ODM-XML reference
Users can request and receive data formatted according to the CDISC ODM version 1.3.2 standard. The tables below display the list of all the subject-related transactions for a specified study. Each table includes the CDISC element, parent element, attribute, comments (which specify certain values for the attribute), source column and source table. Attributes and elements that are not from the CDISC standard are shown as a Clinical One extension.
Clinical data
This table displays the clinical data response elements from your ODM Extract.
Note:
Items with co: in CDISC Element, Parent Element, and Attribute columns denote a Clinical One extension.CDISC Element | Parent Element | Attribute | Comments | Source Table | Source Column |
---|---|---|---|---|---|
ODM | n/a | Description | The same as subjectOID | dh_study_versions | study_refname |
ODM | n/a | FileType | Snapshot | Transactional (default) | n/a | n/a |
ODM | n/a | FileOID | {Tenant shortid}/{StudyRefName}/{UUID} | n/a | n/a |
ODM | n/a | CreationDateTime | YYYY-MM-ddTHH:mm:ss.SSSZ | n/a | n/a |
ODM | n/a | ODMVersion | "1.3.2" | n/a | n/a |
ODM | n/a | Originator | {tenant organization}.{Login of the user that generated the ODM-XML} | n/a | n/a |
ODM | n/a | SourceSystem | "Oracle Life Sciences Clinical One" | n/a | n/a |
ODM | n/a | SourceSystemVersion | "Clinical Data Unblinded API v1.0" | "Clinical Data Blinded API v1.0" | n/a | n/a |
ODM | n/a | xmlns | http://www.cdisc.org/ns/odm/v1.3 | n/a | n/a |
ODM | n/a | xmlns:co | https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1 | n/a | n/a |
ODM | n/a | co:studyMode | test | training | active (production) | n/a | n/a |
ODM | n/a | co:includeCOExtensions | true (default) | false | n/a | n/a |
ODM | n/a | co:excludeHiddenData | true | false (default) | n/a | n/a |
ODM | n/a | co:fromTimestamp | YYYY-MM-ddTHH:mm:ss.SSSZ | n/a | n/a |
ODM | n/a | co:toTimestamp | YYYY-MM-ddTHH:mm:ss.SSSZ | n/a | n/a |
ODM | n/a | co:hasMore | true | false | n/a | n/a |
ODM | n/a | co:totalResults | n/a | n/a | |
ODM | n/a | co:count | n/a | n/a | |
ODM | n/a | co:offset | n/a | n/a | |
ODM | n/a | co:limit | n/a | n/a | |
ClinicalData | ODM | studyOID | dh_study_versions | study_refname | |
ClinicalData | ODM | MetaDataVersionOID | dh_study_versions | study_version | |
ClinicalData | ODM | co:StudyID | dh_study_versions | study_id | |
ClinicalData | ODM | co:StudyVersionStart | dh_study_versions | version_start | |
SubjectData | ClinicalData | SubjectKey | dhvw_subjects_dataset_v3_odm | subject_number | |
SubjectData | ClinicalData | co:SubjectGUID | dhvw_subjects_dataset_v3_odm | subject_id | |
SubjectData | ClinicalData | co:SubjectStatus | New | Active | Screening_Initiated | Screen_Failed | Withdrawn | Auto_Screen_Failed | Complete | Enrolled | dhvw_subjects_dataset_v3_odm | subject_state |
SubjectData | ClinicalData | co:SubjectAction | Complete | Transferred | New | Enrolled | Screen_Failed | Undo_ScrFailed | Code_Break | Randomized |Undo_Withdrawn | Withdrawn | Undo_Complete | dhvw_subjects_dataset_v3_odm | event_type |
SubjectData | ClinicalData | co:SignedStatus | SIGNED | UNSIGNED | NEVER_SIGNED | NOT_APPLICABLE | dhvw_subjects_dataset_v3_odm | signed |
AuditRecord | SubjectData | n/a | n/a | n/a | |
DateTimeStamp | AuditRecord | n/a | dhvw_subjects_dataset_v3_odm | version_start | |
ReasonForChange | AuditRecord | n/a | dhvw_subjects_dataset_v3_odm | reason | |
UserRef | AuditRecord | co:UserOID | dhvw_subjects_dataset_v3_odm | user_name | |
LocationRef | AuditRecord | co:LocationOID | dhvw_subjects_dataset_v3_odm | site_id_name | |
SiteRef | SubjectData | LocationOID | dhvw_subjects_dataset_v3_odm | site_id_name | |
SiteRef | SubjectData | co:Country | dhvw_subjects_dataset_v3_odm | address_country | |
StudyEventData | SubjectData | StudyEventOID | The value is ItemVisitName_ItemEventID .
