Get the metadata of specified visits by study ID and study version
post
/ec-designer-svc/rest/v1.0/studies/{studyId}/visitsMetadata
Retrieves metadata for specified visits in different study versions.
Request
Path Parameters
-
studyId(required): string(uuid)
Study ID. Example: F054C951EB74443C93716CA714AB686E
Supported Media Types
- */*
Root Schema : schema
Type:
Show Source
array-
Array of:
object StudyVersionVisitDto v1.0
Title:
StudyVersionVisitDto v1.0Information about a visit in a study version.
Nested Schema : StudyVersionVisitDto v1.0
Type:
objectTitle:
StudyVersionVisitDto v1.0Information about a visit in a study version.
Show Source
Response
Supported Media Types
- application/json
200 Response
Successful operation.
Root Schema : schema
Type:
Show Source
array-
Array of:
object ODM1
Oracle Clinical Data Management model object for CRF report result data, including study, admin, reference, clinical, and associated metadata.
Nested Schema : ODM1
Type:
objectOracle Clinical Data Management model object for CRF report result data, including study, admin, reference, clinical, and associated metadata.
Show Source
-
AdminData: object
AdminData
ODM AdminData section: definition of users, locations, digital signatures, and study OID metadata.
-
Archival: string
Archival indicator (YES or NO).Example:
YES -
AsOfDateTime: string
As-of timestamp for this ODM.Example:
2025-10-26T23:59:59Z -
Association: object
Association
Association between study and metadata version with embedded content
-
ClinicalData: object
ClinicalData
ODM ClinicalData section containing study OID, metadata version OID, and lists of subject data, audit records, signatures, and annotations.
-
CreationDateTime: string
ISO timestamp for creation of this ODM.Example:
2025-10-27T10:00:00Z -
Description: string
Description of this ODM payload/report.Example:
CRF Report ODM data for sample study. -
FileOID: string
File OID of generated ODM file. (UUID uppercase hex format)Example:
FFBAA1C5287D40679B1ED676151C7F63 -
FileType: string
Output file type of ODM report.The values can be SNAPSHOT or TRANSACTIONALExample:
SNAPSHOT -
Granularity: string
Granularity of report (e.g. ALL, SUBJECT, VISIT).Example:
ALL -
ID: string
Unique report/package identifier (UUID uppercase hex format).Example:
71C8CED11E264FFDB165B07AF5117602 -
ODMVersion: string
ODM version spec string.Example:
1.3.2 -
Originator: string
Originating system for ODM.Example:
ORACLE_CDM_SYSTEM -
PriorFileOID: string
File OID of the prior ODM in the generation sequence.Example:
9678B5A2C18C4A20A1400729839CC661 -
ReferenceData: object
ReferenceData
ReferenceData DTO.
-
Signature: object
Signature
XML Digital Signature container including SignedInfo, SignatureValue, KeyInfo and optional Object elements.
-
SourceSystem: string
Source system identifier.Example:
ClinicalOne -
SourceSystemVersion: string
Source system version.Example:
3.0.0.0 -
Study: object
Study
ODM Study object
Nested Schema : AdminData
Type:
objectODM AdminData section: definition of users, locations, digital signatures, and study OID metadata.
Show Source
-
Location: object
Location
Represents a site or location entity within the ODM context.
-
SignatureDef: object
SignatureDef
Definition of a signature including meaning, legal reason, and identifiers.
-
StudyOID: string
Study OID to which this admin data refers.Example:
D5E16DD550CB4AD1B330E0D09B4B8F3F -
User: object
User
Represents a user in the ODM AdminData structure (site personnel, investigator, etc).
Nested Schema : Association
Type:
objectAssociation between study and metadata version with embedded content
Show Source
-
content: array
content
List of associated elements
-
metaDataVersionOID: string
String representing the version of the study configuration or protocol. Helps track changes in form or study design.Example:
2.0.0.38 -
studyOID: string
Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the study.Example:
2.0.0.39.222eabde-1b96-48f6-9d3b-6250880a2b09
Nested Schema : ClinicalData
Type:
objectODM ClinicalData section containing study OID, metadata version OID, and lists of subject data, audit records, signatures, and annotations.
Show Source
-
Annotations: array
Annotations
List of annotations attached to the clinical data
-
auditRecords: array
auditRecords
List of audit records associated with clinical data
-
MetaDataVersionOID: string
Metadata version OID associated with the study designExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
Signatures: array
Signatures
List of digital signatures applied to the clinical data
-
StudyOID: string
Study OID for which this clinical data appliesExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
subjectData: array
subjectData
List of subject-level clinical data records
Nested Schema : ReferenceData
Type:
objectReferenceData DTO.
Show Source
-
Annotations: object
Annotations
Container for a list of ODM Annotation entries.
-
AuditRecords: object
AuditRecords
Container for a list of ODM audit record entries.
-
ItemGroupData: object
ItemGroupData
Data captured for a Item Group
-
MetaDataVersionOID: string
OID for referenced MetaDataVersionExample:
33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29 -
Signatures: object
Signatures
Container for a list of ODM Signature entries.
-
StudyOID: string
OID of referenced studyExample:
33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29
Nested Schema : Signature
Type:
objectXML Digital Signature container including SignedInfo, SignatureValue, KeyInfo and optional Object elements.
Show Source
-
id: string
Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the recordExample:
ABCDEF1234567890ABCDEF1234567890 -
keyInfo: object
KeyInfoType1
Key information content (e.g., X509Data, KeyName) and optional identifier.
-
object: object
object
Generic container for embedded object content and metadata
-
signatureValue: object
SignatureValueType1
The actual value of the digital signature and optional identifier.
-
signedInfo: object
SignedInfoType1
Contains canonicalization and signature methods, and references used in the XML Digital Signature.
Nested Schema : Study
Type:
objectODM Study object
Show Source
-
BasicDefinitions: object
BasicDefinitions10
Root-level definitions for basic units and reference types in the ODM Study.
-
GlobalVariables: object
GlobalVariables10
ODM GlobalVariables for a Study, providing human-readable study description and identifiers.
-
MetaDataVersion: object
MetaDataVersion
Represents the metadata about the study
-
OID: string
Unique object identifier for the study, uppercase HEX UUID.Example:
D5E16DD550CB4AD1B330E0D09B4B8F3F
Nested Schema : Location
Type:
objectRepresents a site or location entity within the ODM context.
Show Source
-
locationType: string
Allowed Values:
[ "SPONSOR", "SITE", "CRO", "LAB", "OTHER" ]Type of location.Example:OTHER -
metaDataVersionRef: object
metaDataVersionRef
Reference to a specific study metadata version with effective date information.
-
name: string
Name of the location.Example:
Main Site -
oid: string
ID of the site or depot of the kitExample:
A8C41D8062A14FCC89EDA475C3E3AF12
Nested Schema : SignatureDef
Type:
objectDefinition of a signature including meaning, legal reason, and identifiers.
Show Source
-
group: string
Signature group or category.Example:
INVESTIGATOR -
legalReason: object
LegalReason1
Represents the legal reason metadata for an ODM element.
-
meaning: object
Meaning1
Represents the meaning metadata for an ODM element.
-
oid: string
Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the recordExample:
ABCDEF1234567890ABCDEF1234567890 -
type: string
Signature type.Example:
DIGITAL
Nested Schema : User
Type:
objectRepresents a user in the ODM AdminData structure (site personnel, investigator, etc).
Show Source
-
address: object
address
Postal or location address for an ODM user or site, with support for street, city, state, country, and postal code.
-
certificate: object
certificate
Digital certificate or identity for an ODM User.
-
displayName: object
DisplayName1
Human-readable display name for the ODM User.
-
email: object
email
Email address record for an ODM user.
-
fax: object
fax
Fax number/contact for an ODM User.
-
firstName: object
FirstName10
User's first name.
-
fullName: object
FullName10
User's full name as a single value.
-
lastName: object
LastName10
User's last/family/surname.
-
locationRef: object
locationRef
Reference to a study/site location for an ODM User.
-
loginName: object
LoginName1
Login name or identifier for the ODM User.
-
oid: string
User OID valueExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
organization: object
Organization10
Organization name associated with the User.
-
pager: object
Pager1
Pager number or contact info for an ODM User.
-
phone: object
phone
Phone number/contact entry for ODM User.
-
picture: object
Picture1
Profile or avatar image info for ODM User.
-
userType: string
Allowed Values:
[ "SPONSOR", "INVESTIGATOR", "LAB", "OTHER" ]Enumeration of possible user types/roles for ODM User.
Nested Schema : metaDataVersionRef
Type:
objectReference to a specific study metadata version with effective date information.
