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Oracle® Health Sciences Life Sciences Warehouse Application Programming Interface Guide
Release 2.4

E53659-01
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29 Clinical Data Models

This is a public interface for clinical data model-related operations, including creating, modifying, and removing models, and checking models in and out. It also includes APIs for adding, modifying, and removing tables and constraints to tables within models.

Note:

You can also create tables with columns and constraints within a model by uploading metadata files. See the Oracle Health Sciences Data Management Workbench User's Guide for more information.

29.1 Create and Modify Clinical Data Models

This section contains the following public APIs in package DME_PUB_DF_DATA_MODEL.

29.1.1 Create a Study Clinical Data Model

Use this API to create a study clinical data model in a study domain. The model contains no tables. Use "Add a Table to a Clinical Data Model" to add tables to the model. You can use this API to create either target models, whose data is populated from other Oracle DMW study models, or input models, whose data is loaded from InForm or from files. However, for input models you must complete the configuration in the user interface.

The procedure returns an S if the model is created successfully. Otherwise it returns an error.

Name DME_PUB_DF_DATA_MODEL.CreateStudyDataModel

Signature 

PROCEDURE CreateStudyDataModel
(P_API_VERSION      IN NUMBER,   
P_INIT_MSG_LIST    IN VARCHAR2 DEFAULT CDR_PUB_DEF_CONSTANTS.G_FALSE,
P_COMMIT           IN VARCHAR2 DEFAULT CDR_PUB_DEF_CONSTANTS.G_FALSE,
P_VALIDATION_LEVEL IN NUMBER DEFAULT CDR_PUB_DEF_CONSTANTS.G_VALID_LEVEL_FULL,
PIO_STDYMODOBJ     IN OUT NOCOPY CDR_NAMING_VERSION_OBJ_TYPE,
PIO_DMOBJ          IN OUT CDR_DATA_MODEL_OBJ_TYPE,
PIFILETYPE         IN VARCHAR2,
X_RETURN_STATUS OUT NOCOPY VARCHAR2,
X_MSG_COUNT OUT NOCOPY     NUMBER,
X_MSG_DATA OUT NOCOPY      VARCHAR2,
  );

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameters:

  • PIO_STDYMODOBJ (Mandatory). This is a parameter of type CDR_NAMING_VERSION_OBJ_TYPE. Enter values for the following attributes for the new model and its namespace, which is the study domain. To get naming version attribute values for the namespace object, which is the study category domain, see "Get a Naming Version Object".

    • COMPANY_ID To get your company ID, use CDR_PUB_DEF_FACTORY_UTILS.GetCompanyId.

    • NAME Enter a name for the new clinical data model.

    • NAMESPACE_OBJ_ID Enter the object ID of the parent study domain.

    • NAMESPACE_OBJ_VER Enter the object version of the study domain.

    • NAMESPACE_START_OBJ_VER Enter 1

    • NAMESPACE_END_OBJ_VER Enter 999999

    • DESCRIPTION Enter a description for the new clinical data model.

    • OBJECT_TYPE_RC Enter '$OBJTYPES$DATAMODEL'

  • PIO_DMOBJ (Mandatory). This is a parameter of type CDR_DATA_MODEL_OBJ_TYPE. Enter values for the following attributes for the new clinical data model:

    • DM_NAME Enter null.

    • DM_NAMESPACE_OBJ_ID Enter the object ID of the parent study domain.

    • DM_DESCRIPTION Enter null.

    • DM_TABLE_COLL Leave blank. To add tables use "Add a Table to a Clinical Data Model".

    • LIBRARY_FLAG_RC Enter $YESNO$NO because this is a study model, not a library model.

    • MODEL_TYPE_RC

      • To create a target model, enter $MODELTYPE$TARGET.

      • To create an input model, enter $MODELTYPE$INPUT.

    • MODEL_SUBTYPE_RC

      • If the Model Type is $MODELTYPE$TARGET, then Model Subtype is null.

      • If the Model Type is $MODELTYPE$INPUT, then model subtype can be either $INPUTMODTYPE$INFORM or $INPUTMODTYPE$FILE.

    • CREATE_BA_FLAG_RC Enter $YESNO$YES to create a Business Area to enable visualizations of data in the model or $YESNO$NO.

    • BA_SCHEMA_NAME By default, the schema uses the model name. If you want a different schema name, enter it. It must be unique across the DMW instance.

  • PIFILETYPE (Mandatory). To create a target model or an InForm input model, enter NULL. To create a file-type input model, enter either SAS or TEXT for the type of data files to be loaded. For file-type input models, a value here is required to make the File Watcher Configuration tab appear in the user interface so you can complete the model definition.

29.1.2 Create a Study Clinical Data Model from a Library Model

Use this API to create a study clinical data model in a study domain from a clinical data model in a library. The complete model is copied, including all tables, columns, and constraints. The system maintains a relationship between the library model and the study model. If the library model is modified, you can upgrade the study model to the new version—see "Upgrade a Clinical Data Model to the Latest Library Model Version". However, any local changes you have made to the study model are lost.

