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Oracle® Clinical Administrator's Guide
Release 4.6.2

E18818-02
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7 Reference Codelists

This section, which describes Oracle Clinical reference codelists, includes the following topics:

Overview of Reference Codelists

Oracle Clinical uses reference codelists for a wide range of functionality. Certain codelists are used internally by the application, while others set the values the system presents to users performing various tasks in the application. There are different types of reference codelists that are used by different subsystems. Some types of codelists are set during the installation of the application and others are set by users during various tasks.

Although the values of certain codelists are listed and described in this section, you can quickly view the values of any codelist by running the Reference Codelist report. See "Running the Reference Codelists Report" for instructions.

Depending on your assigned roles, you can perform the following types of reference codelist maintenance tasks:

Accessing and Modifying Reference Codelists

You may have authority to access only some of the types of codelist values. In any case, you cannot create new codelists; you can only add values to existing codelists.

You may modify only the following types of codelists:

System codelists are used internally by Oracle Clinical, and cannot be modified.

Viewing Original Reference Codelist Settings

To see the initial settings for a codelist shipped with Oracle Clinical, go into the Developer's Toolkit, Maintain All Codelists, and query for a codelist. You can access all types of codelists through this window, including local, installation, design, and system codelists.

Working in the Maintain or Query Reference Codelists Windows

When you query or maintain a codelist, the system displays the Reference Codelists window. Figure 7-1, "Maintain Reference Codelists Window" depicts a typical "maintain" reference codelist window, which allows you to modify the values in a codelist.

Figure 7-1 Maintain Reference Codelists Window

Description of Figure 7-1 follows
Description of "Figure 7-1 Maintain Reference Codelists Window"

Access

You access the reference codelist windows through the menu paths that are available under the Admin, Reference Codelists path. The available selections are:

  • Local Codelists

  • Qry Local Codelists

  • Installation Codelists

  • Qry Installation Codelists

  • Design Installation Codelists

  • Qry Design Installation Codelists

  • Qry System Codelists

The selections that are prefixed "Qry" open the window in query mode, that is, you can view the codelists only. The other selections open the window in maintenance mode, in which the system allows you to modify the codelist. Note that you can only open the System Reference Codelists in query mode because that set of codelists cannot be modified.

Components

The reference codelist windows consist of two sections: an upper section that identifies the current codelist and provides information about it; and a lower section that lists the values associated with the current reference codelist. Table 7-1, "Components of the Reference Codelist Section" describes the components that comprise the upper section of the window.

Table 7-1 Components of the Reference Codelist Section

Component Type Description

Name

Field

Displays the name of the current reference codelist. In addition, you can use this field to query for a specific codelist.

Active

Check box

Specifies if the codelist is active. You cannot update this component.

Default

Field

Lists the default value, which is the value for which the Default check box in the Values section is selected.

Description

Field

Displays a system-specified description of the current reference codelist.

Type

Field

Displays the type of current codelist.

Data Type

Field

Displays the data type for the values in the codelist.

Max Short Len

Field

Displays the maximum number of characters allowed for the Short Value of each reference codelist value.

Max Long Len

Field

Displays the maximum number of characters allowed for the Long Value of each reference codelist value.

Application

Field

Displays the subsystem with which the codelist is associated.


The lower portion of the window contains the values that are associated with the current reference codelist. In the maintenance windows, you use this section to modify the values. Table 7-2, "Components of the Reference Codelist Values Section" describes the components in the lower portion of the window.

Table 7-2 Components of the Reference Codelist Values Section

Component Type Description

Seq

Field

Displays the sequence number of the value

Short Value

Field

Displays the short value for the value

Long Value

Field

Displays the long value for the value

Active

Check box

Specifies if the value is active, that is, if it is included when the system accesses the reference codelist

Default

Check box

Specifies if the value is the default value for the reference codelist

Description

Field

A text explanation of the value

Exit

Button

Closes the window

Save

Button

Commits all pending changes to the database


Usage

This section provides instructions for basic tasks you can use the reference codelists windows.

Query a reference codelist

To search for a specific reference codelist:

  1. With focus in the Name field, press the F7 key. This puts the system in query mode.

  2. Type the name of the codelist, using the wildcard ("%") as necessary, to construct the search string.

  3. Press the F8 key. The system runs the query and displays the first codelist returned in the Name field.

Navigate a list of codelists

If more than one codelist is returned, there are several methods you can use to navigate to a specific entry:

  • Use the Page Up/Page Down or the Up/Down arrow keys to move one entry up or down in the list.

  • Use the Move, then Last Record to move to the bottom of the list.

  • Use the Move, then First Record to move to the top of the list.

Add a value

To add a value to the current reference codelist, you must be working in the Maintain Reference Codelist window.

  1. Place focus in the row immediately above the location in which you want to add the value.

  2. Select the Data, then Insert Record menu command. The system places a blank row below the current row.

  3. Modify the fields for the row, as appropriate.

Adding a Value to a Reference Codelist

To add values to an existing local, installation, or design installation codelist:

  1. Select Admin, and then Reference Codelists. Choose one option to display the Reference Codelists window for one of these codelist types:

    • Local Codelists

    • Installation Codelists

    • Design Installation Codelists

  2. Find the reference codelist you want: start a query, enter query criteria in one or more enterable fields to define the search, and then execute the query. Use the arrow keys to scroll to the codelist you want.

  3. Click Next Area to move to the Reference Codelist Values block.

    If there are no records, the record lines are blank and you can go to Step 5.

    If there are records, place focus in a field that is one row above the row you want to add. Select Data, then Insert Record.

  4. Enter information about the new value in the following fields:

    • Seq – The order in which the value appears. Used for presentation and in reports.

    • Short Value – Shortened name of the value; used to fill in the application field when selected from a list of values.

    • Long Value – Complete name of the value; used if short value is truncated.

    • Active – For reference codelists that provide a list of values, only those entries whose Active check box is selected appear in the list.

    • Default – For reference codelists that provide a list of values, the entry whose Default box is checked may be highlighted when the list appears.

    • Description – Description of the value.

  5. Click Save. The system adds the new value to the codelist.

Modifying a Value in a Reference Codelist

You cannot delete a value from a reference codelist. However, you can deactivate a value by clearing its Active check box. If a value if not active, Oracle Clinical does not display the value in a list of values, and does not include the value as an acceptable value during validation.

To modify an existing value in a reference codelist:

  1. Perform Steps 1 through 3 in "Adding a Value to a Reference Codelist" to select a reference codelist.

  2. Place focus in the value record you want to change.

  3. Make your changes. You cannot change the Short Value field. Changing the Active check box activates or deactivates the value. Only active values appear in the list of values for the relevant field and are used in field validation.

  4. Click Save. Oracle Clinical modifies the changed codelist records in the database.

Running the Reference Codelists Report

Oracle Clinical includes a large number of reference codelists, many of which you can modify. To obtain the current values in any codelist, or to view the codelist values at any point in time, run the Reference Codelist report. This report summarizes all of the values in one or more reference codelists. You use the Report Submission window, which is depicted in Figure 7-2, to set the values of four parameters and specify the information you want to include in the report.

