The Single Patient View displays all the visits for a Single patient, starting with the first patient in the multi-patient view list, selected directly from the Home page or as the result of a search by patient number.
The Multiple Patient View shows a single visit for a selection of patients.
About the Patient Casebook Page The Patient Casebooks page — either in multiple or single patient view — is the only page in RDC Onsite from which you can start data entry. It also provides a casebook-oriented view of the expected and entered CRFs for the displayed patients. See Figure 3-1.
To open the Patient Casebooks page, you can:
Click the Patient Casebooks tab to access the page directly in the default multiple patient view.
Select one or more patients on the Home page, and then drill down to the Patient Casebooks page, in either multiple or single patient view.
You navigate to the Patient Casebooks page either by selecting the Patient Casebooks tab or by drilling down from the Home page.
The Patient Casebooks in the single patient view displays the current Study and Site at the top of the page, and has the Search panel collapsed. The middle section is the Patient Summary panel. The Search panel is collapsed if you came from the Home page or the multiple patient casebooks view with a patient selection in effect. Otherwise, the Search panel is expanded to allow you to select a patient or patient range.
Patient Casebook grid is at the bottom of the page and it shows all the visits and CRFs for the patient selected. Patient Summary will include all the information independent of account configuration. Please take into consideration that the panel can include a count of 20 CRF's with discrepancies, but you may be able to see only 10 when you click on the link because of your user role.
The Patient Summary displays up-to-date metrics for the current patient selected.
This includes the following information for the selected patient:
Patient Information — Lists the patient number, entered and expected CRF's, and the dates of the first and latest entry.
CRFs — Lists the number of CRFs with active discrepancies, with other discrepancies, and with no open discrepancies. In addition, lists the total number of CRFs with discrepancies, the date of the first entry (earliest) to a CRF, and the date of the latest entry.
Discrepancies — Lists the number of active discrepancies, other discrepancies, and closed discrepancies for the patient. In addition, lists the total number of discrepancies (active, other, and closed).
CRFs Verification Status — Lists the number of CRFs with the following verification statuses: verified, requires verification, and requires re-verification.
Note:
The Verification Status metrics are visible only to users with BROWSE_VERIFY privileges or higher.CRFs Approval Status — Lists the number of CRFs with the following approval statuses: approved, requires approval, and requires re-approval.
Links — Lists up to three custom links that open other Web pages and provide additional information on the patient. These links are available only if your sponsor customized the Patient Summary Report to include the links. For example, your sponsor may include a link to the Adverse Events for the patient.
Custom Review Status - if your sponsor has defined one or more custom review types, and your account has the appropriate privileges, lists the number of CRFs with the following review statuses: Completed, Required, Not Required and Awaiting Re-Review.
About the Counts in the Patient Summary
In each section of the page, except the Discrepancy Counts, you can click on the links describing the respective metrics in order to filter what you see displayed in the Patient Casebook grid at the bottom of the page.
About the Patient Casebook Spreadsheet
The Patient Casebook Grid displays multiple visits for the patient in focus in the single view page.
Using the Single Patient Casebook page, if the patient has not been assigned to a casebook (only possible in non-flexible studies), you can choose the one to use for data entry. You can also filter the CRFs displayed according to status of verification, approval and number of discrepancies. All the options you have in the Filter drop-down list correspond to a link the Patient Summary Panel. You can also add pages, either for an unplanned visit or other.
Note:
If a filter is applied, such that not all of the patient's CRFs are displayed, performing a group action affects even those CRFs which are not visible. To limit the set of CRFs you are working on, use Search in the CRF Review or Multi-Patient Casebook page.The Patient Casebook spreadsheet in the single patient view displays the visits in rows and the expected, visit-related CRFs in columns. To reach the desired data you can use the vertical scrollbar to view more visits, and the horizontal scrollbar to see more CRFs.
If you have multiple patients queried, you can navigate through the list of patients by using the buttons that embed the patient number, like in the following image:
You can also open CRFs from this page and navigate through them without returning to the Patient Casebook spreadsheet.
If this is a Flexible study, you can change the patient focus, which in turn restricts the visit selection list to those visits expected for that patient.
The Patient Casebooks tab displays by default the multiple patient view where you see a single visit for several patients. The Search pane is collapsed if you came from the Home page with a patient selection in effect. Otherwise, if you selected the Patient Casebooks tab, the Search panel is displayed to allow you to search for patients. 
Description of the illustration pat_case_mpc.gif
If a patient has not been assigned to a casebook (only possible in non-flexible studies), you can select a casebook to use for data entry for such a patient. If all patients are assigned to a casebook, changing the casebook may simply change the ordering of the CRF columns.
You can also change the visit in focus and toggle to the single patient view. Please note that the Single View always displays the first patient in the Multiple View list. You can then navigate through each of the patients in turn.
The Patient Casebooks page in the default multiple patient view displays the patients in rows and the expected, visit-related CRFs in columns.
You can scroll up and down the list to view more patients; you can scroll across (left to right) to view more CRFs within the selected visit.
When working with the Patient Casebooks in Multiple view, the Casebook, Visit Set for patient, and Visit fields work differently, depending upon whether you are working in a flexible or non-flexible study. The Visit Set for patient field does not appear for non-Flex studies.
In a flexible study, all patients are assigned to a casebook and a different set of visits may be expected for each patient, even if the patients are all assigned to the same casebook.
The Visit Set for Patient field allows you to restrict the visit selection to the set of visits applicable to a particular patient. You can select all patients or a particular patient.
If the Patient field is set to All, then:
The Casebook field lists the set of casebooks assigned to the set of patients currently displayed. When you select a Casebook, RDC Onsite reorders the CRF columns based on that casebook.
The Visit field lists all the visits defined for the study. When you select a visit, RDC Onsite updates the Multi-Patient Casebooks page with the CRFs for that visit.
If the Patient field is set to a specific patient, then:
The Casebook field displays the name of the casebook assigned to the selected patient. You cannot change the casebook.
The Visit field lists all possible visits for the patient specified in the Patient field. Even if all the patients are assigned to the same casebook, the visits expected for each patient may be different. Therefore, by entering a specific patient in the Patient field, you can then select a visit from the set of visits relevant only to that patient.
Note:
The Patient field lists only the patients currently displayed in the Patient Casebooks page.In a nonflexible study, patients may or may not be assigned to a casebook, but the set of expected visits is the same for any patient assigned to the same casebook. When setting the visit for nonflexible studies:
The Patient field is not displayed. The value is automatically set to All.