Name DME_PUB_DF_DATA_MODEL.CreateStudyDMFromLibDM

Signature 

PROCEDURE CreateStudyDMFromLibDM
(P_API_VERSION      IN NUMBER,   
P_INIT_MSG_LIST    IN VARCHAR2 DEFAULT CDR_PUB_DEF_CONSTANTS.G_FALSE,
P_COMMIT           IN VARCHAR2 DEFAULT CDR_PUB_DEF_CONSTANTS.G_FALSE,
P_VALIDATION_LEVEL IN NUMBER DEFAULT CDR_PUB_DEF_CONSTANTS.G_VALID_LEVEL_FULL,
PI_LIBMODOBJ     IN NOCOPY CDR_NAMING_VERSION_OBJ_TYPE,
PI_STDYMODOBJ    IN NOCOPY CDR_NAMING_VERSION_OBJ_TYPE,
PIO_DMOBJ        IN CDR_DATA_MODEL_OBJ_TYPE,
X_RETURN_STATUS OUT NOCOPY VARCHAR2,
X_MSG_COUNT OUT NOCOPY     NUMBER,
X_MSG_DATA OUT NOCOPY      VARCHAR2,
  );

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameters:

  • PI_LIBMODOBJ (Mandatory). This is a parameter of type CDR_NAMING_VERSION_OBJ_TYPE. Enter values for the following attributes for the library model and its namespace, which is the library domain for the therapeutic area or other category.

    • COMPANY_ID To get your company ID, use CDR_PUB_DEF_FACTORY_UTILS.GetCompanyId.

    • NAME Enter a name for the library clinical data model.

    • NAMESPACE_OBJ_ID Enter the object ID of the parent library domain.

    • NAMESPACE_OBJ_VER Enter the object version of the library domain.

    • NAMESPACE_START_OBJ_VER Enter 1

    • NAMESPACE_END_OBJ_VER Enter 999999

    • DESCRIPTION Enter a description for the library clinical data model.

    • OBJECT_TYPE_RC Enter '$OBJTYPES$DATAMODEL'

  • PI_STDYMODOBJ (Mandatory). This is a parameter of type CDR_NAMING_VERSION_OBJ_TYPE. Enter values for the following attributes for the new study model and its namespace, which is the study domain.

    • COMPANY_ID To get your company ID, use CDR_PUB_DEF_FACTORY_UTILS.GetCompanyId.

    • NAME Enter a name for the study clinical data model.

    • NAMESPACE_OBJ_ID Enter the object ID of the parent study domain.

    • NAMESPACE_OBJ_VER Enter the object version of the study domain.

    • NAMESPACE_START_OBJ_VER Enter 1

    • NAMESPACE_END_OBJ_VER Enter 999999

    • DESCRIPTION Enter a description for the study clinical data model.

    • OBJECT_TYPE_RC Enter '$OBJTYPES$DATAMODEL'

  • PIO_DMOBJ (Mandatory). This is a parameter of type CDR_DATA_MODEL_OBJ_TYPE. Enter values for the following attributes for the new study clinical data model:

    • DM_NAME Enter null.

    • DM_NAMESPACE_OBJ_ID Enter the object ID of the parent study domain.

    • DM_DESCRIPTION Enter null.

    • DM_TABLE_COLL Leave empty. To add tables use "Add a Table to a Clinical Data Model".

    • LIBRARY_FLAG_RC Enter $YESNO$NO because this is a study model, not a library model.

    • MODEL_TYPE_RC

      • To create a target model, enter $MODELTYPE$TARGET.

      • To create an input model, enter $MODELTYPE$INPUT.

    • MODEL_SUBTYPE_RC

      • If the model type is $MODELTYPE$TARGET, then model subtype is null.

      • If the model type is $MODELTYPE$INPUT, then model subtype can be either $INPUTMODTYPE$INFORM or $INPUTMODTYPE$FILE.

    • CREATE_BA_FLAG_RC Enter $YESNO$YES to create a Business Area to enable visualizations of data in the model or $YESNO$NO.

    • BA_SCHEMA_NAME By default, the schema uses the model name. If you want a different schema name, enter it. It must be unique across the DMW instance.

29.1.3 Modify a Model's Name and Description

Use this API to modify a study clinical data model's name and description.

Name DME_PUB_DF_DATA_MODEL.ModifyStudyDataModel

Signature 

PROCEDURE ModifyStudyDataModel
(P_API_VERSION      IN NUMBER,
P_INIT_MSG_LIST     IN VARCHAR2 DEFAULT CDR_PUB_DEF_CONSTANTS.G_FALSE,
P_COMMIT            IN VARCHAR2 DEFAULT CDR_PUB_DEF_CONSTANTS.G_FALSE,
P_VALIDATION_LEVEL  IN NUMBER DEFAULT CDR_PUB_DEF_CONSTANTS.G_VALID_LEVEL_FULL,
PIO_STDYMODOBJ     IN OUT NOCOPY CDR_NAMING_VERSION_OBJ_TYPE,
PIO_DMOBJ          IN OUT CDR_DATA_MODEL_OBJ_TYPE,
X_RETURN_STATUS     OUT NOCOPY VARCHAR2,
X_MSG_COUNT         OUT NOCOPY NUMBER,
X_MSG_DATA          OUT NOCOPY VARCHAR2,
);

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameters:

  • PIO_STDYMODOBJ (Mandatory). This is a parameter of type CDR_NAMING_VERSION_OBJ_TYPE. Enter values for the new name and description.

  • PIO_DMOBJ (Mandatory). This is a parameter of type CDR_DATA_MODEL_OBJ_TYPE. Enter values for the following attributes for the new clinical data model:

    • DM_NAME Enter a name for the model.

    • DM_NAMESPACE_OBJ_ID Enter the object ID of the study or library domain.

    • DM_DESCRIPTION Enter a description for the model.

    • DM_TABLE_COLL Leave empty. To add tables see "Add a Table to a Clinical Data Model".

    • LIBRARY_FLAG_RC Enter $YESNO$NO if this is a study model or $YESNO$YES if it is a library model.

    • MODEL_TYPE_RC Enter the value for the model: $MODELTYPE$TARGET or $MODELTYPE$INPUT.

    • MODEL_SUBTYPE_RC Enter the model's subtype:

      If the model type is $MODELTYPE$TARGET, then model subtype is null.