Figure 7-2 Report Submission Window for Reference Codelist Report

Description of Figure 7-2 follows
Description of "Figure 7-2 Report Submission Window for Reference Codelist Report"

To run the Reference Codelists report:

  1. Navigate to Admin, Admin Reports, and then Reference Codelists. The system opens that Report Submission window with a set of parameters specific to the Reference Codelists report.

  2. In the list of parameters, set that values of the four parameters to setup the report you want to run. Only the Active Flag parameter value is mandatory.

    1. the Modification Date parameter allows you to limit the report to include codelists modified on or after a certain date; use the "DD-MON-YYYY" date format for this field

    2. use the Reference Codelist Name parameter to specify a codelist; the list of values allows you to select from the list of codelists

    3. the Reference Codelist Type parameter allows you to limit the report to certain types of codelists

    4. ensure that the Active Flag parameter is set to its default value of "Y".

  3. Click Job Details. The system opens the Submission Details window.

  4. In the Submission Details window:

    1. Set the Output Type, Output Format, and Printer (if applicable) fields to appropriate values.

    2. Ensure that the Mode of Execution and the Report Server fields are set correctly.

  5. Click Submit Job.

Local Reference Codelists

Local reference codelists control the behavior of some Oracle Clinical features in the selected database only. You can modify local codelists if your user role has one of the following schema: RXC_ADMIN, RXC_SUPER, or RXC_SUPER_NOGL.

BATCH QUEUE NAME Local Codelist

This codelist contains batch queue names to be used by the Parameterized Submission (PSUB) utility for this Oracle Clinical instance.

The reference codelist ships with a short value of RXC_BATCH_QUEUE, and a long value of a. This short value is in turn found in the OCL_JOB_PREF reference codelist, indicating that this is the default batch queue to be used by PSUB.

You can set a different default queue for a particular user by specifying any short value from the BATCH QUEUE NAME reference codelist when you create or modify the user's account. When adding entries, the short value specifies a symbolic name for the queue, and the long value specifies a single character queue like a, d, e. b and c are excluded, as these are reserved.

You can modify the long value for the RXC_BATCH_QUEUE entry in one of 2 ways:

  • change the value to another single-character queue name

  • enter the value RXC_BATCH_QUEUE

If you choose the latter option, PSUB interprets this as an environment variable, whose value is set in the opa_settings file; see Appendix A, "Environment Variables and Registry Settings."

DB_LINKS Local Codelist

This codelist contains the names of database links for standard replication.

Standard replication is a "pulling" operation; that is, the database location requesting the data must initiate the action. Each database in the installation maintains its own local DB_LINKS reference codelist. There should be an entry in the Short Value field for each of the other database locations in the installation. The Long Value contains the name of the private database link to that database, owned by the Oracle user RXC_REP.

DCF COMMENT TEXT Local Codelist

This codelist contains values you can use as the initial text for the DCF comment field.

DCF DEFAULT FOOTERS Local Codelist

This codelist contains values you can use as the footer text to be inserted into the DCF Footer field. See "Defining DCF Headers and Footers".

DCF DEFAULT HEADERS Local Codelist

This codelist contains values you can use as the header text to be inserted into the DCF Header field. See "Defining DCF Headers and Footers".

DCF REPORT LABELS Local Codelist

This codelist contains user-configurable labels for the DCF Report.

DISC COLS Local Codelist

This codelist contains the variables that can be specified for MCU CDS Discrepancy criteria; see "Customizing Mass Changes Local Codelists".

DISC_FLEX1 and DISC_FLEX2 Local Codelists

See "Customizing Flexfields" for information.

DISC_FLEX1_VALUES and DISC_FLEX2_VALUES Local Codelists

See"Customizing Flexfields" for information.

FLD RXCMCMCD RDCI DELETE Local Codelist

This codelist contains the display and order of RDCI Delete Candidate Data Set fields; see "Customizing Mass Changes Local Codelists".

FLD RXCMCMCD RDCI KEY Local Codelist

This codelist contains the display and order of RDCI Key Change Candidate Data Set fields; see "Customizing Mass Changes Local Codelists".

FLD RXCMCMCD RDCM KEY Local Codelist

This codelist contains the display and order of RDCM Key Change Candidate Data Set fields; see "Customizing Mass Changes Local Codelists".

FLD RXCMCMCD RESPONSE Local Codelist

This codelist contains the display and order of response Candidate Data Set fields; see "Customizing Mass Changes Local Codelists".

IND DISC COLS Local Codelist

This codelist contains variables that you can specify for MCU CDS Ind discrepancy criteria; see "Customizing Mass Changes Local Codelists".

MAN DISC COLS Local Codelist

This codelist contains variables that you can specify for MCU CDS manual discrepancy criteria; see "Customizing Mass Changes Local Codelists".

MANHD DISC COLS Local Codelist

This codelist contains variables that you can specify for MCU CDS manual header discrepancy criteria; see "Customizing Mass Changes Local Codelists".

MC CDS SORT ORDER Local Codelist

This codelist contains the sort order of CDS fields; see "Customizing Mass Changes Local Codelists" for information.

MC COLUMNS Local Codelist

This codelist contains variables that you can specify for MCU CDS criteria; see "Customizing Mass Changes Local Codelists".

MULTI DISC COLS Local Codelist

This codelist contains variables that you can specify for MCU CDS multivariate discrepancy criteria; see "Customizing Mass Changes Local Codelists".

NLS_CONFIG Local Codelist

This codelist contains settings that control behavior in Oracle Clinical with NLS Option. See the Oracle Clinical NLS Option User's Guide for details.

OCL_DE_CONFIG Local Codelist

This codelist controls Data Entry configuration settings. The entries for values are listed and described in Table 7-3 .

Note:

The settings with sequence numbers 1-9, 12-14, and 17 are also updatable in the Maintain Installation Configuration window under Admin, DE Admin, DE Config Settings; see "Define Data Entry Configuration Settings".

Table 7-3 Values for the OCL_DE_CONFIG Reference Codelist

Seq Short Value Long Value Description

1

2ND PASS ALERT

Y

Determines if the alert for a 2nd Pass comparison failure is enabled.

2

DISC IN BROWSE

Y

Determines if the user is allowed to initiate a manual discrepancy when working in browse mode.

3

DISC RES IN DE

Y

Determines if the user is allowed to resolve discrepancies during data entry.

4

PRIV UPDATE

N

Determines if the privileged update is enabled at the database level.

5

THESAURUS list of values

Y

Determines if the DVG, which populates the list of values, for thesaurus questions is enabled.

6

UNIVAR ALERT

Y

Determines if the univariate validation alert, which prompts the user to a validation error during data entry, in enabled.

7

USE DCI BOOK

N

Determines if the system initiates a data entry session using a DCI book.

8

UNENROLL ALERT

Y

Determines if the system alerts the user to a patient that has been unenrolled.

9

P2 NOT BY P1

N

Determines if the system prevents a Pass 1 data entry operator from performing Pass 2 data entry.

10

OCL THES DISC

N

Determines if system alerts the user to OLC Thesaurus discrepancies during data entry.

11

OCL THES list of values

N

Determines if the lists of values for OCL Thesaurus questions are enabled.

12

BROWSE ACC ONLY

N

Determines if data in accessible documents is browse only.

13

DEF PAGE HEIGHT

22

Sets the default height of the DCM data entry page in points, pixels, inches, or centimeters, depending on the unit of measure selected in the Maintain Installation Configuration window under Admin, DE Admin, DE Config Settings; see "Define Data Entry Configuration Settings". Applies only to Oracle Clinical and to RDC Classic.