The Casebook field lists all the casebooks defined for the study. For a nonflexible study, the Casebook field:
Defines the order in which RDC Onsite displays the expected and entered CRFs on the Patient Casebooks page for each visit
Represents the casebook to use for patients not assigned to any casebook. For patients not assigned to a casebook, RDC Onsite displays the expected CRFs for the current visit based on the selected casebook.
Note that the value of the Casebook field has little effect if all patients are assigned to casebooks.
The Visit field lists all the visits defined for the study. Select a visit to view the associated CRFs for the currently displayed patients.
You can position the mouse over the patient icon to display the name of the casebook, if any, assigned to the patient.
By default, the spreadsheet heading on the Casebooks page displays only the name of the current visit.
A visit belongs to an interval in the study. An interval denotes the stage of a study and divides the study into logical groupings of visits. An interval can be a phase, a period, or a sub-period. For example, a study may have a screening phase, a dosing phase, and a follow-up phase.
Your sponsor can customize the spreadsheet heading to include the name of the interval along with the name of the current visit. For example:
Interval: SCREENING, Visit: Visit 1
RDC Onsite uses colored icons with various symbols and graphics to represent the current status of each CRF. For example, by looking at a CRF icon, you can determine:
If data entry for the CRF has started, is complete, or is on a second pass
If the CRF has any active discrepancies or other discrepancies
If a custom review or re-review is required, not required, or completed
If the CRF has been verified or if it needs re-verification
If the CRF has been approved or if it needs re-approval
If the CRF is locked
Figure 3-2 shows the CRF icons. See Appendix A, "Description of the CRF Icons" for a detailed description of each icon.
CRF icons appear on the Patient Casebooks page and all Review pages. You open the Data Entry window for a specific CRF by clicking on its associated CRF icon.
| Empty CRF — The Patient Casebooks page is the only page in RDC Onsite that displays the Entry Expected icon (square with a green arrow). This icon indicates that the CRF is empty and you are expected to fill in the data. Click the icon to open the CRF in a Data Entry window and begin to enter patient data. | |
| Entered CRF — An entered CRF contains data and is reflected in all pages. Click an entered CRF icon from the Patient Casebook spreadsheet or any Review page to open it in a Data Entry window and update data. |
When the Data Entry window opens, notice that the title bar displays valuable information for the selected CRF: patient number, visit name, and CRF name, followed by study name, site name, patient number, casebook, user name, and user role.
The schedule for a clinical study includes the intervals (phases, periods, and subperiods), the visits (also called Clinical Planned Events or CPEs), and the CRFs.
A nonflexible study follows the same schedule of treatments, visits, and assessments. Nonflexible studies have a relatively fixed schedule.
On the other hand, a flexible study can have multiple pathways through the trial for different patients. There may be entire intervals (groups of visits) that are required for some treatment groups, but are not required for others.
In addition, not all patients in a flexible study have the same assessments at every visit. For example, a subset of CRFs may be required for patients only if certain criteria are met, such as a detailed smoking history for smokers.
For a flexible study, the study designer uses Oracle Clinical to create a conditional schedule by defining decision points. The designer identifies the particular questions and the responses to those questions that determine which intervals, visits, and CRFs are expected for patients as they progress through the clinical trial.
RDC Onsite displays only the CRFs and visits that are either collected or expected for each particular patient.
As you enter and update data for a particular patient, RDC Onsite automatically:
Checks the data against the conditional rules, if any, defined in Oracle Clinical.
Determines whether the data you entered satisfies one or more of the conditions defined in Oracle Clinical. Each condition may cause different CRFs and intervals to become expected.
Whenever you update data that triggers a conditional rule, RDC Onsite automatically recalculates what is expected for the patient and adjusts the display of the expected CRFs and intervals as necessary.
If the response to a source question meets the define rules, RDC Onsite marks the CRFs or visits as expected for the patient. Furthermore, if the response to the source question changes such that the defined rules are no longer met, any expected CRFs or intervals revert to the status of not expected for the patient.
As you enter, update, and save patient data in a CRF, some CRFs may become expected while other CRFs may no longer be expected. RDC Onsite displays a message if the expected CRFs have changed.
For example, when you open a CRF in a flexible study, the CRFs that are expected may have change because another user may have entered data that caused one or more CRFs or visits to become expected. In addition, when you save a CRF, the CRFs that are expected may change based on the response data you entered.
When the expected CRFs or visits change, you may notice that new CRFs were added to the Casebook Spreadsheet or that some CRFs were dropped from the spreadsheet.
As shown in Figure 3-3, the Patient Casebooks page uses the following characters to indicate which CRFs are not expected for a patient:
Dash (-) symbol — Indicates that the CRF is not expected for the patient.
Letter N beside the CRF icon — Indicates that the CRF is NO longer expected for the patient. In this case, the CRF already has data collected. However, because of an update to the data, the CRF is no longer expected (that is, not expected) for the patient.
For changes in expected visits, RDC Onsite updates the list of visits in the Set Visit Focus: Visit field on the Patient Casebooks page. The Visit field may show new or dropped visits. You can select a patient in the Patient field to display the set of visits relevant only to that patient.
Figure 3-3 Patient Casebooks Page Indicating Changes in Expected CRFs and Visits
In RDC Onsite, the Data Entry window appears in a separate browser window from the application pages. You can have up to three Data Entry windows open simultaneously. Therefore, you can have up to four RDC Onsite browser windows open at a time: one for the application page, such as the Patient Casebooks page, and up to three Data Entry windows. All windows remain active and the title of each browser window is unique.
You can return to the application page you were using, execute another search, or even navigate to another page while a Data Entry window is still open. You can change the context from which the Data Entry window was originally opened. This action has no effect on the status of the Data Entry window, or on your ability to continue work in that window.
Figure 3-4 illustrates the main components of the Data Entry window.
When you are entering and updating data in a CRF, the Data Window provides several options for:
The CRF in the Data Entry window is customized by your sponsor. For questions about the layout of the form, see the training material from your sponsor.
You can use the mouse to select and position the cursor in a field. Alternatively, you can press Tab to go to the next field (from left to right), or press Shift+Tab to go to the previous field.