|
dhvw_subvis_unbld_dataset_v2 | event_id_name |
StudyEventData | SubjectData | co:VisitGUID | dhvw_subvis_unbld_dataset_v2 | event_id | |
StudyEventData | SubjectData | co:VisitName | dhvw_subvis_unbld_dataset_v2 | event_title | |
StudyEventData | SubjectData | co:VisitSequence | dhvw_subvis_unbld_dataset_v2 | visit_order | |
StudyEventData | SubjectData | StudyEventRepeatKey | dhvw_subvis_unbld_dataset_v2 | event_instance_num | |
StudyEventData | SubjectData | co:VisitStatus | NEW | COMPLETE | COMPLETE_ERR | INPROGRESS | INCOMPLETE | INCOMPLETE_ERR | SKIPPED | UNDO_SKIP | dhvw_subvis_unbld_dataset_v2 | visit_status |
StudyEventData | SubjectData | co:VisitStartDate | dhvw_subvis_unbld_dataset_v2 | visit_start_date | |
AuditRecord | StudyEventData | n/a | n/a | n/a | |
DateTimeStamp | AuditRecord | n/a | dhvw_subvis_unbld_dataset_v2 | version_start | |
ReasonForChange | AuditRecord | n/a | dhvw_subvis_unbld_dataset_v2 | reason | |
UserRef | AuditRecord | co:UserOID | dhvw_subvis_unbld_dataset_v2 | user_name | |
LocationRef | AuditRecord | co:LocationOID | dhvw_subvis_unbld_dataset_v2 | site_id_name | |
FormData | StudyEventData | FormOID | ItemFormName_ItemFormId .
|
dhvw_sub_formitems_dataset_v6 | form_refname |
FormData | StudyEventData | co:FormGUID | dhvw_sub_formitems_dataset_v6 | form_id | |
FormData | StudyEventData | FormRepeatKey | dhvw_sub_formitems_dataset_v6 | repeat_sequence_number | |
FormData | StudyEventData | co:FormStatus | COMPLETED | COMPLETED_WITH_ERROR |IN_PROGRESS | INCOMPLETE_WITH_ERROR |INCOMPLETE | dhvw_sub_formitems_dataset_v6 | form_status |
FormData | StudyEventData | co:RepeatFormNumber | dhvw_sub_formitems_dataset_v6 | repeat_form_number | |
FormData | StudyEventData | co:InnerRepeat | dhvw_sub_formitems_dataset_v6 | inner_repeat | |
FormData | StudyEventData | co:OuterRepeat | dhvw_sub_formitems_dataset_v6 | outer_repeat | |
FormData | StudyEventData | co:FormSectionGUID | dhvw_sub_formitems_dataset_v6 | form_section_id | |
FormData | StudyEventData | LabId | dhvw_sub_formitems_dataset_v6 | lab_id | |
FormData | StudyEventData | LabName | dhvw_sub_formitems_dataset_v6 | lab_name | |
ItemGroupData | FormData | ItemGroupOID |
If the item belongs to a group: If the item does not belong to a group: |
dhvw_sub_formitems_dataset_v6/ dh_formitems | reference_code/ group_name |
ItemGroupData | FormData | co:ItemGroupGUID | Group items item id is the value. If the item does not belong to a group, the ItemGUID is the value. | dhvw_sub_formitems_dataset_v6/ dh_formitems | item_id/ group_id |
ItemData | ItemGroupData | ItemOID | ItemName_ItemID .
