Configuring the Access Statuses for Discrepancies

RDC uses the access status to control whether a user can take action against a discrepancy.

When Oracle Clinical is installed, the system automatically creates the following DISCREPANCY STATUS role codelists, where role specifies one of the default user roles:

• DISCREPANCY STATUS CRA
• DISCREPANCY STATUS DM
• DISCREPANCY STATUS INV
• DISCREPANCY STATUS SITE

Only RDC uses the set of DISCREPANCY STATUS role codelists. Each codelist is specific to a user role.

In addition, each codelist maps the Oracle Clinical discrepancy review statuses to the RDC discrepancy access statuses appropriate to the user role. RDC uses the codelist to determine the access status of the discrepancies for a user based on the user's role.

For more information, see:

• Access Status Values
  
• Colors Used to Indicate Discrepancy Access Status
  
• Default Entries for the DISCREPANCY STATUS role Codelists
  
• Rules for the DISCREPANCY STATUS role Codelist
  

Access Status Values

In each DISCREPANCY STATUS role codelist, the short value defines the discrepancy review status. Recall that every short value in each DISCREPANCY STATUS role codelist must also appear in the DISCREPANCY REV STATUS CODE codelist.

The long value defines the discrepancy access status. The access status determines whether users in a certain role can take action on a discrepancy.

Long values must be in uppercase. Acceptable values for the long value are:

• ACTIVE — The current user can take action against this discrepancy.
• OTHER — The discrepancy requires the attention of a different user role. You can prevent users from taking action on OTHER discrepancies. See Preventing Update to OTHER Discrepancies for more information.
• HIDDEN — The current user cannot view or take action against this discrepancy.

  This functionality is intended only for section-type discrepancies. At run time, if the user selects a univariate or multivariate discrepancy, the Action drop-down list excludes any action that would route the discrepancy to a status that is HIDDEN for any role.

  Note:

  If you change the long value to HIDDEN for a status that has already been applied to univariate or other types of discrepancies, these existing discrepancies are hidden to users with the relevant role, even though only section discrepancies are intended to allow hiding.
• CLOSED — If the discrepancy was manually closed by a user, any user with UPDATE or UPD_DISCREP privilege can re-open the discrepancy. System-closed discrepancies cannot be re-opened.

Note that the discrepancy access status does not determine what functions a user can perform on the discrepancy or the patient data. The DISCREPANCY ACTIONS role codelists determine what routing and resolution actions each user role can take on a discrepancy.

Colors Used to Indicate Discrepancy Access Status

The following table describes the colors that RDC uses to indicate the status of the discrepancies, if any, in a CRF. RDC uses these colors to highlight the patient icon, the CRF icon, and the individual fields in a CRF.

Note that:

• HIDDEN discrepancies are not highlighted in any color because they are not visible to particular user roles.
• RDC uses green to highlight the fields in a CRF that have a discrepancy that was manually closed by the user. Fields with a system-closed discrepancy are not highlighted.

Color	Access Status	Implication
Red	ACTIVE	The CRF contains at least one open discrepancy that requires attention by the user role to which the current user is assigned.
Yellow	OTHER	The CRF contains only open discrepancies that require the attention of a user role different from the one to which the current user is assigned.
White	CLOSED	The CRF contains no visible open discrepancies. Three conditions may be true for a white CRF or patient icon: The CRF may contain discrepancies that are hidden from the current user's user role. The CRF may have contained discrepancies at one time, but all discrepancies are closed or obsolete. The CRF never had any discrepancies.

Default Entries for the DISCREPANCY STATUS role Codelists

The access status depends upon the current user's user role and upon how you configure each review status to appear to that user role. For example, a discrepancy with a review status of Under CRA Review should appear as ACTIVE to a CRA, but as OTHER to an investigator.

Table 4-1 lists the entries for the DISCREPANCY STATUS role codelists for the default user roles.

If you combine the information in Colors Used to Indicate Discrepancy Access Status and Table 4-1, you can find how a user assigned the DM role sees a discrepancy of review status DM REVIEW with a red highlight (ACTIVE), while a user assigned the SITE role sees the same discrepancy with a yellow highlight (OTHER).

Table 4-1 User Roles and the Default RDC Discrepancy Access Statuses

Short Value – Oracle Clinical Discrepancy Review Status	Long Value – RDC Discrepancy Access Status
	CRA	DM	INV	SITE
UNREVIEWED	ACTIVE	ACTIVE	ACTIVE	ACTIVE
CRA REVIEW	ACTIVE	OTHER	OTHER	OTHER
INV REVIEW	OTHER	OTHER	ACTIVE	OTHER
DM REVIEW	OTHER	ACTIVE	OTHER	OTHER
TMS EVALUATION	OTHER	OTHER	OTHER	OTHER
TMS IN PROGRESS	OTHER	OTHER	OTHER	OTHER
RESOLVED	CLOSED	CLOSED	CLOSED	CLOSED
IRRESOLVABLE	CLOSED	CLOSED	CLOSED	CLOSED
CLOSED	CLOSED	CLOSED	CLOSED	CLOSED
INT CRA REV	ACTIVE	OTHER	HIDDEN	HIDDEN
INT DM REV	OTHER	ACTIVE	HIDDEN	HIDDEN
INT RESOLVED	CLOSED	N/A	CLOSED	CLOSED

Rules for the DISCREPANCY STATUS role Codelist

When entering and modifying values in a DISCREPANCY STATUS role codelist, you must follow these rules:

• Each DISCREPANCY STATUS role codelist must include all short values that appear in the DISCREPANCY REV STATUS CODE codelist, and must not contain any values not in that codelist. When you add a short value to one codelist, you must add the same short value to the other codelist. (An exception is the CLOSED status, described below).

  You then use the Active check box to enable and disable the review status for a user role.

• Each codelist must contain the short value CLOSED, which has a corresponding long value CLOSED. This is the status that is used for any system-resolved discrepancy, that is, a data discrepancy that was resolved as the result of an update to a non-discrepant value.
• The RESOLVED and IRRESOLVABLE short values must have a long value of CLOSED for all roles.
• If a review status is CLOSED for one user role it must be either CLOSED or HIDDEN for all other user roles. Note also that for any review status that appears as CLOSED in a DISCREPANCY STATUS role codelist, the DISCREPANCY REV STATUS CODE codelist must represent the review status with a long value of IRRESOLVABLE.
• The setting of the Active check box determines whether discrepancies of that status are visible to users with the relevant role. If the Active check box is not selected, users with the role cannot see discrepancies of that status. If the Active check box is selected, users with the role can see discrepancies of that status. The way discrepant values are displayed depends on the long value.

  Note:

  Either disabling the Active check box or setting the long value to HIDDEN has the effect of hiding discrepancies of the relevant status from users with the relevant role. However, to ensure compatibility with future releases and to avoid confusion between the two settings, Oracle recommends that you use the Active check box to hide discrepancies. In addition, the Active check box lets you hide all types of discrepancies (section, manual field, univariate, or multivariate). The HIDDEN value lets you hide section discrepancies only.
• If an entry in a DISCREPANCY STATUS role codelist is active, then the corresponding entry in the DISCREPANCY REV STATUS CODE codelist must also be active. If not, the discrepancy configuration is invalid. RDC will display an error message to alert users to the problem.
• The Description field is optional for all entries.
• The setting of the Default check box has no effect. The default status of a new discrepancy is always UNREVIEWED.