When you select a field, the field comes into focus. The field in focus is outlined in gray. You can then enter or change a value in the field. RDC Onsite performs a field-level validation after you move from a field.
If a CRF is too long for the Data Entry window, a vertical scroll bar appears to the right of the CRF. If a CRF is too wide for the Data Entry window, a horizontal scroll bar appears at the bottom of the page.
If the CRF has multiple pages, the Data Entry window displays an additional set of page navigation tools:
The number of the current page is displayed against the total number of CRF pages. You can click the icons to navigate to the first, previous, next, or last page of the CRF.
When you open a Data Entry window from a surround page, for example a Patient Casebook or CRF Review page, you can use the Previous CRF link and the Next CRF link to navigate from one CRF to another, without having to return to the page that you started from in order to select another CRF.
A surround page is any page in Oracle Clinical other than the Data Entry Window.
The surround pages impose a sequence on the CRFs, which doesn't change as long as you have a data entry window open. When you click one of these links, RDC Onsite navigates to the next or previous CRF in the sequence. These CRFs include planned CRFs with or without data, existing unplanned CRFs with data, and new CRFs that can become expected.
The Previous CRF and Next CRF links:
Are restricted to the CRFs within a single visit for a single patient when you open the Data Entry Window from the Multi- or Single-Patient Casebooks pages.
Are not enabled when you create an unplanned CRF from a Casebooks page. Once you close and reopen the saved CRF, the links are active.
Are not enabled if you are viewing the first CRF (Previous CRF not active) or the last CRF (Next CRF not active).
May be disabled when you save a CRF if the casebook is re-assigned for the patient while you had the CRF open in the Data Entry window.
You can also press Alt+N to open the next CRF and Alt+P to open the previous CRF in the Data Entry window.
When entering data into a CRF, you may notice that some fields are grayed out and inactive. In addition, you may notice that some fields automatically become visible based on the response data you enter.
When setting up the questions for a CRF, your sponsor can associate one or more conditions with a question. Your sponsor can define a data response value so that when you enter that value, other questions and fields become active, and the cursor automatically moves to a specified question within the same CRF. This technique is called conditional branching.
With conditional branching, your sponsor can define a path through the CRF based on the responses you enter. For example, suppose the CRF has the following question:
Are you pregnant?
If the patient response is Yes, an additional set of questions are now required. RDC Onsite automatically makes the questions active and positions the cursor in the first field for the pregnancy-specific questions.
If the patient response is No, RDC Onsite bypasses the pregnancy questions and moves the cursor to the next field.
When creating conditional questions for a CRF, your sponsor can customize how those questions appear when displayed in the Data Entry window. Your sponsor can choose one of the following options:
Gray out the section in the CRF with the conditional questions. You can see the section, but the questions remain disabled until a response value triggers the condition defined for the source question.
Completely hide the section in the CRF with the conditional questions. The section remains hidden until a response value triggers the condition defined for the source question.
RDC Onsite controls the navigation from field to field based on whether your response value triggers the condition defined for the source question. When the trigger response value is entered, RDC Onsite automatically enables the appropriate section and positions the cursor in the next appropriate question.
The icons in the Data Entry window toolbar facilitate working with the CRF. The toolbar icons appear active or grayed out, depending on the privileges you have, such as update, verify, or approve.
Table 3-1 describes each toolbar icon available in the Data Entry window.
Table 3-1 Toolbar Icons in the Data Entry Window
| Icon | Name | Click this icon to... |
|---|---|---|
|
|
Add Discrepancy |
Open the Add Discrepancy dialog box. |
|
|
Investigator Comment |
Open the Add/Update Investigator Comment dialog box. |
|
|
Delete Row |
Open the Delete Row dialog box. |
|
|
Blank Flag Tool |
Open the CRF Blank Selection(s) Processing dialog box. |
|
|
Verify; |
Open the Verify CRF dialog box. |
|
|
Approve; |
Open the Approve CRF dialog box. |
|
|
Custom Review |
Open the Custom Review pop-up window to view custom review history and update the current custom review status. |
|
|
Custom Review History |
This icon appears if you have the BROWSE_REVIEW privilege, but no update privilege for a custom review type. Use it to open the Custom Review pop-up window to view custom review history. |
|
|
Generate CRF Report |
Generate the CRF report. Once selected, the icon is animated (the arrow revolves) to show that report generation is in progress. |
|
|
CRF Report Ready |
This icon appears when the CRF report has been generated and is current. Select to download the report and view it in a new window. |
|
|
CRF Report Generation Failed |
This icon appears if the CRF report fails to generate. Displays a message that describes why CRF report generation failed. |
|
|
Generate CRF History |
Generate the CRF history. Once selected, the icon is animated (the arrow revolves) to show that report generation is in progress. |
|
|
CRF History Ready |
This icon appears when the CRF report has been generated and is current. Select to download the history and view it in a new window. |
|
|
CRF History Report Generation Failed |
This icon appears if the CRF history report fails to generate. Information on why the report generation failed is stored in the PDR log file, accessible from the Reports tab. |
|
|
Delete CRF |
Open the Delete CRF dialog box. |
|
|
CRF Help |
Open the optional CRF Help provided by your sponsor. This icon appears only if your sponsor provided help text for the CRF. |
|
|
Save |
Save the CRF. |
|
|
Navigate to the previous CRF. This link appears only if a CRF is opened from the Casebooks page. The link is disabled in the first CRF in a visit for a patient. |
|
|
|
Next CRF |
Navigate to the next CRF. This link appears only if a CRF is opened from the Casebooks page. The link is disabled in the last CRF in a visit for a patient. |
|
Navigate to the first page in a CRF. This icon appears only if the CRF has more than one page. |
||
|
Navigate to the previous page in a CRF. This icon appears only if the CRF has more than one page. |
||
|
Navigate to the next page in a CRF. This icon appears only if the CRF has more than one page. |
||
|
Navigate to the last page in a CRF. This icon appears only if the CRF has more than one page. |
||
 |
Close |
Close the CRF and the Data Entry window. |
Note:
You can use combinations of keys including Ctrl on all supported devices except for iPad.The Data Entry window uses color to highlight fields in a CRF that have discrepancies, investigator comments, audit history, or changes since a last verification or approval.
To highlight specific fields in a CRF:
Click Highlight in the toolbar in the Data Entry window.
Select an option from the list. Your options for highlighting are:
Active Discrepancies — Highlights all fields associated with active discrepancies in red. Active discrepancies require action by your user role or group.
