Defining Reason Codes for Discrepancies

You define reason codes to separate discrepancies into categories. Reasons provide an explanation of why the discrepancy exists.They are called Reasons in RDC and Category in Oracle Clinical.

For more information, see:

• Reason Codes and Descriptions for Manual Discrepancies
  
• Reason Codes and Descriptions for Univariate Discrepancies
  
• Reason Codes and Descriptions for Multivariate Discrepancies
  

Reason Codes and Descriptions for Manual Discrepancies

When a user creates an Operator Comment (a manual field or section discrepancy in RDC Onsite), the system prompts the user to select a reason code from a list of reasons that is populated by the MANUAL SOURCE TYPE CODE reference codelist in Oracle Clinical. The user can also enter an additional explanation for the discrepancy.

You can add and remove values in the reference codelist (see Figure 3-3):

• For each reason you add, enter a value in the Short Value field and the Description field.
• Set one reason to Default. The first time the user creates a manual discrepancy during a login session, the system inserts the default reason. The user can select a different reason. For subsequent manual discrepancies, RDC Onsite displays the last entered reason. The user can always select a different reason.

Oracle Clinical stores the short value in the database.

Table 3-11 Values for MANUAL SOURCE TYPE CODE Reference Codelist

Seq	Short Value	Long Value	Description
1	STUDY ASSUMP	-	Study assumption
2	CRA COMMENT	-	CRA Correction, Investigator consulted
3	CDA COMMENT	-	CRA Correction, Source Data consulted
4	DE COMMENT	-	Data Entry Comment
5	SOURCE DATA REV	-	Source Data Review

Figure 3-3 Defining Reasons for a Manual Discrepancy

Reason Codes and Descriptions for Univariate Discrepancies

The system creates a univariate discrepancy when the data entered does not match the requirements defined in the underlying question, such as data type or length. You cannot change these underlying causes, but you can change the reason text or define more than one reason associated with a single underlying cause, from which the user can choose.

The system automatically populates the reason code and description when it raises the discrepancy.

To define reason codes and descriptions for univariate discrepancies:

1. Open Oracle Clinical.
2. Select Admin, Discrepancy Mgmt Admin, and then select Standard Text Maintenance. See Figure 3-4.

You use the fields in the Standard Text Maintenance form to define descriptions for each type of univariate discrepancy as follows:

• Text Type — Select COMMENT to specify descriptions for univariate discrepancies.
• Sub Type — Select from the list of valid univariate discrepancy types. RDC Onsite uses the text in the Sub Type field to populate the Reason field when a discrepancy of that type is raised.
• Standard Text Name — Ordinarily, you specify a name to match the Sub Type. However, to specify more than one description for a discrepancy type, use this field to specify a unique identifier.
• Default — If you choose to create a selection of multiple descriptions for a certain discrepancy type, select which description is the default value. RDC Onsite uses the default value the first time a discrepancy of that type is raised. The user can always select one of the alternative descriptions provided.
• Standard Text — Specify the description that you want RDC Onsite to display for the discrepancy type raised. Note that you can use variables to include the data value of the discrepant response as well as the definitional components of the question; for example:

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

  where VALUE_TEXT is the data response entered, SAS_LABEL is the SAS label defined for the Question, and DATA_TYPE is the data type defined for the Question.

Figure 3-4 Defining Descriptions for Univariate Discrepancies

Reason Codes and Descriptions for Multivariate Discrepancies

Oracle Clinical raises multivariate discrepancies when user-defined validation procedures detect invalid or inconsistent data. You specify the reason for multivariate discrepancies in the procedure definition; see Oracle Clinical Creating a Study for details. Oracle Clinical displays the reason; RDC Onsite does not.