| Oracle® Clinical Conducting a Study Release 5.1 E53564-01 |
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PDF · Mobi · ePub |
| Oracle® Clinical Conducting a Study Release 5.1 E53564-01 |
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PDF · Mobi · ePub |
This chapter contains the following topics:
This chapter describes the Oracle Clinical features that affect how the data entry windows appear to you and how you can work most effectively in them:
This section contains the following topics:
You can determine the DCI sequence for entering data in two ways: by query, or by DCI book.
Query sequencing lets you retrieve RDCIs by specifying field values that Oracle Clinical uses as selection criteria. The retrieved RDCIs are sorted in the order specified with the preference, RDCI Sort Order. The value choices are:
Document Number
Patient - Visit - DCI Name - DCI Date
Entry Order
You cannot use query sequencing when you are working in the Initial Log-In or Initial Log-In and First-Pass Entry tasks, since query sequencing works only in purely data entry modes.
When DCI book sequencing is enabled, you can automate and enforce the order in which DCIs are processed, stepping through the specified range of pages in the DCI book in ascending page order.
If your site enforces the use of DCI books by enabling the study configuration parameter Initiate DE Session Using DCI Book, then the study default DCI book displays automatically when you select an option from the Data Entry menu. DCI books help you organize the DCIs required for a study. You can put all required DCIs in one book or use several.
If your site has enabled CRF page tracking, then the use of DCI books is required. Page tracking is defined through DCI books. Even if CRF page tracking is enabled for a study, you can turn it off for individual DCIs.
Note:
In a flexible study, where not all CRFs or visits are required for every patient, there is no indication in Oracle Clinical data entry of whether or not a visit or DCI is expected for a particular patient--unlike Oracle Clinical's Remote Data Capture (RDC) Release 4.6+, where visits and CRFs are displayed and CRFs are enterable only if they are expected.In Initial Log-In and Entry, the DCI and visit values default from the DCI book, clearing the DCI date whenever the visit changes, and clearing the patient whenever the DCI book reaches the end of its sequence.
In modes that query existing RDCIs, such as first- or second-pass entry, Browse, or Update, you must query against an existing patient position to exercise DCI book sequencing.
When autosequencing in modes that query existing RDCIs, the auto-stepping continues automatically to the next Received DCI that meets the task criteria, or until the end of the DCI book sequence is reached. For example, in first-pass entry, a query against Patient 1 brings back all DCI book pages for Patient 1 with a status of Received or Pass 1 Started, and skips pages not matching these statuses. The book is stepped through sequentially, but only returns pages whose status is appropriate to the current task.
Autosequence is turned on by default in first-pass and second-pass data entry; in other modes it is turned on, so that manually selecting RDCIs is the default. You can turn autosequencing on and off by selecting Autosequence from the Special menu. It is a toggle-type control; if you are in a mode where Autosequence is on by default, select Autosequence to turn it off, and select it again to turn it back on.
When manually stepping through a DCI book, you can select any DCI book page or indicate that you want to step to the next page.
To enter all the DCIs in order, click the RDCI window to enter the data from the first DCI in the book. Oracle Clinical will process each DCI in order.
To enter a subset of DCI book pages, enter the number of the first page in the Start Page field of the DCI Book window, and the number of the last page in the End Page field. Then click the RDCI window.
To enter a single DCI from the DCI book, click the DCI Book Page field that you want to enter, and then click the RDCI window.
DCI book sequencing is based on patient associations. When you are working in Data Entry modes that query existing received DCIs, such as first- or second-pass entry, Browse, or Update, you must query against an existing patient position to utilize DCI book sequencing. If you perform a query and do not fill in the Patient field, DCI book sequencing does not occur, even if DCI book sequencing is enabled.
If you have the proper privileges, you can associate patients to a DCI book in the Design subsystem's Maintain Patient Positions window or the Data Entry subsystem's Maintain Patient Enrollment window.
In each of these windows, the field DCI Book Name establishes the name of the DCI book to associate with this patient position. A List of Values is available. If no DCI Book name is associated with a particular patient position, then Oracle Clinical uses either the DCI book currently used in data entry or the default DCI book assigned to the study when no DCI book is used.
The field is protected if production data has been entered for that patient.