Show Source
-
effectiveDate: string
Effective date for this metadata version in YYYY-MM-DD format.Example:
2025-01-31 -
effectiveDateTime: string
Effective date and time for this metadata version in ISO-8601 format.Example:
2025-01-31T10:15:30Z -
metaDataVersionOID: string
Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the metadata version.Example:
A1B2C3D4E5F6478899AABBCCDDEEFF11 -
studyOID: string
Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the study.Example:
0C7CBA3F70034C47947E2FAB086BFBF5
Nested Schema : LegalReason1
Type:
objectRepresents the legal reason metadata for an ODM element.
Show Source
-
value: string
Legal reason value.Example:
CONSENT_OBTAINED
Nested Schema : Meaning1
Type:
objectRepresents the meaning metadata for an ODM element.
Show Source
-
text: string
Human-readable description of the meaning.Example:
Experimental arm -
value: string
Coded meaning value.Example:
EXP
Nested Schema : address
Type:
objectPostal or location address for an ODM user or site, with support for street, city, state, country, and postal code.
Show Source
-
city: object
City1
City component of a postal address.
-
country: object
Country1
Country component of a postal address.
-
otherText: object
OtherText1
Additional address information or notes.
-
postalCode: object
PostalCode1
Postal or ZIP code component of a postal address.
-
stateProv: object
StateProv1
State or province component of a postal address.
-
streetName: object
streetName
Street name component of a postal address.
Nested Schema : certificate
Type:
objectDigital certificate or identity for an ODM User.
Show Source
-
Value: string
Certificate/credential identifier.Example:
CERT123
Nested Schema : DisplayName1
Type:
objectHuman-readable display name for the ODM User.
Show Source
-
value: string
Value for the display name of the user.Example:
Dr. J. Smith
Nested Schema : email
Type:
objectEmail address record for an ODM user.
Show Source
-
value: string
Email address.Example:
john.smith@email.com
Nested Schema : fax
Type:
objectFax number/contact for an ODM User.
Show Source
-
value: string
Fax number.Example:
555-5678
Nested Schema : FirstName10
Type:
objectUser's first name.
Show Source
-
Value: string
Given name of the user.Example:
John
Nested Schema : FullName10
Type:
objectUser's full name as a single value.
Show Source
-
Value: string
Full name for the user.Example:
John Smith
Nested Schema : LastName10
Type:
objectUser's last/family/surname.
Show Source
-
Value: string
Surname of the user.Example:
Smith
Nested Schema : locationRef
Type:
objectReference to a study/site location for an ODM User.
Show Source
-
LocationOID: string
OID/ID for the associated location.Example:
475454D6B7F247C88D401DB25CA2C7D2
Nested Schema : LoginName1
Type:
objectLogin name or identifier for the ODM User.
Show Source
-
value: string
Login/account name for the user.Example:
INVEST001
Nested Schema : Organization10
Type:
objectOrganization name associated with the User.
Show Source
-
Value: string
Name of the user's organization.Example:
Site 101 Hospital
Nested Schema : Pager1
Type:
objectPager number or contact info for an ODM User.
Show Source
-
value: string
Pager contact number or info.Example:
555-1234
Nested Schema : phone
Type:
objectPhone number/contact entry for ODM User.
Show Source
-
Value: string
Phone number.Example:
555-9876
Nested Schema : Picture1
Type:
objectProfile or avatar image info for ODM User.
Show Source
-
imageType: string
MIME/image type information, e.g. image/jpegExample:
image/jpeg -
pictureFileName: string
Picture filename or image reference.Example:
photo.jpg
Nested Schema : City1
Type:
objectCity component of a postal address.
Show Source
-
value: string
City name.Example:
San Francisco
Nested Schema : Country1
Type:
objectCountry component of a postal address.
Show Source
-
value: string
Country code or name.Example:
US
Nested Schema : OtherText1
Type:
objectAdditional address information or notes.
Show Source
-
value: string
Additional address text.Example:
Apt 4B
Nested Schema : PostalCode1
Type:
objectPostal or ZIP code component of a postal address.
Show Source
-
value: string
Postal or ZIP code.Example:
94043
Nested Schema : StateProv1
Type:
objectState or province component of a postal address.
Show Source
-
value: string
State or province code or name.Example:
CA
Nested Schema : streetName
Type:
objectStreet name component of a postal address.
Show Source
-
value: string
Street name line.Example:
123 Main Street
Nested Schema : content
Type:
arrayList of associated elements
Show Source
-
Array of:
object items
List of associated elements
Nested Schema : items
Type:
objectList of associated elements
Nested Schema : Annotations
Type:
arrayList of annotations attached to the clinical data
Show Source
-
Array of:
object Annotations1
Container for a list of ODM Annotation entries.
Nested Schema : auditRecords
Type:
arrayList of audit records associated with clinical data
Show Source
-
Array of:
object AuditRecords1
Container for a list of ODM audit record entries.
Nested Schema : Signatures
Type:
arrayList of digital signatures applied to the clinical data
Show Source
-
Array of:
object Signatures1
Container for a list of ODM Signature entries.
Nested Schema : subjectData
Type:
arrayList of subject-level clinical data records
Show Source
-
Array of:
object SubjectData1
ODM SubjectData structure including audit, signature, references and event data for a subject.
Nested Schema : Annotations1
Type:
objectContainer for a list of ODM Annotation entries.
Show Source
-
annotation: array
annotation
List of Annotation entries associated to the ODM structure.
Nested Schema : annotation
Type:
arrayList of Annotation entries associated to the ODM structure.
Show Source
-
Array of:
object Annotation2
Note, query, or other annotation associated with a data point, including flags and a comment.
Nested Schema : Annotation2
Type:
objectNote, query, or other annotation associated with a data point, including flags and a comment.
Show Source
-
comment: object
Comment2
Comment DTO
-
flag: object
flag
Annotation flag consisting of a type and value to classify or qualify data (e.g., Query, Review Required).
-
id: string
Annotation identifier unique within the context.Example:
475454D6B7F247C88D401DB25CA2C7D2 -
seqNum: integer
(int64)
Sequence number ordering annotations within the same context.Example:
1 -
transactionType: string
Operation represented by this annotation (Example values are- INSERT, UPDATE, DELETE, REMOVE,UPSERT,CONTEXT).Example:
INSERT
Nested Schema : Comment2
Type:
objectComment DTO
Show Source
-
sponsorOrSite: string
Comment origin (Sponsor or Site)Example:
Site -
value: string
CommentExample:
User-entered comment
Nested Schema : flag
Type:
objectAnnotation flag consisting of a type and value to classify or qualify data (e.g., Query, Review Required).
Show Source
-
FlagType: object
FlagType1
Flag type
-
FlagValue: object
FlagValue1
Flag value
Nested Schema : FlagType1
Type:
objectFlag type
Show Source
-
codeListOID: string
CodeList OIDExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
value: string
Flag display valueExample:
Y
Example:
{
"flagOID":"QUERY"
}Nested Schema : FlagValue1
Type:
objectFlag value
Show Source
-
codeListOID: string
CodeList OIDExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
value: string
Flag valueExample:
Y
Example:
{
"value":"Review"
}Nested Schema : AuditRecords1
Type:
objectContainer for a list of ODM audit record entries.
Show Source
-
auditRecord: array
auditRecord
List of audit records associated with the subject or form.
Nested Schema : auditRecord
Type:
arrayList of audit records associated with the subject or form.
Show Source
-
Array of:
object AuditRecord100
Audit trail entry describing who performed a change, where it occurred, when it happened, and the justification.
Nested Schema : AuditRecord100
Type:
objectAudit trail entry describing who performed a change, where it occurred, when it happened, and the justification.
Show Source
-
dateTimeStamp: object
DateTimeStamp1
Date/time stamp value with formatted representation.
-
id: string
(identifier)
Audit record identifierExample:
AUD1 -
locationRef: object
LocationRef1
Reference to a study/site location for an ODM User.
-
reasonForChange: object
ReasonForChange1
Explanation provided to justify why a data value was created or modified.
-
sourceID: object
SourceID1
Identifier of the originating system or source that provided the data.
-
userRef: object
UserRef10
Reference to a user within the study.
Nested Schema : DateTimeStamp1
Type:
objectDate/time stamp value with formatted representation.
Show Source
-
formattedValue: string
Human-readable formatted date/time valueExample:
29-Oct-2025 20:24:09 India Time ( Asia/Kolkata ) -
value: string
Raw date/time valueExample:
2025-10-29T14:54:09
Nested Schema : LocationRef1
Type:
objectReference to a study/site location for an ODM User.