14

DEF PAGE WIDTH

78

Sets the default height of the DCM data entry page in points, pixels, inches, or centimeters, depending on the unit of measure selected in the Maintain Installation Configuration window under Admin, DE Admin, DE Config Settings; see "Define Data Entry Configuration Settings". Applies only to Oracle Clinical and to RDC Classic.

15

P2 ALWAYS ALERT

Y

Determines if the system alerts the user whenever Pass 2 data differs from the corresponding Pass 1 data. Note: The Long Value should be a maximum of 2 characters; longer values cause problems in Oracle Clinical data entry.

16

AUTO SEQ DFLT

Y

Sets the default auto sequence behavior; when a user presses tab in the last field of a DCM/CRF Section, the system opens the next DCM for data entry.

17

DCI DATE REQ

Y

Sets the default as to whether the DCI date is required in the Log-in form.

18

DVGSEQOVERALPHA

N

Used only when a question meets the following criteria:

  • An internal DVG and an alpha DVG are assigned.

  • An Enter By Sequence is enabled for the internal DVG.

  • The internal DVG and the alpha DVG have values with the same sequence number.

When the user enters a sequence number that exists in both DVGs, the system:

  • Records the internal DVG value if the DVGSEQOVERALPHA value is set to Y.

  • Records the alpha DVG value with the same sequence number if the DVGSEQOVERALPHA value is set to N.

19

DVG List of Values STYLE

SEQ

Determines how the system displays the list of values for DVG and Alpha DVG questions. Note: The Long Value should be a maximum of 15 characters; longer values cause problems in Oracle Clinical data entry

20

COMMCHGREAS_REQ

Y

Determines if a change reason is required for updates to RDCI comments in accessible documents.

21

JUSTENTERP1TIME

0

Sets the time period (in minutes) during which a Pass 1 Complete RDCI/RDCM can be modified in Pass 1 mode.

22

JUSTENTERP2TIME

0

Sets the time period (in minutes) during which a Pass 2 Complete RDCI/RDCM can be modified in Pass 2 mode.

23

SEQUENCEBUFFER

1000000

Defines the sequence buffer used to prevent the sequence from reaching its maximum value. At this setting, when a sequence number is within 1,000,000 of 2,147,483,647, the system displays a warning message when a user attempts to use a relevant subsystem and the system exits the current screen.

24

RSTRCT LCKD CRF

N

Determines if some actions are permitted on a locked CRF. Applies to RDC Onsite only.


DVG List of Values STYLE

This value determines how the system displays the list of values for DVG and Alpha DVG questions. The options for this value are SEQ and SHORT.

Note:

If "Enter by Sequence" is not selected in the DVG definition, this reference codelist setting (SEQ or SHORT) has no effect. The list of values does not display the sequence number, sorts records by the DVG value, and displays these columns in this order:
  1. Short Value, which is titled "DVG Value" in the list of values

  2. Alpha Column, which contains "A" if it is an Alpha DVG value or is null for all others

  3. Long Value, which is titled "Description" in the list of values.

SEQ

If the Long Value is set to "SEQ" and "Enter by Sequence" is selected in the DVG definition, the columns in the list of values are displayed in this order:

  1. Display SN (prefixed with "A" if it is an Alpha DVG value)

  2. Short Value, which is titled, "DVG value" in the list of values

  3. Long Value, which is titled "Description" in the list of values.

The records are sorted by DVG sequence number.

SHORT

If the Long Value is set to "SHORT" and "Enter by Sequence" is selected in the DVG definition, the columns in the list of values are displayed in this order:

  1. Short Value, which is titled "DVG Value" in the list of values

  2. Display SN (prefixed with "A" if it is an Alpha DVG value)

    Note:

    The sequence number is displayed only if there is an alpha DVG associated with the question.
  3. Long Value, which is title "Description" in the list of values.

The records are sorted by DVG sequence number.

COMMCHGREAS_REQ

This value determines if the system requires a change reason when the RDCI comment is updated and the document is internally accessible. The options for this value are "Y" and "N". The default value is "Y", which causes the system to require a change reason for an update to the RDCI comment.

JUSTENTERP1TIME

This value defines time period (in minutes) during which a user can modify or query a previously Pass 1 Complete RDCI/RDCM in Pass 1 mode.

The initial value of this entry is "0".

JUSTENTERP2TIME

This value defines the time period (in minutes) during which a user can modify/query a previously Pass 2 Complete RDCI/RDCM in Pass 2 mode.

The initial value of this entry is "0".

RSTRCT LCKD CRF

By default, RDC Onsite restricts access to locked CRFs. You can use the RSTRCT LCKD CRF setting in the OCL_DE_CONFIG local reference codelist to allow some users to take actions on locked CRFs.

  • Y — Specifies that users cannot update discrepancies for a locked CRF, verify a locked CRF, or approve a locked CRF unless the CRF is specifically unlocked for them.

  • N — Specifies that any user with UPD_DISCREP privileges can work on discrepancies in a locked CRF, any user with VERIFY privileges can verify a locked CRF, and any user with APPROVE privileges can approve a locked CRF.

OCL_DE_PREFS Local Codelist

This codelist enables you to set the default data entry preferences for this instance. The default entries are displayed and described in Table 7-4, "Values for the OCL_DE_PREF Reference Codelist". You can also set almost all of these values in the Maintain Installation Preferences under Admin, DE Admin, DE User Prefs. The exceptions, which you can set only here, are: AUTO NEXT FORM and AUTO SEQ DEFLT.

Table 7-4 Values for the OCL_DE_PREF Reference Codelist

Seq Short Value Long Value Description

1

AUTO SKIP

Y

Determines if auto skip is enabled.

2

AUTO FILL

Y

Determines if auto fill is enabled.

3

UNIVAR BEEP

Y

Determines if the system sounds a beep when a recorded response value generates a validation error.

4

COMPARISON FAILURE

Y

Determines if the system sounds a beep when a response value generates a comparison failure.

5

END FORM BEEP

Y

Determines if the system sounds a beep when the user navigates from the last field in a form.

6

DATE ENTRY FMT

US

Determines the default format for dates that the system assumes during data entry.

7

DATE DISPLAY FMT

STANDARD

Determines the format the system uses to present dates in the display.

8

RDCI ORDER

PATIENT

The "order-by" the system uses for RDCI queries.

9

AUTO NEXT FORM

Y

Determines if the system automatically displays the next data entry form in the sequence.

10

AUTO SEQ DEFLT

Y

Determines if auto-sequence is set by default.


OCL_JOB_PREF Local Codelist

This codelist sets default values in the Oracle Clinical PSUB job window.

Oracle Clinical ships default system-wide values in the local reference codelist OCL_JOB_PREF. Each entry refers to a specific row in another reference codelist, which must be updated with correct values for your installation. The long value in this reference codelist is populated from the short value in the other reference codelist. Table 7-5 lists the defaults you can set.