Page tracking actually happens at the DCI level, since the DCI is the online version of the CRF. As you enter data into an RDCI, Oracle Clinical automatically translates that activity into page-level information, if CRF page tracking is enabled.
When you log in a DCI and it is validated, Oracle Clinical creates its pages based on your specifications. It stores a page number and a page-level status. The page numbering scheme is derived from your definition for planned pages. DCIs that do not appear in the DCI book, or DCIs that appear in the DCI book but for another event, use the unplanned numbering scheme. You can edit both the page numbering scheme and the page status. Oracle Clinical maintains a history of these changes, which you can display for that DCI.
When CRF page tracking is enabled for the study, the DCI definition includes information to specify the expected number of pages, as well as a numbering scheme to use for both planned and unplanned DCIs in the book. A DCI is regarded as planned or 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 by the system as unexpected.
Oracle Clinical tries to find the last page of the relevant DCI book for the specified visit. Oracle Clinical adds one unit to that page number, using the unplanned numbering scheme for the specified DCI. If that page number already exists in the book, Oracle Clinical assigns a temporary page number that consists of an "x" concatenated with a sequence number.
If there is no entry in the DCI book for that visit, Oracle Clinical finds the last page of the book and adds one unit, using the unplanned numbering scheme for that DCI.
A relevant DCI book is defined as follows:
a book assigned to a patient
if no book has been assigned to a patient, the book used to sequence the log-in function
if no book is used to sequence the log-in function, the default book defined at the study level
To check on the status of the pages in a DCI:
Select a Data Entry task.
You cannot change the information in the block if you have gone into the form from the Browse task of Log-In.
From the Special menu, select Maintain Page Tracking Status.
Oracle Clinical displays a form with the following fields:
Book Page the page number of the physical page in the CRF.
Page Status one of the status choices displayed in the table below. If the field is completed by the system, Oracle Clinical chooses the status that matches the status of the DCI. If the Blank field is set to Y, then the status of all pages is set to blank. You can manually change the status of any page, using the list of values from the Help menu. For example, if one page of a CRF cannot be located, you can set the status to missing, then perhaps add information in the Comment field.
Has Data? if any data is recorded on the page, this box is automatically checked.
Comment an optional field for comments related to the page.
By default, Oracle Clinical provides the following statuses that apply to CRF page tracking and appear in the Page Tracking field:
Table 2-1 List of Values for Page Status
| Status Value | Description |
|---|---|
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RECEIVED |
Page has been received. |
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UNKNOWN |
Page has no data |
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MISSING |
Page has not been received. |
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BLANK |
Page has been received with no data. |
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PRESENT |
Page has been received with no data and Oracle Clinical did not mark it as blank |
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PASS 1 COMPLETE |
Pass 1 has been performed on this page. |
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PASS 2 COMPLETE |
Pass 2 has been performed on this page. |
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REMOVED |
Page has been removed by the system. |
The following restrictions are in effect if you are trying to change the status displayed in the Page Tracking field:
unknown can only be changed to missing or present
status cannot manually be changed to Received, Pass 1 Complete, Pass 2 Complete, Removed, Blank
status of Received, Pass 1 Complete, Pass 2 Complete, and Removed cannot manually be changed.
You can modify this list of available statuses, by customizing the ChangePageStatus function provided in the ocl_client_pack. Currently this function is empty and returns the string dummy. Whenever the page status changes, Oracle Clinical calls the user-defined function ChangePageStatus. If it returns the string dummy, Oracle Clinical performs some status validations. If the string has a different value, indicating that the function has been customized, these validations are not performed.
In tracking the status of a page, you can go a step further and actually look at the history of changes to that page.
To check the history of a page:
From the Page Tracking Status block, click the History button. Oracle Clinical displays a form with the following fields:
Book Page (display only) the page number of the physical page in the CRF.
Page Status (display only) one of the status choices displayed in the table above. If the field is completed by the system, Oracle Clinical chooses the status that matches the status of the DCI.
Has Data? if any data is recorded on the page, this box is checked.
Comment an optional field for comments related to the page.
Created By a status field maintained by Oracle Clinical to track each individual making a change. It is display-only and tracks based on user IDs.
Created Date displays the date and time when the change was made.
Click Back to return to the previous block.
