DMW 3.3
Browse field descriptions of the DMW 3.3 extract data by table.
Clinical data extract common columns
Note:
The columns described in this section are common to all clinical data extract tables.Column name | Data type | Description |
---|---|---|
TENANT | VARCHAR2(64 CHAR) | Tenant name |
TENANT_ID | RAW(16 BYTE) | GUID tenant ID |
TENANT_WID | NUMBER(38) | Numeric tenant ID |
STUDY | VARCHAR2(64 CHAR) | Study name |
STUDY_ID | RAW(16 BYTE) | GUID study ID |
STUDY_WID | NUMBER(38) | Numeric study ID |
STUDY_VERSION | VARCHAR2(32 CHAR) | The study version of a given record |
COUNTRY | VARCHAR2(100 CHAR) | Site address country |
COUNTRY_ID | RAW(16 BYTE) | GUID country ID |
COUNTRY_WID | NUMBER(38) | Numeric country ID |
INVESTIGATOR | VARCHAR2(100 CHAR) | Investigator associated with the given record |
INVESTIGATOR_ID | RAW(16 BYTE) | GUID investigator ID |
INVESTIGATOR_WID | NUMBER(38) | Numeric investigator ID |
SITE | VARCHAR2(200 CHAR) | Site name |
SITE_ID | RAW(16 BYTE) | GUID site ID |
SITE_WID | NUMBER(38) | Numeric site ID |
VISIT | VARCHAR2(64 CHAR) | Visit (Event) Refname as defined in Oracle Clinical One Platform Note: This differs from Visit Title and Visit ID. |
VISIT_ID | RAW(16 BYTE) | GUID visit ID |
VISIT_WID | NUMBER(38) | Numeric visit ID |
VISIT_DATE | DATE | Date on which the visit occurred |
EVENT_INSTANCE_NUMBER | NUMBER | Event instance number for the visit |
FORM | VARCHAR2(64 CHAR) | Form Refname as defined in Oracle Clinical One Platform |
FORM_ID | RAW(16 BYTE) | GUID form ID |
FORM_WID | NUMBER(38) | Numeric form ID |
FORM_SECTION_ID | RAW(16 BYTE) | GUID form section ID |
FORM_SECTION_WID | NUMBER(38) | Numeric form section ID |
REPEAT_SEQUENCE_NUMBER | NUMBER | Usage dependent on form type:
|
UNSCHEDULED | NUMBER | Flag indicating if the visit where the form was collected was an unscheduled one |
SUBJECT | VARCHAR2(500 CHAR) | Subject name |
SUBJECT_ID | RAW(16 BYTE) | GUID subject ID |
SUBJECT_WID | NUMBER(38) | Numeric subject ID |
ENTERED_BY | VARCHAR2(255 CHAR) | User that created the record |
ENTERED_ID | RAW(16 BYTE) | GUID user ID who entered the record |
ENTERED_WID | NUMBER(38) | Numeric user ID who entered the record |
ENTERED_DATE | TIMESTAMP(6) | Date of record entry |
LASTCHANGED_BY | VARCHAR2(255 CHAR) | User that updated the record |
LASTCHANGED_ID | RAW(16 BYTE) | GUID user ID who last updated the record |
LASTCHANGED_WID | NUMBER(38) | Numeric user ID who last updated the record |
LASTCHANGED_DATE | TIMESTAMP(6) |
|
DELETED | VARCHAR2(1) | Boolean value that indicates whether a record was deleted |
DH_TIMESTAMP | TIMESTAMP(6) | Timestamp of when the record was written to Data Hub |
VISIT_SEQ | NUMBER | Sequential number of a visit for a subject |
SOFTWARE_VERSION_NUMBER | NUMBER | Internal on-disk version number for the record |
REPEAT_FORM_NUMBER | NUMBER | For two-section Forms: Numeric value to
represent the form instance
Note: For lab forms this value is defaulted to 1 and for repeating forms this value isNULL .
|
INNER_REPEAT | NUMBER | For Lab and two-Section Form Designs: Sequential number to represent the table (repeating section) row the extract data pertains to |
OUTER_REPEAT | NUMBER | For Repeating Forms (including one-section and two-section forms): Sequential number to represent the form instance |
NONREPEATING | VARCHAR2(1) | Column usage dependent on Form Type:
|
ROW_ID | RAW(16 BYTE) | GUID generated in DataHub to uniquely identify a row in the Data Extract table |
<ItemName> | VARCHAR2(4000 CHAR) | Item value collected in the form (1 column per
item)
Note: See column mapping details in Form item output mapping in data extracts. |
<ItemName_R> | VARCHAR2(4000 CHAR) | Raw value of the item collected (1 column per
item)
Note: See column mapping details in Form item output mapping in data extracts. |
<ItemName_F> | VARCHAR2(4000 CHAR) | Formatted value of the item collected (1 column per
item)
Note: See column mapping details in Form item output mapping in data extracts. |
<ItemName_D> | VARCHAR2(4000 CHAR) | Decoded value of the item collected (1 column per
item)
Note: See column mapping details in Form item output mapping in data extracts. |
Table: DHVW_CODELISTS_V
Column name | Data type | Description |
---|---|---|
CODELIST_WID | NUMBER(38) | Numeric codelist ID |
STUDY_WID | NUMBER(38) | Numeric study ID |
STUDY_NAME | VARCHAR2(64 CHAR) | Study name |
USER_WID | NUMBER(38) | Numeric user ID |
USER_NAME | VARCHAR2(255 CHAR) | User name |
DH_TIMESTAMP | TIMESTAMP(6) | Timestamp of when the record was written to Data Hub |
CODELIST_ID | RAW(16 BYTE) | GUID of the codelist |
VERSION_START | TIMESTAMP(6) | Timestamp of when the record was previously changed |
VERSION_END | TIMESTAMP(6) | Timestamp of when the record was changed |
OPERATION_TYPE | VARCHAR2(16 CHAR) | Type of operation:
|
USER_ID | RAW(16 BYTE) | GUID of the user |
STUDY_ID | RAW(16 BYTE) | GUID of the study |
REFNAME | VARCHAR2(64 CHAR) | System reference name of a codelist |
TITLE | VARCHAR2(64 CHAR) | Codelist title |
DESCRIPTION | VARCHAR2(4000 CHAR) | Codelist description |
CODELIST_TYPE | VARCHAR2(16 CHAR) | Codelist type |
SOFTWARE_VERSION_NUMBER | NUMBER | Internal on-disk version number for the record |
OBJECT_VERSION_NUMBER | NUMBER | Version number of the codelist |
STUDY_VERSION | VARCHAR2(32) | The study version of a given record |
REASON | VARCHAR2(255 CHAR) | User provided reason for record change |
COMMENT | VARCHAR2(2048 CHAR) | Comment for record change |
Table: DHVW_CODELIST_ITEMS_V
Column name | Data type | Description |
---|---|---|
CODELISTITEM_WID | NUMBER(38) | Numeric codelist item ID |
STUDY_WID | NUMBER(38) | Numeric study ID |
STUDY_NAME | VARCHAR2(64 CHAR) | Study name |
USER_WID | NUMBER(38) | Numeric user ID |
USER_NAME | VARCHAR2(255 CHAR) | User name |
DH_TIMESTAMP | TIMESTAMP(6) | Timestamp of when the record was written to Data Hub |
CODELISTITEM_ID | RAW(16 BYTE) | GUID of the codelist item |
VERSION_START | TIMESTAMP(6) | Timestamp of when the record was previously changed |
VERSION_END | TIMESTAMP(6) | Timestamp of when the record was changed |
OPERATION_TYPE | VARCHAR2(16 CHAR) | Type of operation:
|
USER_ID | RAW(16 BYTE) | GUID of the User |
STUDY_ID | RAW(16 BYTE) | GUID of the study |
CODELIST_ID | RAW(16 BYTE) | GUID of the codelist |
CODELIST_WID | NUMBER(38) | Numeric codelist ID |
CODELIST_NAME | VARCHAR2(64 CHAR) | Refname of the codelist |