|
dhvw_sub_formitems_dataset_v6 | reference_code |
ItemData | ItemGroupData | co:ItemGUID | dhvw_sub_formitems_dataset_v6 | item_id | |
ItemData | ItemGroupData | Value | dhvw_sub_formitems_dataset_v6 | value | |
ItemData | ItemGroupData | co:DecodedValue | dhvw_sub_formitems_dataset_v6 | item_r | |
ItemData | ItemGroupData | IsNull | Value is Yes or else the tag is excluded. Yes signifies the value is null | n/a | n/a |
ItemData | ItemGroupData | co:ValidationStatus | SUCCESS | RULE_VALIDATION_FAILED | FAILED | ERROR | ENROLL_FAILED | dhvw_sub_formitems_dataset_v6 | validation_status |
ItemData | ItemGroupData | co:ValidationError | dhvw_sub_formitems_dataset_v6 | validation_failure | |
ItemData | ItemGroupData | co:Frozen | FROZEN | UNFROZEN| NEVER_FROZEN | NOT_APPLICABLE | dhvw_sub_formitems_dataset_v6 | freeze |
ItemData | ItemGroupData | co:Verified | VERIFIED | UNVERIFIED | NEVER_VERIFIED | NOT_APPLICABLE | dhvw_sub_formitems_dataset_v6 | verified |
ItemData | ItemGroupData | co:Signed | SIGNED | UNSIGNED | NEVER_SIGNED | NOT_APPLICABLE | dhvw_sub_formitems_dataset_v6 | signed |
ItemData | ItemGroupData | co:DataFlag | Not Applicable | Not Done | Unknown | Not Answered | dhvw_sub_formitems_dataset_v6 | data_flag |
ItemData | ItemGroupData | TransactionType | Upsert | Remove | n/a | n/a |
MeasurementUnitRef | ItemData | MeasurementUnitOID | dhvw_sub_formitems_dataset_v3 | measure_unit | |
Query | ItemData | co:QueryId | dhvw_queries_dataset_v1 | query_ID | |
Query | ItemData | co:QueryText | dhvw_queries_dataset_v1 | query_comment | |
Query | ItemData | co:QueryDBUID | dhvw_queries_dataset_v1 | query_wid | |
Query | ItemData | co:Revision | dhvw_queries_dataset_v1 | dh_timestamp | |
Query | ItemData | co:QueryType | site | assigned | candidate | dhvw_queries_dataset_v4 | QUERY_TYPE |
Query | ItemData | co:AssignedRole | dhvw_queries_dataset_v4 | ASSIGNED_ROLES | |
Query | ItemData | co:QueryRaised | manual | auto | dhvw_queries_dataset_v4 | IS_AUTO_QUERY |
QueryState | Query | co:Status | Candidate | Opened | Answered | Deleted |Closed | dhvw_queries_dataset_v1 | state |
AuditRecord | QueryState | n/a | No text. | n/a | n/a |
DateTimeStamp | AuditRecord | n/a | dhvw_queries_dataset_v1 | version_start | |
ReasonForChange | AuditRecord | n/a | dhvw_queries_dataset_v1 | reason | |