Active and Other Discrepancies — Highlights all fields associated with active discrepancies in red and all fields associated with other discrepancies in yellow. Other discrepancies require action by another user role or group.
Closed Discrepancies — Highlights all fields associated with a manually resolved (user closed) discrepancy in green.
All Discrepancies — Highlights all fields associated with active, other, and closed discrepancies in their respective colors (red, yellow, and green).
Investigator Comments — Highlights all fields that have an investigator comment in magenta.
Audit History — Highlights all fields that have changed since original data entry, and therefore have an audit history, in blue.
Changed since last verified — Available if you have the appropriate privileges. Highlights all fields that have changed since the last verification of the CRF in blue. Note that fields whose only update is an update to the investigator comment are highlighted.
Changed since last approved — Highlights all fields changed since the last approval of the CRF in blue. Note that fields whose only update is an update to the investigator comment are highlighted.
Changed since last reviewed — Highlights the fields that changed since the last Review Complete. If the CRF has or had a Review Complete status for multiple review types for which you have update privileges, highlights fields changed after the earliest of the current Review Complete status changes. If you also have browse privileges, these custom review types are ignored. If have only browse capability, highlights fields changed from the earliest of the current Review Complete status changes across all review types.
None — Highlights no fields.
All CRFs, whether empty or entered, already contain basic information such as the study, site, patient, CRF name, and investigator name. You must enter responses to the remaining questions in the CRF. You enter your responses into the appropriate field.
A CRF can have one or more fields into which you insert data. When designing the layout and format of a CRF, your sponsor can define the field as a standard text field or as an extended text field. In addition, your sponsor can define the maximum number of characters allowed in the field.
A standard text field can have up to 200 characters. Most fields in a CRF are standard text fields.
An extended text field can have up to 10,000 characters. In an extended text field, you can enter lengthy comments and narratives, such as patient case history or serious adverse events.
The following privileges apply to both standard text fields and extended text fields:
If you have browse-only privileges, you can view but not edit the data.
If you have update privileges, you can view and modify the data.
When you open a CRF in the Data Entry window, RDC Onsite indicates an extended text field by displaying a yellow note icon to the right of the field. See Figure 3-5.
RDC Onsite always displays the Extended Text icon regardless of whether the field has any data. Once the field has data, the Data Entry window displays the beginning of your extended text followed by the ellipsis (…) character.
To view all the data associated with an extended text field, click the Extended Text icon (that is, the yellow note) to open the Show Extended Text dialog box. Alternatively, you can double-click in the field or use the right-click menu to open the Show Extended Text dialog box.
Note:
You can use double-click or right-click on all supported devices except for iPad.In the Audit History pane, the Discrepancies Details pane, and the Patient Data Reports, RDC Onsite uses the following prefix to indicate that the value is an extended text value:
ATTACHMENT V <X.Y>:
where X is the version number and Y is the sub-version number. The system increments these numbers each time the data in an extended text field is saved.
After the ATTACHMENT prefix, RDC Onsite adds the beginning of your extended text followed by the ellipsis (…) character. For example:
ATTACHMENT V<1.1>: A 21-year-old woman presented…
To enter data in a standard text field in a CRF:
Open a CRF in the Data Entry window.
Click a standard text field. Ensure that the cursor is in the correct field. Alternatively, use the Tab key to move from field to field.
Enter data in the field.
Tab or mouse-click from the field after adding or changing a value. RDC Onsite then performs a field-level validation.
The data you entered may fail a validation check and raise an error. To resolve a validation error, see "Processing Validation Errors During Initial Data Entry" for more information.
A standard text field may contain more information than can be displayed in the space defined on the CRF.
To view the complete text for a standard text field, you can:
Press the left and right arrow keys to scroll through the text.
Double-click the standard text field. The Show Full Text dialog box displays the complete text.
Right-click the standard text field and select Show Full Text from the menu. The Show Full Text dialog box displays the complete text.
Note:
You can use double-click or right-click on all supported devices except for iPad.You can edit text in the Show Full Text dialog box under the following circumstances:
You have update privileges.
The field is not display-only.
The form is not being updated by another user.
The patient data is not frozen.
The CRF is unlocked. But if locked, you have update privileges to the CRF or privileged update.
After you modify text in the Show Full Text dialog box, you can either click OK for RDC Onsite to accept your changes, or click Cancel to close the dialog box without keeping your changes.
In an extended text field, you can enter lengthy comments and narratives, such as patient case history or serious adverse events.
Before you can enter or update data for an extended text field, you must open the Show Extended Text dialog box. You cannot make changes directly in an extended text field in the Data Entry window.
To open the Show Extended Text dialog box, you can:
Click the Extended Text icon next to the field.
Double-click the extended text field.
Right-click the extended text field and select Show Extended Text from the menu.
Note:
You can use double-click or right-click on all supported devices except for iPad.To view or enter data in an extended text field:
Open the Show Extended Text dialog box for the field you want to modify.
Enter new data or update the existing data.
See Table 3-2 for a list of keys that are useful for entering data in the Show Extended Text dialog box.
See "Using Special Characters and Advanced Formatting in Extended Text Fields" for restrictions and recommendations on entering data.
Click OK to process your changes.
If the data in the Show Extended Text dialog box:
Is less than 10,000 characters, RDC Onsite closes the dialog box and returns to the CRF in the Data Entry window.
Is greater than 10,000 characters, RDC Onsite displays an error message that the maximum number of characters allowed has been exceeded. To continue, select one of the following options:
To return to the Show Extended Text dialog box, click Cancel. You can now edit the data for the extended text field and reduce the length of the text.
To automatically delete all characters beyond the 10,000-character limit, click OK. RDC Onsite keeps 10,000 characters only, closes the Show Extended Text dialog box, and returns to the CRF in the Data Entry window.
Click the Save icon in the Data Entry window to save your changes.
Table 3-2 lists several keys that are useful for entering data in the Show Extended Text dialog box.