REFNAME | VARCHAR2(64 CHAR) | System reference name of a codelist |
TITLE | VARCHAR2(64 CHAR) | Codelist title |
DESCRIPTION | VARCHAR2(4000 CHAR) | Codelist description |
ITEM_SEQ | NUMBER | Sequence of the item within the codelist |
VALUEREF_ID | RAW(16 BYTE) | Reference ID of the String resource record (nls) |
CODELIST_TYPE | VARCHAR2(16 CHAR) | Codelist type
Note: Only STRING for now |
CODE | VARCHAR2(64 CHAR) | Code value corresponding to the codelist item |
SOFTWARE_VERSION_NUMBER | NUMBER | Internal on-disk version number for the record |
OBJECT_VERSION_NUMBER | NUMBER | Version number of the codelist |
STUDY_VERSION | VARCHAR2(32) | The study version of a given record |
REASON | VARCHAR2(255 CHAR) | User provided reason for record change |
COMMENT | VARCHAR2(2048 CHAR) | Comment for record change |
CL_CODE | VARCHAR2(255 CHAR) | Code corresponding to the codelist item |
Table: DHVW_FORMS_ASSOCIATIONS_V
Column name | Data type | Description |
---|---|---|
ID | RAW(16 BYTE) | Clinical One GUID for the form association. |
FORMS_ASSOCIATION_WID | NUMBER(38) | Uniquely identifies a form association in DHTBD |
VERSION_START | TIMESTAMP(6) | Indicates the date and time of when the data was changed. |
VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that represents the type of operation performed (for example, create or modify). |
USER_ID | RAW(16 BYTE) | GUID of the user |
USER_WID | NUMBER(38) | Indicates a user's numeric identifier. |
USER_NAME | VARCHAR2(255 CHAR) |
Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
SOFTWARE_VERSION_NUMBER | NUMBER | A number that represents an incremental increase every time a data point is modified. |
REASON | VARCHAR2(255 CHAR) | Indicates a reason for changes in a subject's data. Populated by drop-down list. |
COMMENT | VARCHAR2(2048 CHAR) | Required comment in a reason for change if ‘Other’ is selected. Populated as Rule Execution for calculated values. |
STUDY_ID | RAW(16 BYTE) | User entered study ID. |
STUDY_WID | NUMBER(38) | A number that represents the unique identifier of the study. |
STUDY_NAME | VARCHAR2(64 CHAR) | Study name |
SUBJECT_ID | RAW(16 BYTE) | GUID of the subject |
SUBJECT_WID | NUMBER(38) | Indicates a subject's numeric identifier. |
SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. |
SITE_ID | RAW(16 BYTE) | User entered Site number/ID |
SITE_WID | NUMBER(38) | A number that represents the unique identifier of a site. |
SITE_NAME | VARCHAR2(200 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
SRC_EVENT_ID | RAW(16 BYTE) | Source form event ID |
SRC_EVENT_WID | NUMBER(38) | Source unique event Id assigned in DH to uniquely identify the event in DH |
SRC_EVENT_NAME | VARCHAR2(64 CHAR) | Source form event name |
SRC_EVENT_INSTANCE_NUM | NUMBER | Source form instance number - applies to unscheduled/repeating visits |
SRC_FORM_ID | RAW(16 BYTE) | Source form ID |
SRC_FORM_WID | NUMBER(38) | Source unique form Id assigned in DH to uniquely identify in DH |
SRC_FORM_NAME | VARCHAR2(64 CHAR) | Source for name |
SRC_REPEAT_SEQUENCE_NUMBER | NUMBER |
Source repeat sequence number for repeating forms. Refers to the row instance number of all applicable
form types with repeating data:
|
SRC_STUDY_VERSION | VARCHAR2(100 CHAR) | Source study version |
ASSOCIATED_EVENT_ID | RAW(16 BYTE) | The event ID for an associated event. |
ASSOCIATED_EVENT_WID | NUMBER(38) | A number that represents the unique identifier of the event to which the form is assigned when a form association is present. |
ASSOCIATED_EVENT_NAME | VARCHAR2(64 CHAR) | The name of the associated event. |
ASSOCIATED_EVENT_INSTANCE_NUM | NUMBER |
The unique identifier for an associated event.
Note: If the visit is not UnScheduleAbleVisit, this field will not be populated with any value. |
ASSOCIATED_FORM_ID | RAW(16 BYTE) | The form ID that represents the associated form. |
ASSOCIATED_FORM_WID | NUMBER(38) | A number that represents the unique identifier of the associated form, if present. |
ASSOCIATED_FORM_NAME | VARCHAR2(64 CHAR) | The name of the associated form. |
ASSOCIATED_REPEAT_SEQUENCE_NUM | NUMBER | When association is with a repeating form, indicates the associated sequence number. |
ASSOCIATED_STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version of the associated form. |
SRC_ITEM_ID | RAW(16 BYTE) | Source form item ID |
SRC_ITEM_WID | NUMBER(38) | Source unique form item ID assigned in DH to uniquely identify in DH |
SRC_ITEM_NAME | VARCHAR2(4000 CHAR) | Source form item name |
SRC_FORM_SECTION_ID | RAW(16 BYTE) | Source form section ID |
ASSOCIATED_FORM_SECTION_ID | RAW(16 BYTE) | The section ID of the associated form. |
SRC_REPEAT_FORM_NUM | NUMBER |
Source repeat form number Refers to the form instance number of all applicable
form types with repeating data:
|
ASSOCIATED_REPEAT_FORM_NUM | NUMBER | When association is with a repeating form, indicates the associated repeating form number. |
DH_TIMESTAMP | TIMESTAMP(6) | A time stamp that indicates when the data became available in the dataset. |
IS_CURRENT | CHAR(1) | Audit trail field to display either current status or full audit trail of the data. |
SRC_FORM_REFNAME | VARCHAR2(64 CHAR) | Source form refname |
ASSOCIATED_FORM_REFNAME | VARCHAR2(64 CHAR) | Indicates the reference code of the associated form. |
SRC_FORM_TYPE | NUMBER | Indicates the source form type, such as a two-section or lab form. |
ASSOCIATED_FORM_TYPE | NUMBER | Indicates the form type of the associated form. |
Table: DHVW_QUERY_V
Column name | Data type | Description |
---|---|---|
QUERY_WID | NUMBER(38) | Numeric query ID |
QUERY_ID | RAW(32 BYTE) | GUID of the query |
VERSION_START | TIMESTAMP(6) | Version start |
VERSION_END | TIMESTAMP(6) | Version end |
OPERATION_TYPE | VARCHAR2(16 CHAR) | Type of operation:
|
USER_ID | RAW(32 BYTE) | GUID of the user |
USER_WID | NUMBER(38) | Numeric user ID |
USER_NAME | VARCHAR2(255 CHAR) | Oracle Clinical One Platform user name |
OBJECT_VERSION_NUMBER | NUMBER | Change version number for the record |
SOFTWARE_VERSION_NUMBER | NUMBER | Internal on-disk version number for the record |
STATE | NUMBER | The state of a given query row:
|
SUBJECT_ID | RAW(32 BYTE) | GUID of the subject |
SUBJECT_WID | NUMBER(38) | Numeric subject ID |
SUBJECT_NUMBER | VARCHAR2(500 CHAR) | Subject number |
DATA_ELEMENT_ID | RAW(16 BYTE) | GUID of the data element |
REASON | VARCHAR2(255 CHAR) | User provided reason for record change |
