DMW 3.4

Browse field descriptions of the DMW 3.4 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:
  • One-section repeating form type: Numeric value to represent the Form Instance for Repeating Forms.
  • Lab and two-section form types: Sequential number to represent the Table (Repeating Section) row the Extract data pertains to.
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)
  • Indicates the date when a form instance changes, such as when a user updates clinical data or deletes a form or a form section.
  • This does not include changes made outside the form instance, such as Visit Date or Subject Number updates. Changes such as these are tracked under the DH_TIMESTAMP, ensuring they get integrated into DMW.
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 is NULL.
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:
  • For a given row in two-section Form Type:
    • Value = Y: Indicates the given row is populated for only flat section data. All table (repeating section) columns remain blank.
    • Value = N: Indicates the given row is populated with both flat section data and data for a corresponding table (repeating section) row
  • For 1 Section Form Type, for a given row:
    • Value = Y: Indicates the Form in question is not a repeating form.
    • Value = N: Indicates the form in question is a repeating form.
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:
  • CREATE
  • MODIFY
  • DELETE
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:
  • CREATE
  • MODIFY
  • DELETE
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 CHAR) 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) The code corresponding to the codelist item.
CL_VALUE VARCHAR2(32767 CHAR) The value (for example, Plasma) associated to the CL_CODE.

Table: DHVW_DESIGN_DATASET_V

Column name Data type Description
MODIFIED_BY_ID RAW(16 BYTE) Numeric ID of the user who modified the design.
MODIFIED_BY_WID NUMBER(38) The unique numeric identifier of the user who modified the study.
CURRENT_STUDY_ROLE_ID RAW(16 BYTE) The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user.
CURRENT_STUDY_ROLE_WID NUMBER(38) Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user.
CURRENT_STUDY_ROLE_NAME VARCHAR2(100 CHAR) Specifies the role of the user who updated the given record. If the user's study role changes, this field will show the current study role of the given user.
STUDY_DESIGN_STATUS VARCHAR2(16 CHAR) Indicates the study mode used in the referencing data in a custom report, such as Testing, Training, or Active.
EVENT_ID RAW(16 BYTE) GUID of the event.
EVENT_WID NUMBER(38) A number that represents the unique identifier of an event.
EVENT_TITLE VARCHAR2(64 CHAR) The event's title, defined by the user when an event is created.
EVENT_REFNAME VARCHAR2(64 CHAR)

The events refname.

