1. Administrator's Guide
  2. Configuration Tasks
  3. Configuring Discrepancy Management
  4. Creating Reusable Standard Text for Discrepancies and DCFs

Creating Reusable Standard Text for Discrepancies and DCFs

The standard text utility allows you to create uniform, reusable text for discrepancy comments and error messages and for DCF headers and footers. Using standard text saves time and promotes consistency. There are four types of standard text, used as follows by the system:

  • Comment. Displayed as an error message during Data Entry and Data Entry Update for univariate discrepant responses; also displayed in the Comment field in the Maintain Discrepancy Database window for univariate discrepancies. Oracle Clinical ships with a set of default univariate error messages, one for each type of univariate discrepancy. You can edit the existing default and/or create alternatives to be available for use in Data Entry, Data Entry Update, and discrepancy management; see Customizing Default Standard Text Entries.

    Comment-type standard text is also available by pressing F9 in the Comment field of the Maintain Discrepancy Database window. Comment text is displayed in the Create DCF window List of Values to help the user choose which discrepancy to include in a DCF when creating a DCF by discrepancy number.

  • Internal Comment. In the Maintain Discrepancy Database window, users can enter an original comment in free form text or, by pressing F9 in the Inter Com field, choose from the internal comments you define here.

  • Resolution. In the Maintain Discrepancy Database window, users can enter an original comment in free form text when they resolve a discrepancy or, by pressing F9 in the Res Com field, choose from the resolution comments you define here.

  • Header and Footer Text on DCFs. The header and footer text you define appears on each page of a DCF. See Defining DCF Headers and Footers.

For each type of standard text definition, you can include replacement parameters, or variables. When the system displays the standard text, it substitutes the actual value of the parameter; see Inserting Replacement Parameters.

For more information, see:

Parent topic: Configuring Discrepancy Management

Creating New Standard Text

To create new standard text entries:

  1. From the Admin menu, select Discrepancy Mgmt, then select  Standard Text Maintenance.

    The Standard Text Maintenance form opens, with columns for Text Type, Sub Type, Standard Text Name, a Default box, and a line for the standard text string.

  2. Choose a text type. The text type identifies where the system uses the definition: In DCF headers or footers or discrepancy comments and Data Entry. The choices are: Comment, Footer, Header, Internal Comment, Resolution. For more information, see the introduction in Creating Reusable Standard Text for Discrepancies and DCFs.

  3. Choose a subtype only if you are creating an alternative univariate error text (you must have chosen a Text Type of Comment as well). See Customizing Default Standard Text Entries. Choose the subtype corresponding to the univariate error type for which you are creating a standard text.

    For discrepancy comments, internal comments, and resolution comments, and DCF headers and footers, do not enter a subtype. If you do, the text will not be available for use even though it is successfully saved.

  4. Name the entry in the Standard Text Name field. Each standard text definition must have a unique name. Users see the name and the text definition in the list of values for Comments, Internal Comments, and Resolution Comments of the Maintain Discrepancy Database.

  5. Toggle the Default box. For the COMMENT type, the box controls which standard text value the system displays during Data Entry and DE Update. For HEADER and FOOTER types, a check identifies the default when a new DCF is created. Only one entry can be checked as default for each text type/subtype combination.

  6. Write the text in the Standard Text field.

    You can embed variables in your standard text that the system replaces with values from individual records. Press F9 to see the list of values, select and insert a variable. For more information, see Inserting Replacement Parameters and, for examples of how the system replaces variables with actual values, Table 3-29.

Parent topic: Creating Reusable Standard Text for Discrepancies and DCFs

Inserting Replacement Parameters

Standard text definitions can contain standard replacement parameters, or variables. You can insert one of the replacement parameters shown in the following table into your standard text. When the system displays the standard text, it displays the actual value of the parameter. The replacement parameters are in UPPERCASE and are delimited by backslashes (\); for example, \SAS_LABEL\.

To insert a parameter in a standard text string, put your cursor in the location in the text where you want to insert the variable, press F9 or click the ellipsis (…) to display the list of values, and select it from the list of values. The following table describes each available variable and its source table or view and column.