Table 3-2 Keys for Entering Data in the Show Extended Dialog Box
| Key | Description |
|---|---|
|
Backspace |
Delete the previous character |
|
Ctrl + A |
Select all text in the dialog box |
|
Ctrl + C |
Copy text |
|
Ctrl + V |
Paste Text |
|
Ctrl + X |
Cut text |
|
Delete |
Delete the next character |
|
End |
Move the cursor to the end of the line |
|
Enter |
Insert a line break |
|
Page Up |
Move the cursor to the start of the text |
|
Page Down |
Move the cursor to the end of the text |
|
Tab |
Move the cursor to the OK and then the Cancel button in the dialog box |
Note:
You can use combinations of keys including Ctrl on all supported devices except for iPad.Like all dialog boxes, the Show Extended Text dialog box supports a simple text editor that you use to enter and edit plain text. You can enter standard keyboard alphanumeric characters, punctuation marks, and spaces. However, extended text fields:
Do not support special characters such as symbols, dingbats, accented letters, and ALT characters. Special characters might not display properly in all areas of the RDC Onsite application.
Do not support advanced formatting such as font sizes and styles, alignment, automatic line spacing, automatic numbered or bulleted lists, indents, and tables. If you copy text from a document processing application, such as Microsoft Word, RDC Onsite ignores all advanced formatting.
Keep formatting plain. Use spaces to create indents; use the Enter key to create blank lines.
When defining the study database protocol, the sponsor specifies a list of acceptable values for some fields.
To select a value from a pre-defined list:
Click any header or response field. If a list of values has been defined for the selected field, a magnifying glass icon appears.
Click the Magnifying Glass icon to open a dialog box and view the list of possible values for the field. Alternatively, you can press Alt+L.
Select a value from the list. Use the scroll bar to scroll through the list if necessary. You can also press the up and down arrow keys on the keyboard.
Click OK. RDC Onsite inserts your selected value into the field. (The selected value may appear abbreviated in the field.)
To enter a date, click the Calendar icon beside a date field, and then click a date from the calendar.
Your sponsor defines rules your data entries must meet. For example, you cannot enter a numeral in a field defined as requiring characters. Or, you cannot enter characters in a defined date field that requires numerals. If you enter data that conflicts with defined validation rules, RDC Onsite alerts you accordingly with a Validation Error dialog box.
To process a Validation Error, check that your entered data matches the source data and:
Enter an explanatory comment if you want.
Click OK if the entered data is correct. The Validation Error dialog box closes. You can resume data entry.
Click Cancel if the entered data is incorrect or you want to navigate back to the response field. The Validation Error dialog box closes. RDC Onsite returns the previously saved values to the response field that generated the error.
Note:
Your configuration may suppress the Validation Error dialog box from appearing during data entry or update. In that case, you must deal with discrepancies later.If the Highlight field in the toolbar is set to Active Discrepancies or Active and Other Discrepancies, you see discrepant responses highlighted in red. See Chapter 4, "Managing Discrepancies" for more information routing and resolving discrepancies.
When you are entering or updating the patient data in a CRF, you may want to add an investigator comment to the response.
You can add and update investigator comments from the Data Entry window only. In addition, you can perform these actions only if you have update privileges and if your sponsor has configured RDC Onsite to allow it.
The process to add or update an investigator comment is similar. When you create an investigator comment, RDC Onsite displays an Add Investigator Comment dialog box. If you reopen a saved investigator comment, RDC Onsite displays an Update Investigator Comment dialog box.
To add an investigator comment to a field in the CRF:
Open the CRF in the Data Entry window.
Position the cursor in the field you want to add the investigator comment to, and then click the Investigator Comment icon in the toolbar.
Alternatively, you can right-click a field in the CRF, and then select Investigator Comment from the menu.
Add text in the Investigator Comment field.
Click the Change Reason field, and then select an explanation for this change from the list. Note that:
If the CRF status is Saved Complete, and you add an investigator comment, you may or may not need to provide a change reason as configured by your sponsor.
If the CRF status is Saved Incomplete, you are not required to specify a change reason when you add or update an investigator comment.
If you modify a previously saved investigator comment, you must enter a change reason.
Click the Change Comment field if you want to provide any additional information about your changes or comments.
Click OK to save your changes and add the investigator comment.
See Chapter 5, "Reviewing Investigator Comments" for more information on reviewing investigator comments in the Data Entry window and on working with the Review Investigator Comments page.
The Data Entry window may display a Preferences link if your sponsor choose to include the link when installing the RDC Onsite application.
If the Preferences link is available, you can customize whether RDC Onsite:
Gives you a choice to save the CRF as complete or incomplete
Alerts you if a validation error occurs during data entry or update
To set your preferences for data entry:
Open the Data Entry window.
Click the Preferences link at the top of the window. The Preferences dialog box opens:
Select the appropriate check boxes to set your preferences for data entry.
If the Prompt for Save Complete check box is selected and you save a CRF, RDC Onsite prompts if you want to save the CRF as complete or incomplete.
When you save a CRF as incomplete, its status is Entry Started. By saving a CRF as incomplete, you can:
Save data without raising system-generated discrepancies.
Continue data entry in the same CRF later, without being prompted for a change reason on every field input.
If not selected, RDC Onsite does not prompt you with a choice of saving the CRF as complete or incomplete.
If the Suppress Validation Error Alert check box is not selected, RDC Onsite alerts you to possible validation errors that occur during data entry or data update. You then have the opportunity to correct the data before continuing to the next field.
If selected, RDC Onsite suppresses the error message. RDC Onsite creates a discrepancy when the validation error occurs, but does not alert you to the problem.
Click OK to confirm your choices.
The content, format, and layout of CRFs used in a clinical trial vary from study to study. The information requested on each form may be unique to your study. In addition, you may need help with the type of information required in a field or have questions about a particular field.
When setting up the RDC Onsite application, your sponsor has the option of creating help information for a CRF and for each data entry field in a CRF. You can then open and view this information when you are entering or updating the data in a CRF.
Description of the illustration crfhelp_dew.gif
To view customized help for the CRF, click the Help icon in the toolbar in the Data Entry window. This icon appears only if your sponsor provided help text for the CRF.
To view customized help text for a data entry field in a CRF:
Open a CRF in the Data Entry window.
Right-click a field in the CRF and then select Field Help from the menu. The Oracle Clinical Data Collection Help dialog box displays help text for the question group, help text for the question (that is, the field you selected), and details about how the field is defined in the Oracle Clinical database.
Note:
If visible to you, the Help from the browser toolbar or main menu provides information on browser related issues. It is not the RDC Onsite Online Help that appears within the application.To update the existing data in a CRF, you can use any RDC Onsite page that displays CRF icons: Casebooks, Review CRFs, Review Discrepancies, and Review Investigator Comments pages. You can update data in a CRF by selecting the CRF icon for the patient, visit, and CRF you want to update.