UserRef | AuditRecord | co:UserOID | dhvw_queries_dataset_v1 | user_name | |
LocationRef | AuditRecord | co:LocationOID | dhvw_queries_dataset_v1 | site_id_name | |
AuditRecord | ItemData | n/a | No text | n/a | n/a |
DateTimeStamp | AuditRecord | n/a | YYYY-MM-ddTHH:mm:ss.SSSZ | dhvw_sub_formitems_dataset_v6 | version_start |
ReasonForChange | AuditRecord | n/a | dhvw_sub_formitems_dataset_v6 | reason | |
ReasonForChange | AuditRecord | co:Comments | Is only present if reason for change is selected as other | dhvw_sub_formitems_dataset_v6 | comment |
UserRef | AuditRecord | UserOID | dhvw_sub_formitems_dataset_v6 | user_name | |
LocationRef | AuditRecord | LocationOID | dhvw_sub_formitems_dataset_v6 | site_id_name | |
KeySet | Association | FormSectionGUID | DH_FORMS_ASSOCIATIONS | SRC_FORM_ID | |
KeySet | Association | StudyOID | DH_FORMS_ASSOCIATIONS | STUDY_NAME | |
KeySet | Association | SubjectKey | DH_FORMS_ASSOCIATIONS | SUBJECT_NUMBER | |
KeySet | Association | StudyEventOID | DH_FORMS_ASSOCIATIONS | SRC_EVENT_ID | ASSOCIATED_EVENT_ID | |
KeySet | Association | FormOID | DH_FORMS_ASSOCIATIONS | SRC_FORM_NAME | ASSOCIATED_FORM_NAME | |
KeySet | Association | FormRepeatKey | DH_FORMS_ASSOCIATIONS | ASSOCIATED_REPEAT_SEQUENCE_NUM | SRC_REPEAT_SEQUENCE_NUMBER | |
KeySet | Association | ItemGroupOID | DH_FORMS_ASSOCIATIONS | SRC_ITEM_ID | |
KeySet | Association | ItemOID | DH_FORMS_ASSOCIATIONS | SRC_ITEM_ID | |
KeySet | Association | RepeatFormNumber | DH_FORMS_ASSOCIATIONS | SRC_REPEAT_FORM_NUM | |
KeySet | Association | StudyEventRepeatKey | DH_FORMS_ASSOCIATIONS | SRC_EVENT_INSTANCE_NUM | ASSOCIATED_EVENT_INSTANCE_NUM | |
Annotation | Association | SeqNum | DH_FORMS_ASSOCIATIONS | FORMS_ASSOCIATION_WID | |
Comment | Annotation | n/a | Clinical One Form Association | n/a | n/a |
FlagType | Flag | n/a | Association | ||
FlagType | Flag | CodeListOID | FlagType | ||
FlagValue | Flag | n/a | CREATED | REMOVED | DH_FORMS_ASSOCIATIONS | OPERATION_TYPE |
FlagValue | Flag | CodeListOID | AssociationAction | ||
UserRef | AuditRecord | co:UserOID | DH_FORMS_ASSOCIATIONS | USER_NAME | |
LocationRef | AuditRecord | co:LocationOID | DH_SITE_DEPOTS (DH_FORMS_ASSOCIATIONS) | SDF_STUDY_ORG_ID (site_name) | |
DateTimeStamp | AuditRecord | n/a | DH_FORMS_ASSOCIATIONS | DH_TIMESTAMP |
Metadata
This table displays the meta data response elements from your ODM Extract.