Show Source
-
LocationOID: string
OID/ID for the associated location.Example:
475454D6B7F247C88D401DB25CA2C7D2
Nested Schema : ReasonForChange1
Type:
objectExplanation provided to justify why a data value was created or modified.
Show Source
-
Value: string
Free-text reason describing the change.Example:
Correction of data entry error
Nested Schema : SourceID1
Type:
objectIdentifier of the originating system or source that provided the data.
Show Source
-
Value: string
(identifier)
Source identifier value (e.g., system code or external app ID).Example:
SYS
Nested Schema : UserRef10
Type:
objectReference to a user within the study.
Show Source
-
UserOID: string
(oid)
OID of the referenced userExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29
Nested Schema : Signatures1
Type:
objectContainer for a list of ODM Signature entries.
Show Source
-
signature: array
signature
List of signature entries associated with the ODM structure.
Nested Schema : signature
Type:
arrayList of signature entries associated with the ODM structure.
Show Source
-
Array of:
object Signature1
Digital signature record including signer, location, timestamp, and cryptographic binding manifest.
Nested Schema : Signature1
Type:
objectDigital signature record including signer, location, timestamp, and cryptographic binding manifest.
Show Source
-
CryptoBindingManifest: object
CryptoBindingManifest10
Cryptographic binding manifest that ties the signature to the signed payload.
-
DateTimeStamp: object
DateTimeStamp1
Date/time stamp value with formatted representation.
-
ID: string
(identifier)
Signature identifierExample:
SIG123 -
LocationRef: object
LocationRef1
Reference to a study/site location for an ODM User.
-
SignatureRef: object
SignatureRef1
Reference to a signature object used to approve or verify data.
-
UserRef: object
UserRef10
Reference to a user within the study.
Nested Schema : CryptoBindingManifest10
Type:
objectCryptographic binding manifest that ties the signature to the signed payload.
Show Source
-
value: string
Base64-encoded manifest payload.Example:
VGhpcyBpcyBhIG1hbmlmZXN0IHBheWxvYWQ=
Nested Schema : SignatureRef1
Type:
objectReference to a signature object used to approve or verify data.
Show Source
-
SignatureOID: string
Identifier (OID) of the referenced signature.Example:
SIG-0001
Nested Schema : SubjectData1
Type:
objectODM SubjectData structure including audit, signature, references and event data for a subject.
Show Source
-
annotation: array
annotation
List of annotations (queries, notes, flags) linked to the subject data.
-
auditRecord: object
AuditRecord100
Audit trail entry describing who performed a change, where it occurred, when it happened, and the justification.
-
initials: string
Subject initials if captured.Example:
JD -
investigatorRef: object
InvestigatorRef1
Reference to an investigator user participating in the study.
-
signature: object
Signature1
Digital signature record including signer, location, timestamp, and cryptographic binding manifest.
-
siteRef: object
SiteRef10
Reference to a study site/location.
-
studyEventData: array
studyEventData
All scheduled or unscheduled visit/event data for the subject.
-
subjectHistory: array
subjectHistory
Chronological history of key actions for this subject.
-
subjectKey: string
(identifier)
Unique key of the subject within the study/site.Example:
SUBJ-0001 -
transactionType: string
Operation represented by this payload, such as Insert, Update, or Delete.Example:
Update -
transferData: array
transferData
Data transfer records for this subject (e.g., imports or system migrations).
Nested Schema : annotation
Type:
arrayList of annotations (queries, notes, flags) linked to the subject data.
Show Source
-
Array of:
object Annotation2
Note, query, or other annotation associated with a data point, including flags and a comment.
Nested Schema : InvestigatorRef1
Type:
objectReference to an investigator user participating in the study.
Show Source
-
userOID: string
Identifier (OID) of the investigator user within the study.Example:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29
Nested Schema : SiteRef10
Type:
objectReference to a study site/location.
Show Source
-
LocationOID: string
(oid)
Identifier (OID) of the site location.Example:
475454D6B7F247C88D401DB25CA2C7D2 -
Name: string
Human-readable site name.Example:
475454D6B7F247C88D401DB25CA2C7D2
Nested Schema : studyEventData
Type:
arrayAll scheduled or unscheduled visit/event data for the subject.
Show Source
-
Array of:
object StudyEventData1
Subject visit or study event data block including forms, annotations and references.
Nested Schema : subjectHistory
Type:
arrayChronological history of key actions for this subject.
Show Source
-
Array of:
object History1
Historical record describing an action performed on an ODM entity, with optional details and timestamp.
Nested Schema : transferData
Type:
arrayData transfer records for this subject (e.g., imports or system migrations).
Show Source
-
Array of:
object TransferData1
Subject transfer details between sites
Nested Schema : StudyEventData1
Type:
objectSubject visit or study event data block including forms, annotations and references.
Show Source
-
annotation: array
annotation
Annotations (queries, comments, flags) on this study event.
-
auditRecord: object
AuditRecord100
Audit trail entry describing who performed a change, where it occurred, when it happened, and the justification.
-
EventHistory: array
EventHistory
History of actions performed on this study event.
-
formData: array
formData
Forms captured within this study event.
-
repeatingFormSummary: object
RepeatingFormSummary1
Summary container for sets of repeating forms within a study event.
-
signature: object
Signature1
Digital signature record including signer, location, timestamp, and cryptographic binding manifest.
-
studyEventOID: string
(oid)
Identifier (OID) of the study event definition.Example:
SE.VISIT1 -
studyEventRepeatKey: string
Repeat key when the same study event occurs multiple times.Example:
1
Nested Schema : annotation
Type:
arrayAnnotations (queries, comments, flags) on this study event.
Show Source
-
Array of:
object Annotation2
Note, query, or other annotation associated with a data point, including flags and a comment.
Nested Schema : EventHistory
Type:
arrayHistory of actions performed on this study event.
Show Source
-
Array of:
object History1
Historical record describing an action performed on an ODM entity, with optional details and timestamp.
Example:
[
{
"action":"Locked",
"actionDate":"2025-11-01T14:00:00Z"
}
]Nested Schema : formData
Type:
arrayForms captured within this study event.
Show Source
-
Array of:
object FormData10
Data captured for a single form within a study event, including items, annotations, signatures, and status.
Nested Schema : RepeatingFormSummary1
Type:
objectSummary container for sets of repeating forms within a study event.
Show Source
-
repeatingFormData: array
repeatingFormData
Collection of repeating form data entries.
Nested Schema : History1
Type:
objectHistorical record describing an action performed on an ODM entity, with optional details and timestamp.
Show Source
-
action: string
Action taken on the entity.Example:
Verification -
actionDate: string
(date-time)
Timestamp when the action occurred (ISO 8601).Example:
2025-11-01T14:00:00Z -
details: array
details
Additional details about the action.
Nested Schema : details
Type:
arrayAdditional details about the action.
Show Source
-
Array of:
string
Additional details about the action.Example:
["Verified by Data Manager","No discrepancies found"]
Example:
[
"Verified by Data Manager",
"No discrepancies found"
]Nested Schema : FormData10
Type:
objectData captured for a single form within a study event, including items, annotations, signatures, and status.
Show Source
-
Annotation: array
Annotation
Annotations (queries, notes, flags) for this form.
-
archiveLayoutRef: object
ArchiveLayoutRef1
Archive layout reference
-
AuditRecord: object
AuditRecord100
Audit trail entry describing who performed a change, where it occurred, when it happened, and the justification.
-
FormOID: string
Identifier (OID) of the form definition.Example:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
FormRepeatKey: string
Repeat key when the same form occurs multiple times within an event.Example:
1 -
FormStatus: string
System-specific form status.Example:
LOCKED -
ItemGroupData: array
ItemGroupData
Groups of item data contained in this form.
-
NotDoneValue: string
Reason/value indicating form was not performed.Example:
SUBJECT_UNAVAILABLE -
signature: object
Signature1
Digital signature record including signer, location, timestamp, and cryptographic binding manifest.
-
Signatures: object
Signatures1
Container for a list of ODM Signature entries.
-
Status: string
High-level status of the form (e.g., In Progress, Completed).Example:
Completed -
TitleAddendum: string
Additional title information for display.Example:
Follow-up Visit -
TransactionType: string
Operation represented by this annotation (Example values are- INSERT, UPDATE, DELETE, REMOVE,UPSERT,CONTEXT).Example:
Update
Nested Schema : Annotation
Type:
arrayAnnotations (queries, notes, flags) for this form.
Show Source
-
Array of:
object Annotation2
Note, query, or other annotation associated with a data point, including flags and a comment.