      If the model type is $MODELTYPE$INPUT, then model subtype can be either $INPUTMODTYPE$INFORM or $INPUTMODTYPE$FILE.

    • CREATE_BA_FLAG_RC Enter $YESNO$YES to create a Business Area to enable visualizations of data in the model or $YESNO$NO.

    • BA_SCHEMA_NAME By default, the schema uses the model name. If you want a different schema name, enter it. It must be unique across the DMW instance.

  • PIFILETYPE (Mandatory). If you are modifying a target model or an InForm input model, enter NULL. If you are modifying a file-type input model, enter either SAS or TEXT.

29.1.4 Check Out a Clinical Data Model

Use this API to check out a study or library clinical data model.

Name DME_PUB_DF_DATA_MODEL.CheckoutDataModel

Signature 

procedure CheckoutDataModel(
p_api_version IN NUMBER
p_init_msg_list    IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_commit         IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_validation_level        IN NUMBER default       CDR_PUB_DEF_CONSTANTS.G_VALID_LEVEL_FULL
pio_naming       IN OUT NOCOPY  cdr_naming_version_obj_type,
pi_comment       IN VARCHAR2,
x_return_status   OUT NOCOPY  VARCHAR2,
x_msg_count       OUT NOCOPY  NUMBER,
x_msg_data        OUT NOCOPY  VARCHAR2);

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameters:

  • PIO_NAMING (Mandatory). This is a parameter of type CDR_NAMING_VERSION_OBJ_TYPE. Enter attributes for the clinical data model you are checking out.

  • PI_COMMENT Enter a checkout comment.

29.1.5 Check In a Clinical Data Model

Use this API to check in a study or library clinical data model.

Name DME_PUB_DF_DATA_MODEL.CheckinDataModel

Signature 

procedure CheckinDataModel( 
p_api_version IN NUMBER,
p_init_msg_list IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_commit IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_validation_level IN NUMBER default CDR_PUB_DEF_CONSTANTS.G_VALID_LEVEL_FULL
pio_naming IN OUT NOCOPY cdr_naming_version_obj_type
pi_comment IN  VARCHAR2
x_return_status OUT NOCOPY  VARCHAR2
x_msg_count       OUT NOCOPY  NUMBER
x_msg_data OUT NOCOPY  VARCHAR2);

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameters:

  • PIO_NAMING (Mandatory). This is a parameter of type CDR_NAMING_VERSION_OBJ_TYPE. Enter attributes for the clinical data model you are checking in.

  • PI_COMMENT Enter a checkin comment.

29.1.6 Undo a Clinical Data Model Checkout

Use this API to undo the checkout of a study or library clinical data model.

Name DME_PUB_DF_DATA_MODEL.UncheckoutDataModel

Signature 

PROCEDURE UncheckoutModel(
p_api_version             IN NUMBER
p_init_msg_list    IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_commit                 IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_validation_level        IN NUMBER default CDR_PUB_DEF_CONSTANTS.G_VALID_LEVEL_FULL
pio_naming               IN OUT NOCOPY cdr_naming_version_obj_type
x_return_status   OUT NOCOPY VARCHAR2
x_msg_count               OUT NOCOPY NUMBER
x_msg_data                OUT NOCOPY VARCHAR2);

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameters:

  • PIO_NAMING (Mandatory). This is a parameter of type CDR_NAMING_VERSION_OBJ_TYPE. Enter attributes for the clinical data model for which you are undoing the checkout.

29.1.7 Install a Study Clinical Data Model

Use this API to install a study clinical data model.

Name DME_PUB_DF_DATA_MODEL.DeployStudyDataModel

Signature 

procedure DeployStudyDataModel(
p_api_version IN NUMBER
p_init_msg_list IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_commit IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_validation_level        IN NUMBER default CDR_PUB_DEF_CONSTANTS.G_VALID_LEVEL_FULL
x_return_status OUT NOCOPY VARCHAR2
x_msg_count OUT NOCOPY NUMBER
x_msg_data OUT NOCOPY VARCHAR2
pi_StudyModObj IN OUT NOCOPY cdr_naming_version_obj_type
pi_Context IN VARCHAR2);

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameters:

  • PI_STUDYMODOBJ (Mandatory): This is a parameter of type CDR_NAMING_VERSION_OBJ_TYPE. Enter attributes for the clinical data model that you are installing.

  • PI_CONTEXT (Mandatory): Enter the lifecycle area in which you are installing the clinical data model:

    • '$LIFECYCLE$DEV'

    • '$LIFECYCLE$PROD'

    • '$LIFECYCLE$QC'

29.1.8 Promote a Clinical Data Model to Quality Control or Production

Use this API to promote a study clinical data model to either the Quality Control or Production validation status.

Name DME_PUB_DF_DATA_MODEL.UpdateValStatus

Signature 

PROCEDURE updateValStatus( 
p_api_version             IN NUMBER
p_init_msg_list    IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_commit                 IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_validation_level        IN NUMBER default CDR_PUB_DEF_CONSTANTS.G_VALID_LEVEL_FULL
pio_naming      in out nocopy cdr_naming_version_obj_type
x_return_status   OUT NOCOPY VARCHAR2
x_msg_count       out nocopy number
x_msg_data        OUT NOCOPY VARCHAR2);

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameters:

  • PIO_NAMING (Mandatory): This is a parameter of type CDR_NAMING_VERSION_OBJ_TYPE. Enter attributes for the clinical data model that you are promoting.