Note:
Items with co: in CDISC Element, Parent Element, and Attribute columns denote a Clinical One extension.CDISC Element | Parent Element | Attribute | Comments | Source Table | Source Column |
---|---|---|---|---|---|
ODM | n/a | Description | The same as subjectOID | dh_study_versions | study_refname |
ODM | n/a | FileType | Transactional | N/A | N/A |
ODM | n/a | FileOID | {Tenant shortid}/{StudyRefName}/{UUID} | N/A | N/A |
ODM | n/a | CreationDateTime | YYYY-MM-ddTHH:mm:ss.SSSZ | N/A | N/A |
ODM | n/a | ODMVersion | "1.3.2" | N/A | N/A |
ODM | n/a | Originator | {Tenant organization}.{Login of the user that generated the ODM-XML} | N/A | N/A |
ODM | n/a | SourceSystem | "Oracle Life Sciences Clinical One" | N/A | N/A |
ODM | n/a | SourceSystemVersion | "MetaData API v1.0" | N/A | N/A |
ODM | n/a | xmlns | http://www.cdisc.org/ns/odm/v1.3 | N/A | N/A |
ODM | n/a | xmlns:co | https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1 | N/A | N/A |
ODM | n/a | co:studyMode | test | training | active (production) | N/A | N/A |
ODM | n/a | co:includeCOExtensions | true (default) | false | N/A | N/A |
ODM | n/a | co:fromTimestamp | YYYY-MM-ddTHH:mm:ss.SSSZ (StudyVersionCutOff) | N/A | N/A |
ODM | n/a | co:studyVersion | N/A | N/A | |
ODM | n/a | co:studyVersionSummary | true | false (default) | N/A | N/A |
ODM | N/A | co:hasMore | true | false | N/A | N/A |
ODM | N/A | co:totalResults | N/A | N/A | |
ODM | N/A | co:count | N/A | N/A | |
ODM | N/A | co:offset | N/A | N/A | |
ODM | N/A | co:limit | N/A | N/A | |
Study | ODM | OID | dh_study_versions | study_refname | |
GlobalVariables | Study | No text | N/A | N/A | |
StudyName | GlobalVariables | dh_study_versions | study_refname | ||
StudyDescription | GlobalVariables | dh_study_versions | description | ||
ProtocolName | GlobalVariables | dh_study_versions | study_refname | ||
BasicDefinitions | Study | No text | N/A | N/A | |
MeasurementUnit | BasicDefinitions | OID | dh_formitems | unitofmeasure | |
MeasurementUnit | BasicDefinitions | Name | dh_formitems | unitofmeasure | |
Symbol | MeasurementUnit | No text | N/A | N/A | |
TranslatedText | Symbol | dh_formitems | unitofmeasure | ||
MetaDataVersion | Study | OID | dh_study_versions | study_refname + "v"+study_version | |
MetaDataVersion | Study | Name | dh_study_versions | study_refname | |
MetaDataVersion | Study | co:StudyWid | dh_study_versions | study_wid | |
MetaDataVersion | Study | co:GUID | dh_study_versions | study_id | |
MetaDataVersion | Study | co:VersionStart | YYYY-MM-ddTHH:mm:ss.SSSZ | dh_study_versions | version_start |
Protocol | MetaDataVersion | N/A | N/A | ||
StudyEventRef | Protocol | StudyEventOID | ItemVisitName_ItemEventID .
|
dh_studyevents | refname |
StudyEventRef | Protocol | OrderNumber | dh_studyevents | visit_seq | |
StudyEventRef | Protocol | Mandatory | Yes | No | dh_studyevents | required |
StudyEventDef | MetaDataVersion | OID | ItemVisitName_ItemEventID .
|
dh_studyevents | refname |
StudyEventDef | MetaDataVersion | Name | dh_studyevents | refname | |
StudyEventDef | MetaDataVersion | Repeating | dh_studyevents | repeating | |
StudyEventDef | MetaDataVersion | Type | Scheduled | Unscheduled | dh_studyevents | visit_type |
StudyEventDef | MetaDataVersion | Category | dh_studyevents | visit_type | |
StudyEventDef | MetaDataVersion | co:StudyEventWid | dh_studyevents | studyevent_wid | |
StudyEventDef | MetaDataVersion | co:GUID | dh_studyevents | studyevent_id | |
StudyEventDef | MetaDataVersion | co:VersionStart | YYYY-MM-ddTHH:mm:ss.SSSZ | dh_studyevents | version_start |
StudyEventDef | MetaDataVersion | co:DelayDays | dh_studyevent_schedules | delay_days | |
StudyEventDef | MetaDataVersion | co:DelayHours | dh_studyevent_schedules | delay_hours | |
StudyEventDef | MetaDataVersion | co:DelayWindowBeforeDays | dh_studyevent_schedules | delaywindow_before_days | |
StudyEventDef | MetaDataVersion | co:DelayWindowBeforeHours | dh_studyevent_schedules | delaywindow_before_hours | |
StudyEventDef | MetaDataVersion | co:DelayWindowAfterDays | dh_studyevent_schedules | delaywindow_after_days | |
StudyEventDef | MetaDataVersion | co:DelayWindowAfterHours | dh_studyevent_schedules | delaywindow_after_hours | |
StudyEventDef | MetaDataVersion | co:DelayWindowHardStop | dh_studyevent_schedules | delaywindow_hardstop | |
StudyEventDef | MetaDataVersion | co:DelayWindowVisitApproval | dh_studyevent_schedules | delaywindow_visitapproval | |
FormRef | StudyEventDef | FormOID | ItemFormName_ItemFormId .