Nested Schema : ArchiveLayoutRef1
Type:
objectArchive layout reference
Show Source
-
archiveLayoutOID: string
Archive Layout OIDExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29
Nested Schema : ItemGroupData
Type:
arrayGroups of item data contained in this form.
Show Source
-
Array of:
object ItemGroupData1
Data captured for a Item Group
Nested Schema : ItemGroupData1
Type:
objectData captured for a Item Group
Show Source
-
annotation: object
annotation
Note, query, or other annotation associated with a data point, including flags and a comment.
-
auditRecord: object
AuditRecord100
Audit trail entry describing who performed a change, where it occurred, when it happened, and the justification.
-
itemGroupOID: string
OID for this item groupExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
itemGroupRepeatKey: string
Repeat key for this groupExample:
RPT1 -
items: object
items
Data captured for a Item
-
signature: object
Signature1
Digital signature record including signer, location, timestamp, and cryptographic binding manifest.
-
transactionType: string
Allowed Values:
[ "INSERT", "UPDATE", "REMOVE", "UPSERT", "CONTEXT" ]Transaction type for the groupExample:INSERT
Nested Schema : annotation
Type:
objectNote, query, or other annotation associated with a data point, including flags and a comment.
Show Source
-
comment: object
Comment2
Comment DTO
-
flag: object
flag
Annotation flag consisting of a type and value to classify or qualify data (e.g., Query, Review Required).
-
id: string
Annotation identifier unique within the context.Example:
475454D6B7F247C88D401DB25CA2C7D2 -
seqNum: integer
(int64)
Sequence number ordering annotations within the same context.Example:
1 -
transactionType: string
Operation represented by this annotation (Example values are- INSERT, UPDATE, DELETE, REMOVE,UPSERT,CONTEXT).Example:
INSERT
Nested Schema : items
Type:
objectData captured for a Item
Show Source
-
Annotation: object
Annotation
Note, query, or other annotation associated with a data point, including flags and a comment.
-
AuditRecord: object
AuditRecord100
Audit trail entry describing who performed a change, where it occurred, when it happened, and the justification.
-
DocumentId: string
Document ID referenceExample:
475454D6B7F247C88D401DB25CA2C7D2 -
DocumentVersion: number
Document versionExample:
1 -
ItemOID: string
OID of the itemExample:
33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29 -
MeasurementUnitRef: object
MeasurementUnitRef1
Data captured for a Measurement Unit
-
NotDone: string
Whether item is not done (0 or 1)Example:
0 -
ParentItemOID: string
OID of parent itemExample:
475454D6B7F247C88D401DB25CA2C7D2 -
SelectedCodeListItemsType: string
Selected code list items typeExample:
CODE_A -
Signature: object
Signature1
Digital signature record including signer, location, timestamp, and cryptographic binding manifest.
-
TransactionType: string
Allowed Values:
[ "INSERT", "UPDATE", "REMOVE", "UPSERT", "CONTEXT" ]Transaction type- INSERT, UPDATE, REMOVE, UPSERT or CONTEXTExample:UPDATE -
Value: string
Value for this itemExample:
130
Nested Schema : flag
Type:
objectAnnotation flag consisting of a type and value to classify or qualify data (e.g., Query, Review Required).
Show Source
-
FlagType: object
FlagType1
Flag type
-
FlagValue: object
FlagValue1
Flag value
Nested Schema : Annotation
Type:
objectNote, query, or other annotation associated with a data point, including flags and a comment.
Show Source
-
comment: object
Comment2
Comment DTO
-
flag: object
flag
Annotation flag consisting of a type and value to classify or qualify data (e.g., Query, Review Required).
-
id: string
Annotation identifier unique within the context.Example:
475454D6B7F247C88D401DB25CA2C7D2 -
seqNum: integer
(int64)
Sequence number ordering annotations within the same context.Example:
1 -
transactionType: string
Operation represented by this annotation (Example values are- INSERT, UPDATE, DELETE, REMOVE,UPSERT,CONTEXT).Example:
INSERT
Nested Schema : MeasurementUnitRef1
Type:
objectData captured for a Measurement Unit
Show Source
-
MeasurementUnitOID: string
OID of the referenced measurement unitExample:
33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29
Nested Schema : flag
Type:
objectAnnotation flag consisting of a type and value to classify or qualify data (e.g., Query, Review Required).
Show Source
-
FlagType: object
FlagType1
Flag type
-
FlagValue: object
FlagValue1
Flag value
Nested Schema : repeatingFormData
Type:
arrayCollection of repeating form data entries.
Show Source
-
Array of:
object RepeatingFormData1
A single repeating form instance including headers and rows of item data.
Nested Schema : RepeatingFormData1
Type:
objectA single repeating form instance including headers and rows of item data.
Show Source
-
formHeader: array
formHeader
Header section for the repeating form instance (metadata about the form).
-
formID: string
Human-readable identifier for the form instance.Example:
475454D6B7F247C88D401DB25CA2C7D2 -
formOID: string
(oid)
Identifier (OID) of the repeating form definition.Example:
95dc21fd-e522-4cc6-9d94-92ece0f25120.1_8_0_29 -
Row: array
Row
Rows comprising items captured in this form instance.
-
summaryNote: string
Optional summary or note for the form instance.Example:
Patient reported mild headache.
Nested Schema : formHeader
Type:
arrayHeader section for the repeating form instance (metadata about the form).
Show Source
-
Array of:
object FormHeader1
Header metadata for a form instance, including basic identity and display information.
Nested Schema : Row
Type:
arrayRows comprising items captured in this form instance.
Show Source
-
Array of:
object Row2
A single row within a repeating form instance containing associated forms and item data.
Nested Schema : FormHeader1
Type:
objectHeader metadata for a form instance, including basic identity and display information.
Show Source
-
itemset: string
Indicates whether this header represents an itemset.Example:
false -
itemsetHeader: string
Optional label or identifier for the itemset header.Example:
Vital Signs Panel -
name: string
Human-readable form name.Example:
Vital Signs -
oid: string
(oid)
Object Identifier for the form (matches the form definition OID).Example:
FORM.VITALS
Nested Schema : Row2
Type:
objectA single row within a repeating form instance containing associated forms and item data.
Show Source
-
associated: boolean
Indicates whether the row is associated to another form or entity.Example:
true -
associatedFormList: array
associatedFormList
List of forms associated with this row, if any.
-
deleted: string
Marks the row as logically deleted.Example:
false -
formIndex: string
Index value used to order or group rows.Example:
1 -
item: array
item
Items captured within this row.
-
rowNo: string
Row sequence identifier within the repeating form.Example:
1
Nested Schema : associatedFormList
Type:
arrayList of forms associated with this row, if any.
Show Source
-
Array of:
object AssociatedFormList1
Associated form details including visit and audit metadata
Nested Schema : item
Type:
arrayItems captured within this row.
Show Source
-
Array of:
object Item1
ODM Item instance with value and identifiers
Nested Schema : AssociatedFormList1
Type:
objectAssociated form details including visit and audit metadata
Show Source
-
auditTrail: array
auditTrail
List of audit trail entries
-
deleted: boolean
Indicates whether the associated form is deletedExample:
false -
formIndex: number
Index of the form within the visitExample:
1 -
formName: string
Human readable name of the formExample:
Medical History -
formOID: string
Form IdentifierExample:
5ca47933-ab3c-4018-86c2-c6b77d2c5104.1_8_0_29 -
instanceNumber: integer
(int64)
Instance number of the unscheduled visitExample:
1 -
visitIndex: number
Index of the visit within the scheduleExample:
1 -
visitName: string
Human readable name of the visitExample:
Visit 1 -
visitOID: string
Visit IdentifierExample:
6ca47933-ab3c-4018-86c2-c6b77d2c5104.1_8_0_29
Nested Schema : auditTrail
Type:
arrayList of audit trail entries
Show Source
-
Array of:
object AuditTrail1
Audit trail entry with timestamp, user, deletion status and note
Nested Schema : AuditTrail1
Type:
objectAudit trail entry with timestamp, user, deletion status and note
Show Source
-
dateTimeStamp: string
Date and time of the change in ISO-8601 formatExample:
2025-01-01T12:34:56Z -
deleted: boolean
Indicates whether the record was deleted as part of this changeExample:
false -
note: string
Optional note associated with the changeExample:
Correction applied -
user: string
User who performed the actionExample:
john.doe
Nested Schema : Item1
Type:
objectODM Item instance with value and identifiers
Show Source
-
itemset: boolean
Indicates whether this item represents an itemset (grid or repeating values).Example:
false -
itemsetRows: string
Row identifiers or count for the itemset when itemset is true.Example:
1 -
oid: string
Unique Item identifier (UUID, 32-character uppercase hexadecimal string) from the study Designer, associated to a form.Example:
3F2504E04F8911D39A0C0305E82C3301 -
value: string
The decoded value of the raw value, which provides a more meaningful representation of the data. For dates, it follows the ISO 8601 standard. For questions with multiple choice options, it uses the corresponding code from the codelist. Additionally, ItemD decodes special flags like NA, ND, and UNK to their corresponding meanings, making it easier to understand the data.Example:
SAMPLE_VALUE
Nested Schema : TransferData1
Type:
objectSubject transfer details between sites
Show Source
-
fromSiteName: string
Name of the site the subject is transferred fromExample:
Previous Site Name -
toSiteName: string
Name of the site the subject is transferred toExample:
New Site Name -
transferDate: string
Date when the subject transfer occurredExample:
2023-12-31
Nested Schema : Annotations
Type:
objectContainer for a list of ODM Annotation entries.