To update a response in a CRF:
Open a CRF in the Data Entry window.
Select a response field.
Change the value of the response.
Navigate to another field. Depending on the CRF status, RDC Onsite processes your change as follows:
For a CRF status of Entry Started (the CRF was previously saved incomplete):
If the entry you recorded is valid, the system accepts the update.
If your response evokes a validation error, the Validation Error dialog box opens. See "Processing Validation Errors During Initial Data Entry" for information.
For a CRF status of Entry Complete:
If the entry you recorded is valid, the Reason for Change dialog box opens. See "Specifying the Reason for Changing a Data Value" for details.
If your response evokes a validation error, a change reason is also generally required for the update. In this case, a combination Validation Error and Reason for Change dialog box opens. See "Processing Validation Errors During Data Update" for more information.
Click Save to save all pending CRF changes.
When you update a CRF previously saved as complete (Entry Complete status), RDC Onsite opens a Reason for Change dialog box.
To enter a reason why you changed a value on the CRF:
Click the Reason field and select an explanation from the list. The Reason field is a mandatory field.
Click the Comment field and enter additional information about why the value was changed.
Click OK to process your changes.
If the CRF was saved as incomplete (Entry Started status), you do not have to provide a change reason.
When a validation error occurs during a data update, RDC Onsite displays a combination Validation Error and Reason for Change dialog box. See Figure 3-6.
This dialog box lets you acknowledge that the current value of the response field raised a discrepancy. In addition, and perhaps more importantly, you can use the dialog box to take immediate action on the discrepancy.
To respond to the validation error, select one of the following actions:
The system lists the discrepant response in the Description field of the Validation Error and Reason for Change dialog box.
To revise data in the discrepant response field:
Click Cancel. The system closes the dialog box, deletes the discrepant response value, rolls back previously entered data, if any, and returns focus to the response field.
Revise the discrepant entry.
Continue to the next field.
If you feel that the entered data is correct, complete the Validation Error and Reason for Change dialog box as follows:
Review the Error Message. Ensure it has relevant information about the data entered.
Enter a comment in the Comment text box.
Select a Change Reason from the dropdown list provided in the Reason field. RDC Onsite also allows for user-supplied change reasons.
Enter an explanatory comment in the Comment field of the Change Reason section, if you want. The OK button becomes active.
Click OK. The dialog box closes and RDC Onsite moves the cursor to the next response field.
See "Changing Your Preferences for Data Entry" for information on disabling validation error messages.
After entering data in the CRF, you must save your changes. Depending upon how your sponsor configures RDC Onsite, you can save a CRF as complete or as incomplete.
Description of the illustration save_dew.gif
To save a CRF, click the Save icon in Data Entry window toolbar. Alternatively, you can press Alt+S.
When you initiate the save of a CRF, one of the following actions can take place:
RDC Onsite displays a Processing... message, and then displays a Saved confirmation message, indicating a successful CRF save. The CRF is always saved as Complete.
RDC Onsite displays a Save Complete? dialog box. This dialog box appears only if RDC Onsite is configured to show it. See "Changing Your Preferences for Data Entry" for information on configuring this prompt.
The Save Complete? dialog box offers you the option of saving the CRF as Save Complete or Save Incomplete. See Figure 3-7.
Click Save Complete if you met the form requirements and data entry is complete.
After you make a choice, the Save Complete? dialog box closes. The system confirms the save through a dialog box and focus returns to the CRF.
When you save complete, RDC Onsite may raise additional discrepancies. If you work with the Highlight option set to show Active, Active and Other, or All discrepancies, and you have used a Save option that does not close the CRF, newly discrepant fields are highlighted in red.
To review and address those discrepancies immediately, see "Resolving and Routing Discrepancies".
When addressing all discrepancies at a later date, see "Finding CRFs with Discrepancies".
Click Save Incomplete if data entry is incomplete, and you intend to complete the document later. Saving incomplete is possible if you at least fill in the header fields in the CRF.
When a CRF is saved incomplete, its status is Entry Started. By saving as incomplete, you can:
Save data without raising system-generated discrepancies.
Continue data entry in the same CRF later, without being prompted for a change reason on every field input.
You must enter data in the header fields of a CRF before you save the CRF either as Save Complete or Save Incomplete. If you try to save the CRF without filling in the header fields, RDC Onsite highlights, and lists the required fields in a Missing Required Responses dialog box. Each field missing an entry in the CRF is highlighted with a red dashed line.
Note:
RDC Onsite treats non-header, mandatory response fields differently from header response fields. RDC Onsite raises a discrepancy when you save without entering a response for a non-header, mandatory question.RDC Onsite automatically prompts you to save your pending changes if you attempt any of the following actions before saving the CRF:
Click the Previous CRF link (Alt+P) or the Next CRF link (Alt+N) if you open the CRF from the Casebooks page.
Click the Close icon or press Ctrl+W to close the dialog box.
Note:
You can use combinations of keys including Ctrl on all supported devices except for iPad.When you select one of these actions, RDC Onsite displays a Save Edits? dialog box.
You can take one of the following actions:
To cancel the attempted action and return focus to the CRF, click Cancel. Pending changes remain unaltered.
To discard pending changes in the CRF and proceed with your selected action, click Discard.
To save pending changes in the CRF and return to the CRF, click Save.
If the CRF was previously saved, the system rolls back all saved values to response and information fields, maintains the current data entry status, and closes the CRF.
If the CRF was not previously saved, the system clears values in all response and information fields, and closes the CRF. The CRF data entry status remains as empty.
Any time you save or delete a CRF, RDC Onsite checks the data and determines if there are any changes to the CRFs or intervals that are expected for the patient.
If new CRFs for the current visit are now expected, then RDC Onsite automatically inserts the newly expected CRFs into the Next/Prev list in the Data Entry window. Note that:
RDC Onsite inserts the newly expected CRFs regardless of the CRF search criteria currently in effect.
RDC Onsite inserts the newly expected CRFs only if you have the proper CRF access privileges and update privileges.
RDC Onsite inserts the newly expected CRFs immediately after the current CRF. You can click Next CRF to view the newly expected CRF.
The newly expected CRFs may include those that have been made newly expected by another user.