|
dh_studyevent_forms | form_name |
FormRef | StudyEventDef | OrderNumber | dh_studyevent_forms | component_seq | |
FormRef | StudyEventDef | Mandatory | Yes | No (Not available at form level: derived from form items, if any of the form items are mandatory, then the form is mandatory) | N/A | N/A |
FormDef | MetaDataVersion | OID | ItemFormName_ItemFormId .
|
dh_studyevent_forms | form_name |
FormDef | MetaDataVersion | Name | dh_dataviews | title | |
FormDef | MetaDataVersion | Repeating | Yes | No | dh_dataviews |
|
FormDef | MetaDataVersion | co:FormWid | dh_studyevent_forms | form_wid | |
FormDef | MetaDataVersion | co:GUID | dh_studyevent_forms | form_id | |
FormDef | MetaDataVersion | co:FormVersionStart | YYYY-MM-ddTHH:mm:ss.SSSZ | dh_dataviews | version_start |
FormDef | MetaDataVersion | co:FormType | STANDARD_FORM | LAB_FORM | TWO_SECTION_FORM | dh_form_table_map | form_type_desc |
ItemGroupRef | FormDef | ItemGroupOID |
If the item belongs to a group: If the item does not belong to a group: |
dh_formitems | item_refname |
ItemGroupRef | FormDef | OrderNumber | dh_formitems | item_seq | |
ItemGroupRef | FormDef | Mandatory | Yes | No | dh_formitems | required |
ItemGroupDef | MetaDataVersion | OID | For form items which are not part of item groups, a dummy item group is created with same as form item details. ItemGroupRef.ItemGroupOID = "IG:"+item_refname ItemGroupDef.OID = "IG:"+item_refname | dh_formitems | item_refname |
ItemGroupDef | MetaDataVersion | Name | dh_formitems | question_name | |
ItemGroupDef | MetaDataVersion | Repeating | Yes | No (Not available at item or itemgroup level). Hard coded to No | N/A | N/A |
ItemGroupDef | MetaDataVersion | co:ItemGroupWid | dh_formitems | item_wid | |
ItemGroupDef | MetaDataVersion | co:GUID | dh_formitems | item_id | |
ItemGroupDef | MetaDataVersion | co:QuestionGroup | Yes | No | dh_formitems | group_type |
ItemRef | ItemGroupDef | ItemOID | ItemName_ItemID .
|
dh_formitems | item_refname |
ItemRef | ItemGroupDef | OrderNumber | 1 (Default will be 1 for items directly under the form in Clinical One ) | dh_formitems | group_item_seq |
ItemRef | ItemGroupDef | Mandatory | Yes | No | dh_formitems | required |
ItemDef | MetaDataVersion | OID | ItemName_ItemID .