COMMENT | VARCHAR2(20 CHAR) | Comment for record change |
QUERY_COMMENT | VARCHAR2(2048 CHAR) | Query comment provided by user for change |
RULE_ID | RAW(32 BYTE) | GUID of the rule |
FORM_ID | RAW(32 BYTE) | GUID of the form |
FORM_WID | NUMBER(38) | Numeric form ID |
FORM_NAME | VARCHAR2(64 CHAR) | Form name |
EVENT_ID | RAW(32 BYTE) | GUID of the event |
EVENT_WID | NUMBER(38) | Numeric event ID |
EVENT_NAME | VARCHAR2(64 CHAR) | Name of the event for the current record |
DATA_ELEMENT_VERSION_START | TIMESTAMP(6) | Timestamp of a given item's start date |
EVENT_INSTANCE_NUMBER | NUMBER | Event instance number of the visit where the form with the query is collected |
FORM_INSTANCE_NUMBER | NUMBER | Form repeat instance of the form where the query is present |
ITEM_ID | RAW(32 BYTE) | GUID of the item |
ITEM_WID | NUMBER(38) | Numeric item ID |
ITEM_NAME | VARCHAR2(4000 CHAR) | Name of an item |
SITE_ID | RAW(32 BYTE) | GUID of the site |
SITE_WID | NUMBER(38) | Numeric site ID |
SITE_NAME | VARCHAR2(200 CHAR) | Name of a site |
STUDY_ID | RAW(16 BYTE) | GUID of the study |
STUDY_WID | NUMBER(38) | Numeric study ID |
STUDY_NAME | VARCHAR2(100 CHAR) | Study name |
BRANCH_ID | RAW(32 BYTE) | GUID of the visit branch where the form with the query is collected |
STUDY_ROLE_ID | RAW(32 BYTE) | GUID of the study role |
CREATOR_STUDY_ROLE_ID | RAW(32 BYTE) | GUID of the study role who created the query |
DH_TIMESTAMP | TIMESTAMP(6) | Timestamp of when the record was written to Data Hub |
DATA_ELEMENT_WID | NUMBER(38) | Numeric Data Element ID |
STUDY_ROLE_WID | NUMBER(38) | Numeric ID of a study role |
STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Name of a study role |
CREATOR_STUDY_ROLE_WID | NUMBER(38) | Numeric ID of the study role who created the query |
CREATOR_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Name of the study role who created the query |
DISCREPANCY_ID | NUMBER(38) | GUID of the query in DMW |
IS_CURRENT | CHAR(1) | Boolean flag stating whether or not the record has an associated query |
HAS_QUERY | CHAR(1) | Boolean flag stating whether a given record is the most recent version |
HIDDEN | NUMBER(1) | Numeric value to represent whether the item is hidden or not |
REPEAT_FORM_NUMBER | NUMBER | Numeric value to represent the instance number of a two-section form |
Table: DHVW_RAND_KITS_DESIGN_DATASET_V
Column name | Data type | Description |
---|---|---|
STUDY_ID | RAW(16 BYTE) | Numeric ID value for study |
STUDY_WID | NUMBER(38) | GUID of the study |
STUDY_ID_NAME | VARCHAR2(64 CHAR) | Study ID name |
STUDY_TITLE | VARCHAR2(4000 CHAR) | Title of the study |
STUDY_REFNAME | VARCHAR2(64 CHAR) | Study ref name |
THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Therapeutic area of the study |
STUDY_PHASE | VARCHAR2(64 CHAR) | Phase of the study |
BLINDING_TYPE | VARCHAR2(64 CHAR) | Blinding type of the study:
|
STUDY_VERSION | VARCHAR2(32 CHAR) | Version of the study |
MODIFIED_BY_ID | RAW(16 BYTE) | Numeric ID of the user name |
MODIFIED_BY_WID | NUMBER(38) | GUID of the username |
MODIFIED_BY | VARCHAR2(255 CHAR) | Name of the user |
STUDY_DESIGN_STATUS | VARCHAR2(16 CHAR) | Status of the study version |
VERSION_START | TIMESTAMP(6) | Version start value of the study version |
VERSION_END | TIMESTAMP(6) | Version end value of the study version |
RAND_WID | NUMBER | GUID of the randomization |
RAND_ID | RAW(16 BYTE) | Numeric ID for randomization |
RANDOMIZATION_TITLE | VARCHAR2(64 CHAR) | Randomization title |
RANDOMIZATION_DESCRIPTION | VARCHAR2(4000 CHAR) | Description of the randomization |
RANDOMIZATION_TYPE | VARCHAR2(32 CHAR) | Type of randomization |
COHORTTYPE | VARCHAR2(32 CHAR) | Type of cohorts |
RERANDOMIZATION | NUMBER | Specifies if the study allows rerandomization |
DH_TIMESTAMP | TIMESTAMP(6) | Timestamp of when the record was written to Data Hub |
ARM_WID | NUMBER | Numeric ID of the treatment arm |
ARM_ID | RAW(16 BYTE) | GUID of the treatment arm |
TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | Treatment arm title |
TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | Treatment arm description |
TREATMENT_ARM_ID | VARCHAR2(64 CHAR) | Unique numeric ID of the treatment arm |
RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES | NUMBER | Specifies if randomization needs to restrict to available kit types |
ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS | NUMBER | Specifies if the skipped randomization number has to be assigned |
RANDOMIZATION_VERSION_START | TIMESTAMP(6) | Randomization version start date in study design |
RANDOMIZATION_VERSION_END | TIMESTAMP(6) | Randomization version end date in study design |
COHORT_ID | VARCHAR2(32767) | GUID of the cohort |
COHORT_WID | VARCHAR2(32767) | Numeric ID of the cohort |
COHORT_NAME | VARCHAR2(32767 CHAR) | Cohort name |
VISIT_IS_REQUIRED | CHAR(1) | Specifies if the visit is mandatory |
IS_SCHEDULED_VISIT | CHAR(1) | Specifies if the visit is scheduled or unscheduled |
SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) |
Displays the EVENT_TITLE (visit title) of the Scheduled From
visit as defined in the Visit Schedule.
Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit’s own title. For example, Screening Visit is displayed for the Screening Visit, as it is the first visit in the schedule. |
STUDYEVENT_ID | RAW(16 BYTE) | GUID of the visit in study design |
STUDYEVENT_WID | NUMBER(38) | Numeric ID of the visit in study design |
VISIT_TYPE | VARCHAR2(32 CHAR) | Visit type categorization:
|
EVENT_TYPE | VARCHAR2(32) | Event type categorization:
|
DELAY_DAYS | NUMBER | Visit delay days |
DELAY_HOURS | NUMBER | Visit delay hours |
VISIT_WINDOW_BEFORE_DAYS | NUMBER | Number of days before the expected visit date when the visit could start |
VISIT_WINDOW_BEFORE_HOURS | NUMBER | Number of hours before the expected visit date when the visit could start |
VISIT_WINDOW_AFTER_DAYS | NUMBER | Number of days after the expected visit date when the visit could start |
VISIT_WINDOW_AFTER_HOURS | NUMBER | Number of hours after the expected visit date when the visit could start |
EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
EVENT_REFNAME | VARCHAR2(64 CHAR) |
The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE
with blank spaces removed. Oracle Clinical One Analytics
generates this value, which is not displayed in the Oracle
Clinical One Platform user interface.
Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
EVENT_ID_NAME | VARCHAR2(16 CHAR) | Event/Visit ID name |
VISIT_HOUR_SEQ_ORDER | NUMBER | Sequence of the visit based on schedule (number of hours) |
KIT_WID | NUMBER(38) | GUID of the kit at study design |
KIT_ID | RAW(16 BYTE) | Numeric ID of the kit at study design |
DEVICE_TYPE | VARCHAR2(255) | Device type kit:
|
DEVICE_CONNECTION | VARCHAR2(255) | Whether the device is connected or non connected |
CALCULATING_DOSES | NUMBER | Do kit has calculation does |
DISTRIBUTION_SETTINGS | VARCHAR2(16 CHAR) | Indicates the type of distribution a kit has, as
specified by the study designer.
The following values can be
displayed:
|
KIT_TYPE_ID | VARCHAR2(64 CHAR) | Kit type ID at study design |
TYPE | VARCHAR2(16 CHAR) | Type of the kit at study design |
MINIMUM_KITS_TO_SHIP | NUMBER | Numeric value that represents the minimum kits to be shipped |
UNITS_PER_KIT | NUMBER | Number of units in a kit |
SINGLE_UNIT_DOSE_VALUE | NUMBER(20,2) | Dose value of single unit in a kit |
SINGLE_UNIT_DOSE_UNITS | VARCHAR2(16 CHAR) | Dose unit of the kit |
TITRATION | NUMBER | Specifies if the kit is a titration kit |
KIT_VERSION_START | TIMESTAMP(6) | Version start of the kit at study design |
KIT_VERSION_END | TIMESTAMP(6) | Version end of the kit at study design |
KIT_TYPE | VARCHAR2(23) | Type of the kit |
CALCULATED_DOSE_TITLE | VARCHAR2(64 CHAR) | Calculation dose name of the kit |
FORM_QUESTION_FOR_CALCULATED_DOSE | VARCHAR2(64 CHAR) | Question used for dosage calculation |
VISIT_WHERE_FORM_IS_COLLECTED | VARCHAR2(64 CHAR) | Visit used for dosage calculation |
PERCISION_FOR_EACH_DOSE | NUMBER | Dosage precision for calculated doses |
ROUND_UP_FOR | NUMBER | Specifies if dosage calculations should be round up |
DOSING_FREQUENCY | VARCHAR2(21 CHAR) | Specifies the frequency of doses in calculated doses |
USE_LEFTOVER_UNITS_IN_NEXT_DOSE | NUMBER | Numeric field that represents if the use of left over kits/units in next dosage is allowed |
KIT_MEASUREMENT | NUMBER(20,2) | Measure of the kit dosage used in dosage calculation |
SUBJECT_MEASUREMENT | NUMBER(20,2) | Measurement of the subject reading |
Table: DHVW_SUBJECT_FORMITEMS_V
Column name | Data type | Description |
---|---|---|
ID | RAW(16 BYTE) | GUID of the subject form item record |
SUBJECT_EVENTINST_FORMITEM_WID | NUMBER(38) | Numeric ID of a subject form item record |
VERSION_START | TIMESTAMP(6) | Timestamp of when the record was previously changed |
VERSION_END | TIMESTAMP(6) | Timestamp for when the record was changed |
OPERATION_TYPE | VARCHAR2(16 CHAR) | Type of operation:
|
USER_ID | RAW(16 BYTE) | GUID of the User |
USER_WID | NUMBER(38) | Numeric user ID |
USER_NAME | VARCHAR2(255 CHAR) | Oracle Clinical One Platform user name |
OBJECT_VERSION_NUMBER | NUMBER | Change version number for the record |
SOFTWARE_VERSION_NUMBER | NUMBER | Internal on-disk version number for the record |
REASON | VARCHAR2(255 CHAR) | User provided reason for record change |
COMMENT | VARCHAR2(2048 CHAR) | Comment for record change |
TRANSACTION_START | DATE | Reserved for future use |
TRANSACTION_END | DATE | Reserved for future use |
VALIDATION_STATUS | VARCHAR2(25 CHAR) | Status of a validation:
|
VALIDATION_FAILURE | VARCHAR2(4000 CHAR) | Validation failure message |
STUDY_ID | RAW(16 BYTE) | GUID of the study |
STUDY_WID | NUMBER(38) | Numeric study ID |
STUDY_NAME | VARCHAR2(100 CHAR) | Study name |
STUDY_VERSION | VARCHAR2(100 CHAR) | The study version of a given record |
SUBJECT_ID | RAW(16 BYTE) | GUID of the subject |
SUBJECT_WID | NUMBER(38) | Numeric subject ID |
SUBJECT_NAME | VARCHAR2(500 CHAR) | Subject name |
EVENT_ID | RAW(16 BYTE) | GUID of the event |
EVENT_WID | NUMBER(38) | Numeric event ID |
EVENT_NAME | VARCHAR2(64 CHAR) | Name of the event for the current record |
FORM_ID | RAW(16 BYTE) | GUID of the form |
FORM_WID | NUMBER(38) | Numeric form ID |
FORM_NAME | VARCHAR2(64 CHAR) | The name of the form created in Oracle Clinical One Platform |
FORM_REFNAME | VARCHAR2(64 CHAR) | System reference name of a form
Note: This value is used to create the Clinical Data Extract table name in the database, which is then copied into Oracle DMW. Once a table is created for a form, the table name will not be recreated with a different name in Oracle DMW, even if the REFNAME is updated in Oracle Clinical One Platform. |
FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section |
REPEAT_SEQUENCE_NUMBER | NUMBER | Usage dependent on Form Type:
|
ITEM_ID | RAW(16 BYTE) | GUID of the item |
ITEM_WID | NUMBER(38) | Numeric item ID |
ITEM_NAME | VARCHAR2(4000 CHAR) | The name of an item on a form |
SITE_ID | RAW(16 BYTE) | GUID of the site |
SITE_WID | NUMBER(38) | Numeric site ID |
SITE_NAME | VARCHAR2(200 CHAR) | Site name |
VARIABLE_ID | RAW(16 BYTE) | GUID of the variable |
ORIGINATOR_ID | RAW(16 BYTE) | GUID of the originator |
VENDOR_CODE | VARCHAR2(100 CHAR) | Populated and used by Clinical One Integrations |
VALUE | VARCHAR2(4000 CHAR) | Response to the question (form item) |
MEASURE_UNIT | VARCHAR2(64 CHAR) | Unit of measurement |
NORMALIZED_VALUE | VARCHAR2(100 CHAR) | Reserved for future use |
NORMALIZED_UNIT_ID | RAW(16 BYTE) | GUID of normalized unit |
NUM_VALUE | NUMBER | Response if the value collected was of number type |
FLOAT_VALUE | NUMBER | Response if the value collected was of float type |
UTC_DATETIME_VALUE | TIMESTAMP(6) | Response in UTC if the value collected was of datetime type |
MONTH_VALUE | NUMBER(38) | Numeric value of the given month |
DAY_VALUE | NUMBER(38) | Numeric value of the given day |
YEAR_VALUE | NUMBER(38) | Numeric value of the given year |
HOUR_VALUE | NUMBER(38) | Numeric value of the given hour |
MINUTE_VALUE | NUMBER(38) | Numeric value of the given minute |