Table 7-5 Entries in the OCL_JOB_PREF Reference Codelist

Short Value Description Refers to Reference Codelist

PSUB_PRINTER

Default PSUB Printer

PRINT QUEUE NAME Local Codelist

DFLT_PSUB_QUEUE

Default PSUB Queue

BATCH QUEUE NAME Local Codelist

DFLT_REPORT_RS

Default Reports Server

REPORT_SERVER Local Codelist

DFLT_JOBSET_RS

Default Job Set Reports Server

REPORT_SERVER Local Codelist

DFLT_PSUBSCH_RS

Default for PSUB Scheduling, generating DCI Forms, and previewing

REPORT_SERVER Local Codelist

DFLT_RS_PRINTER

Default Reports Server Printer

PRINT QUEUE NAME Local Codelist


For example, to set a printer as the default for reports at an installation:

  1. Navigate to Admin, then Reference Codelists, and Local Codelists.

  2. Insert a record in the PRINT QUEUE NAME Local Codelist:

    Short Value – Name of the printer, for example, boston09
    Long Value – Printer specification, for example, \\ocldsn1\boston09
    Description – Information about the printer that may be helpful to the end user

    (Note that all three values display in the Submission Details screens.)

  3. In the OCL_JOB_PREF codelist, update the Long Value of the DFLT_RS_PRINTER entry with the Short Value of the printer from Step 2.

OCL MC PREFS Local Codelist

This codelist's single value, MAX_CDS_RECORDS, sets the default maximum number of records to change using the Mass Changes utility. Its initial value is 1000; see "Customizing Mass Changes Local Codelists".

OCL_MENU_ACCESS Local Codelist

This codelist contains settings that support configuration of menu options.

Table 7-6 OCL_MENU_ACCESS Default Values

Seq Short Value Long Value

1

PRPJ

Y

2

ORUN

Y

3

REGION

Y

4

STUDY

Y

5

FACTOR

Y

6

STRATA

Y

7

ACSU

Y

8

DRUG

Y

9

REGIMEN

Y

10

SITES

Y

11

INVEST

Y

12

PATTEN

Y


OCL_STATE Local Codelist

OCL_STATE tracks information about the database, such as its name, operating system, and RDBMS version, which Oracle Clinical requires to complete certain processes. Some of the short values are described in more detail following the table.

Table 7-7 Values for the OCL_STATE Reference Codelist

Seq Short Value Long Value Description

1

DB_NAME

name of database

Name of the database.

2

SERVER_OS

Server operating system

Indicates the operating system that the server is running. Valid entries are NT (to represent any supported version of Windows) or UNIX (to represent any supported version of UNIX).

3

LOCATION_CODE

 

Client name for the current location.

4

PRINTER_TYPE

 

Default type of printer used - ASCII.

5

DB_VERSION

 

The database version, this is used by Data Extract to determine optimization.

6

INVOKE_IMAGE

N

 

7

BDL_R_SE

 

Specifies the rollback segment for Batch Data Load processes. Set to active and enter a long value of Y if you have created a database rollback segment for use in batch data load.

8

DFLT_PAGE_TRACK

N

Specifies the default value of the "Page Tracking Enabled" study level setting.

9

FILE_VIEWER

Y

Used by PSUB to view the log and output files.

10

SERVER_NAME

 

Used by PSUB to open SFTP and FTP sessions.

11

DB_BLOCK_SIZE

 

The database block size from init.ora.

12

TEMP_TABLES

 

Temporary Tablespace for use in new account creation activities.

13

DM_PROMPT

 

Prompt for the DM window.

14

INVOKE_WORKFLOW

N

Used by the Login form to determine if a workflow system can be used.

15

USR_SAVE_OCPASS

Y

Determines if the user can save the OS password in the database; see "UNIX Passwords".

16

PROC_LAB_ALIAS

LAB

The name of the lab variable for the standard Procedure question group prompt.

17

DISC_DCM_PROMPT

QUESTION_NAME

The single-record mode of the Maintain Discrepancy Database form's Characteristics panel has a button that toggles the three long value settings. Choose the value to display by default: question_name (displays the name of the question associated with the discrepancy).

18

DCF_TEXT_SYNC

N

Edits comments and resolutions text DCFs propagates to disc mgmt.

19

DISC_AUTO_HDFT

Y

Auto Generation of Header/Footer Text.

20

DISC_AUTO_CRFPG

Y

Auto Generation of CRF Page Number.

21

BOOK_USAGE

IGNORE

(Applies only to RDC Classic) If set to IGNORE (the default) the system allows the user to use any book for the patient, regardless of the patient's book assignment. If set to PROMPT, the sytem allows the use of any book but gives a warning. If set to ENFORCE, the system does not allow using any book other than the one to which the patient is assigned.

23

BOOK_CHANGE

ALLOW

Change of DCI Book for patient: ALLOW, DISALLOW, or DISALLOW IF DATA.

25

BOOK_ASSIGN

N

Assign DCI book to patient on first data entry: Y or N.

25

TMS_FAIL_BV_ACT

FAIL

Determines whether Batch Validation continues when TMS derivation fails during Batch Validation: WARN or FAIL.

26

DB_HOST

 

Host name for the database, as entered in tnsnames.ora file.

27

DB_PORT

1532

Port number for the database as entered in tnsnames.ora file.

28

DMGR RDC ACCESS

YES

"Granting Automatic Access in RDC to Studies Granted in Oracle Clinical".

29

UPD_FV_INCREM

N

Y or N - Y means do only incremental PDR Templates and HTML Forms gen.


SERVER_OS

Make sure the Long Value of the SERVER_OS entry in the OCL_STATE local reference codelist is correct for your operating system. You can enter one of the following values:

  • NT — Indicates the server is running one of the Windows operating systems currently supported by Oracle Clinical.

  • UNIX — Indicates the server is running the UNIX operating system.

LOCATION_CODE

For replication, the specific piece of information required is the LOCATION_CODE value, which is the client name for the current location. The system collects and stores this value during database creation.

SERVER_NAME

Set the SERVER_NAME value in this codelist to the database/PSUB server.

On UNIX systems, the Long Value of the SERVER_NAME entry must be in lowercase letters.

DB_BLOCK_SIZE

This entry is used by the DX table code to obtain the block size, which is used for space calculations. It is used for the dictionary-managed tablespace algorithm.

TEMP_TABLES

This entry specifies the name of the temporary tablespace the system users when creating DX study_access_accounts.

DM_PROMPT

This entry is used by the Discrepancy Management form as the prompt to use for Study site.

PROC_LAB_ALIAS

This entry is used during procedure generation to determine the alias of the standard RDCM Question LAB in the Procedure Question Group declarations. The system sets this to a default value of "LAB". This default value for the alias will conflict with the Question QGalias.LAB if you have a study question named "LAB."

If there is a conflict with the study question named LAB, you should redefine PROC_LAB_ALIAS to a different name, such as, "RDCM_LAB," to avoid errors during procedure generation. In this case, any references to the standard Received DCM Lab question must be changed to RDCM_LAB, or a generation error will occur. When you do this, procedure references to QGalias.LAB will relate to the study question LAB and references to QGalias.RDCM_LAB will relate to the standard Received DCM Lab.

DISC_DCM_PROMPT

Specifies the source of the question in a discrepancy. The options for the Long Value are:

  • DEFAULT_PROMPT

  • QUESTION_NAME

  • SAS_LABEL

BOOK_ASSIGN

If set to Y, the system automatically assigns the DCI Book defined as the default for the study (in DCI Books or Enhanced DCI Books, under Definition) to each patient when data is first entered for the patient.