Show Source
-
annotation: array
annotation
List of Annotation entries associated to the ODM structure.
Nested Schema : AuditRecords
Type:
objectContainer for a list of ODM audit record entries.
Show Source
-
auditRecord: array
auditRecord
List of audit records associated with the subject or form.
Nested Schema : ItemGroupData
Type:
objectData captured for a Item Group
Show Source
-
annotation: object
annotation
Note, query, or other annotation associated with a data point, including flags and a comment.
-
auditRecord: object
AuditRecord100
Audit trail entry describing who performed a change, where it occurred, when it happened, and the justification.
-
itemGroupOID: string
OID for this item groupExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
itemGroupRepeatKey: string
Repeat key for this groupExample:
RPT1 -
items: object
items
Data captured for a Item
-
signature: object
Signature1
Digital signature record including signer, location, timestamp, and cryptographic binding manifest.
-
transactionType: string
Allowed Values:
[ "INSERT", "UPDATE", "REMOVE", "UPSERT", "CONTEXT" ]Transaction type for the groupExample:INSERT
Nested Schema : Signatures
Type:
objectContainer for a list of ODM Signature entries.
Show Source
-
signature: array
signature
List of signature entries associated with the ODM structure.
Nested Schema : annotation
Type:
arrayList of Annotation entries associated to the ODM structure.
Show Source
-
Array of:
object Annotation2
Note, query, or other annotation associated with a data point, including flags and a comment.
Nested Schema : auditRecord
Type:
arrayList of audit records associated with the subject or form.
Show Source
-
Array of:
object AuditRecord100
Audit trail entry describing who performed a change, where it occurred, when it happened, and the justification.
Nested Schema : annotation
Type:
objectNote, query, or other annotation associated with a data point, including flags and a comment.
Show Source
-
comment: object
Comment2
Comment DTO
-
flag: object
flag
Annotation flag consisting of a type and value to classify or qualify data (e.g., Query, Review Required).
-
id: string
Annotation identifier unique within the context.Example:
475454D6B7F247C88D401DB25CA2C7D2 -
seqNum: integer
(int64)
Sequence number ordering annotations within the same context.Example:
1 -
transactionType: string
Operation represented by this annotation (Example values are- INSERT, UPDATE, DELETE, REMOVE,UPSERT,CONTEXT).Example:
INSERT
Nested Schema : items
Type:
objectData captured for a Item
Show Source
-
Annotation: object
Annotation
Note, query, or other annotation associated with a data point, including flags and a comment.
-
AuditRecord: object
AuditRecord100
Audit trail entry describing who performed a change, where it occurred, when it happened, and the justification.
-
DocumentId: string
Document ID referenceExample:
475454D6B7F247C88D401DB25CA2C7D2 -
DocumentVersion: number
Document versionExample:
1 -
ItemOID: string
OID of the itemExample:
33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29 -
MeasurementUnitRef: object
MeasurementUnitRef1
Data captured for a Measurement Unit
-
NotDone: string
Whether item is not done (0 or 1)Example:
0 -
ParentItemOID: string
OID of parent itemExample:
475454D6B7F247C88D401DB25CA2C7D2 -
SelectedCodeListItemsType: string
Selected code list items typeExample:
CODE_A -
Signature: object
Signature1
Digital signature record including signer, location, timestamp, and cryptographic binding manifest.
-
TransactionType: string
Allowed Values:
[ "INSERT", "UPDATE", "REMOVE", "UPSERT", "CONTEXT" ]Transaction type- INSERT, UPDATE, REMOVE, UPSERT or CONTEXTExample:UPDATE -
Value: string
Value for this itemExample:
130
Nested Schema : flag
Type:
objectAnnotation flag consisting of a type and value to classify or qualify data (e.g., Query, Review Required).
Show Source
-
FlagType: object
FlagType1
Flag type
-
FlagValue: object
FlagValue1
Flag value
Nested Schema : Annotation
Type:
objectNote, query, or other annotation associated with a data point, including flags and a comment.
Show Source
-
comment: object
Comment2
Comment DTO
-
flag: object
flag
Annotation flag consisting of a type and value to classify or qualify data (e.g., Query, Review Required).
-
id: string
Annotation identifier unique within the context.Example:
475454D6B7F247C88D401DB25CA2C7D2 -
seqNum: integer
(int64)
Sequence number ordering annotations within the same context.Example:
1 -
transactionType: string
Operation represented by this annotation (Example values are- INSERT, UPDATE, DELETE, REMOVE,UPSERT,CONTEXT).Example:
INSERT
Nested Schema : flag
Type:
objectAnnotation flag consisting of a type and value to classify or qualify data (e.g., Query, Review Required).
Show Source
-
FlagType: object
FlagType1
Flag type
-
FlagValue: object
FlagValue1
Flag value
Nested Schema : signature
Type:
arrayList of signature entries associated with the ODM structure.
Show Source
-
Array of:
object Signature1
Digital signature record including signer, location, timestamp, and cryptographic binding manifest.
Nested Schema : KeyInfoType1
Type:
objectKey information content (e.g., X509Data, KeyName) and optional identifier.
Show Source
-
content: object
content
Key information content (e.g., X509Data, KeyName).
-
id: string
Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the recordExample:
ABCDEF1234567890ABCDEF1234567890
Nested Schema : object
Type:
objectGeneric container for embedded object content and metadata
Show Source
-
content: array
content
List of embedded content
-
encoding: string
Character encoding of the contentExample:
UTF-8 -
id: string
Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the recordExample:
3F2504E04F8911D39A0C0305E82C3301 -
mimeType: string
MIME type of the encapsulated contentExample:
application/pdf
Nested Schema : SignatureValueType1
Type:
objectThe actual value of the digital signature and optional identifier.
Show Source
-
id: string
Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the recordExample:
ABCDEF1234567890ABCDEF1234567890 -
value: string
(byte)
Base64-encoded signature value.
Nested Schema : SignedInfoType1
Type:
objectContains canonicalization and signature methods, and references used in the XML Digital Signature.
Show Source
-
canonicalizationMethod: object
CanonicalizationMethodType1
Canonicalization method definition per XML Digital Signature specification.
-
id: string
Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the recordExample:
ABCDEF1234567890ABCDEF1234567890 -
reference: object
reference
Reference to signed data including transforms, digest method, and digest value.
-
signatureMethod: object
SignatureMethodType1
Signature algorithm definition and associated parameters for XML Digital Signatures.
Nested Schema : content
Type:
objectKey information content (e.g., X509Data, KeyName).
Nested Schema : content
Type:
arrayList of embedded content
Show Source
-
Array of:
object items
List of embedded content
Nested Schema : items
Type:
objectList of embedded content
Nested Schema : CanonicalizationMethodType1
Type:
objectCanonicalization method definition per XML Digital Signature specification.
Show Source
-
algorithm: string
Canonicalization algorithm URI.Example:
http://www.w3.org/TR/2001/REC-xml-c14n-20010315 -
content: object
content
Arbitrary content for CanonicalizationMethod child nodes.
Nested Schema : reference
Type:
objectReference to signed data including transforms, digest method, and digest value.
Show Source
-
digestMethod: object
DigestMethodType1
Digest method definition and optional parameters for computing the message digest in XML Digital Signatures.
-
digestValue: string
(byte)
Base64-encoded digest value of the referenced data.Example:
WVdKak1USXo= -
id: string
Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the recordExample:
ABCDEF1234567890ABCDEF1234567890 -
transforms: object
TransformsType1
Collection of Transform elements applied to the referenced data.
-
type: string
Type of the reference, typically a URI indicating the nature of the resource.Example:
http://www.w3.org/2000/09/xmldsig#Object -
uri: string
URI of the referenced resource.Example:
#object
Nested Schema : SignatureMethodType1
Type:
objectSignature algorithm definition and associated parameters for XML Digital Signatures.