  • PIO_NAMING.VALIDATION_STATUS_RC (Mandatory): Enter the validation status to which you are promoting the clinical data model:

    • '$SYSVALDNSTEPS$DEVELOPMENT'

    • '$SYSVALDNSTEPS$QUALITYCONTROL'

    • '$SYSVALDNSTEPS$PRODUCTION'

29.1.9 Remove a Clinical Data Model

Use this API to delete a study clinical data model.

Name DME_PUB_DF_DATA_MODEL.RemoveStudyDataModel

Signature 

Procedure RemoveStudyDataModel( 
p_api_version IN NUMBER
p_init_msg_list IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_commit IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_validation_level IN NUMBER default CDR_PUB_DEF_CONSTANTS.G_VALID_LEVEL_FULL
pio_StdyModObj IN OUT NOCOPY cdr_naming_version_obj_type
x_return_status OUT NOCOPY VARCHAR2
x_msg_count OUT NOCOPY NUMBER
x_msg_data OUT NOCOPY VARCHAR2);

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameter:

PIO_STDYMODOBJ (Mandatory): This is a parameter of type CDR_NAMING_VERSION_OBJ_TYPE. Enter attributes for the clinical data model that you are removing.

29.1.10 Upgrade a Clinical Data Model to the Latest Library Model Version

Use this API to upgrade a study clinical data model that was created from a library model to the latest version of the library model.

Name DME_PUB_DF_DATA_MODEL.UpgradeSDMToLatestLDM

Signature 

PROCEDURE UpgradeSDMToLatestLDM(p_api_version               IN NUMBER
p_init_msg_list    IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_commit                 in varchar2 default cdr_pub_def_constants.g_false
p_validation_level        in number default cdr_pub_def_constants.g_valid_level_full
pio_StudyModObj    IN OUT NOCOPY  cdr_naming_version_obj_type
x_return_status   OUT NOCOPY VARCHAR2
x_msg_count               OUT NOCOPY NUMBER
x_msg_data                OUT NOCOPY VARCHAR2);

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameter:

PIO_STDYMODOBJ (Mandatory): This is a parameter of type CDR_NAMING_VERSION_OBJ_TYPE. Enter attributes for the clinical data model that you are upgrading.

29.1.11 Copy the Subject and/or Subject/Visit Table

Use this API to copy the SUBJECT table, the SUBJECT/VISIT table, or both tables from a library data model or from the shipped default structures.

Name DME_PUB_DF_DATA_MODEL.Copy_Subj_Vist_From_Lib

Signature 

procedure copy_subj_vist_from_lib(
p_api_version             IN NUMBER
p_init_msg_list    IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_commit                 in varchar2 default cdr_pub_def_constants.g_false
p_validation_level        in number default cdr_pub_def_constants.g_valid_level_full
pilibmod        in cdr_naming_version_obj_type
pitgtstdymod    in cdr_naming_version_obj_type
piCopySel       IN VARCHAR2
x_return_status out nocopy varchar2
x_msg_count       out nocopy number
x_msg_data        out nocopy varchar2);

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameters:

  • PILIBMOD (Mandatory): Enter values for the library model from which you want to copy the tables, if any. This is a parameter of type CDR_NAMING_VERSION_OBJ_TYPE.

    • To copy from a library data model, enter attribute values for the library data model.

    • To copy default table structures, enter null values.

  • PITGTSTDYMOD (Mandatory): Enter values for the study clinical data model into which you want to copy one or both tables. This is a parameter of type CDR_NAMING_VERSION_OBJ_TYPE.

  • PICOPYSEL (Mandatory) Specify which table(s) to copy:

    • SUB to copy the Subject table only.

    • VIS to copy the Subject/Visit table only.

    • BOTH to copy both tables.

29.1.12 Add a Table to a Clinical Data Model

Use this API to add a table to clinical data model. The table is created without columns or constraints. To add columns, see Section 29.1.15, "Add Column to a Table in a Clinical Data Model". To add constraints, see Section 29.1.18, "Add a Constraint to a Clinical Data Model Table". Note that you can create a table with columns and constraints by uploading a metadata file through the user interface. See Oracle Health Sciences Data Management Workbench User's Guide for more information.

Name DME_PUB_DF_DATA_MODEL.AddTableToDataModel

Signature 

Procedure AddTableToDataModel (
p_api_version     IN NUMBER
p_init_msg_list    IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_commit         IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_validation_level        IN NUMBER default CDR_PUB_DEF_CONSTANTS.G_VALID_LEVEL_FULL
x_return_status   OUT NOCOPY VARCHAR2
x_msg_count       OUT NOCOPY NUMBER
x_msg_data        OUT NOCOPY VARCHAR2
pio_naming       IN OUT NOCOPY        cdr_naming_version_obj_type
pio_table                IN OUT NOCOPY            cdr_dm_table_obj_type
pi_defClassificationColl IN CDR_CLASSIFICATIONS_COLL);

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameters:

  • PIO_NAMING (Mandatory): Enter values for the study clinical data model to which you want to add a table. This is a parameter of type CDR_NAMING_VERSION_OBJ_TYPE.

  • PIO_TABLE (Mandatory): Enter values for the table:

    • COMPANY_ID To get your company ID, use CDR_PUB_DEF_FACTORY_UTILS.GetCompanyId.

    • ORACLE_NAME: Enter an Oracle name.

    • SAS_NAME: Enter a SAS name.

    • SAS_LABEL: Enter a SAS label.

    • SAS_V6_FLAG_RC: If you are using SAS version 6, enter '$YESNO$YES'. If you are using a more recent version, enter '$YESNO$NO'.

    • AUDIT_TABC_COMPANY_ID, AUDIT_TABC_OBJ_ID, AUDIT_TABC_OBJ_VER: Leave these three blank.