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) The event's id as in Oracle Clinical One Platform.
VISIT_IS_REQUIRED CHAR(1) Indicates whether or not a visit is required.
VISIT_TYPE VARCHAR2(32 CHAR) Displays the type of visit: Screening, Randomization, Dispensation, Non-Dispensation, Optional, Withdrawal or Study Completion.
EVENT_TYPE VARCHAR2(32) Displays the type of event (visit started, visit completed).
IS_SCHEDULED_VISIT CHAR(1) Indicates whether the 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.
SCHEDULED_FROM_EVENT_REFNAME VARCHAR2(64 CHAR)
Displays the EVENT_REFNAME 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 refname. For example, SCREENINGVISIT is displayed for the Screening Visit, as it is the first visit in the schedule.
SCHEDULED_FROM_EVENT_ID RAW(16 BYTE) GUID of the event from which the given visit is scheduled from.
SCHEDULED_FROM_EVENT_WID NUMBER Numeric ID of the event from which the given visit is scheduled from
VISIT_WINDOW_AFTER_DAYS NUMBER Indicates how many days after the scheduled date and time the visit can occur.
VISIT_WINDOW_AFTER_HOURS NUMBER Indicates how many hours after the scheduled date and time the visit can occur.
VISIT_WINDOW_BEFORE_DAYS NUMBER Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer.
VISIT_WINDOW_BEFORE_HOURS NUMBER Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer.
DELAY_DAYS NUMBER The number of days between the prior scheduled visit.
DELAY_HOURS NUMBER The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field).
VISIT_HOUR_SEQ_ORDER NUMBER The order in which subject visits occur, as configured in the study design.
VISIT_CREATION_ORDER NUMBER Numeric visit order that follows the visit schedule as it was created.
BRANCH_WID NUMBER(38) Indicates the unique numeric identifier of the branch.
BRANCH_TITLE VARCHAR2(64 CHAR) Indicates the branch title or name.
BRANCH_REFNAME VARCHAR2(64 CHAR) Indicates the REFNAME of the branch title or name.
BRANCH_ID RAW(16 BYTE) A branch's ID as specified by a study designer.
IS_CYCLE_BRANCH CHAR(1) States whether the branch is cycled or not.
CYCLE_COUNT NUMBER Specifies the number of cycles in case the branch is cycled.
ASSIGN_SUBJECT_USING_TREATMENT_ARM CHAR(1) Indicates if subjects are assigned to the branch by Treatment arm.
ASSIGN_SUBJECT_USING_FORM_QUESTION CHAR(1) Indicates if subjects get assigned to branch by a form question.
BRANCH_ARM VARCHAR2(32767 CHAR) Specifies which treatment arm(s) correspond to the current branch, in case subjects are assigned to the branch by treatment arm.
BRANCH_FORM VARCHAR2(64 CHAR) Specifies which form contains the question used to assign subjects to the current branch, in case subjects are assigned to the branch by form question.
BRANCH_QUESTION VARCHAR2(4000 CHAR) Specifies which question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question.
BRANCH_ANSWER VARCHAR2(4000 CHAR) Specifies which exact answer to the selected question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question.
BRANCH_VISIT VARCHAR2(64 CHAR) Specifies the visit containing the selected form and question that is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question.
FORM_ID RAW(16 BYTE) GUID of the form.
FORM_WID NUMBER A number that represents the unique identifier of a form.
FORM_NAME VARCHAR2(64 CHAR) The name of the form, as specified by the study designer.
FORM_REFNAME VARCHAR2(64 CHAR) A form's reference name.
FORM_TYPE VARCHAR2(14 CHAR)
Indicates the type of form:
  • One-section form
  • Two-section form
  • Lab form
FORM_IS_REPEATING CHAR(1) Indicates whether the form is repeating or not.
ALLOW_ADDITIONAL_ROWS CHAR(1) Indicates if this is a repeating form that allows additional rows.
SOURCE_DATAVIEW_WID NUMBER If it is a copied form, indicates the numeric identifier of the form it was copied from.
SOURCE_DATAVIEW_NAME VARCHAR2(64 CHAR) If it is a copied form, indicates the original form it was copied from.
SOURCE_STUDY_WID NUMBER If it is a copied form, indicates the numeric identifier of the study it was copied from.
SOURCE_STUDY_NAME VARCHAR2(64 CHAR) If it is a copied form, indicates the name of the study it was copied from.
SOURCE_STUDY_VERSION VARCHAR2(32 CHAR) If it is a copied form, indicates the study version of the study it was copied from.
SOURCE_VERSION_START TIMESTAMP(6) If it is a copied form, indicates the date and time of when the copied data was entered.
RULE_COPY_STATUS NUMBER If it is a copied form, indicates the status of the source form rules copy.
ITEM_ID RAW(16 BYTE) GUID of the item.
ITEM_WID NUMBER(38) A number that represents the unique identifier of an item.
ITEM_NAME VARCHAR2(4000 CHAR) Indicates the title of the question, as entered by a study designer.
MEASURE_UNIT VARCHAR2(64 CHAR) Indicates the measure of unit specified by a study designer for a Number type of question.
QUESTION_TYPE VARCHAR2(32 CHAR) Indicates the type of question as defined by a study designer.
QUESTION_HINT VARCHAR2(4000 CHAR) Indicates information that a study designer provided as a hint to help answer a question.
FORMITEM_IS_REQUIRED CHAR(1) Indicates whether the question is required or not. Required questions must be answered in order to save the form that contains it.
READONLY CHAR(1) Indicates that the question is marked as read-only by a study designer.
SAS_VARIABLE VARCHAR2(32 CHAR) Indicates the SAS Variable of a form defined by a study designer.
SAS_LABEL VARCHAR2(4000CHAR) Indicates the SAS Label of a form defined by a study designer.
REFERENCE_CODE VARCHAR2(64 CHAR) Indicates a question's reference code.
ITEM_GROUP_ID NUMBER(64 CHAR) If this is a group question, indicates the group question ID.
ITEM_GROUP VARCHAR2(64 CHAR) If this is a group question, indicates the group question title.
GROUP_TYPE VARCHAR2(32 CHAR) Indicates if this is a group question.
HIDDEN CHAR(1) Indicates whether a question is hidden or not, as marked by a study designer
VALIDATION_RULES VARCHAR2(32767)
Specifies the question's validation rule if any. Validation rules types available depend on the type of question:
  • Text questions:
    • Doesn't contain
  • Date/Time and Date of Birth questions:
    • After
    • On or After
    • Before
    • On or Before
    • On
    • Not On
    • Not Between
    • Range
  • Number and Age questions:
    • Greater Than
    • Greater Than or Equal To
    • Less Than
    • Less Than or Equal To
    • Is
    • Not Equal To
    • Not Between
    • Range
  • Drop-down and check box questions
    • Select at Least
    • Select at Most
    • Select Exactly
    • Answer Must Be
  • Radio Button questions
    • Answer Must Be
RULE_ERROR VARCHAR2(32767) Reason for failure if validation status is failed or the rule validation failed
ACTION_RULES VARCHAR2(32767 CHAR)
Details the action rule of a question which can be of the types:
  • Show Question
  • Show Form
  • Show Visit
  • Link & Show Form
CODE_QUESTION VARCHAR2(32767 CHAR)
If the question has a Coding Question property, lists the following information:
  • Dictionary
  • Coding Item Type
  • Tag for Central Coding
SDV VARCHAR2(12 CHAR) Specifies if the question has any SDV parameter and if it is of the type SDV for All Subjects or Critical Variables (Targeted SDV).
FORM_IS_ROLLOVER CHAR(1) Indicates whether the form is rollover or not.
FORMAT VARCHAR2(40 CHAR) Specifies the answer format. For example an specific date format, or the number of decimals after the point
ITEM_DATE_PARTIAL_REQUIRED VARCHAR2(32 CHAR) The partial date format allowed for the item. If a partial date is not allowed this value will be null.
ITEM_VALUES VARCHAR2(32767) The raw value of the form question value (can be an array in questions with decodes)
CODELIST_VALUES VARCHAR2(32767) Lists the codelist values added as answers to the current question.
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.
DH_TIMESTAMP TIMESTAMP(6) A time stamp that indicates when the data became available in the dataset.
MODIFIED_BY VARCHAR2(255 CHAR) The user who last modify the study.
STUDY_ID RAW(16 BYTE) User entered ID of the study.
STUDY_WID NUMBER(38) A number that represents the unique identifier of the study.
STUDY_ID_NAME VARCHAR2(64 CHAR) A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number.
STUDY_TITLE VARCHAR2(4000 CHAR) A protocol's title as specified by the study manager.
STUDY_REFNAME VARCHAR2(64 CHAR) The STUDY_ID_NAME data element that is converted to uppercase and spaces are removed. This value never changes after created even if STUDY_ID_NAME changes.
THERAPEUTIC_AREA VARCHAR2(64 CHAR) Indicates the therapeutic area as specified by the study manager when they created the study.
STUDY_PHASE VARCHAR2(64 CHAR) A study's phase as indicated by the study manager when they created the study.
BLINDING_TYPE VARCHAR2(64 CHAR) Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study.
STUDY_VERSION VARCHAR2(32 CHAR) Indicates the study version number of the referencing data in a custom report.