Show Source
-
algorithm: string
Signature algorithm URI.Example:
Algo1 -
content: object
content
Optional content/parameters for the SignatureMethod.
Nested Schema : content
Type:
objectArbitrary content for CanonicalizationMethod child nodes.
Nested Schema : DigestMethodType1
Type:
objectDigest method definition and optional parameters for computing the message digest in XML Digital Signatures.
Show Source
-
algorithm: string
Digest algorithm URI.Example:
http://www.w3.org/2001/04/xmlenc#sha256 -
content: object
content
Optional content/parameters for the DigestMethod.
Nested Schema : TransformsType1
Type:
objectCollection of Transform elements applied to the referenced data.
Show Source
-
transform: object
transform
Transform algorithm definition and optional parameters applied to referenced data.
Nested Schema : content
Type:
objectOptional content/parameters for the DigestMethod.
Nested Schema : transform
Type:
objectTransform algorithm definition and optional parameters applied to referenced data.
Show Source
-
algorithm: string
Transform algorithm URI.Example:
http://www.w3.org/2000/09/xmldsig#enveloped-signature -
content: object
content
Optional content/parameters for the Transform.
Nested Schema : content
Type:
objectOptional content/parameters for the Transform.
Nested Schema : content
Type:
objectOptional content/parameters for the SignatureMethod.
Nested Schema : BasicDefinitions10
Type:
objectRoot-level definitions for basic units and reference types in the ODM Study.
Show Source
-
MeasurementUnit: object
MeasurementUnit
A measurement unit reference used in study forms, such as mg/dL.
Nested Schema : GlobalVariables10
Type:
objectODM GlobalVariables for a Study, providing human-readable study description and identifiers.
Show Source
-
ProtocolName: object
ProtocolName10
Protocol identifier/name for the ODM Study.
-
StudyDescription: object
StudyDescription10
Free-text description of the ODM Study.
-
StudyName: object
StudyName10
Human-readable display name for the ODM Study.
Nested Schema : MetaDataVersion
Type:
objectRepresents the metadata about the study
Show Source
-
codeList: object
codeList
Code list definition including items or external mappings.
-
conditionDef: object
conditionDef
Condition definition containing formal expressions and metadata.
-
description: string
Description of this study versionExample:
Main Study Metadata for Diabetes Trial -
formDef: object
formDef
Form definition containing item group references, archive layouts and metadata.
-
imputationMethod: object
imputationMethod
Imputation method definition with value and identifier.
-
include: object
Include10
Includes the metadata about the study version
-
itemDef: object
itemDef
Item definition including question, code list, range checks and metadata.
-
itemGroupDef: object
itemGroupDef
ItemGroup definition containing item references and metadata.
-
methodDef: object
methodDef
Method definition containing formal expressions and metadata.
-
name: string
Name of this study versionExample:
Main Study MetaData v1 -
oid: string
Unique identifier for this MetaDataVersionExample:
33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29 -
presentation: object
presentation
Presentation metadata including value, identifier and language.
-
protocol: object
Protocol10
Protocol metadata
-
studyEventDef: object
studyEventDef
Study Event Def data
Nested Schema : MeasurementUnit
Type:
objectA measurement unit reference used in study forms, such as mg/dL.
Show Source
-
Alias: object
Alias
A synonym, translation, or locale-specific label for a MeasurementUnit.
-
Name: string
Formal name of this measurement unit.Example:
mg/dL -
OID: string
Unique OID for this measurement unit. UUID uppercase hex.Example:
33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29 -
Symbol: object
Symbol10
Symbol element for a MeasurementUnit.
Nested Schema : Alias
Type:
objectA synonym, translation, or locale-specific label for a MeasurementUnit.
Show Source
-
Context: string
Locale, region, or terminology context.Example:
US -
Name: string
Alternative or alias name for the unit in this context.Example:
mg per deciliter
Nested Schema : Symbol10
Type:
objectSymbol element for a MeasurementUnit.
Show Source
-
TranslatedText: object
TranslatedText
A localizable or translated representation of a symbol, label, or similar text element.
Nested Schema : TranslatedText
Type:
objectA localizable or translated representation of a symbol, label, or similar text element.
Show Source
-
lang: string
Language code for this translation, e.g. 'en'.Example:
null -
Value: string
Text value for this locale/language.Example:
gender
Nested Schema : ProtocolName10
Type:
objectProtocol identifier/name for the ODM Study.
Show Source
-
Value: string
Protocol name/code for the Study.Example:
P-2024-0001
Nested Schema : StudyDescription10
Type:
objectFree-text description of the ODM Study.
Show Source
-
Value: string
Free-text description of the Study.Example:
Phase 3, double blind, randomized clinical study in Diabetes.
Nested Schema : StudyName10
Type:
objectHuman-readable display name for the ODM Study.
Show Source
-
Value: string
Display name for the Study.Example:
Sample Study
Nested Schema : codeList
Type:
objectCode list definition including items or external mappings.
Show Source
-
alias: object
alias
A synonym, translation, or locale-specific label for a MeasurementUnit.
-
codeListItem: object
codeListItem
Represents a single code list item with decode and metadata.
-
dataType: string
Allowed Values:
[ "INTEGER", "FLOAT", "TEXT", "STRING" ]Code list data type -
description: object
Description10
Description DTO having information on the translated text
-
enumeratedItem: object
enumeratedItem
Enumerated item value with optional ordering and aliases.
-
externalCodeList: object
ExternalCodeList1
Reference to an external dictionary-based code list.
-
name: string
Code list nameExample:
GENDER -
oid: string
CodeList object identifierExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
SASFormatName: string
SAS format name for the code listExample:
BEST12.
Nested Schema : conditionDef
Type:
objectCondition definition containing formal expressions and metadata.
Show Source
-
alias: object
alias
A synonym, translation, or locale-specific label for a MeasurementUnit.
-
description: object
Description10
Description DTO having information on the translated text
-
formalExpression: object
formalExpression
Formal expression used for validation.
-
name: string
Condition nameExample:
AgeGreaterThan18 -
oid: string
Condition object identifierExample:
86e83895-8674-443d-b2c9-f3a7ed25d119.2_0_0_39
Nested Schema : formDef
Type:
objectForm definition containing item group references, archive layouts and metadata.
Show Source
-
alias: array
alias
Aliases for the form
-
archiveLayout: array
archiveLayout
Archive layouts defined for this form
-
description: object
Description10
Description DTO having information on the translated text
-
hasIPR: boolean
Indicates IPR exists for the formExample:
true -
id: string
Form identifierExample:
9B9B96B684BA4822B98BFA612A070251 -
itemGroupRef: array
itemGroupRef
Item group references for this form
-
name: string
Form nameExample:
Demographics -
note: string
Additional note for the formExample:
Requires supervisor review -
oid: string
Form object identifierExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
repeating: string
Allowed Values:
[ "Yes", "No" ]Whether the form is repeating -
revisionDate: string
Form revision dateExample:
2023-01-01
Nested Schema : imputationMethod
Type:
objectImputation method definition with value and identifier.
Show Source
-
oid: string
Imputation method object identifierExample:
a4a7124a-0056-4fb5-9a7e-4a1b0068a966.1_8_0_29 -
value: string
Imputation method valueExample:
MeanImputation
Nested Schema : Include10
Type:
objectIncludes the metadata about the study version
Show Source
-
MetaDataVersionOID: string
OID of the referenced MetaDataVersionExample:
77ad209a-99bc-4b84-901a-2dcd173dcda7.2_0_0_39 -
StudyOID: string
OID of the referenced studyExample:
a4a7124a-0056-4fb5-9a7e-4a1b0068a966.1_8_0_29
Nested Schema : itemDef
Type:
objectItem definition including question, code list, range checks and metadata.
Show Source
-
alias: object
alias
A synonym, translation, or locale-specific label for a MeasurementUnit.
-
Calculated: string
Is this item calculated?Example:
1 -
CaptionAlignment: string
Allowed Values:
[ "0", "1", "2", "3", "4", "5", "6" ]Caption alignment. Allowed Values are INF_NOTDEFINED ,INF_LEFT ,INF_CENTER ,INF_RIGHT ,INF_TOP ,INF_MIDDLE ,INF_BOTTOMExample:INF_TOP -
CaptionText: string
UI caption textExample:
Please enter your name -
codeListRef: object
CodeListRef1
Reference to a CodeList by its OID.