SECOND_VALUE | NUMBER(38) | Numeric value of the given second |
PARENT_ID | RAW(16 BYTE) | GUID of the parent record |
PARENT_WID | NUMBER(38) | Numeric parent record ID |
PARENT_NAME | VARCHAR2(4000 CHAR) | Reserved for future use |
ROOT_ID | RAW(16 BYTE) | GUID of the root |
ROOT_WID | NUMBER(38) | Reserved for future use |
ROOT_NAME | VARCHAR2(4000 CHAR) | Reserved for future use |
EVENT_INSTANCE_NUM | NUMBER | Event instance number for the visit |
DATA_FLAG | RAW(16 BYTE) | GUID of the data flag (if existing, for example if the value was marked as not collected etc.) |
ITEM_D | VARCHAR2(4000 CHAR) | Decoded response to the question |
ITEM_R | VARCHAR2(4000 CHAR) | Raw value of the response to the question |
ITEM_F | VARCHAR2(4000 CHAR) | Formatted response to the question |
ITEM_TYPE | VARCHAR2(255 CHAR) | Type of question |
PROPERTY_ID | RAW(16 BYTE) | GUID of the property |
PROPERTY_VERSION_START | TIMESTAMP(6) | Timestamp of when the record was previously changed |
QUESTION_TYPE | VARCHAR2(32 CHAR) | The type of question asked:
|
QUESTION_HINT | VARCHAR2(4000 CHAR) | User provided hint to assist in answering a question |
REQUIRED | NUMBER | Boolean value that denotes whether or not a question is required |
READONLY | NUMBER(1) | Boolean value that denotes whether or not a question is read-only |
SAS_VARIABLE | VARCHAR2(32 CHAR) | SAS Variable name associated with the question |
SAS_LABEL | VARCHAR2(4000 CHAR) | SAS Label associated with the question |
IS_CURRENT | CHAR(1) | Boolean flag stating whether a given record is the most recent version |
IS_ROLLOVER | CHAR(1) | Indicator if the question is associated with rollover study |
IS_REPEATING | CHAR(1) | Denotes whether an item has repeating entries |
REFERENCE_CODE | VARCHAR2(64 CHAR) | Question reference code |
HIDDEN | NUMBER(1) | Boolean value denoting whether an item is hidden |
DH_TIMESTAMP | TIMESTAMP(6) | Timestamp of when the record was written to Data Hub |
FREEZE | VARCHAR2(16 CHAR) | String value to represent the freeze status |
VERIFIED | VARCHAR2(16 CHAR) | String value to represent the verified status |
SIGNED | VARCHAR2(16 CHAR) | String value to represent the signed status |
REPEAT_FORM_NUMBER | NUMBER | For two-section Forms: Numeric value to
represent the form instance
Note: For lab forms this value is defaulted to 1 and for repeating forms this value isNULL .
|
INNER_REPEAT | NUMBER | Sequential number for a form/item with repeating entries |
OUTER_REPEAT | NUMBER | For Repeating Forms (including one-section and two-section forms): Sequential number to represent the form instance |
Table: DHVW_SUBJECT_VISITS_V
Column name | Data type | Description |
---|---|---|
SUBJECT_EVENT_INST_WID | NUMBER(38) | Numeric subject visit event ID |
ID | RAW(16 BYTE) | GUID of the subject visit |
VERSION_START | TIMESTAMP(6) | Timestamp of when the record was previously changed |
VERSION_END | TIMESTAMP(6) | Timestamp of when the record was changed |
OPERATION_TYPE | VARCHAR2(16 CHAR) | Categorization of the type of modification made to a given
record:
|
USER_ID | RAW(16 BYTE) | GUID of the user |
USER_WID | NUMBER(38) | Numeric user ID |
USER_NAME | VARCHAR2(255 CHAR) | The user who modified the given record |
OBJECT_VERSION_NUMBER | NUMBER | Sequential versioning of a given record |
SOFTWARE_VERSION_NUMBER | NUMBER | Internal on-disk version number for the record |
REASON | VARCHAR2(255 CHAR) | User provided reason for record change |
COMMENT | VARCHAR2(2048 CHAR) | Comment for record change |
STUDY_VERSION | VARCHAR2(100 CHAR) | The study version of a given record |
SUBJECT_ID | RAW(16 BYTE) | GUID of the subject |
SUBJECT_WID | NUMBER(38) | Numeric Subject ID |
SUBJECT_NAME | VARCHAR2(64 CHAR) | Name of the subject |
EVENT_ID | RAW(16 BYTE) | GUID of the event |
EVENT_WID | NUMBER(38) | Numeric event ID |
EVENT_NAME | VARCHAR2(64 CHAR) | Name of the event for the current record |
SITE_ID | RAW(16 BYTE) | GUID of the site |
SITE_WID | NUMBER(38) | Numeric site ID |
SITE_NAME | VARCHAR2(200 CHAR) | Name of a site |
VISIT_STATUS | VARCHAR2(32 CHAR) | Status of a given visit:
|
VISIT_START_DATE | DATE | Timestamp of when a visit began |
VISIT_TYPE | VARCHAR2(100 CHAR) | Visit type categorization:
|
EVENT_TYPE | VARCHAR2(100) | Event type categorization:
|
STUDY_ID | RAW(16 BYTE) | GUID of the study |
STUDY_WID | NUMBER(38) | Numeric study ID |
STUDY_NAME | VARCHAR2(64 CHAR) | Study name |
EVENT_INSTANCE_NUM | NUMBER | Event instance number for the visit |
INVESTIGATOR | VARCHAR2(100 CHAR) | Investigator associated with a given visit |
SUBJECT_NUMBER | VARCHAR2(500 CHAR) | Subject number |
ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | Site address street 1 |
ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | Site address street 2 |
ADDRESS_CITY | VARCHAR2(100 CHAR) | Site address city |
ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | Site address state, province, or county |
ADDRESS_POSTALCODE | VARCHAR2(20) | Site address postal code |
ADDRESS_COUNTRY | VARCHAR2(100 CHAR) | Site address country |
PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Projected date of visit start |
PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Projected date of visit end |
PROJECTED_VISIT_DATE | TIMESTAMP(6) | Projected visit date |
IS_REQUIRED | CHAR(1) | Boolean value indicating whether a visit is required |
IS_SCHEDULED_VISIT | CHAR(1) | Boolean value indicating whether a visit is scheduled |
SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the event from which the given visit is scheduled from |
SCHEDULED_FROM_EVENT_WID | NUMBER(38) | Numeric ID of the event from which the given visit is scheduled from |
SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) |
Displays the EVENT_TITLE (visit title) of the Scheduled From
visit as defined in the Visit Schedule.
Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit’s own title. For example, Screening Visit is displayed for the Screening Visit, as it is the first visit in the schedule. |
DELAY_DAYS | NUMBER | Visit delay days |
DELAY_HOURS | NUMBER | Visit delay hours |
VISIT_WINDOW_BEFORE_DAYS | NUMBER | Number of days before the expected visit date when the visit could start |
VISIT_WINDOW_BEFORE_HOURS | NUMBER | Number of hours before the expected visit date when the visit could start |
VISIT_WINDOW_AFTER_DAYS | NUMBER | Number of days after the expected visit date when the visit could start |
VISIT_WINDOW_AFTER_HOURS | NUMBER | Number of hours after the expected visit date when the visit could start |
IS_CURRENT | CHAR(1) | Boolean flag stating whether a given record is the most recent version |
DH_TIMESTAMP | TIMESTAMP(6) | Timestamp of when the record was written to Data Hub |
COMPONENT_SEQ | NUMBER | Sequence of the visit based on schedule (number of hours) |
FREEZE | VARCHAR2(16 CHAR) | String value to represent the freeze status |
VERIFIED | VARCHAR2(16 CHAR) | String value to represent the verified status |
SIGNED | VARCHAR2(16 CHAR) | String value to represent the signed status |
Table: DHVW_SUBJECTS_DATASET_V
Column name | Data type | Description |
---|---|---|
ID | RAW(16 BYTE) | GUID of the subject |
SUBJECT_WID | NUMBER(38) | Numeric ID of the subject |
DESCRIPTION | VARCHAR2(500 CHAR) | This is a placeholder column that does not contain any data |
SUBJECT_NUMBER | VARCHAR2(500 CHAR) | Subject number |
STUDY_ID | RAW(16 BYTE) | GUID of the study |
STUDY_WID | NUMBER(38) | Numeric ID of the study |
SITE_ID | RAW(16 BYTE) | GUID of the site |
SITE_WID | NUMBER(38) | Numeric ID of the site |
SITE_NAME | VARCHAR2(200 CHAR) | Name of the site |
DOB | DATE | Reserved for future use |
SCREENING_DATE | DATE | Date of the screening |
STATE | VARCHAR2(100 CHAR) | Subject status |
STATE_DATE | DATE | Date of the current status of the subject |
SCREENING_FAILURE | VARCHAR2(255 CHAR) | Subject screening failure message |
ENROLLMENT_FAILURE | VARCHAR2(255 CHAR) | Subject enrollment failure message |
ENROLLMENT_OVERRIDE | VARCHAR2(255 CHAR) | Subject enrollment override message |
INFORMED_CONSENT_DATE | DATE | Reserved for future use |
GENDER | VARCHAR2(10 CHAR) | Reserved for future use |
SUBJECT_TRANSFER_ID | RAW(16 BYTE) | GUID of the subject transfer |
STUDY_VERSION | VARCHAR2(32 CHAR) | Version of the study |
CODE_BREAK | VARCHAR2(2 CHAR) | Specifies if the subject undergoes a code break |
EVENT_TYPE | VARCHAR2(100) | Event type categorization at the subject level:
|
SITE_SERIAL_NUMBER | NUMBER | The serial number of the site |
STUDY_SERIAL_NUMBER | NUMBER | For internal use only.Internal Clinical One study identifier |
COUNTRY_NAME | VARCHAR2(100 CHAR) | Country name of the site |
INVESTIGATOR | VARCHAR2(100 CHAR) | Investigator name |
VERSION_START | TIMESTAMP(6) | Version start of the current subject record |
VERSION_END | TIMESTAMP(6) | Version end of the current subject record |
OPERATION_TYPE | VARCHAR2(16 CHAR) | Operation type of the current record:
|
USER_ID | RAW(16 BYTE) | GUID of the user who performed this action |
USER_WID | NUMBER(38) | Numeric ID of the user who performed this action |
USER_NAME | VARCHAR2(255 CHAR) | Name of the user |
OBJECT_VERSION_NUMBER | NUMBER | Change version number for the record |
SOFTWARE_VERSION_NUMBER | NUMBER | Internal on-disk version number for the record |
REASON | VARCHAR2(255 CHAR) | User provided reason for record change |
COMMENT | VARCHAR2(2048 CHAR) | Comment for record change |
IS_CURRENT | CHAR(1) | Specifies if this is an active record or history record |
DH_TIMESTAMP | TIMESTAMP(6) | Timestamp of when the record was written to Data Hub |
TOTAL_VISITS | NUMBER | Total scheduled visits that are available for this subject based on site study version |
TOTAL_FORMS | NUMBER | Total number of forms across the scheduled visits that are available for this subject based on site study version |
COMPLETED_VISITS | NUMBER | Number of completed visits for a subject |
TOTAL_FORMS_COMPLETED_VISITS | NUMBER | Number of forms that are present in the completed visit of the subject |
COMPLETED_FORMS | NUMBER | Number of completed forms across the scheduled visits entered for the subject |
STUDY_ID_NAME | VARCHAR2(64 CHAR) | Study ID name |
STUDY_TITLE | VARCHAR2(4000 CHAR) | Title of the study |
STUDY_REFNAME | VARCHAR2(64 CHAR) | Study ref name |
STUDY_PHASE | VARCHAR2(64 CHAR) | Phase of the study |
THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Therapeutic area of the study |
BLINDING_TYPE | VARCHAR2(64 CHAR) | Blinding type of the study:
|
FROM_SITE_ID | RAW(16 BYTE) | GUID of the site from which the subject is transferred |
FROM_SITE_WID | NUMBER(38) | Numeric ID of the site from which the subject is transferred |
FROM_SITE_NAME | VARCHAR2(200 CHAR) | Site name from which the subject is transferred |
OLD_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | Old subject number |
SITE_ID_NAME | VARCHAR2(50 CHAR) | Site ID name |
SITE_STATUS | VARCHAR2(50 CHAR) | Status of the site |
ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | Primary site address1 |
ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | Primary site address2 |
ADDRESS_CITY | VARCHAR2(100 CHAR) | Primary site city |
ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | Primary site state |
ADDRESS_POSTALCODE | VARCHAR2(20) | Primary site postal code |
ADDRESS_COUNTRY | VARCHAR2(100 CHAR) | Primary site country |
FAX | VARCHAR2(50 CHAR) | Primary site fax number |
VARCHAR2(255 CHAR) | Primary site email address | |
PHONE | VARCHAR2(50 CHAR) | Primary site phone number |
SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | Site shipping addres1 |
SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | Site shipping addres2 |
SHIPPING_CITY | VARCHAR2(100 CHAR) | Site shipping city |
SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | Site shipping country |
SHIPPING_ZIP | VARCHAR2(20) | Site shipping postal code |
SHIPPING_COUNTRY | VARCHAR2(100 CHAR) | Site shipping country |
SHIPPING_FAX | VARCHAR2(50 CHAR) | Site shipping fax |
SHIPPING_EMAIL | VARCHAR2(255 CHAR) | Site shipping email |
SHIPPING_PHONE | VARCHAR2(50 CHAR) | Site shipping phone |
SITE_STUDY_VERSION | VARCHAR2(100 CHAR) | Study version of the site |
DRUG_DESTRUCTION_CAPABLE | VARCHAR2(100 CHAR) | Specifies if site is capable for drug destruction |
PI_PREFIX | VARCHAR2(100 CHAR) | Prefix value of principal investigator |
ADD_SUBJECTS | VARCHAR2(100 CHAR) | Specifies if site is can add subjects |
SCREEN_SUBJECTS | VARCHAR2(100 CHAR) | Specifies if site can screen subjects |
RANDOMIZE_SUBJECTS | VARCHAR2(100 CHAR) | Specifies if site can randomize subjects |
DISPENSE_TO_SUBJECTS | VARCHAR2(100 CHAR) | Specifies if site can dispense to subjects |
DEA_NUMBER | VARCHAR2(100 CHAR) | DEA registration number as defined by site manager |
EXPIRATION | VARCHAR2(100 CHAR) | Expiration date of the DEA registration number as defined by the site manager |
TIMEZONE | VARCHAR2(100 CHAR) | Site time zone |