    • SNAPSHOT_FLAG_RC: To allow creating snapshots on this table, enter '$YESNO$YES'. To prevent creating snapshots on this table, enter '$YESNO$NO'.

    • PROCESS_TYPE_RC: Enter '$PROCESSTYPES$STAGINGWAUDIT'. This is the required type for newly created tables in Oracle DMW.

    • BLINDING_FLAG_RC: If this table may ever contain sensitive data that should be blinded or masked, enter '$YESNO$YES'. If not, enter '$YESNO$NO'.

    • REQUIRED_FLAG_RC: Enter '$YESNO$YES' or '$YESNO$NO'. This value is not used by the system.

    • DM_TAB_COL_COLL: Pass all null values to this collection. To add columns to the table, see Section 29.1.15, "Add Column to a Table in a Clinical Data Model".

    • DM_TAB_CONS_COLL: Pass all null values to this collection. To add constraints to the table, see Section 29.1.18, "Add a Constraint to a Clinical Data Model Table".

    • STAGING_FLAG_RC: If this is a temporary staging table required for use in a transformation, enter '$YESNO$YES'. Otherwise enter '$YESNO$NO'.

    • USABLE_FLAG_RC: Enter '$YESNO$YES' or '$YESNO$NO'. This value is not used by the system.

    • IDENTIFIER_TAB_COMP_ID: If you are assigning an SDTM ID to the table, enter the company ID of SDTM identifier. To find this and related values, query public view DME_SDTM_TAB_IDENTIFIERS_V.

    • IDENTIFIER_TAB_OBJ_ID: If you are assigning an SDTM ID to the table, enter the object ID of SDTM identifier.

    • IDENTIFIER_TAB_OBJ_VER: If you are assigning an SDTM ID to the table, enter the object version of SDTM identifier.

    • BLINDING_CRITERIA: If the table has row-level blinding (set in the MASKING_TYPE_RC attribute below), enter the blinding criteria as a SQL expression.

    • ALIASES: Enter one or more alternate names for the column in a comma-separated list with no spaces, for use in automapping transformations.

    • INFORM_REF_PATH_NAME: Leave blank.

    • MASKING_TYPE_RC: If the table's BLINDING_FLAG_RC is set to '$YESNO$NO', enter '$MASKING_TYPE$NONE'.

      If the table's BLINDING_FLAG_RC is set to '$YESNO$YES', specify the type of blinding: '$MASKING_TYPE$COLUMN', '$MASKING_TYPE$ROW', or '$MASKING_TYPE$TABLE'.

    • BLINDING_CRITERIA_EXPR_ID: Enter null.

    • BLINDING_CRITERIA_EXPRESSION: This is a parameter of type DME_XFORM_EXPRESSION_OBJ_TYPE. Enter details for the blinding criteria:

      EXPRESSION_ID: Enter null (to create a new expression ID).

      POSITION: Position of component.

      COMPONENT_TYPE_RC: Enter '$EXPCOMPTYPE$OPERATOR' or '$EXPCOMPTYPE$CONSTANT'

      COMPONENT: Enter component STATIC_REFS: If the expression references an existing function, enter the function ID.

      For example, the expression:

      BLINDING_CRITERIA= 'ADDN_TABL1.DEPTNO>0';
      

      has three components:

      "ADDN_TABL1.DEPTNO"
       ">"
       "0"
      

      To create a collection of type DME_XFORM_EXPRESSION_OBJ_TYPE with these components:

      oExprType :=DME_XFORM_EXPRESSION_OBJ_TYPE(NULL,1,'$EXPCOMPTYPE$CONSTANT','ADDN_TABL1.DEPTNO',NULL);
      oExprColl.extend;
      oExprColl(oExprColl.last):=oExprType;
       
      oExprType :=DME_XFORM_EXPRESSION_OBJ_TYPE(NULL,2,'$EXPCOMPTYPE$OPERATOR','>',NULL);
      oExprColl.extend;
      oExprColl(oExprColl.last):=oExprType;
      oExprType                :=DME_XFORM_EXPRESSION_OBJ_TYPE(NULL,3,'$EXPCOMPTYPE$CONSTANT','0',NULL);
       
      oExprColl.extend;
      oExprColl(oExprColl.last)         :=oExprType;
       
      BLINDING_CRITERIA_EXPR_COLL:=oExprColl;
      
    • UOW_PROCESS_TYPE_RC:

      If programs writing to the table do not use Unit of Work processing, it uses Reload processing. Enter '$UOWPROCTYPES$NONUOW'.

      If programs writing to the table use Subject Visit Unit of Work processing, enter '$UOWPROCTYPES$SUBJ_VISIT'.

      If programs writing to the table use Subject Unit of Work processing, enter '$UOWPROCTYPES$SUBJ'.

  • PI_DEFCLASSIFICATIONCOLL: This is a parameter of type CDR_CLASSIFICATIONS_COLL. Pass all null values to this collection.

29.1.13 Modify Table in Clinical Data Model

Use this API to modify a table in a study or library clinical data model.

Name DME_PUB_DF_DATA_MODEL.ModifyTableInDataModel

Signature 

procedure ModifyTableInDataModel(
p_api_version             IN NUMBER
p_init_msg_list    IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_commit                 IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_validation_level        IN NUMBER default CDR_PUB_DEF_CONSTANTS.G_VALID_LEVEL_FULL
x_return_status   OUT NOCOPY VARCHAR2
x_msg_count               OUT NOCOPY NUMBER
x_msg_data                OUT NOCOPY VARCHAR2
pio_naming               IN OUT NOCOPY cdr_naming_version_obj_type
pio_table                IN OUT NOCOPY  cdr_dm_table_obj_type );

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameter:

PIO_NAMING_COLL (Mandatory): Enter current or modified values for the table as required. This is a parameter of type CDR_NAMING_VERSION_OBJ_TYPE.