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:
  • Two-section forms: unique numeric identifier of the row in the repeating section.
  • Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.
  • Repeating forms: indicates the repeating form number.
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: 
  • Two-section forms: indicates the form instance number.
  • Lab forms: defaults to a value of 1.
  • Repeating forms: this value is null.
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.
PREVIOUS_SUBJECT_NUMBER VARCHAR2(500 CHAR) When a subject number change is applied, this field holds the number that was assigned to the subject before the change.

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:
  • CREATE
  • MODIFY
  • DELETE
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:
  • Answered
  • Closed
  • Deleted
  • Opened
  • Candidate
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
IS_AUTO_QUERY VARCHAR2(1 CHAR) Indicates whether this is an automated query.
PREVIOUS_SUBJECT_NUMBER VARCHAR2(500 CHAR) When a subject number change is applied, this field holds the number that was assigned to the subject before the change.
QUERY_TYPE VARCHAR2(16 CHAR) Indicates the query type.

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:
  • Blinded
  • Unblinded
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 re-randomization
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:
  • ADVERSE_EVENT
  • DISPENSATION
  • NON_DISPENSATION
  • OPTIONAL
  • RANDOMIZATION
  • SCREENING
  • SUBJECT_COMPLETE
  • UNSCHEDULED
  • WITHDRAW
EVENT_TYPE VARCHAR2(32) Event type categorization:
  • Visit_Complete
  • Visit_Started
  • Visit_Date_Changed
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:
  • D2C
  • C2C
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:
  • Blinded: if blinded users should never see the kit type description.
  • Unblinded: if blinded users should always see the kit type description.
  • Unblinded Pharmacist: if blinded users should never see these kits at all and only pharmacists or unblinded site users can dispense these kit types.
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:
  • CREATE
  • MODIFY
  • DELETE
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:
  • FAILED
  • RULE_VALIDATION_FAILED
  • SUCCESS
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:
  • One-section repeating form type: Numeric value to represent the form instance for repeating forms.
  • Lab and two-section form types: Sequential number to represent the table (repeating section) row the extract data pertains to.
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 Oracle Clinical One Platform 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 date time 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:
  • Calculation
  • Choice
  • DateTime
  • Measurement
  • Number
  • Text
  • Label
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 is NULL.
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
EVENT_ID_NAME VARCHAR2(16 CHAR) The event's id as in Oracle Clinical One Platform.
EVENT_TITLE VARCHAR2(64 CHAR) The event's title, defined by the user when an event is created.
HAS_QUERY CHAR(1) Indicates whether there is a query raised against a question or not, irrespective of the status.
LAB_ID VARCHAR2(50 CHAR) Indicates the associated lab ID, when the item is part of a lab form.
LAB_NAME VARCHAR2(200 CHAR) Indicates the associated lab name, when the item is part of a lab form.
PREVIOUS_SUBJECT_NUMBER VARCHAR2(500 CHAR) When a subject number change is applied, this field holds the number that was assigned to the subject before the change.