SHIPPING_ATTENTION | VARCHAR2(100 CHAR) | Shipping attention of the site |
SDV_GROUP_NAME | VARCHAR2(255) | Source Data verification group name |
INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Initial subject count for SDV |
INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Specifies if only critical or all questions have to be verified for initial subject |
REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Value for percentage of remaining subject for SDV |
REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Specifies if only critical or all questions have to be verified for remaining subject |
Table: DHVW_UNBLD_KITS_DATASET_V
Column name | Data type | Description |
---|---|---|
STUDY_ID | RAW(16 BYTE) | GUID of the study |
STUDY_WID | NUMBER(38) | Numeric study ID |
STUDY_ID_NAME | VARCHAR2(64 CHAR) | Name of the study |
STUDY_TITLE | VARCHAR2(4000 CHAR) | Title of the study |
STUDY_REFNAME | VARCHAR2(64 CHAR) | Refname of the study |
THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Therapeutic area of the study |
STUDY_PHASE | VARCHAR2(64 CHAR) | Phase of the study |
BLINDING_TYPE | VARCHAR2(64 CHAR) | Blinding type of the study:
|
COUNTRY_NAME | VARCHAR2(100 CHAR) | Country name |
DRUG_DESTRUCTION_CAPABLE | VARCHAR2(100 CHAR) | Drug destruction capability of the site |
PI_PREFIX | VARCHAR2(100 CHAR) | Prefix value of principal investigator |
ADD_SUBJECTS | VARCHAR2(100 CHAR) | Specifies if site can add subjects |
SCREEN_SUBJECTS | VARCHAR2(100 CHAR) | Specifies if site can screen subject |
RANDOMIZE_SUBJECTS | VARCHAR2(100 CHAR) | Specifies if site can randomize subject |
DISPENSE_TO_SUBJECTS | VARCHAR2(100 CHAR) | specifies if site can dispense to subjects |
DEA_NUMBER | VARCHAR2(100 CHAR) | DEA registration number as defined by the site manager |
EXPIRATION | VARCHAR2(100 CHAR) | Expiration date of DEA registration number as defined by the site manager |
TIMEZONE | VARCHAR2(100 CHAR) | Time zone of site |
SHIPPING_ATTENTION | VARCHAR2(100 CHAR) | Shipping attention of the site |
INVESTIGATOR | VARCHAR2(100 CHAR) | Investigator name |
SDV_GROUP_NAME | VARCHAR2(255) | Source Data verification Group name |
INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Initial subject count for SDV |
INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Specifies if only critical or all questions have to be verified for the initial subject |
REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Value for percentage of remaining subject for SDV |
REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Specifies if only critical or all questions have to be verified for remaining subject |
ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | Primary site address1 |
ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | Primary site address2 |
ADDRESS_CITY | VARCHAR2(100 CHAR) | Primary site city |
ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | Primary site state |
ADDRESS_POSTALCODE | VARCHAR2(20) | Primary site postal code |
ADDRESS_COUNTRY | VARCHAR2(100 CHAR) | Primary site country |
PHONE | VARCHAR2(50 CHAR) | Primary site phone number |
FAX | VARCHAR2(50 CHAR) | Primary site fax number |
VARCHAR2(255 CHAR) | Primary site email id | |
SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | Site shipping addres1 |
SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | Site shipping addres2 |
SHIPPING_CITY | VARCHAR2(100 CHAR) | Site shipping city |
SHIPPING_COUNTRY | VARCHAR2(100 CHAR) | Site shipping country |
SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | Site or cnty |
SHIPPING_ZIP | VARCHAR2(20) | GUID of the value for shipping |
SHIPPING_PHONE | VARCHAR2(50 CHAR) | Site shipping phone |
SHIPPING_FAX | VARCHAR2(50 CHAR) | Site shipping fax |
SHIPPING_EMAIL | VARCHAR2(255 CHAR) | Site shipping email |
SITE_STATUS | VARCHAR2(50 CHAR) | Site status |
SITE_STUDY_VERSION | VARCHAR2(100 CHAR) | Site study version |
SITE_ID | RAW(16 BYTE) | Numeric ID value for site |
SITE_WID | NUMBER(38) | GUID of the value for site |
SITE_NAME | VARCHAR2(200 CHAR) | Site name |
SITE_ID_NAME | VARCHAR2(50 CHAR) | Site ID name |
SITE_TYPE | VARCHAR2(50 CHAR) | Type of the site |
SUBJECT_ID | RAW(16 BYTE) | GUID of the subject |
SUBJECT_WID | NUMBER(38) | Numeric ID of the subject |
SUBJECT_NUMBER | VARCHAR2(500 CHAR) | Subject name |
SUBJECT_STATE | VARCHAR2(100 CHAR) | State of the subject |
RANDOMIZATION_TITLE | VARCHAR2(64 CHAR) | Randomization title |
RANDOMIZATION_DESCRIPTION | VARCHAR2(4000 CHAR) | Randomization description |
RANDOMIZATION_TYPE | VARCHAR2(32 CHAR) | Type of randomization |
COHORT_ID | RAW(16 BYTE) | GUID of the cohort |
COHORT_WID | NUMBER(38) | Numeric ID of the cohort |
COHORT_NAME | VARCHAR2(64 CHAR) | Cohort name |
RERANDOMIZATION | NUMBER | Specifies if it allows rerandomization |
TREATMENT_ID | RAW(16 BYTE) | GUID of the treatment arm |
TREATMENT_WID | NUMBER(38) | Numeric ID of the treatment arm |
TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | Treatment arm title |
TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | Treatment arm description |
TREATMENT_ARM_ID | VARCHAR2(64 CHAR) | Treatment arm ID name |
RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES | NUMBER | Specifies if randomization needs to restrict to available kit types |
ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS | NUMBER | Specifies if skipped randomization number has to be assigned |
RAND_NUMBER | NUMBER | Randomization number |
RND_STATUS | VARCHAR2(64 CHAR) | State of Randomization |
RANDOMIZATION_DATE | TIMESTAMP(6) | Subject randomization date |
MANFACTURING_LOT_TITLE | VARCHAR2(64 CHAR) | Manufacturing lot title name |
BLINDED_LOT_TITLE | VARCHAR2(64 CHAR) | Blinded lot title name |
MANFACTURING_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Manufacturing lot short name |
BLINDED_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Blinded lot short name |
MANFACTURING_LOT_EXPIRATION_DATE | DATE | Manufacturing lot expiration date |
BLINDED_LOT_EXPIRATION_DATE | DATE | Blinded lot expiration date |
MANFACTURING_LOT_DO_NOT_SHIP_DAYS | NUMBER | Do-not-ship days for manufacturing lot |
BLINDED_LOT_DO_NOT_SHIP_DAYS | NUMBER | Do-not-ship days for blinded lot |
MANFACTURING_LOT_DO_NOT_COUNT_DAYS | NUMBER | Do-not-count days for manufacturing lot |
BLINDED_LOT_DO_NOT_COUNT_DAYS | NUMBER | Do-not-count days for blinded lot |
SHIPMENT_ID | RAW(16 BYTE) | GUID of the shipment |
SHIPMENT_WID | NUMBER(38) | Numeric ID for the shipment |
SHIPMENT_NAME | VARCHAR2(64 CHAR) | Shipment name |
SHIPMENT_STATUS | VARCHAR2(64 CHAR) | Status of the shipment |
SHIPMENT_CREATED_DATE | TIMESTAMP(6) | Shipment creation date |
SHIPMENT_DATE | TIMESTAMP(6) | Shipment date |
TRACKING_NUMBER | VARCHAR2(64 CHAR) | Shipment tracking number |
VISIT_IS_REQUIRED | CHAR(1) | Specifies if visit is required or not |
IS_SCHEDULED_VISIT | CHAR(1) | Specifies if visit is scheduled or not |
SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) |
Displays the EVENT_TITLE (visit title) of the Scheduled From
visit as defined in the Visit Schedule.
Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit’s own title. For example, Screening Visit is displayed for the Screening Visit, as it is the first visit in the schedule. |
VISIT_STATUS | VARCHAR2(32 CHAR) | Status of a given visit:
|
VISIT_START_DATE | DATE | Visit date |
VISIT_TYPE | VARCHAR2(100 CHAR) | Type of the visit |
EVENT_TYPE | VARCHAR2(100) | Event type categorization:
|
PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Projected start date of this visit |
PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Projected end date of this visit |
PROJECTED_VISIT_DATE | TIMESTAMP(6) | Projected visit date |
DELAY_DAYS | NUMBER | Delay days of the visit |
DELAY_HOURS | NUMBER | Delay hours of the visit |
VISIT_WINDOW_BEFORE_DAYS | NUMBER | Number of days before the expected visit date when the visit could start |
VISIT_WINDOW_BEFORE_HOURS | NUMBER | Number of hours before the expected visit date when the visit could start |
VISIT_WINDOW_AFTER_DAYS | NUMBER | Number of days after the expected visit date when the visit could start |
VISIT_WINDOW_AFTER_HOURS | NUMBER | Number of hours after the expected visit date when the visit could start |
EVENT_ID | RAW(16 BYTE) | GUID of the visit |
EVENT_WID | NUMBER(38) | Numeric ID of the visit |
EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
EVENT_REFNAME | VARCHAR2(64 CHAR) |
The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE
with blank spaces removed. Oracle Clinical One Analytics
generates this value, which is not displayed in the Oracle
Clinical One Platform user interface.
Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
EVENT_ID_NAME | VARCHAR2(16 CHAR) | Visit ID name |
VISIT_ORDER | NUMBER | Order of the visit in design |
KIT_TYPE | VARCHAR2(255 CHAR) | Type of the kit |
DEVICE_TYPE | VARCHAR2(255) | Device type kit:
|
DEVICE_CONNECTION | VARCHAR2(255) | Whether the device is connected or non connected |
CALCULATING_DOSES | NUMBER | Name of the calculated dose kit |
DISTRIBUTION_SETTINGS | VARCHAR2(16 CHAR) | Indicates the type of distribution a kit has, as
specified by the study designer.
The following values can be
displayed:
|
KIT_DESIGN_ID | RAW(16 BYTE) | GUID of the kit at study design |
KIT_DESIGN_WID | NUMBER(38) | Numeric ID of the kit at study design |
KIT_TYPE_ID | VARCHAR2(64 CHAR) | Kit type ID as per study design |
TRIAL_SUPPLY_TYPE | VARCHAR2(16 CHAR) | Indicates the supply type of the kit, as specified
by the study designer.
The following values can be displayed:
|
MINIMUM_KITS_TO_SHIP | NUMBER | Minimum number of kits to ship |
UNITS_PER_KIT | NUMBER | Number of units in a kit |
SINGLE_UNIT_DOSE_VALUE | NUMBER(20,2) | Dose value of single unit in a kit |
SINGLE_UNIT_DOSE_UNITS | VARCHAR2(16 CHAR) | Dose unit of the kit |
CRA_VERIFIED | NUMBER | Specifies if kit is verified by CRA |
BALANCE_UNITS | NUMBER | Balance number of units of a kit |
TITRATION | NUMBER | Specifies if kit is a titration kit |
INVENTORY_ID | RAW(16 BYTE) | Runtime GUID of the kit |
INVENTORY_WID | NUMBER(38) | Number ID of kit at runtime |
KIT_NUMBER | NUMBER | Kit number |
SEQUENCE_NUMBER | NUMBER | Sequence number of the kit |
KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Description of the kit |
KIT_STATUS | VARCHAR2(64 CHAR) | Status of the kit |
DISPENSATION_DATE | TIMESTAMP(6) | Kit dispensation date |
DOSAGE | NUMBER | Dosage of the kit |
BAR_CODE | VARCHAR2(1000 CHAR) | Barcode of the kit |
DISPENSATION_CONFIRMED | NUMBER | Specifies if kit dispensation is confirmed |
MEASUREMENT | VARCHAR2(1000 CHAR) | Measurement of kit in dosage calculation |
FREQUENCY | VARCHAR2(64 CHAR) | Frequency of the kit as per dosage calculation |
RETURNED_UNITS | NUMBER | Number of units returned in the kit |
MISSING_UNITS | NUMBER | Number of units missing in the kit |
CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user or not |
QUANTITY | NUMBER | Kit quantity |
INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit |
CALCULATED_DOSE_ID | RAW(16 BYTE) | GUID of dosage calculation |
CALCULATED_DOSE_WID | NUMBER(38) | Numeric ID of dosage calculation |
CALCULATED_DOSE_TITLE | VARCHAR2(64 CHAR) | Dosage calculation title |
FORM_QUESTION_FOR_CALCULATED_DOSE | VARCHAR2(64 CHAR) | Question used for dosage calculation |
VISIT_WHERE_FORM_IS_COLLECTED | VARCHAR2(64 CHAR) | Visit name used for dosage calculation |
DOSE_PRECISION | NUMBER | Dosage precision for calculated doses |
DOSE_ROUND_UP | NUMBER | Specifies if dosage calculations should be round up |
DOSE_FREQUENCY | VARCHAR2(21 CHAR) | Specifies how many doses the subject must consume, as specified by the study designer |
DOSE_LEFT_OVER_UNITS | NUMBER | Indicates whether leftover units from a previous dose can be used in a next dose, during the study conduct period, as specified by the study designer |
KIT_MEASUREMENT | NUMBER(20,2) | Measure of the kit dosage used in dosage calculation |
SUBJECT_MEASUREMENT | NUMBER(20,2) | Measurement of the subject reading |
VERSION_START | TIMESTAMP(6) | Version start of the current kit record |
VERSION_END | TIMESTAMP(6) | Version end of the current kit record |
OPERATION_TYPE | VARCHAR2(16 CHAR) | Type of operation:
|
OBJECT_VERSION_NUMBER | NUMBER | Change version number for the record |
REASON | VARCHAR2(255 CHAR) | User provided reason for record change |
COMMENT | VARCHAR2(2048 CHAR) | Comment for record change |
USER_ID | RAW(16 BYTE) | GUID of the user who performed this action |
USER_WID | NUMBER(38) | Numeric ID of the user who performed this action |
USER_NAME | VARCHAR2(255 CHAR) | User name |
IS_CURRENT | CHAR(1) | Specifies if this record is an active record or history record |
VERIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who verified the kit |
VERIFIED_BY_WID | NUMBER(38) | Numeric ID of the user who verified the kit |
VERIFIED_BY | VARCHAR2(255 CHAR) | User name who verified the kit |
VERIFIED_DATE | TIMESTAMP(6) | Kit verified date |
CONFIRMED_BY_ID | RAW(16 BYTE) | GUID of the user who confirmed the kit dispensation |
CONFIRMED_BY_WID | NUMBER(38) | Numeric ID of the user who confirmed the kit dispensation |
CONFIRMED_BY | VARCHAR2(255 CHAR) | User name who confirmed the kit dispensation |
CONFIRMED_DATE | TIMESTAMP(6) | Kit confirmed date |
SOFTWARE_VERSION_NUMBER | NUMBER | Internal on-disk version number for the record |
DH_TIMESTAMP | TIMESTAMP(6) | Timestamp of when the record was written to Data Hub |
BLOCK_NUMBER | VARCHAR2(512 CHAR) | Block number of the kit |
Parent topic: DMW extract data dictionary