This section contains the following topics:
The section explains the unique navigation techniques available during data entry. Navigation in Data Entry is different from navigation in the rest of Oracle Clinical, since the underlying structure of the Data Entry windows is different from the rest of the system.
Most of the special functions described in this section can be accessed through the menus, but many functions also have icons on the toolbar or function key equivalents. To see a function key mapping for your keyboard, select Help Key Definitions from the Special menu. In this manual, all special functions are denoted in square brackets, for example, [Next Field].
The behavior of some navigational features can be controlled by configuration settings and user preferences.
When operating in data entry blocks, you can navigate between fields as described in the following sections.
In addition to navigating by mouse, you can navigate between fields by using the [Next Field] and [Previous Field] key sequences. At the last enterable field of a non-repeating block of questions, [Next Field] moves the cursor to the first enterable field of the next group of questions. Within a repeating question group at the last enterable field of a repeat, [Next Field] moves the cursor to the first enterable field of the next repeat, or, if that repeat is not enterable, to the next question group.
Note:
If a field has been defined as nonenterable, the cursor skips over that field when you use [Next Field] and [Previous Field]. However, you can use the mouse to move to the field—for instance, to get field help information; but even in this case, the field is not updateable.In repeating groups, [Down] and [Up] move your cursor to the same field on the next or previous record. If you are on the first repeat, [Up] moves the cursor out of the group into the first field on a line above the current field. When you are on the last repeat, if you cannot create new repeats, [Down] moves the cursor out of the group to the first field on a line below the current field. If you can create new repeats and are on the last repeat, [Down] creates a new repeat.
In non-repeating groups, [Down] moves your cursor to the first field on a line below the current field. Similarly, in non-repeating groups, [Up] moves your cursor to the first field on a line above the current field.
In repeating groups, [Previous Record] and [Next Record] move the cursor to the first enterable field in the previous or next record, respectively.
When navigating into a repeating group, [Up] and [Down] skip blank repeats.
When a DCM question is defined with the auto skip property enabled, the cursor automatically moves to the next field as soon as the field is filled to its maximum defined length.
By design then, a field with auto skip enabled will not accept data greater than the defined length. You can toggle this behavior on or off with a user preference. When disabled, an auto skip field behaves like a normal field and accepts the entry of data of any length, creating a discrepancy for lengths exceeding the maximum length. Auto skip is available only on fields with a length of 20 or fewer characters.
One of the behaviors that can be specified when a question is defined allows for certain responses to trigger the cursor to jump to a target when [Next Field] or [Previous Field] is selected. Within a repeating question group, a target question within the same group but on or before the current question, triggers navigation to the target question on the next repeat.
Conditional branching covers the case where a response to a particular question eliminates the need to answer a number of subsequent questions. During data entry, when you enter the predefined response value to the question with conditional branching defined for it, the cursor automatically moves to the specified target field. You can override the default navigation and enter values in the skipped fields by repositioning your cursor using the mouse or the [Previous Field] keys.
As an example of conditional navigation, consider the question, "Have you ever been pregnant?" If this is defined to have conditional branching, when you enter "NO", the cursor passes over a group of pregnancy-specific questions to the first question and question group not pregnancy-related.
Conditional branching functionality also extends to numeric, time, and date fields. Oracle Clinical supports three methods of conditional navigation, based on the value entered: greater than, less than, or equal to the provided branch value.
Indicator questions automatically have the conditional navigation feature enabled. The target question default is either to the first enterable question following the question group associated with the indicator question, or the last enterable field of a question group if that is the last question group on the form. Standard navigation into the question group occurs when the response value entered equals the indicator value for the indicator question.
As an example of an indicator question, consider the question, "Do you have a history of allergies?". If this indicator question has a defined indicator value of "YES", and you enter "NO", the cursor jumps to the first field following the group of allergy history questions.
This section describes the following navigation features in Oracle Clinical.
[Next Block] and [Previous Block] move your cursor to the first enterable field of the next or previous question group. You can also navigate to any field, at random, by mouse click.
To see the detailed Received DCM window, select the special function [RDCM].
Oracle Clinical behaves in different ways when you have finished data entry on a particular form and selected Save. First, it preserves your changes and returns you to the header. If entry on the RDCM is complete, your changes are saved, and you exit the form. However, if the system determines that the form is not complete—for instance, if mandatory fields have not been filled out, or if fields entered in first pass were not entered in second pass, a message specifies what must be completed, and the cursor is placed in the first incomplete field.