-
Comment: string
Free-text commentExample:
This is a calculated item. -
ControlLayout: string
Allowed Values:
[ "0", "1", "2", "3", "4", "5" ]UI control layout style.Allowed values are INF_NOTDEFINED,INF_HORIZONTAL,INF_VERTICAL,INF_NOWRAP,INF_TWOCOLUMN,INF_THREECOLUMNExample:INF_NOTDEFINED -
ControlType: string
Allowed Values:
[ "pulldown", "text", "group", "radiogroup", "checkbox", "calendar", "element", "calculated", "instructionaltext", "file" ]UI control typeExample:TEXTBOX -
DataType: string
Allowed Values:
[ "integer", "float", "date", "datetime", "time", "text", "string", "double", "URI", "boolean", "hexBinary", "base64Binary", "hexFloat", "base64Float", "partialDate", "partialTime", "partialDatetime", "durationDatetime", "intervalDatetime", "incompleteDatetime", "incompleteDate", "incompleteTime" ]Data type (e.g., STRING, INT)Example:string -
description: object
Description10
Description DTO having information on the translated text
-
DisplayMask: string
Display mask for inputExample:
999-99-9999 -
EndYear: string
End year for date inputExample:
2025 -
externalQuestion: object
ExternalQuestion1
External question reference details.
-
InitialRowCount: string
Initial number of rowsExample:
1 -
IsDynamic: integer
(int32)
Is this item dynamic?Example:
0 -
IsSmartItem: integer
(int32)
Is this a smart item?Example:
1 -
itemRef: object
itemRef
Reference to an Item within an ItemGroup.
-
Length: integer
(int32)
Length of string/numericExample:
255 -
measurementUnitRef: object
measurementUnitRef
Data captured for a Measurement Unit
-
Name: string
Item nameExample:
DROPDOWN_03 -
OID: string
Unique OIDExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
Origin: string
Item's origin dataExample:
derived -
question: object
Question1
Question containing translated display text.
-
rangeCheck: object
rangeCheck
Range check configuration for item validation.
-
role: object
role
Represents the role associated with an item or definition.
-
SASFieldName: string
Field name in SAS exportExample:
HEIGHT_SAS -
SDSVarName: string
Field name in SDS exportExample:
HEIGHT_SDS -
SelectionValue: string
Selection value for this itemExample:
Y -
SignificantDigits: integer
(int32)
Number of significant digitsExample:
2 -
StartYear: string
Start year for date inputExample:
2000 -
UnknownMask: string
Unknown input maskExample:
UNK
Nested Schema : itemGroupDef
Type:
objectItemGroup definition containing item references and metadata.
Show Source
-
alias: array
alias
Aliases for the ItemGroup
-
comment: string
Additional comments for the ItemGroupExample:
No special handling -
description: object
Description10
Description DTO having information on the translated text
-
domain: string
Domain name for the ItemGroupExample:
DM -
isReferenceData: string
Allowed Values:
[ "Yes", "No" ]Indicates whether the ItemGroup holds reference data -
itemRef: array
itemRef
References to Items within this ItemGroup
-
name: string
ItemGroup nameExample:
Demographics Group -
oid: string
ItemGroup object identifierExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
origin: string
Origin of the ItemGroup dataExample:
Collected -
purpose: string
Purpose of the ItemGroupExample:
Analysis -
repeating: string
Allowed Values:
[ "Yes", "No" ]Whether the ItemGroup is repeating -
role: string
Role of the ItemGroupExample:
CRF -
SASDatasetName: string
SAS dataset name mapped for the ItemGroupExample:
DM
Nested Schema : methodDef
Type:
objectMethod definition containing formal expressions and metadata.
Show Source
-
alias: object
alias
A synonym, translation, or locale-specific label for a MeasurementUnit.
-
description: object
Description10
Description DTO having information on the translated text
-
formalExpression: object
formalExpression
Formal expression used for validation.
-
name: string
Method nameExample:
DeriveBMI -
oid: string
Method object identifierExample:
86e83895-8674-443d-b2c9-f3a7ed25d119.2_0_0_39 -
type: string
Allowed Values:
[ "COMPUTATION", "IMPUTATION", "TRANSPOSE", "OTHER" ]Method type
Nested Schema : presentation
Type:
objectPresentation metadata including value, identifier and language.
Show Source
-
lang: string
Language codeExample:
en -
oid: string
Presentation object identifierExample:
a4a7124a-0056-4fb5-9a7e-4a1b0068a966.1_8_0_29 -
value: string
Presentation valueExample:
Form Layout A
Nested Schema : Protocol10
Type:
objectProtocol metadata
Show Source
-
alias: object
alias
A synonym, translation, or locale-specific label for a MeasurementUnit.
-
description: object
Description10
Description DTO having information on the translated text
-
studyEventRef: object
studyEventRef
Study Event Ref data
Nested Schema : studyEventDef
Type:
objectStudy Event Def data
Show Source
-
alias: object
alias
A synonym, translation, or locale-specific label for a MeasurementUnit.
-
category: string
Event categoryExample:
Main -
description: object
Description10
Description DTO having information on the translated text
-
formRef: object
formRef
FormRef metadata
-
name: string
Event nameExample:
Screening Event -
oid: string
Unique identifier OID for the eventExample:
SE1 -
repeating: string
Allowed Values:
[ "Yes", "No" ]Whether this event may repeatExample:Yes -
type: string
Allowed Values:
[ "Scheduled", "Unscheduled", "Common" ]Type of eventExample:SCHEDULED
Nested Schema : alias
Type:
objectA synonym, translation, or locale-specific label for a MeasurementUnit.
Show Source
-
Context: string
Locale, region, or terminology context.Example:
US -
Name: string
Alternative or alias name for the unit in this context.Example:
mg per deciliter
Nested Schema : codeListItem
Type:
objectRepresents a single code list item with decode and metadata.
Show Source
-
alias: object
alias
A synonym, translation, or locale-specific label for a MeasurementUnit.
-
codedValue: string
Coded valueExample:
M -
decode: object
Decode1
Decoded text for a code list item with translations.
-
orderNumber: integer
(int64)
Order number of this itemExample:
1
Nested Schema : Description10
Type:
objectDescription DTO having information on the translated text
Show Source
-
translatedText: object
translatedText
A localizable or translated representation of a symbol, label, or similar text element.
Nested Schema : enumeratedItem
Type:
objectEnumerated item value with optional ordering and aliases.
Show Source
-
alias: object
alias
A synonym, translation, or locale-specific label for a MeasurementUnit.
-
codedValue: string
Coded valueExample:
M -
orderNumber: integer
(int64)
Order number within the code listExample:
1 -
rank: number
Optional rank for orderingExample:
1
Nested Schema : ExternalCodeList1
Type:
objectReference to an external dictionary-based code list.
Show Source
-
dictionary: string
External dictionary nameExample:
MedDRA -
href: string
Hyperlink reference to the external code listExample:
https://example.com/codelist/CL001 -
ref: string
Reference identifier within the external systemExample:
CL001 -
version: string
External dictionary versionExample:
24.0
Nested Schema : alias
Type:
objectA synonym, translation, or locale-specific label for a MeasurementUnit.
Show Source
-
Context: string
Locale, region, or terminology context.Example:
US -
Name: string
Alternative or alias name for the unit in this context.Example:
mg per deciliter
Nested Schema : Decode1
Type:
objectDecoded text for a code list item with translations.
Show Source
-
translatedText: object
translatedText
A localizable or translated representation of a symbol, label, or similar text element.
Nested Schema : translatedText
Type:
objectA localizable or translated representation of a symbol, label, or similar text element.
Show Source
-
lang: string
Language code for this translation, e.g. 'en'.Example:
null -
Value: string
Text value for this locale/language.Example:
gender
Nested Schema : translatedText
Type:
objectA localizable or translated representation of a symbol, label, or similar text element.
Show Source
-
lang: string
Language code for this translation, e.g. 'en'.Example:
null -
Value: string
Text value for this locale/language.Example:
gender
Nested Schema : alias
Type:
objectA synonym, translation, or locale-specific label for a MeasurementUnit.
Show Source
-
Context: string
Locale, region, or terminology context.Example:
US -
Name: string
Alternative or alias name for the unit in this context.Example:
mg per deciliter
Nested Schema : alias
Type:
objectA synonym, translation, or locale-specific label for a MeasurementUnit.
Show Source
-
Context: string
Locale, region, or terminology context.Example:
US -
Name: string
Alternative or alias name for the unit in this context.Example:
mg per deciliter
Nested Schema : formalExpression
Type:
objectFormal expression used for validation.
Show Source
-
context: string
Context or language for expressionExample:
XPath -
value: string
Formal expression for validationExample:
@AGE > 18
Nested Schema : alias
Type:
arrayAliases for the form
Show Source
-
Array of:
object Alias1
A synonym, translation, or locale-specific label for a MeasurementUnit.