29.1.14 Remove Table from Clinical Data Model

Use this API to remove a table from a study or library clinical data model.

Name DME_PUB_DF_DATA_MODEL.RemoveTablesInDataModel

Signature 

procedure RemoveTablesInDataModel( 
p_api_version     IN NUMBER
p_init_msg_list    IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_commit                 IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_validation_level        IN NUMBER default CDR_PUB_DEF_CONSTANTS.G_VALID_LEVEL_FULL
x_return_status   OUT NOCOPY VARCHAR2
x_msg_count               OUT NOCOPY NUMBER
x_msg_data                OUT NOCOPY VARCHAR2
pi_naming_coll IN cdr_naming_list_coll);

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameter:

PIO_NAMING_COLL (Mandatory): Enter values to identify the table to be removed. This is a parameter of type CDR_NAMING_VERSION_OBJ_TYPE.

29.1.15 Add Column to a Table in a Clinical Data Model

Use this API to add a column to a table in a clinical data model.

Name DME_PUB_DF_DATA_MODEL.AddColumnToDataModelTab

Signature 

procedure AddColumnToDataModelTab( 
p_api_version     IN NUMBER
p_init_msg_list    IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_commit                 IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_validation_level        IN NUMBER default CDR_PUB_DEF_CONSTANTS.G_VALID_LEVEL_FULL
x_return_status   OUT NOCOPY VARCHAR2
x_msg_count               OUT NOCOPY NUMBER
x_msg_data                OUT NOCOPY VARCHAR2
pio_naming               IN OUT NOCOPY cdr_naming_version_obj_type
pio_variable             IN OUT NOCOPY cdr_var_obj_type
pio_column               IN OUT NOCOPY cdr_dm_column_obj_type );

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameters:

  • PIO_NAMING_COLL (Mandatory): Enter values for the column and its namespace, the table. For OBJECT_TYPE_RC enter $OBJTYPES$COLUMN. This is a parameter of type CDR_NAMING_VERSION_OBJ_TYPE.

  • PIO_VARIABLE (Mandatory): This is a parameter of type CDR_VAR_OBJ_TYPE. Column objects are based on variable objects. Enter values as follows:

    • COMPANY_ID To get your company ID, use CDR_PUB_DEF_FACTORY_UTILS.GetCompanyId.

    • ORACLE_NAME: Enter an Oracle name for the column.

    • ORACLE_DATATYPE_RC: Specify the data type. Enter one:

      '$ORADATATYPES$VARCHAR2', '$ORADATATYPES$DATE', or '$ORADATATYPES$NUMBER'

    • LENGTH:

      For Date data type columns, no length is required.

      For VARCHAR2 data type columns, the value must be between 1 and 4000.

      For Number data type columns, the maximum value is 38.

    • PRECISION: If the column is of data type Number, enter the precision.

    • SAS_V6_NAME: Enter a name that conforms to SAS V6 requirements, if needed.

    • SAS_V8_NAME: Enter a name that conforms to SAS V8 requirements, if needed.

    • SAS LABEL: Enter a SAS label, up to 200 characters.

    • SAS_FORMAT: Enter a SAS format or leave blank to default to the value you entered for LENGTH preceded by a dollar sign ($).

    • NULLABLE_FLAG_RC: If null values are allowed in the column, enter '$YESNO$YES'. If not (the column is mandatory) enter '$YESNO$NO'.

    • DEFAULT_VALUE: Enter NULL or, if the column should always have a particular data value, enter the value.

  • PIO_COLUMN: This is a parameter of type CDR_DM_COLUMN_OBJ_TYPE. Some attributes are the same as for the variable parameter PIO_VARIABLE. Enter the same values you did for the variable. In addition:

    • OBJ_ID and OBJ_VER: Enter NULL.

    • POSITION: Enter the column's position in the table relative to other columns.

    • REQUIRED_FLAG_RC: Enter the opposite value that you entered for Nullable in the Variable parameter.

    • CODE_LIST_COMPANY_ID: To associate the column with a codelist, enter the company ID of the codelist. To find this and related values, query public view DME_PUB_CODELIST_V.

    • CODE_LIST_OBJ_ID: To associate the column the column with a codelist, enter the object ID of the codelist.

    • CODE_LIST_OBJ_VER: To associate the column the column with a codelist, enter the object version of the codelist.

    • IDENTIFIER_VAR_COMP_ID: If you are assigning an SDTM ID to the column, enter the company ID of SDTM identifier. To find this and related values, query public view DME_SDTM_COL_IDENTIFIERS_V.

    • IDENTIFIER_VAR_OBJ_ID: If you are assigning an SDTM ID to the column, enter the object ID of SDTM identifier.

    • IDENTIFIER_VAR_OBJ_VER: If you are assigning an SDTM ID to the column, enter the object version of SDTM identifier.

    • USABLE_FLAG_RC: Enter '$YESNO$YES' or '$YESNO$NO'. This value is not used by the system.

    • MAPPABLE_FLAG_RC: Enter '$YESNO$YES' if the column can be mapped to a source column in a transformation. Internal columns such as CDR$DUP_NUM and CDR$SKEY should have the value '$YESNO$NO'.

      If set to '$YESNO$NO', the system ignores the column when calculating mapping completeness and when automapping.

    • MASKING_VALUE: If the column belongs to a table with column-level blinding and should be blinded, enter the masking value.

    • MASKING_CRITERIA: If the column data values should be masked only in some rows, enter the masking criteria as a SQL expression.

    • SOURCE_KEY_FLAG_RC: Enter null.