TMS_FAIL_BV_ACT

Use this entry to indicate whether batch validation should continue or stop after a TMS-related error is encountered. The two values are 'WARN' and 'FAIL,' which is the default value. It causes batch validation to fail when there is a TMS failure; for example, when either an invalid dictionary or an invalid domain is defined. Irrespective of the value for TMS_FAIL_BV_ACT, if a TMS-related error occurs, the batch validation status is always failure and batch validation completes the process with a TMS warning.

UPD_FV_INCREM

This setting pertains to the upgrade utility provided with Oracle Clinical/RDC 4.5.3 and above that allows you to migrate from PDF to HTML data entry forms. By default, the Upgrade utility generates the HTML data entry forms and the PDR templates for all DCI Form Versions in the study that have PDF data entry forms generated.

There may be times when you have problems with the form or template generation. For example, perhaps some images used in the form layout are no longer in the correct location so the Upgrade utility does not generate a few of the DCI Form versions. For such cases, you can temporarily change the utility to run in incremental mode. In incremental mode, the Upgrade utility only creates the HTML data entry forms and the PDR templates if they do not already exist.

Set the long value to Y or N:

  • Y — Forces the Upgrade utility to run in incremental mode. In incremental mode, the utility will not regenerate HTML data entry forms and PDR templates for form versions that already exist.

  • N (default) — Forces the Upgrade utility to generate all form versions.

This setting applies only to running the Upgrade utility for existing DCI Form versions.

Note:

Running the Upgrade utility in incremental mode is for resolving problems. Oracle recommends that you do not continue to run the utility in incremental mode. Be sure to change the UPD_FV_INCREM value back to N after you generate the forms you need

PRINT QUEUE NAME Local Codelist

This codelist populates the list of printers that you can use when you submit a batch job or a reports job and when you set up a user account.

Oracle Clinical users can select a printer name from a list of values when they submit a job. You specify that list by defining entries in this local reference codelist. Both the long and short values appear in the list of values.

The short value is a code or abbreviation for the printer. The long value of the printer name is the printer specification. You can use either an absolute path or an environment variable for the long value. For example:

  • \\opaprtsrv\waltprt9 where walprt9 is the printer name

  • %RXC_PRINTER% where RXC_PRINTER is the environment variable

The Default setting in the reference codelist has no effect. The OCL_JOB_PREF reference codelist determines the default printer. You can override the default when you set up a user account with any of the values in the PRINT QUEUE NAME reference codelist, and a user can override his or her own default when he or she submits a job.

PUBLIC_DB_LINKS Local Codelist

This codelist provides a list of database links for replication; it is used by RXA_DES.

Each database in the installation maintains its own PUBLIC_DB_LINKS local reference codelist. There should be an entry in the Short Value field for each of the other database locations in the installation. The Long Value contains the name of the public database link to that database.

RDC CONFIGURATION Role Local Codelists

This set of local codelists let you define the configuration settings for the Remote Data Capture application based on user role, such as CRA or investigator.

For more information about creating a configuration, defining its settings, and assigning the configuration to one or more users, see the Oracle Clinical Remote Data Capture Onsite User's Guide or the Oracle Clinical Remote Data Capture Classic Data Entry User's Guide.

REPORT_SERVER Local Codelist

This codelist defines the list of reports servers from which the user can select when setting up to run a report.

SAS_QUEUE Local Codelist

This codelist specifies the value(s) in the BATCH QUEUE NAME Local Codelist that is required to run SAS.

SQL FUNCTIONS Local Codelist

This codelist provides a list SQL functions that you can then use when building queries.

TMS_DSI Local Codelist

This codelist defines settings specific to the Disconnected System Integration (DSI) feature for Oracle Thesaurus Management System. For details about this codelist, see the Oracle Thesaurus Management System User's Guide.

TMS_OPTIONS Local Codelist

This local codelist contains TMS-specific options. It is populated only if TMS is installed in the Oracle Clinical database. When TMS is installed, currently the only option defined is FIRST_REVIEW. If the Long Value for this option is set to Y, and the Review Before TMS flag is also set to Y in the question set, then the first review for a thesaurus omission happens in the Oracle Clinical discrepancy management system, rather than in TMS. For more information on the interaction between the Oracle Clinical discrepancy management system and TMS, see the "Defining a question set" topic in the Oracle Thesaurus Management System User's Guide.

UNI DISC COLS Local Codelist

This codelist contains variables that you can specify for Mass Change Utility CDS Univariate Discrepancy criteria.

WEB_DOCUMENT_CONFIG Local Codelist

TMS refers to the settings in this codelist to configure several aspects of the Document Repository searches in the TMS HTML Browser. For details about this codelist, see the Oracle Thesaurus Management System User's Guide.

WEB_DOCUMENT_GROUPS Local Codelist

This codelist lets you define categories for the documents you retrieve using Document Repository searches in the HTML Browser. For example, you might want to specify that all documents loaded from your internal servers be categorized as Internal documents. For details about this codelist, see the Oracle Thesaurus Management System User's Guide.

Installation Reference Codelists

Installation codelists control Oracle Clinical behavior installation-wide; that is, across an installation of multiple Oracle Clinical databases. This section describes the purpose of and the settings in each installation codelist.

APPLICATION AREA CODE Installation Codelist

This codelist contains settings for areas on the body where the medication can be given.

APPLICATION SYSTEM NAME Installation Codelist

This codelist contains a list of application systems used by Oracle Clinical.

APPROVE VERIFY RETAIN CODE Installation Codelist

Enter one or more reasons to supply if CRF approvals or verifications are retained during DCI Form version migration.

You can limit the options available in a particular study in the DCI Form Study Settings window. If User Override to Reverse Approvals? or User Override to Reverse Verifications? is set to N in the DCI Form Local Database Settings window, the user running the migration cannot change the default value.

  1. In the row with the short value DFLT_RETAIN_R, enter the text you want to appear as the initial default value as the long value.

  2. If you want to allow the user to select other reasons for retaining approvals, enter an appropriate short and long value for each reason. Both values appear in the list of values.

  3. Set each value to Active.

APPROVE VERIFY REVERSE CODE Installation Codelist

Enter one or more reasons to supply if CRF approvals or verifications are reversed during DCI Form version migration.

You can limit the options available in a particular study in the DCI Form Study Settings window. If User Override to Reverse Approvals? or User Override to Reverse Verifications? is set to N in the DCI Form Local Database Settings window, the user running the migration cannot change the default value.

  1. In the row with the short value DFLT_REVERSE_R, enter the text you want to appear as the initial default value as the long value.

  2. If you want to allow the user to select other reasons for retaining approvals, enter an appropriate short and long value for each reason. Both values appear in the list of values.

  3. Set each value to Active.

BLIND TYPE CODE Installation Codelist

This codelist contains a list of types of blinding that are available in a study.

CLINICAL PHASE Installation Codelist

This codelist list the clinical phases that are available in the design of a study.

COUNTRIES Installation Codelist

This codelist contains the list of valid countries.

CRF PAGE NUMBERING SCHEME Installation Codelist

This codelist contains the list of valid page tracking statuses that is used by the CRF Page Tracking feature.