If CRFs with data are now no longer expected, then RDC Onsite displays the letter N (no longer expected) next to the CRF icon to indicate the change in status. Note that RDC Onsite indicates this change to the CRF icon on the Casebooks page only.
Upon completion of the save, RDC Onsite alerts you with a message that the expected CRFs have changed.
Your sponsor may instruct you to save the CRF incomplete instead of complete, after your initial data entry. Saving as incomplete lets you return to the CRF, review or update data, and then save the CRF as complete.
No data update is required to change the CRF status from Entry Started to Entry Complete.
Note:
Once a document is Saved Complete, you cannot reverse CRF status from Entry Complete to Entry Started.During a clinical study, patient events may occur that require CRF sections to be marked as blank or to be deleted.
In certain circumstances, you may need to mark a CRF as intentionally blank; for example, if a patient fails to appear for a scheduled visit. When you mark a CRF or a CRF section as blank, its information becomes inaccessible and the section is grayed out. You can mark a CRF as blank only if you have update privileges.
For the CRF currently displayed in the Data Entry window, you can mark a CRF or CRF section blank by:
Note:
You cannot mark a CRF or a CRF section as blank when:The CRF status is Pass 2 Started, Pass 2 Pending, Pass 2 Complete, or Batch Loaded.
The CRF is opened in browse-only mode.
To use the Blank Flag icon to mark a CRF as blank:
Open the CRF in the Data Entry window.
Click the CRF or CRF section.
Click the Blank Flag icon in the Data Entry window toolbar. RDC Onsite displays the CRF Blank Selection(s) Processing dialog box.
Select the check box for how you want to mark this data.
Mark this CRF as having no responses.
Mark section section-name (number) as having no responses. The system lists each section separately.
Click OK. The CRF or the related CRF section is marked blank, associated fields are grayed out, and cannot be updated. If the marked section contains data, the data remains visible until you save the CRF, but the values cannot be modified.
Depending upon the design of the CRFs you use, select the Blank Flag check box in the CRF header or CRF section header. The Blank Flag check box option may not be available to you.
To use the Blank Flag check box to mark CRFs as blank:
Click the CRF or CRF section.
Select the Blank Flag check box in either the CRF header or CRF section header. A CRF Blank Selection(s) Processing dialog box appears with these choices:
Mark entire CRF as having no responses.
Mark section n as having no responses. The system lists each section separately.
RDC Onsite grays out the CRF or the CRF section that you marked blank. If the marked section contains data, the data remains visible but cannot be modified.
If you mark a CRF or CRF section blank, and then unmark and save the CRF, the previous values appear in the CRF without being grayed out.
To enter or modify data after marking a section blank:
Open the CRF that you marked blank in a Data Entry window.
Click the CRF or CRF section.
Deselect the Blank Flag check box.
If a CRF of status Entry Complete was marked blank (sectionally or fully), and you undo the blank selection, you must provide a change reason.
When you save changes after marking the CRF or a CRF section as blank, RDC Onsite deletes any existing responses in the marked sections or CRF. However, header field information is maintained.
The response fields of a repeating question group appear in many rows in the CRF. If necessary, you can delete a row from a repeating question group from within the CRF in the Data Entry window.
To delete a row, you can:
Right-click a field in the row and select Delete Row from the menu.
Click a field in the row and then click the Delete Row icon in the Data Entry window toolbar.
If the CRF status is Entry Complete, RDC Onsite prompts you for a change reason.
You can delete a CRF only under certain circumstances. You can delete a CRF even if changes to it are pending.
You cannot delete a CRF if:
Your sponsor has disabled the Delete CRF icon.
You do not have update or batch update privileges
The CRF is locked and you do not have the privileges to work with locked CRFs.
The CRF data is frozen.
The CRF is being updated by another user.
To delete a CRF:
Description of the illustration delete_dew.gif
Open a CRF in a Data Entry window.
Click the Delete CRF icon (trash can) in the toolbar. RDC Onsite opens the Delete CRF dialog box.
Click the Change Reason field and select an explanation from the list.
The Change Reason field and the Change Comment field appear only if the CRF status is Entry Complete or Blank. These fields do not appear if the CRF status is Entry Started, or Saved as Incomplete with header data entered.
Enter a Change Comment if the field appears.
Select the check box if you want RDC Onsite to remember and reuse your comment information for subsequent CRF deletions.
Click Delete to proceed with the action. RDC Onsite prompts for confirmation that you want to delete the CRF.
To delete the CRF, click OK. RDC Onsite deletes the CRF and closes the Data Entry window.
To cancel the delete operation, click Cancel. The CRF remains at the same status.
The Data Entry Window allows you to generate two reports that are specific to the current CRF, the CRF Report and the CRF History Report.
The purpose of the CRF History report is to provide audit information that is not otherwise available in the data entry window. This includes:
CRF Creation information (user, user role, date and time)
History for fields not displayed in the CRF
Deleted rows and prior history
Prior history if the CRF was ever deleted
The CRF Report is a single-CRF Patient Data Report that includes the CRF representation itself, followed by all available ancillary data, including discrepancies, audit history and approval history.
Both reports are generated in a background process, and the 'download' icon appears when the report completes. You select that icon to open the PDF in a separate window. If data is updated for the CRF after the report has been generated, the 'download' icon changes to a 'stale' icon, indicating that you can no longer view the latest report. You can generate a new report if needed.
The Audit History pane, which appears at the bottom of the Data Entry window, provides a history of the field currently selected in the CRF.
By default, the Audit History pane is collapsed. To open the pane, click the arrow on the horizontal splitter bar at the bottom of the window.
The audit history records the date of change, the content of the field before and after change, the person who made the change, the reason for the change, and the change comment.
To view the audit history of a CRF field:
Open a CRF in the Data Entry window.
Click the arrow on the horizontal splitter bar at the bottom of the window to open the Audit History pane.
Click the Highlight field in the toolbar and then select Audit History from the list. RDC Onsite highlights all fields that have an audit history in blue.
Click a highlighted field. The Audit History pane displays a complete audit trail for the selected field.
To view more information in the Audit History pane, you can:
If the Audit History pane is already open, click a field to view its audit history.
Alternatively, you can right-click a field and then select Show Audit History from the menu.
RDC Onsite automatically opens the Audit History pane and displays a complete audit trail for the selected field.