    • ALIASES: Enter one or more alternate names for the column in a comma-separated list with no spaces, for use in automapping transformations.

    • INFORM_REF_PATH_NAME: Leave blank.

    • MASKING_LEVEL_RC: Specify the masking level for the column: , '$MASKING_LEVEL$NONE', '$MASKING_LEVEL$COLUMN', or '$MASKING_LEVEL$CELL'.

    • MASK_VALUE_EXPR_ID: To use a predefined expression to generate masking values, enter the expression's object ID.

    • MASK_VALUE_EXPRESSION: If Masking Value is '$MASKING_LEVEL$NONE' then pass NULL values. For others pass expression details to parameter DME_XFORM_EXPR_OBJ_TYPE type; see Section 29.1.12, "Add a Table to a Clinical Data Model" parameter BLINDING_CRITERIA_EXPRESSION.

    • MASK_CRITERIA_EXPR_ID: To use a predefined expression to determine which cells to mask, enter the expression's object ID.

    • MASK_CRITERIA_EXPRESSION: If Masking value is '$MASKING_LEVEL$COLUMN' or '$MASKING_LEVEL$NONE' then pass the NULL values. For '$MASKING_LEVEL$CELL' pass criteria expression details to parameter DME_XFORM_EXPR_OBJ_TYPE type; see Section 29.1.12, "Add a Table to a Clinical Data Model" parameter BLINDING_CRITERIA_EXPRESSION.

29.1.16 Modify a Column in a Clinical Data Model Table

Use this API to modify a column.

Name DME_PUB_DF_DATA_MODEL.ModifyColumnInDataModelTab

Signature 

procedure ModifyColumnInDataModelTab(p_api_version  IN NUMBER
p_init_msg_list    IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_commit                 IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_validation_level        IN NUMBER default CDR_PUB_DEF_CONSTANTS.G_VALID_LEVEL_FULL
x_return_status   OUT NOCOPY VARCHAR2
x_msg_count               OUT NOCOPY NUMBER
x_msg_data                OUT NOCOPY VARCHAR2
pio_naming               IN OUT NOCOPY cdr_naming_version_obj_type
pio_column               IN OUT NOCOPY cdr_dm_column_obj_type );

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameters:

  • PIO_NAMING (Mandatory): Enter values for the column. This is a parameter of type CDR_NAMING_VERSION_OBJ_TYPE.

  • PIO_COLUMN (Mandatory): This is a parameter of type CDR_DM_COLUMN_OBJ_TYPE. Enter current or modified values for the column as required.

29.1.17 Remove Column from Clinical Data Model Table

Use this API to delete a column from a table.

Name DME_PUB_DF_DATA_MODEL.RemoveColumnsInDataModelTab

Signature 

procedure RemoveColumnsInDataModelTab(
p_api_version     IN NUMBER
p_init_msg_list    IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_commit                 IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_validation_level        IN NUMBER default CDR_PUB_DEF_CONSTANTS.G_VALID_LEVEL_FULL
x_return_status   OUT NOCOPY VARCHAR2
x_msg_count               OUT NOCOPY NUMBER
x_msg_data                OUT NOCOPY VARCHAR2
pi_naming_coll    IN  cdr_naming_list_coll);

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameters:

PI_NAMING_COLL (Mandatory): Identify the column to be removed. This is a parameter of type CDR_NAMING_LIST_COLL.

29.1.18 Add a Constraint to a Clinical Data Model Table

Use this API to add a constraint to a table in a study or library clinical data model.

Name DME_PUB_DF_DATA_MODEL.AddConstraintToDataModelTab

Signature 

procedure AddConstraintToDataModelTab(
p_api_version     IN NUMBER
p_init_msg_list    IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_commit                 IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_validation_level        IN NUMBER default CDR_PUB_DEF_CONSTANTS.G_VALID_LEVEL_FULL
x_return_status   OUT NOCOPY VARCHAR2
x_msg_count       OUT NOCOPY NUMBER
x_msg_data        OUT NOCOPY VARCHAR2
pio_naming       IN OUT NOCOPY cdr_naming_version_obj_type
pio_constraint   IN OUT NOCOPY cdr_dm_tab_cons_obj_type
pi_constraintColumns IN OUT NOCOPY cdr_table_concols_list_coll
pi_vals          IN cdr_vals_coll);

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameters:

  • PIO_NAMING (Mandatory): Enter values for the new constraint and the parent table. This is a parameter of type CDR_NAMING_VERSION_OBJ_TYPE. For OBJECT_TYPE_RC, enter '$OBJTYPES$TABLECNSTR'.

  • PIO_CONSTRAINT (Mandatory): This is a parameter of type CDR_DM_TAB_CONS_OBJ_TYPE. Enter values as follows:

    • COMPANY_ID: To get your company ID, use CDR_PUB_DEF_FACTORY_UTILS.GetCompanyId.

    • OBJ_ID and OBJ_VER: Enter NULL.

    • CONSTRAINT_NAME: Enter a name.

    • CONSTRAINT_TYPE_RC: Identify the type of constraint:

      $CONSTRAINTYPES$CHECK

      $CONSTRAINTYPES$PRIMARYKEY

      $CONSTRAINTYPES$BITMAP

      $CONSTRAINTYPES$UNIQUE

      $CONSTRAINTYPES$NUINDEX

    • SURROGATE_KEY_FLAG_RC: Enter null. If you are creating a primary key and a surrogate key column does not exist in the table, the system creates it as CDR$SKEY. The column stores surrogate key values, which are required for data lineage tracing.