CRF PAGE STATUS CODES Installation Codelist

This codelist contains the list of valid CRF page statuses that is used in Maintain Page Status Tracking form.

CRF PAGE STATUS QUERY Installation Codelist

This codelist contains the list of valid statuses for CRF page types that is used in Log-In Query window.

DATA CHANGE REASON TYPE CODE Installation Codelist

This codelist contains the list of valid data change reason type codes for data update. The system uses it to provide a default value and to validate user-supplied response change reasons for Oracle Clinical data entry and mass changes (response changes), RDC, and DCAPI.

The default value is presented initially in each user session. If the user selects a different change reason, the system presents the user's last selection as the default. Subsequent changes use the value that was selected last.

To set the default data change reason for a user group, put the group name in the Long Value field of that reason code (Short Value column). You can also put a comma-separated list of roles in a single field.

To prevent the reason from appearing at all in RDC Onsite HTML, enter NOTRDC as the long value.

Note:

Changing the Long Value of a DATA CHANGE REASON TYPE CODE entry has no effect on data update in Oracle Clinical DE forms. This feature is affects RDC data entry only.

You can customize this codelist. However, the following values are reserved by the system and cannot be used as custom values: 'PASS1', 'PASS2', 'BATCH', 'UPDATE', 'REMOVED', 'TRANSLATION', 'KEY CHANGE', 'BROWSE', 'RECONCILIATION'.

Table 7-8 Values for the DATA CHANGE REASON TYPE CODE Reference Codelist

Short Value Long Value Description

CRA CORR

 

CRA Correction

DATA ENTRY ERR

 

Error during data entry

BATCH

 

Batch-loaded data

CRA CORR-INV

 

CRA corrected, after consulting with the Investigator

CRA CORR-SRC

 

CRA correction, after consulting the source data

INV CORR

 

Investigator correction

STUDY ASSUM

 

Study assumption

THES CLARIF

 

Thesaurus clarification

ANALYSIS CORR

 

Analysis correction

REMOVED

 

RDCI removed

VAL STATUS CHG

 

Validation status changed

DATA ENTRY MODE

 

Data entry mode


Note:

Set the LONG VALUE of one the reference codelist values in this list or in DATA CHANGE REASON2 TYPE CODE Installation Codelist, to "DCAPIDEL" and another to "DCAPIINV" (comma-separated, if there are other values in the LONG VALUE).

DATA CHANGE REASON2 TYPE CODE Installation Codelist

This codelist is used to provide a default value and for validation in DCAPI. It works in conjunction with the DATA CHANGE REASON TYPE CODE Installation Codelist. It is not used by Oracle Clinical or RDC, but provides a method for you to provide an additional list of values of change reasons that are used by your external applications.

There are no default values for this codelist. Although you can customize this codelist, note that the following set of values are reserved by the system and cannot be used as custom values: PASS1, PASS2, BATCH, UPDATE, REMOVED, TRANSLATION, KEY CHANGE, BROWSE, and RECONCILIATION.

DCF LOCK CONDITIONS Installation Codelist

This codelist contains statuses that refer to particular actions that should be limited; see "DCF LOCK CONDITIONS" for information.

DCF OPTIONAL STATUS CODES Installation Codelist

This codelist contains optional status codes for DCFs; see "DCF OPTIONAL STATUS CODES".

DCF STATUS CODES Installation Codelist

This codelist contains status codes for DCFs; see "DCF STATUS CODES".

DCIF CHECKBOX SIZE Installation Codelist

This codelist controls the allowable sizes for check boxes in DCI Forms. These values are available in the DCI Form Local Database Settings window; see "Setting DCI Form Default Values for RDC Data Entry and Patient Data Reports".

The values refer to point sizes. The values are:

10
12
15
20

DCIF FONT TYPESIZE Installation Codelist

This codelist contains the list of valid font type sizes that can be used in DCI Form graphic layouts in prompts and fields; see "Setting DCI Form Default Values for RDC Data Entry and Patient Data Reports".

The default values refer to point sizes. The values are:

8
9
10
11
12
14

DCIF PAGE DEFINITION Installation Codelist

This codelist contains the list of page definitions that can be used by the DCI form; see "Setting DCI Form Default Values for RDC Data Entry and Patient Data Reports". The four values that are installed are:

US Portrait
US Landscape
A4 Portrait
A4 Landscape

The long value specifies the height width, and binding offset. With 0 Binding offset, the form layout template appears in the middle of the page. If you specify a non-zero (positive or negative) offset, the FLT moves left/right (for portrait) or up/down (for landscape).

DCM DCI QG TYPE CODE Installation Codelist

This codelist contains the values you use to categorize DCMs, DCIs, and Question Groups. The values appear in the lists of values in the DCI Type field in the Maintain DCIs window, the Type field in the Maintain DCMs window, and the QG Type field of the Maintain Question Groups window.

DISCREPANCY ACTIONS ROLE Installation Codelist

See "Configuring the Actions Allowed on Discrepancies" for information.

DISCREPANCY MESSAGES Installation Codelist

The function of this codelist has been replaced by the Standard Text Maintenance form under Admin, Discrepancy Mgmt Maintenance. See "Reason Codes and Descriptions for Univariate Discrepancies" for information.

DISCREPANCY NO OTHER UPDATE Installation Codelist

See "Preventing Update to OTHER Discrepancies" for information.

DISCREPANCY RESOLU TYPE CODE Installation Codelist

See"Defining Resolution Reasons for Discrepancies" for information.

DISCREPANCY REV STATUS CODE Installation Codelist

See "Defining the Possible Review Statuses for Discrepancies" for information.

DISCREPANCY STATUS ROLE Installation Codelists

See "Configuring Discrepancy Display by User Role" for information.

DISCRETE VAL GRP TYPE CODE Installation Codelist

This codelist lists the severity codes for DVGs.

DISC_STDST_VALUES Installation Codelist

This codelist contains discrepancy Study Site Values.

DOSE FORM TYPE CODE Installation Codelist

This codelist contains Dosage Form Types.

DOSE FREQUENCY TYPE CODE Installation Codelist

This codelist contains frequencies of dose administration.

DX_CONFIG Installation Codelist

This codelist contains default settings for data extract.

The DX installation Configuration window includes exactly the same settings. When you change a setting here, the change is reflected there. When you change a setting there, the change is reflected here. For additional explanation of each setting, see "Configuring Default Installation Data Extract Settings".

Table 7-9 Values for DX_CONFIG Reference Codelist

Seq Short Value Long Value Description

1

KEY_TEMPLATE

STANDARD

Default Key Template Name

2

DOMAIN

STANDARD

Domain of Default Key Template

3

SEPARATE_SAS_YN

N

Separate Oracle and SAS names?

4

DCM_LINK_YN

Y

DCM default views are linked to source DCM as default conditions?

5

ACTIVE_KTEDT_YN

N

Enable edit of active key templates?

6

ACTIVE_XMEDT_YN

Y

Enable edit of active extract macros?

7

FREE_KT_SEL_YN

N

Enable selection of nonaggregate, nondefault key template?

8

INC_VALSTAT_YN

N

Include validation status in default view definition?

9

DVGDEFAULT_SN

N

Include DVG sequence number in default view definition?

10

DVGDEFAULT_SV

Y

Include DVG short value in default view definition?