To exit without saving changes, select Exit. If you have pending changes, the Changes Pending dialog box gives you the following choices. If you have made changes, the Changes Pending dialog box offers the options:
Cancel—Places you back in Data Entry and allows you to continue data entry.
Discard—Exits the form and discards all pending changes.
Save Incomplete—Saves pending changes, and exits the form with the RDCM in an incomplete state with a status of pass 2 started.
If you are not in First-Pass Data Entry and have not made any changes, clicking Exit exits the form without confirmation. If you are in First-Pass Data Entry and the RDCM has a status of Received, you can choose Discard or Save as Blank. The Save as Blank option sets the Blank flag to Y.
Note:
You can set the Blank flag to Y in the Initial Login, Initial Login and First-Pass Data Entry, and First-Pass Data Entry modes. If a DCI or DCM has the Blank flag set to Y, it means that this CRF is logged in but the form is blank. Blank RDCIs and RDCMs are not accessible.To go directly to the next form when you leave the last field on the current form, set the user preference Autosequence. If this preference is enabled, Oracle Clinical silently saves your work before proceeding to the next form. If you prefer an audible signal, enable the preference End of Form Beep. Depending on your current entry mode, the cursor returns to the entry header if Log-In cannot be completed or goes to the first enterable data entry field of the next form in sequence.
Table 2-2 Autosequence Impact on RDCIs from Last Enterable Field
| Action | RDCM info Required | Result in Log-In or Key Changes | Result in Log-In and First-Pass Entry |
|---|---|---|---|
|
Autosequence Enabled |
|||
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[Next Field] |
Y |
Cursor moves to RDCM window, then to Data Entry. |
Cursor moves to RDCM window, then to Data Entry. |
|
N |
RDCI/RDCM saved; status set to RECEIVED; RDCI cleared for next RDCI. |
Cursor moves to Data Entry. |
|
|
[Save] |
Y |
Cursor moves to RDCM window, then to Data Entry. |
Cursor moves to RDCM window, then to Data Entry. |
|
N |
RDCI/RDCM saved; status set to RECEIVED; RDCI cleared for next RDCI. |
Cursor moves to Data Entry. |
|
|
[Next Block] |
Y |
Cursor moves to RDCM window, then to Data Entry. |
Cursor moves to RDCM window, then to Data Entry. |
|
N |
RDCI/RDCM saved; status set to RECEIVED; RDCI cleared for next RDCI. |
Cursor moves to Data Entry. |
|
|
Autosequence Disabled |
|||
|
[Next Field] |
Y |
Cursor cycles through RDCI fields. |
Cursor cycles through RDCI fields. |
|
N |
Cursor cycles through RDCI fields. |
Cursor cycles through RDCI fields. |
|
|
[Save] |
Y |
RDCI validated; RDCM displayed to collect RDCM-level information. |
Cursor moves to RDCM window, then to Data Entry. |
|
N |
RDCI/RDCM saved; status set to RECEIVED; RDCI cleared for next RDCI. |
RDCI/RDCM saved; status set to Received; RDCI continues to display. |
|
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[Next Block] |
Y |
RDCI validated; RDCM displayed to collect RDCM-level information. |
Cursor moves to Data Entry. |
|
N |
Completed RDCM window displays; press second time— a message informs you that RDCM is complete. |
Cursor moves to Data Entry. |
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Two types of comments are captured during data entry: Investigator comments and operator comments. These comments are entered in pop-up windows that can contain up to 200 characters of explanatory text.
The Investigator may write an explanatory comment next to the actual question response. Use [Investigator Comment] to enter these comments and associate them with the CRF.
To enter Investigator comments:
Position the cursor in the field for which you want to add the comment.
Select the [Investigator Comment] function.
The Investigator Comment window appears.
Enter the Investigator's comment, exactly as it appears on the CRF.
Select Save to save the new comment and return to the original Data Entry window, or Cancel to discard the comment.
The Investigator comment is saved as part of the response, not in the discrepancy database.
A value with an Investigator comment displays in green, and an Investigator comment lamp (<Inv.>) displays in the Data Entry window title. If there is also a univariate discrepancy or operator comment for the field, the response value displays in red to indicate multiple comments or discrepancies, and the appropriate lamps are displayed in the window title.