|
dh_formitems | item_refname |
ItemDef | MetaDataVersion | Name | dh_formitems | item_title | |
ItemDef | MetaDataVersion | DataType | text | integer | float | date | datetime | string partialDate | partialDatetime | dh_formitems | item_type |
ItemDef | MetaDataVersion | Length | dh_formitems | length | |
ItemDef | MetaDataVersion | co:GUID | dh_formitems | item_id | |
ItemDef | MetaDataVersion | co:ItemWid | dh_formitems | item_wid | |
ItemDef | MetaDataVersion | co:ItemVersionStart | YYYY-MM-ddTHH:mm:ss.SSSZ | dh_formitems | version_start |
ItemDef | MetaDataVersion | co:Precision | dh_formitems | precision | |
ItemDef | MetaDataVersion | co:AllowFutureDate | Yes or No value to indicate if item allows future dates. | dh_formitems | allow_future_date |
Question | ItemDef | no text | N/A | N/A | |
TranslatedText | Question | value | Value of the ItemDef OID | dh_formitems | question_name |
MeasurementUnitRef | ItemDef | MeasurementUnitOID | dh_formitems | unitofmeasure | |
CodeListRef | ItemDef | CodeListOID | Prefixed with the Item refname: OID = "item refname"."codelist refname"."codelist id". | dh_codelists | refname |
CodeList | MetaDataVersion | OID | Prefixed with the Item refname: OID = "item refname"."codelist refname"."codelist id". | dh_codelists | refname |
CodeList | MetaDataVersion | Name | dh_codelists | title | |
CodeList | MetaDataVersion | DataType | integer |float | text | string | dh_codelists | codelist_type |
CodeListItem | CodeList | CodedValue | dh_codelist_items | code | |
CodeListItem | CodeList | co:SelectionOID | Prefixed with the Item refname and codelist refname. (SelectionOID = "item refname"."codelist refname"."codelistitem refname") | dh_codelist_items | refname |
Decode | CodeListItem | N/A | N/A | ||
TranslatedText | Decode | dh_stringresources | strvalue |
Administrative data
This table displays the admin data response elements from your ODM Extract.
Note:
Items with co: in CDISC Element, Parent Element, and Attribute columns denote a Clinical One extension.CDISC Element | Parent Element | Attribute | Comments | Source Table | Source Column |
---|---|---|---|---|---|
ODM | n/a | Description | The same as subjectOID | dh_study_versions | study_refname |
ODM | n/a | FileType | Snapshot | n/a | n/a |
ODM | n/a | FileOID | {Tenant shortid}/{StudyRefName}/{UUID} | n/a | n/a |
ODM | n/a | CreationDateTime | YYYY-MM-ddTHH:mm:ss.SSSZ | n/a | n/a |
ODM | n/a | ODMVersion | "1.3.2" | n/a | n/a |
ODM | n/a | Originator | {Tenant shortid}.{Login of the user that generated the ODM-XML} | n/a | n/a |
ODM | n/a | SourceSystem | "Oracle Life Sciences Clinical One" | n/a | n/a |
ODM | n/a | SourceSystemVersion | "AdminData API v1.0" | n/a | n/a |
ODM | n/a | xmlns | http://www.cdisc.org/ns/odm/v1.3 | n/a | n/a |
ODM | n/a | xmlns:co | https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1 | n/a | n/a |
ODM | n/a | co:studyMode | test | training | active (production) | n/a | n/a |
ODM | n/a | co:includeCOExtensions | true (default) | false | n/a | n/a |
ODM | n/a | co:fromTimestamp | YYYY-MM-ddTHH:mm:ss.SSSZ | n/a | n/a |
ODM | n/a | co:toTimestamp | YYYY-MM-ddTHH:mm:ss.SSSZ | n/a | n/a |
ODM | n/a | co:includeUsers | true (default) | false | n/a | n/a |
ODM | n/a | co:includeLocations | true (default) | false | n/a | n/a |
ODM | n/a | co:hasMore | true | false | n/a | n/a |
ODM | n/a | co:totalResults | n/a | n/a | |
ODM | n/a | co:count | n/a | n/a | |
ODM | n/a | co:offset | n/a | n/a | |