11

DVGDEFAULT_LV

N

Include DVG long value in default view definition?

12

THESAURUS_TERM1

Y

Include thesaurus term1 in default view definition?

13

THESAURUS_TERM2

Y

Include thesaurus term2 in default view definition?

14

THESAURUS_TERM3

Y

Include thesaurus term3 in default view definition?

15

SAS_ATTREDT_YN

N

Enable update of SAS and Oracle column names?

15

INC_FULL_VALTXT

N

Include Full Value Text in default view definition?

16

MAX_AUDIT_LEN

200

Maximum length of Audit Comment

17

MAX_DATCOM_LEN

200

Maximum length of Data Comment

18

DVG_LNG_LEN

200

Maximum length of DVG long value

19

ACTIVE_VTEDT_YN

N

Enable edit of active view templates?

20

ENABLE_VB

N

Enable View Builder as default in new studies?

22

VB_DVG_SUBSET

N

Use DCM Question-specific DVG attributes?

23

USE_DCM_SAS

N

Use DCM SAS Label as seed for attributes in default view definition?

24

FAST_VIEWS

N

Build fast views?


DX_EXTENDED_ATTRIBUTES Installation Codelist

This codelist contains settings for Global Library Questions extended attribute creation.

Oracle Clinical offers the option of enabling additional question or response attributes for use in building views and view templates. The extended attributes are enabled at database creation when this reference codelist is populated. Attributes whose long value is set to Y here can be used as extended attributes in data extract.

If you change the settings in this reference codelist, run the script vb_def_que_attr.sql again.

Table 7-10 Extended Attributes for Questions

Attribute Meaning

AUDIT_COMMENT_TEXT

Audit comment text from the response.

DATA_CHANGE_REASON_TYPE_

CODE

Code value for the reason the data was changed.

DATA_COMMENT_TEXT

Data comment text from the response.

DISCREPANCY_INDICATOR

Discrepancy indicator for the response.

DVG_LONG_VALUE

DVG long value, if this is a DVG question.

DVG_NUMBER

DVG sequence number, if this is a DVG question.

DVG_SHORT_VALUE VALUE_TEXT

DVG short value, if this is a DVG question. Value of the response, if not.

EXCEPTION_VALUE_TEXT

Exception value text for the response.

FULL_VALUE_TEXT

Response value, or, if error, the exception text.

VALIDATION_STATUS

Validation status of the response

TERM_COL1

Thesaurus DVG first term column

TERM_COL2

Thesaurus DVG second term column

TERM_COL3

Thesaurus DVG third term column


DX_INDEX_TABLESPACE Installation Codelist

This codelist contains a list of index tablespaces for use with the Data Extract View Builder. The long values appear in the list of values for the Index Tablespace field in the Maintain Study Access Accounts window under Conduct, then Data Extract.

You must:

  • Uncheck the Active check box for the long values RXC_APP_IDX_TSPA and RXC_DCD_IDX_TSPA. These values are not valid and should not be available to users.

  • Enter the names of each tablespace you create for the purpose of containing data extract indexes, and check its Active check box. See "Creating Tablespaces for Data Extract Tables and Indexes" for more information.

DX_KEY_NAME Installation Codelist

This codelist contains the column alias for a data extract view keys

DX_ROLES Installation Codelist

This codelist contains the list of default roles for accessing data extract views. Values set here appear in a list of values in the View Definition window; users with the selected role have access to the view. You can add roles; see "Controlling Access to Data Extract Views" for more information.

DX_VIEW_TABLESPACE Installation Codelist

This codelist contains a list of view tablespaces for use with the Data Extract View Builder. The long values appear in the list of values for the Tablespace field in the Maintain Study Access Accounts window under Conduct, Data Extract.

You must:

  • Uncheck the Active check box for the long values RXC_APP_TSPA and RXC_DCD_TSPA. These values are not valid and should not be available to users.

  • Enter the names of each tablespace you create for the purpose of containing data extract tables, and check its Active check box. See "Creating Tablespaces for Data Extract Tables and Indexes" for more information.

EXP DESIGN TYPE CODE Installation Codelist

This codelist contains experimental design types for studies.

EXTERNAL_TRANS_TYPE Installation Codelist

This codelist provides transaction types for the Data Capture API function SetExternalContext.

LAB RANGE SUBSET CODE Installation Codelist

This codelist contains the set of Lab Range Subset Codes.

MANUAL SOURCE TYPE CODE Installation Codelist

See "Reason Codes and Descriptions for Manual Discrepancies" for information.

MAPPING_TYPE Installation Codelist

This codelist contains the list of possible file transfer protocols that you allow for use in your Oracle Clinical installation. These values appear in the list of values for the Mapping Code field in the Maintain Directory Mappings window. See Chapter 11, "Setting Up File Viewing" for information on mapping directories.

Table 7-11 Values for MAPPING_TYPE Installation Codelist

Seq Short Value Long Value Description

1

HTTP

HTTP

Hypertext Transfer Protocol

2

FTP

FTP

File Transfer Protocol

3

HTTPS

HTTPS

Secure-socket layer HTTP

4

UNC

UNC

Universal Naming Convention protocol

5

SFTP

SFTP

Secure File Transfer Protocol


MEDICAL EVAL TYPE CODE Installation Codelist

This codelist contains the values you use to categorize Questions. The values appear in the list of values for the Medical Evaluation Type field in the Maintain Questions window.

OBJECTIVE TYPE CODE Installation Codelist

This codelist contains the list of types of Clinical Planned Objective.

OCL_DOMAINS Installation Codelist

This codelist contains the installation-wide list of global library domains. For information, see Oracle Clinical Creating a Study.

OCL_INSTALLATION Installation Codelist

This codelist defines the location code of the database that owns the Global Library. The system requests and stores this value during database creation. Oracle Clinical checks the OCL_STATE Local Codelist to determine if the location code specified for the current database matches the one for the Global Library stored in OCL_INSTALLATION. If these values match, Oracle Clinical allows updates to the Global Library.

OCL_OPTIONS_TYPE_CODE Installation Codelist

This codelist contains a list of Optional Subsystems.

Table 7-12 Default Values for OCL_OPTIONS_TYPE_CODE Reference Codelist

Seq Short Value Long Value Description

1

TMO_INSTALLED

Y

TMO Installed (obsolete).

2

TMS_INSTALLED

Y

Set to Y if TMS installed; to N if not.

3

VAL_STATUS

Y

If set to Y, Batch Validation skips documents that have had a validation status change since the last validation and are currently open (locked) in OC data entry.

If set to NONE, Batch Validation processes such documents.

4

SR_INSTALLED

Y

Set to Y if Symmetric Replication installed.


OPA_MENU_ROLES Installation Codelist

This codelist contains the list of menu roles available in your Oracle Clinical installation. Any custom roles you create are not available until you enter them in this reference codelist; see "Adding a Custom Role to OPA_MENU_ROLES" for information.

PATIENT STATUS CODE Installation Codelist

This codelist describes patient statuses such as enrolled or terminated.

PLAN STUDY INT TYPE CODE Installation Codelist

This codelist describes types of Planned Study Intervals, such as baseline, dosing, and qualifying.

PROCEDURE TYPE CODE Installation Codelist

This codelist contains the list of user code for PROCEDURES.