Because an extended text field can have up to 10,000 characters, the information and the layout of the information in the Audit History pane is different from the layout of other fields. Specifically, the Changed From field displays only the ATTACHMENT prefix and the truncated response text.
In addition, the Changed To, and Comment fields may be lengthy for an extended text field. To display the full text for each field, click the Details button in the Audit History pane.
The Navigator pane appears at the right edge of the Data Entry window. You use this pane to review, in list format, all discrepancies or investigator comments for a CRF.
When you are entering and updating data in a CRF, you can use the Navigator pane:
To view detailed information about a discrepancy or an investigator comment
To view the history of a discrepancy or an investigator comment
To update a discrepancy or an investigator comment
To route or resolve a discrepancy
For detailed information on using the Navigator pane for discrepancies and investigator comments, see Chapter 4, "Managing Discrepancies" and Chapter 5, "Reviewing Investigator Comments."
When you open the Data Entry window for the first time in a session, the Navigator pane is collapsed. Upon subsequent openings of the Data Entry window, the Navigator pane displays as you left it in the previously opened Data Entry window. The Navigator pane reverts to its default state (collapsed) when you log out or when you change to another study.
In the Navigator pane, the List pane and the Details pane organize information and facilitate navigation in the CRF.
The List pane lists the fields in the CRF that have either a discrepancy or an investigator comment, depending on the currently selected tab. The Details pane displays more information about the discrepancy or investigator comment.
When you select an item in the List pane, RDC Onsite:
Scrolls the CRF, if necessary, to display the associated field. The associated field is outlined with a blue dashed line.
Outlines the associated field with a blue dashed line.
Refreshes the information in the Details pane.
When working with the List or Details pane:
To expand or collapse a pane, click the + or – icon in the title bar.
To view long lists, use the scroll bar at the edge of the pane.
To select an item in the List pane, use the mouse or press the up and down arrow keys. In addition, you can click the navigation icons in the List pane to go to the first, previous, next, and last item in the list.
The Patient Casebooks page provides options for:
From the Patient Casebooks page, you can add an unplanned page to a visit using a CRF that has already been used once for the visit. The Add Visit Page button is active only if you have update privileges.
You can add an unplanned visit page when:
There is no space in the initial CRF planned for the visit, and additional information needs to be added, using the same form. In this case, RDC Onsite assigns unique sub-visit numbers to identify each of the CRF instances.
The patient makes an unscheduled visit. In this case, the sub-visit number correlates to a visit that happens after Visit X and before Visit Y. (You add the Visit pages to Visit X.) You can add Visit pages multiple times to include all the required CRFs for the unscheduled visit.
To add a visit page:
Navigate to the Patient Casebooks page.
Enter the search criteria for your patient and click Search.
Click the Visit field and select a visit number from the list.
Select the row with your patient.
Click the Add Visit Page button. The Add Visit Page dialog box opens, listing all the planned CRFs for the current visit, patient, study, and site.
Select the CRF that you want to add to the visit and then click Continue. RDC Onsite prompts you to select a sub-visit to add to the current visit.
Select the sub-visit number from the list. The new CRF is identified accordingly. For example, if the sub-visit is 1 and the CRF is PE, the new visit page is PE.1.
If you have previously added visit pages, there may be more than one choice for a sub-visit. If you are adding a page for lack of space in the first CRF, accept the default.
Otherwise, the sub-visit number may represent actual unscheduled visit numbers, and you should choose accordingly.
Click Continue to add the new page to the current visit.
Return to the Patient Casebooks page to view the new, empty CRF icon in the designated patient row and CRF column of the Casebook Spreadsheet.
Notice that a new CRF column may have been inserted, labeled with both the CRF name and the sub-visit number.
Click the newly inserted CRF icon to open the CRF in a Data Entry window.
Enter data and save the CRF.
Note:
The Add Visit Page dialog box lists the set of planned CRFs for the selected visit and patient. However, during the study design, one or more of these CRFs may have been identified as a CRF that cannot be used for unplanned use. Such CRFs do not appear in the selection list.From the Patient Casebooks page, you can add a page to a visit, using CRFs not already planned for the current visit, with the Add Other Page function. The Add Other Page button is active only if you have update privileges.
To add an Other page to a casebook:
Navigate to the Patient Casebooks page.
Enter the search criteria for your patient and click Search.
Click the Visit field and select a visit number from the list.
Select the check box for your patient.
Click the Add Other Page button. The Add Other Page dialog box opens and lists the CRFs that you can add to the current visit for the selected patient. The dialog box also displays the study and site name.
Select the CRF and then click Continue.
If one or more sub-visits are already added to the visit, RDC Onsite prompts you to select a sub-visit number. Select the sub-visit number and click Continue.
RDC Onsite closes the dialog box and returns to the Patient Casebooks page. If necessary, a new CRF column is added to the spreadsheet. A new, empty CRF icon appears in the appropriate column.
Click the newly inserted CRF icon to open the CRF in a Data Entry window.
Enter data and save the CRF.
RDC Onsite numbers the new CRF based on the total number of planned CRFs for the visit, and the existence of other unplanned pages. For example, if the current visit has three planned pages, and you add your first unplanned page with a CRF called AE, after the third CRF, then the system numbers it as 3 U1.
Note:
The Add Other Page dialog box lists all CRFs in the Oracle Clinical casebook definition that are checked for unplanned use. The list excludes CRFs planned for the current visit.The sponsor designs validation checks to prevent data entry errors and to streamline responses in CRFs. If you enter or update a response that does not meet specified criteria, RDC Onsite prompts you for clarification.
In addition, your sponsor defines complex validation checks as well as the ones that execute when you navigate from a field after entering a value. These complex checks are executed by the Validate patient(s) option provided on the Patient Casebooks page.
According to instructions from your sponsor, you can validate patient data on completion of data entry for a visit. RDC Onsite only validates CRFs of status Entry Complete, and CRFs currently not being updated by another user.
The Validate option is available only if you have update privileges.
To validate patient data after data entry is complete:
Navigate to the Patient Casebooks page.
Select one or more patients.
Click the Action menu in the table bar and select Validate from the list.
Click Continue. RDC Onsite prompts for confirmation that you want to validate the selected patients.
Click Continue. A dialog box confirms the validation of the selected patients.
Click Close to close the dialog box and return to the Patient Casebooks page.
RDC Onsite refreshes the patient and CRF icons in the casebook spreadsheet to reflect the validated CRFs.
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