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) and 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. This parameter is used for validation purposes.
    • 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.