Nested Schema : archiveLayout
Type:
arrayArchive layouts defined for this form
Show Source
-
Array of:
object ArchiveLayout1
Archive layout metadata for a form.
Nested Schema : itemGroupRef
Type:
arrayItem group references for this form
Show Source
-
Array of:
object ItemGroupRef1
Reference to an ItemGroup within a form.
Nested Schema : Alias1
Type:
objectA synonym, translation, or locale-specific label for a MeasurementUnit.
Show Source
-
Context: string
Locale, region, or terminology context.Example:
US -
Name: string
Alternative or alias name for the unit in this context.Example:
mg per deciliter
Nested Schema : ArchiveLayout1
Type:
objectArchive layout metadata for a form.
Show Source
-
oid: string
ArchiveLayout object identifierExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
pdfFileName: string
Name of the PDF fileExample:
layout.pdf -
presentationOID: string
Presentation object identifierExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29
Nested Schema : ItemGroupRef1
Type:
objectReference to an ItemGroup within a form.
Show Source
-
collectionExceptionConditionOID: string
Condition OID that allows exception to collectionExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
itemGroupOID: string
ItemGroup object identifierExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
mandatory: string
Allowed Values:
[ "Yes", "No" ]Whether collection of the item group is mandatory -
orderNumber: integer
(int64)
Order number within the formExample:
1
Nested Schema : alias
Type:
objectA synonym, translation, or locale-specific label for a MeasurementUnit.
Show Source
-
Context: string
Locale, region, or terminology context.Example:
US -
Name: string
Alternative or alias name for the unit in this context.Example:
mg per deciliter
Nested Schema : CodeListRef1
Type:
objectReference to a CodeList by its OID.
Show Source
-
codeListOID: string
OID of the referenced code listExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29
Nested Schema : ExternalQuestion1
Type:
objectExternal question reference details.
Show Source
-
code: string
External question codeExample:
QCODE123 -
dictionary: string
Source dictionary nameExample:
MedDRA -
version: string
Dictionary versionExample:
24.0
Nested Schema : itemRef
Type:
objectReference to an Item within an ItemGroup.
Show Source
-
collectionExceptionConditionOID: string
OID for collection exception conditionExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
imputationMethodOID: string
Imputation method OIDExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
itemOID: string
OID of referenced itemExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
keySequence: integer
(int64)
Key sequence for composite keyExample:
1 -
mandatory: string
Allowed Values:
[ "Yes", "No" ]Is this item mandatory? -
methodOID: string
Method OID for derivationExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
orderNumber: integer
(int64)
Order of the itemExample:
2 -
role: string
Role of the referenced itemExample:
DataEntry -
roleCodeListOID: string
OID for role code listExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29
Nested Schema : measurementUnitRef
Type:
objectData captured for a Measurement Unit
Show Source
-
MeasurementUnitOID: string
OID of the referenced measurement unitExample:
33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29
Nested Schema : Question1
Type:
objectQuestion containing translated display text.
Show Source
-
translatedText: object
translatedText
A localizable or translated representation of a symbol, label, or similar text element.
Nested Schema : rangeCheck
Type:
objectRange check configuration for item validation.
Show Source
-
checkValue: object
checkValue
A value used within a range validation.
-
comparator: string
Allowed Values:
[ "LT", "LE", "GT", "GE", "EQ", "NE", "IN", "NOTIN" ]Comparator operation -
errorMessage: object
ErrorMessage1
Error message details for validation failures.
-
formalExpression: object
formalExpression
Formal expression used for validation.
-
measurementUnitRef: object
MeasurementUnitRef1
Data captured for a Measurement Unit
-
softHard: string
Allowed Values:
[ "SOFT", "HARD" ]Indicates hard or soft validation
Nested Schema : role
Type:
objectRepresents the role associated with an item or definition.
Show Source
-
value: string
Value or name of the roleExample:
DataEntry
Nested Schema : translatedText
Type:
objectA localizable or translated representation of a symbol, label, or similar text element.
Show Source
-
lang: string
Language code for this translation, e.g. 'en'.Example:
null -
Value: string
Text value for this locale/language.Example:
gender
Nested Schema : checkValue
Type:
objectA value used within a range validation.
Show Source
-
value: string
Value to check in a range validationExample:
10
Nested Schema : ErrorMessage1
Type:
objectError message details for validation failures.
Show Source
-
translatedText: object
translatedText
A localizable or translated representation of a symbol, label, or similar text element.
Nested Schema : formalExpression
Type:
objectFormal expression used for validation.
Show Source
-
context: string
Context or language for expressionExample:
XPath -
value: string
Formal expression for validationExample:
@AGE > 18
Nested Schema : translatedText
Type:
objectA localizable or translated representation of a symbol, label, or similar text element.
Show Source
-
lang: string
Language code for this translation, e.g. 'en'.Example:
null -
Value: string
Text value for this locale/language.Example:
gender
Nested Schema : alias
Type:
arrayAliases for the ItemGroup
Show Source
-
Array of:
object Alias1
A synonym, translation, or locale-specific label for a MeasurementUnit.
Nested Schema : itemRef
Type:
arrayReferences to Items within this ItemGroup
Show Source
-
Array of:
object ItemRef1
Reference to an Item within an ItemGroup.
Nested Schema : ItemRef1
Type:
objectReference to an Item within an ItemGroup.
Show Source
-
collectionExceptionConditionOID: string
OID for collection exception conditionExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
imputationMethodOID: string
Imputation method OIDExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
itemOID: string
OID of referenced itemExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
keySequence: integer
(int64)
Key sequence for composite keyExample:
1 -
mandatory: string
Allowed Values:
[ "Yes", "No" ]Is this item mandatory? -
methodOID: string
Method OID for derivationExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29 -
orderNumber: integer
(int64)
Order of the itemExample:
2 -
role: string
Role of the referenced itemExample:
DataEntry -
roleCodeListOID: string
OID for role code listExample:
c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29
Nested Schema : alias
Type:
objectA synonym, translation, or locale-specific label for a MeasurementUnit.
Show Source
-
Context: string
Locale, region, or terminology context.Example:
US -
Name: string
Alternative or alias name for the unit in this context.Example:
mg per deciliter
Nested Schema : formalExpression
Type:
objectFormal expression used for validation.
Show Source
-
context: string
Context or language for expressionExample:
XPath -
value: string
Formal expression for validationExample:
@AGE > 18
Nested Schema : alias
Type:
objectA synonym, translation, or locale-specific label for a MeasurementUnit.
Show Source
-
Context: string
Locale, region, or terminology context.Example:
US -
Name: string
Alternative or alias name for the unit in this context.Example:
mg per deciliter
Example:
[
{
"context":"CDASH",
"name":"PROTID"
}
]Nested Schema : studyEventRef
Type:
objectStudy Event Ref data
Show Source
-
collectionExceptionConditionOID: string
OID for collection exceptionExample:
COND1 -
mandatory: string
Allowed Values:
[ "Yes", "No" ]Is this event mandatory? YES or NOExample:Yes -
orderNumber: integer
(int32)
Order of the event in scheduleExample:
1 -
studyEventOID: string
OID of the referenced study eventExample:
SE1
Example:
[
{
"eventOID":"SE1"
}
]Nested Schema : alias
Type:
objectA synonym, translation, or locale-specific label for a MeasurementUnit.
Show Source
-
Context: string
Locale, region, or terminology context.Example:
US -
Name: string
Alternative or alias name for the unit in this context.Example:
mg per deciliter
Nested Schema : formRef
Type:
objectFormRef metadata
Show Source
-
collectionExceptionConditionOID: string
OID for collection exceptionExample:
43caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29 -
formOID: string
OID of the referenced formExample:
33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29 -
mandatory: string
Allowed Values:
[ "Yes", "No" ]Is this form mandatory in the event?Example:Yes -
orderNumber: integer
(int32)
Order of this form in the eventExample:
1
500 Response
Error
Root Schema : ErrorResponseData
Type:
objectStructure representing an error response from the reporting service. Contains an error code, human-readable message, and details.
Show Source
-
details: object
details
Detailed error context or debugging information such as validation error, stack trace, or field/parameter cause.
-
errorCode: string
Application or business-specific error code representing the error type.Example:
REPT_401 -
errorMessage: string
Human-readable error message describing the failure or issue.Example:
Unauthorized: User does not have access to the requested resource
Nested Schema : details
Type:
objectDetailed error context or debugging information such as validation error, stack trace, or field/parameter cause.
Example:
User role is missing required permission REPORTING_VIEW. Field: userId