Table 3-27 Replacement Parameters

Parameter Name Description Source

assoc_id

Associated ID for the discrepancy

discrepancy_management.associated_id

crf_page_no

CRF Page number for the discrepancy

discrepancy_management.crf_page_number

data_type

Data Type of the question

dcm_questions.question_data_type_code

date_time_format

Precision for date and time

dcm_questions.date_time_type_code

dcm_name

DCM Name for the discrepancy

discrepancy_management.name

dcm_prompt

DCM Prompt of the question

discrepancy_management.default_prompt

dcm_subset

DCM Subset name for the discrepancy

discrepancy_management.dcm_subset_sn

decimal_places

Decimal places for a numeric question

dcm_questions.decimal_places

descriptor1

First descriptor for question group

dcm_question_groups.repeat_descr1_label

descriptor2

Second descriptor for question group

dcm_question_groups.repeat_descr2_label

discrete_values

Comma-delimited list of values

discrete_values.discrete_value_value

dvg_name

DVG Name of the question

discrete_value_groups.name

length

Length of the question

dcm_questions.length

lower_bound

Lower bound of the question

dcm_questions.lower_bound

repeat_sn

Repeat sequence number for the discrepancy

responses.repeat_sn

sas_label

SAS Label of the question

discrepancy_management.sas_label

sas_name

SAS Name of the question

dcm_questions. sas_name

upper_bound

Upper Bound of the question

dcm_questions.upper_bound

value_text

Value Text of discrepancy responses.

value_text or responses.exception_value_text

Parent topic: Creating Reusable Standard Text for Discrepancies and DCFs

Customizing Default Standard Text Entries

You can modify the default standard text in the Standard Text Maintenance form. From the Admin menu, select Discrepancy Mgmt Admin, then select Standard Text Maintenance. The window is populated with the default values for each type of univariate error message shipped with Oracle Clinical. The following table lists the default standard text definitions for Oracle Clinical.

Table 3-28 Default Univariate Discrepancy Messages

Discrepancy Type Default Text

data type

Value of \VALUE_TEXT\ for \SAS_LABEL\ is not a valid \DATA_TYPE\

dvg

Value of \VALUE_TEXT\ for \SAS_LABEL\ not found in \DISCRETE_VALUES\

dvg subset

Value of \VALUE_TEXT\ for \SAS_LABEL\ not found in \DISCRETE_VALUES\

length

Value of \VALUE_TEXT\ for \SAS_LABEL\ exceeds expected length of \LENGTH\

lowerbound

Value of \VALUE_TEXT\ for \SAS_LABEL\ below the minimum value of \LOWER_BOUND\

mandatory

Value for \SAS_LABEL\ has not been supplied

missing_pt

Value of \VALUE_TEXT\ for \SAS_LABEL\ is awaiting classification

missing_sct

Value of \VALUE_TEXT\ for \SAS_LABEL\ is awaiting classification

partial date

Value of \VALUE_TEXT\ for \SAS_LABEL\ is an incomplete date or time

precision

Value of \VALUE_TEXT\ for \SAS_LABEL\ exceeds \DECIMAL_PLACES\ decimal places

thesaurus

Value of \VALUE_TEXT\ for \SAS_LABEL\ is not in the lookup thesaurus

upperbound

Value of \VALUE_TEXT\ for \SAS_LABEL\ above the maximum value of \UPPER_BOUND\

Example 3-3 Standard Text

The following table illustrates how you can use standard text definitions with different replacement parameters to create appropriate alternative error messages for DVG univariate discrepancies.

The system generates a different error message from same standard text definition by populating the replacement parameters with values from the question definition and entered data. The first column contains standard text definitions using replacement parameters. The second column shows the error message that would appear during data entry if the operator entered "X" as a response to the question PATIENT_SEX, which has a DVG containing the values M(ale) and F(emale). The third column shows the error message that would result from the same standard text if an operator entered "X" for the question SMOKING, which has a DVG containing the values Y(es) and N(o).

Table 3-29 Examples of Alternative Standard Text for Univariate Errors

Standard Text Sex Example Smoking Example

Value '\VALUE_TEXT\' for question \SAS.LABEL\ is not in expected list '\DISCRETE_VALUES\.'

Value 'X' for question SEX is not in expected list 'M,F.'

Value 'X' for question\SMOKING\ is not in expected list 'Y,N.'

Value of \VALUE_TEXT\ does not exist in Discrete Value Group \DVG_NAME\.'

Value of X does not exist in Discrete Value Group PATIENT_SEX.

Value of X does not exist in Discrete Value Group Yes/No.

Value of \VALUE_TEXT\ for \SAS.LABEL\ is invalid.

Value of X for SEX is invalid.

Value of X for SMOKING is invalid.

Parent topic: Creating Reusable Standard Text for Discrepancies and DCFs