As you enter responses from the CRF into the RDCI, you may find errors the Investigator made. However, your company's procedures may require you to enter the response exactly as it appears on the form.
You can use the Operator Comment window to record a comment about how the response appeared on the CRF. Your comment creates a manual discrepancy, which is recorded in the discrepancy database.
To record a manual discrepancy:
Position the cursor in the response field for which you want to enter the operator comment.
Select the [Operator Comment] function. The Operator Comment window appears. Enter information in the following fields:
Operator Comment Reason—A default reason is automatically filled in. If this is not correct, make a selection from the list of values.
Comment—Enter your comment.
Select Save to save the comment and return to the original Data Entry window. The Data Entry window is re-displayed, with the cursor at the beginning of the original input field. Select Cancel if you decide not to make the comment.
A value with an operator comment displays in blue, and an operator comment lamp (<Oper.>) displays in the Data Entry window title. If there is also an Investigator comment for the field, the value displays in red to indicate the presence of multiple comments or discrepancies, and all the appropriate lamps are displayed in the window title.
You can change the Discrepancy Review Status or Resolution if the Resolve Discrepancies During Data Entry configuration setting is enabled.
In Browse mode, the configuration setting Manual Discrepancy in Browse determines whether you can create Operator Comments.
Each of the following attributes is described in a separate section:
The display characteristics of a field indicate information associated with the data in the field. In particular, certain colors indicate the presence of operator comments and univariate discrepancies (blue), Investigator comments (green), and, in the case of comparison reconciliation, comparison failures (field background in blue). When there are both a discrepancy and a comment, or multiple comments for a field, the field is displayed in red.
Date- and time-type data entry fields have special characteristics that are controlled both by their definition within the DCM and, in the case of dates, by the setting of DCM Layout and configuration settings.
Date- and time-type DCM questions have a characteristic that affects their physical appearance: the Date Time Format defined at DCM question definition time indicates, for dates, whether to display the complete day, month, and year portions of the date; just the month and year portions; or the year portion alone. For times, it indicates whether to display hours, minutes, and seconds, or just hours and minutes.
The Date Order formats used for the header information in Log-In are available for Data Entry fields. The Date Order format in effect is specified during definition of a DCM Layout. If dynamic is defined, the form uses the Date Order that controls date display in the header. The data displays in the appropriate Date Order format during entry or Browse mode at any location other than where it was entered.
Table 2-3 Date and Time Formats
| Date Time Format | Display | Date Order Mask |
|---|---|---|
|
DMY |
12-31-1998 31-12-1998 1998-12-31 31-DEC-1998 |
US MM-DD-YYYY EUROPEAN DD-MM-YYYY SWEDISH YYYY-MM-DD STANDARD DD-MON-YYYY |
|
MY |
12-1998 1998-12 DEC-1998 |
US/EUROPEAN MM-YYYY SWEDISH YYYY-MM STANDARDMON-YYYY |
|
Y |
1998 |
All date formats |
|
HMS |
14:10:30 |
HH:MI:SS |
|
HM |
14:10 |
HH:MI |
When entering the responses for date fields, you can either enter all four characters of the year, e.g., "1998", or you can simply enter the last two characters, e.g., "98". The system displays four characters in the field, whichever method you choose.
Note:
You must type all four digits to enter a date in a future year.When assigning a century to years entered during Data Entry with only two digits, Oracle Clinical's default behavior is:
Until January 1, 2000, Oracle Clinical will assume that all two-digit years entered are in the 1900s.
In the 2000s, Oracle Clinical will compare the two-digit year entered with the current year's last two digits. If the year entered is less than or equal to the current year, Oracle Clinical will assume the year is in the 2000s. If it is greater than the current year, Oracle Clinical will assume it is in the 1900s.
You can override this default behavior by typing all four digits.
Some Data Entry fields accept more characters than are displayed on the form. For example, a Comments field may display only 80 characters, but you can enter up to 200 characters. Values longer than the display length scroll within the field, with the exception of fields that have been auto skip-enabled at DCM question definition time (when you have the Auto Skip user preference enabled for the field).
There are two ways to enter or view text in a field longer than the display, if you do not enable the Auto Skip user preference:
Use the field on the Data Entry window by doing the following:
Move your cursor to the field.