QUESTION CATEGORY TYPE CODE Installation Codelist

This codelist contains the list of user codes for QUESTION_CATEGORY_RELATIONS.

RDCI CHANGE REASON TYPE CODE Installation Codelist

RDCI change reason code for Oracle Clinical data entry and mass changes (key changes and soft deletes), RDC, and DCAPI applications during key data update and when deleting an accessible CRF. Table 7-13 describes each values in this codelist.

This following subsystems use this installation codelist during processing to provide a change reason for audited changes:

  1. Patient Transfer

  2. Lab Assignment Criteria

  3. Mass Changes

  4. Data Entry Login

The user is always prompted for a change reason during items 1 through 3. During data entry login, the user is prompted for a change reason when the document is internally accessible. For each case in which a user-supplied change reason is required, the system prompts the user and presents the list of values in this codelist as the set of options from which the user chooses.

The initial set of values in this codelist are copied from the DATA CHANGE REASON TYPE CODE Installation Codelist.

You can choose which values should not appear in RDC HTML Data Entry by adding 'NOTRDC' as the long value. HTML Data Entry displays all active values in the reference codelist that do not have 'NOTRDC' specified as the long value.

Although you can customize this codelist, note that the following set of values are reserved by the system and cannot be used as custom values: 'PASS1', 'PASS2', 'BATCH', 'UPDATE', 'REMOVED', 'TRANSLATION', 'KEY CHANGE', 'BROWSE', 'RECONCILIATION'.

Table 7-13 Initial Values for the RDCI CHANGE REASON TYPE CODE Codelist

Short Value Long Value Description

CRA CORR

 

CRA Correction

DATA ENTRY ERR

 

Error during data entry

BATCH

 

Batch-loaded data

CRA CORR-INV

 

CRA corrected, after consulting with the Investigator

CRA CORR-SRC

 

CRA correction, after consulting the source data

INV CORR

 

Investigator correction

STUDY ASSUM

 

Study assumption

THES CLARIF

 

Thesaurus clarification

ANALYSIS CORR

 

Analysis correction

REMOVED

 

RDCI removed

VAL STATUS CHG

 

Validation status changed

DATA ENTRY MODE

 

Data entry mode


RDCI CHANGE REASON2 TYPE CODE Installation Codelist

An additional set of RDCI change reason codes that are used by DCAPI. This codelist allows you to provide an additional list of valid change reason values that can be used by your external applications.

There are no default values for this codelist. Although you can customize this codelist, note that the following set of values are reserved by the system and cannot be used as custom values: 'PASS1', 'PASS2', 'BATCH', 'UPDATE', 'REMOVED', 'TRANSLATION', 'KEY CHANGE', 'BROWSE', 'RECONCILIATION'.

REGION TYPE CODE Installation Codelist

This codelist contains types of region such as state, country, or continents.

RETIREMENT REASON TYPE CODE Installation Codelist

This codelist contains the list of user codes for DCIS, DCMS, DVGS, PROCEDURES, QUES, QUES_GROUPS.

ROUTE OF ADMIN TYPE CODE Installation Codelist

This codelist contains routes of drug administration such as oral, intravenous, and inhalation.

SAS_FORMATS Installation Codelist

This codelist contains a list of optional subsystems.

SINGLE DCI TYPES Installation Codelist

This codelist contains DCI types that do not allow duplicates. That is, the user is not permitted to add DCIs in this codelist as unplanned pages to a visit. Also, if the user adds an unplanned visit to the study, only those DCIs that are not listed in this codelist are included in the new visit.

The short value must correspond to a short value in the DCM DCI QG TYPE CODE installation reference codelist because DCIs can only be created of DCI types defined in that codelist.

Table 7-14 lists the default values for the SINGLE DCI TYPES codelist.

Table 7-14 Default Values for the SINGLE DCI TYPES Codelist

Seq Short Value

1

DEMOGRAPHY

2

COMPLETION


SOURCE LOCATION CODE Installation Codelist

This codelist contains the unique location code for each location in the installation.

The Global Library-owning location maintains this codelist. The Long Value field stores the offset in hours of that location from Greenwich Mean Time (GMT). Locations in a time zone east of Greenwich, England have a positive offset and those to the west have a negative offset. This reference codelist is replicated to the other locations as part of Global Library replication.

STANDARDS AFFIL TYPE CODE Installation Codelist

This codelist contains the user code for STANDARDS_AFFILIATIONS.

STUDY STATUS TYPE CODE Installation Codelist

This codelist contains types of Clinical Study Status.

TMS_CONFIGURATION Installation Codelist

This codelist contains settings that control various default behaviors in the Oracle Thesaurus Management System. See the Oracle Thesaurus Management System User's Guide for details.

TMS_LANGUAGES Installation Codelist

This codelist populates the Language field in the Define Dictionaries window for Oracle Thesaurus Management System. English is the default dictionary language. See the Oracle Thesaurus Management System User's Guide for details

TMS_QUERY_TYPE Installation Codelist

This codelist populates the Query fields in Oracle Thesaurus Management System with default choices for query type. See the Oracle Thesaurus Management System User's Guide for details.

TMS_SOURCE_MAT_VIEWS Installation Codelist

This codelist controls whether Oracle Thesaurus Management System uses materialized views or regular views to populate the list of values for each external system value in the Filter window, which launches from Reclassify Verbatim Terms and Approve VTAs. See the Oracle Thesaurus Management System User's Guide for details.

TMS_TAL_POOL_CONFIGURATION Installation Codelist

This codelist configures the task allocation for omissions, unapproved VTAs, and unapproved Action assignments specific to Oracle Thesaurus Management System. See the Oracle Thesaurus Management System User's Guide for details.

TMS_X_SEARCH Installation Codelist

This codelist populates the list of values for the Search Type field in Oracle Thesaurus Management System. It currently has only one value, Cross Search. See the Oracle Thesaurus Management System User's Guide for details.

TREAT CHG REASON TYPE CODE Installation Codelist

This codelist contains the list of valid Treatment Change Reason Type Codes.

UNITS_OF_MEASURE_TYPE_CODE Installation Codelist

This codelist contains units of measure that are available for use in studies in the database.

USER GROUP ROLES Installation Codelist

See "Mapping Database Roles to User Roles".

USER GROUPS Installation Codelist

See "Specifying User Roles for the Oracle Clinical Discrepancy Database" for information on this reference codelist.

VALIDATION FAILURE TYPE CODE Installation Codelist

This codelist contains the user code for DCM_QUESTIONS, PROCEDURE_DETAILS, QUES, and QUES_GROUP_QUES.

Design Installation Reference Codelists

Design Installation codelists are a subset of the Installation Reference Codelists relating to study design. Using a database role with access to the appropriate menu item, you can grant a study designer access to either of the Design Installation Codelists windows (Query or normal), and enable the designer to maintain this subset of the reference codelists without providing access to change all of the installation reference codelists.

Each of the design installation codelists is documented in the main Installation Codelists section:

System Reference Codelists

System reference codelists provide values for Oracle Clinical's internal use only. You can browse or query for system codelist values, but you cannot change them. System codelists provide standard values across distributed environments.

To access the System codelists, navigate to Admin, Reference Codelists, and then Qry System Codelists. Alternatively, you can run a Reference Codelist report for one or all system codelists. See "Running the Reference Codelists Report" for instructions.