    • DUPLICATE_RECORD_FLAG_RC: The system uses this value only for primary keys. In most cases this should be set to '$YESNO$NO' but you can enable loading records with the same primary key value by entering '$YESNO$YES'. See the Oracle Health Sciences Data Management Workbench User's Guide for more information.

    • DM_CONS_COL_COLL: Pass NULL values.

  • PI_CONSTRAINTCOLUMNS: This is a parameter of type CDR_TABLE_CONCOLS_LIST_COLL. Identify the table and the table's columns where you want to apply the constraints. Depending on the constraint, you must also provide values for attributes that define foreign key, or that identify the list of values object to store the values for a CHECK constraint.

    • TABC_COMPANY_ID: To get your company ID, use CDR_PUB_DEF_FACTORY_UTILS.GetCompanyId.

    • TABC_OBJ_ID and TABC_OBJ_VER: Enter NULL.

      FK_COL_COMPANY_ID: Enter NULL.

      FK_COL_OBJ_ID: Enter NULL.

      FK_COL_OBJ_VER: Enter NULL.

      POSITION: Enter the position of the constraint column in constraint.

      COL_COMPANY_ID: Enter the column company ID.

      COL_OBJ_ID: Enter the column's object ID.

      COL_OBJ_VER: Enter the column's object version.

      LOV_COMPANY_ID: Enter the column company ID.

      LOV_OBJ_ID: Enter NULL.

      LOV_OBJ_VER: Enter NULL.

  • PI_VALS. This is a parameter of type CDR_VALS_COLL that is based on CDR_VAL_OBJ_TYPE type. It applies only to Check constraints. The type has two attributes for each value.

    • POSITION: The position of the value in the list.

    • VALUE: The valid value.

29.1.19 Modify a Constraint in a Clinical Data Model Table

Use this API to modify an existing constraint.

Name DME_PUB_DF_DATA_MODEL.ModifyConsInDataModelTab

Signature 

procedure ModifyConsInDataModelTab(p_api_version    IN NUMBER
p_init_msg_list    IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_commit                 IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_validation_level        IN NUMBER default CDR_PUB_DEF_CONSTANTS.G_VALID_LEVEL_FULL
x_return_status   OUT NOCOPY VARCHAR2
x_msg_count               OUT NOCOPY NUMBER
x_msg_data                OUT NOCOPY VARCHAR2
pio_naming               IN OUT NOCOPY cdr_naming_version_obj_type
pio_constraint   IN OUT NOCOPY cdr_dm_tab_cons_obj_type
pi_constraintColumns IN OUT NOCOPY cdr_table_concols_list_coll
pi_vals IN cdr_vals_coll );

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameters:

  • PIO_NAMING (Mandatory): Enter values for the constraint. This is a parameter of type CDR_NAMING_VERSION_OBJ_TYPE.

  • PIO_CONSTRAINT(Mandatory): This is a parameter of type CDR_DM_TAB_CONS_OBJ_TYPE. Enter current or modified values for the constraint as required.

  • PI_VALS. This is a parameter of type CDR_VALS_COLL that is based on CDR_VAL_OBJ_TYPE type. Enter current or modified values for a check constraint as required.

29.1.20 Remove Constraint from a Clinical Data Model Table

Use this API to remove a constraint from a table.

Name DME_PUB_DF_DATA_MODEL.RemoveConsInDataModelTab

Signature 

procedure RemoveConsInDataModelTab(
p_api_version     IN NUMBER
p_init_msg_list    IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_commit                 IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_validation_level        IN NUMBER default CDR_PUB_DEF_CONSTANTS.G_VALID_LEVEL_FULL
x_return_status   OUT NOCOPY VARCHAR2
x_msg_count       OUT NOCOPY NUMBER
x_msg_data                OUT NOCOPY VARCHAR2
pi_naming_coll    IN  cdr_naming_list_coll);

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameters:

PI_NAMING_COLL (Mandatory): Identify the constraint to be removed. This is a parameter of type CDR_NAMING_LIST_COLL that contains list of CDR naming version attributes.

29.1.21 Reorder Columns in a Clinical Data Model Table

Use this API to change the order of columns in a table.

Name DME_PUB_DF_DATA_MODEL.ReorderColumnInDMTable

Signature 

procedure ReorderColumnInDMTable(
p_api_version             IN NUMBER
p_init_msg_list    IN VARCHAR2 default CDR_PUB_DEF_CONSTANTS.G_FALSE
p_commit                 in varchar2 default cdr_pub_def_constants.g_false
p_validation_level        in number default cdr_pub_def_constants.g_valid_level_full
pi_reorderObjColl IN cdr_reorder_obj_coll
x_return_status   OUT NOCOPY VARCHAR2
x_msg_count               OUT NOCOPY NUMBER
x_msg_data                OUT NOCOPY VARCHAR2);

Parameters This API has standard parameters (see "Standard Parameters") as well as the following parameters:

PI_REORDEROBJCOLL (Mandatory): This is a parameter of type CDR_REORDER_OBJ_COLL, which is based on the CDR_REORDER_OBJ_TYPE type. Pass one set of CDR_REORDER_OBJ_TYPE to CDR_REORDER_OBJ_COLL for each column whose order needs to be changed.

  • COMPANY_ID: To get your company ID, use CDR_PUB_DEF_FACTORY_UTILS.GetCompanyId.

  • OBJ_ID: Enter the column's object ID.

  • OBJ_VER: Enter the column's object version.

  • NAMESPACE_OBJ_ID: Enter the table's object ID.

  • NAMESPACE_OBJ_VER: Enter the table's object version.

  • POSITION: Enter the new position for the column, relative to other columns in the table.

  • ENTRY_NUMBER: Enter null.

  • OBJECT_VERSION_NUMBER: Enter null.