ODM | n/a | co:limit | n/a | n/a | |
AdminData | ODM | n/a | No text | n/a | n/a |
User | AdminData | OID | Includes the tenant shortid | dh_users | user_name |
User | AdminData | co:UserWid | dh_users | user_wid | |
User | AdminData | co:GUID | dh_users | authorized_user_id | |
User | AdminData | co:Active | Yes | No | dh_users | version_end > sysdate => Y |
User | AdminData | co:Terminated | Yes | No | dh_users | version_end > sysdate => N |
LocationRef | User | LocationOID | dh_site_depots | sdf_study_org_id join with dh_user_sitedepot_access | |
RoleRef | User | co:RoleOID | dh_user_role_studies | study_role_name | |
RoleDef | AdminData | co:OID | dh_study_roles | study_role_name | |
RoleDef | AdminData | co:RoleType | Sponsor | Site | Design | dh_study_roles | study_role_type |
Permisson | RoleDef | co:Description | dh_user_role_studies | role_name | |
DataClassification | RoleDef | co:name | dh_sr_dcs_mappings | data_classification_name | |
DataClassification | RoleDef | co:DataAccessLevelView | Yes | No | dh_sr_dcs_mappings | data_access_level |
DataClassification | RoleDef | co:DataAccessLevelEdit | Yes | No | dh_sr_dcs_mappings | data_access_level |
LoginName | User | n/a | dh_users | user_name | |
FullName | User | n/a | dh_users | given_name + family_name | |
FirstName | User | n/a | dh_users | given_name | |
LastName | User | n/a | dh_users | family_name | |
User | n/a | dh_users | work_email | ||
Location | AdminData | OID | dh_site_depots | sdf_study_org_id | |
Location | AdminData | Name | dh_site_depots | sdf_name | |
Location | AdminData | LocationType | Site | dh_site_depots | sdf_type |
Location | AdminData | co:LocationStatus | New | Active | Retired | dh_site_depots | sdf_status |
Location | AdminData | co:LocationCountry | dh_site_depot_address | address_country join with dh_countries - on iso_code to get name | |
Location | AdminData | co:LocationTimezone | dh_site_depot_attributes | property_value where property_name = 'TIMEZONE' | |
Location | AdminData | co:InvestigatorPrefix | dh_site_depot_attributes | property_value where property_name = 'PIPrefix' | |
Location | AdminData | co:InvestigatorFirstName | dh_site_depot_attributes | property_value where property_name = 'PIFirstName' | |
Location | AdminData | co:InvestigatorLastName | dh_site_depot_attributes | property_value where property_name = 'PIN' | |
Location | AdminData | co:GUID | dh_site_depots | sdf_id | |
Location | AdminData | co:Revision | YYYY-MM-ddTHH:mm:ss.SSSZ | dh_site_depots | version_start |
Location | AdminData | co:SVTitle | dh_sdvgroup_info | sdv_group_name | |
Location | AdminData | co:SVInitSubjectCount | dh_sdvgroup_info | attribute_value where attribute_key = 'INITIAL_SUBJECTS_SDV_COUNT' | |
Location | AdminData | co:SVInitSubjectType | dh_sdvgroup_info | attribute_value where attribute_key = 'INITIAL_SUBJECTS_SDV_TYPE' | |
Location | AdminData | co:SVRemainSubjectPercentage | dh_sdvgroup_info | attribute_value where attribute_key = 'REMAINING_SUBJECTS_PERCENTAGE' | |
Location | AdminData | co:SVRemainSubjectType | dh_sdvgroup_info | attribute_value where attribute_key = 'REMAINING_SUBJECTS_SDV_TYPE' | |
MetaDataVersionRef | Location | StudyOID | dh_study_versions | study_refname | |
MetaDataVersionRef | Location | MetaDataVersionOID | dh_study_versions | study_refname + "v"+study_version | |
MetaDataVersionRef | Location | EffectiveDate | YYYY-MM-DD | dh_site_depot_attributes | version_start where property_name='studyVersion' |