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.

For more information , see:

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 Approval? 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 (see Version Migration

  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. 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 (see Version Migration for more details).

  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. 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.

CUSTOM REVIEW TYPE Installation Codelist

See Configuring Custom Review Types

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 DCAPIDE 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

SeeDefining 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 Setting Up File and Image 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 has two values:

  1. Verify that the Long Value for the GLIB_LOCATION has the correct name of the Global Library-owning location. In addition, make sure the value is in all uppercase letters. Replication fails if the value is not in uppercase.

    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.

    Note:

    If you need to change the GLIB_LOCATION value in the OCL_INSTALLATION reference codelist, run the oclstate.sql script located in the Install directory.

  2. The Long Value for the ALLOW_DISC_REPL parameter. defines whether to replicate all discrepancies and associated data clarification forms (DCFs). You set this value at the Global Library-owning location only.

    • Y — The system copies all discrepancies and all associated data clarification forms (DCFs) during study data replication.

    • N — The system does not copy discrepancies and DCFs during study data replication. If you execute the study replication with the Refresh All value set to Y, any previously replicated discrepancies and DCFs will be removed from the target database.

      Note:

      If you specify page reference numbers for DCFs, the numbers must be unique in each database instance. Therefore, if you choose to replicate discrepancies and DCFs, you must ensure that the page reference numbers for DCFs are unique across all databases in the replicated installation.

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 is installed; to N if not.

3

VAL_STATUS

Y

Optionally, batch validation determines whether there has been any overall change in the validation status of each response based on discrepancies created or closed for that response. This setting determines whether or not the calculation will be performed and results stored with the response, and whether a change in response validation status will create a versioned response entry (audit) in the database.

If set to Y, batch validation calculates validation status for affected responses and if there is a change, versions (audits) the change.

If set to NO_AUDIT, Batch Validation calculates validation status for affected responses, but stores changed validation status in the current response record, without versioning (auditing) the change.

If set to NONE, Batch Validation does not calculate validation status for affected responses.

4

SR_INSTALLED

Y

Set to Y if Symmetric Replication is 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.

The following table 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.