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:
  • CLEARED
  • CREATED
  • MODIFIED
  • REMOVED
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:
  • COMPLETE
  • COMPLETE_ERR
  • INCOMPLETE
  • INCOMPLETE_ERR
  • INPROGRESS
  • NEW
VISIT_START_DATE DATE Timestamp of when a visit began
VISIT_TYPE VARCHAR2(100 CHAR) Visit type categorization:
  • ADVERSE_EVENT
  • DISPENSATION
  • NON_DISPENSATION
  • OPTIONAL
  • RANDOMIZATION
  • SCREENING
  • SUBJECT_COMPLETE
  • UNSCHEDULED
  • WITHDRAW
EVENT_TYPE VARCHAR2(100) Event type categorization:
  • Visit_Complete
  • Visit_Started
  • Visit_Date_Changed
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
PREVIOUS_SUBJECT_NUMBER VARCHAR2(500 CHAR) When a subject number change is applied, this field holds the number that was assigned to the subject before the change.

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:
  • Code_Break
  • Complete
  • Enrolled
  • New
  • Randomized
  • Screen_Failed
  • Screened
  • SubjectNumberChanged
  • Transferred
  • Undo_Complete
  • Undo_ScrFailed
  • Undo_Withdrawn
  • Withdrawn
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:
  • Created
  • Modified
  • Deleted
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:
  • Blinded
  • Unblinded
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
EMAIL 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
CURRENT_STUDY_ROLE_ID RAW(16 BYTE) The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user.
CURRENT_STUDY_ROLE_NAME VARCHAR2(100 CHAR) Specifies the role of the user who updated the given record. If the user's study role changes, this field will show the current study role of the given user.
CURRENT_STUDY_ROLE_WID NUMBER(38) Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user.
EXTERNAL_SOURCE_STATUS_DATE TIMESTAMP(6) Indicates the date on which the subject status was updated by an external source.
FREEZE VARCHAR2(16 CHAR) String value to represent the freeze status
PREVIOUS_SUBJECT_NUMBER VARCHAR2(500 CHAR) When a subject number change is applied, this field holds the number that was assigned to the subject before the change.
SIGNED VARCHAR2(16 CHAR) String value to represent the signed status
VERIFIED VARCHAR2(16 CHAR) String value to represent the verified status

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:
  • Blind
  • Unblind
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
EMAIL 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 city
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 re-randomization
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:
  • COMPLETE
  • COMPLETE_ERR
  • INCOMPLETE
  • INCOMPLETE_ERR
  • INPROGRESS
  • NEW
VISIT_START_DATE DATE Visit date
VISIT_TYPE VARCHAR2(100 CHAR) Type of the visit
EVENT_TYPE VARCHAR2(100) Event type categorization:
  • Visit_Complete
  • Visit_Started
  • Visit_Date_Changed
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:
  • D2C
  • C2C
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:
  • Blinded: if blinded users should never see the kit type description.
  • Unblinded: if blinded users should always see the kit type description.
  • Unblinded Pharmacist: if blinded users should never see these kits at all and only pharmacists or unblinded site users can dispense these kit types.
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:
  • Blister
  • Pack
  • Bottle
  • Device
  • Syringe
  • Topical
  • Ointment
  • Vial
  • Inhaler
  • Infusion
  • Box
  • Other
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:
  • CREATE
  • MODIFY
  • DELETE
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
CURRENT_STUDY_ROLE_ID RAW(6 BYTE) The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user.
CURRENT_STUDY_ROLE_NAME VARCHAR2(100 CHAR) Specifies the role of the user who updated the given record. If the user's study role changes, this field will show the current study role of the given user.
CURRENT_STUDY_ROLE_WID NUMBER(38) Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user.
ITEM_NUMBER VARCHAR2(64 CHAR)
Numeric value used as a reference element for batch processing.

Note:

This field is part of the SAP system and populated via integration. This field does not display in Oracle Clinical One Platform.
KIT_NUMBER VARCHAR2(1024 CHAR) Indicates a kit's number, as assigned in the system.
MATERIAL_ID VARCHAR2(64 CHAR)
Alphanumeric identifier of the material of a given kit, used as a reference element for batch processing.

Note:

This field is part of the SAP system and populated via integration. This field does not display in Oracle Clinical One Platform.
PREVIOUS_SUBJECT_NUMBER VARCHAR2(500 CHAR) When a subject number change is applied, this field holds the number that was assigned to the subject before the change.