Type in all text. The field shows the current characters as you type.
To view the text, use the arrow keys to scroll right and left through the text, or use Scroll Right and Scroll Left.
Use the field editor pop-up window by doing the following:
Move the cursor to the field.
Select Edit. The pop-up window appears, with the cursor at the beginning of the field.
Enter, view, and modify the text. You see all the text in the window at once. Do not enter a carriage return at the end of lines. The editor breaks up lines.
While in an Update mode session, you can return to a field you modified and invoke the [Modify Audit Comment] function from the Special menu or from the toolbar to display the Audit Comment window. In this window you can modify the audit comment you entered. This function is only available before you save your changes.
This section contains the following topics:
The Data Entry features that Oracle Clinical provides assist in populating fields with values. Defaulting — both single and repeating — can only occur in interactive data entry. Loading data in batch mode is not covered under the heading "Data Entry" in this section.
During DCM question definition, a default response value can be defined for a given question in either a repeating or a non-repeating question group. When the field is displayed during both first-pass and second-pass entry, the default value displays in the field and need not be re-entered. If the field is enterable, you can modify the default value. In repeating question groups, single default values are displayed in each row when you first go to a new repeat, but are treated as entered data only if you explicitly enter data for other fields on the repeat.
During DCM question definition, repeating default values can be defined for repeating question groups, and these defaults can be protected so that they cannot be updated. In the Data Entry form, the repeating defaults are displayed in the fields. Unlike non-repeating defaults, entry of any data in any repeat of a DCM question group with repeating defaults causes all the repeat values to be saved.
If the repeating defaults have been protected in the DCM question group by enabling the Protect Repeating Defaults attribute, then the response fields are treated as non-enterable, even if the DCM question itself is enterable. In this case, you can also not insert repeats within the rows or delete repeats from the rows of repeating defaults. However, provided the DCM question group attribute Enforce Max Repeats is not enabled, you can add additional repeats after the end of the repeating defaults. In those repeats, the repeating default fields are enterable.
A DCM question can be defined to require only sight verification during Second-pass Data Entry. In this case, during Second-pass Data Entry, the values of the response fields corresponding to these questions are pre-populated with the first-pass value to allow visual verification of correctness, so that you are not required to re-enter the value. This feature is used most often with long text fields, which can be more efficiently reviewed for accuracy visually rather than by retyping the entire text response.
During data entry, a list of values is available for fields that are defined with an associated Discrete Value Group (DVG).
When you move your cursor into a data entry field that supports lists of values, <List> appears on the status line at the bottom of the window. These lists of values always support autoreduction; they support autofill based on the value of a user preference. Also, entry by sequence number is available for DVGs enabled for it during DVG definition.
Assuming that all appropriate configuration settings and preferences are enabled:
Standard list of values behavior
To display all the values from the list of values for a field in a Data Entry window, select List. All values are displayed for you to choose.
Autoreduction
Autoreduction is enabled for all fields. To use it, enter a few characters in the field, and then click List. Only those values beginning with the characters you entered are displayed. If your entry matches one of the values exactly, or if only one value matches your partial entry, the system returns the value to your field.
Entry by sequence
You can enable this feature at DVG definition time. During Data Entry, if you know the sequence number of the value, enter the number in the data entry field. The system enters the value in the field as you navigate out of the field. For example, if you enter 1 in the Patient Position for Blood Pressure field, that field is automatically populated with the value sitting.
Autofill
If Autofill is enabled, fill in a unique combination of characters that matches only one value from the list of values, and the system fills in the rest of the values.
Duplicate Field, Duplicate Repeat Functions
In a repeating question group, you can copy the value of the same field from the previous repeat by invoking [Duplicate Field].
You can also copy all the values from the previous record to the current record by invoking [Duplicate Record]. The values replace all the values on the current repeat except those in non-enterable fields.
The [Duplicate Record] and [Duplicate Field] functions have no equivalents in non-repeating question groups.
Within a repeating question group, you can insert and delete records by invoking [Delete Record] and [Insert Record]. Within protected repeating defaults you cannot invoke [Insert Record] or [Delete Record] unless you are in Update mode and have the configuration setting Privileged Update enabled.
The [Insert Record] and [Delete Record] functions have no equivalents in non-repeating question groups.
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