(registered 2018-11-28, last updated 2018-11-28) Media type name: application Media subtype name: odm+xml Required parameters: N/A Optional parameters: granularity=( All | Metadata | AdminData | ReferenceData | AllClinicalData | SingleSite | SingleSubject ) Granularity is intended to provide a shorthand way to describe the breadth of the information in the document, for certain common types of documents. All means the entire study; Metadata means the MetaDataVersion element; AdminData and ReferenceData mean the corresponding elements; AllClinicalData, SingleSite, and SingleSubject are successively more tightly focused subset of the study's clinical data. Each of the granularities listed represents a valid ODM document structure. If not present, no default granularity value is implied. odmversion=x.y.z ODMVersion indicates the CDISC ODM standard version of the document. For example, odmversion=(1.2.0 | 1.2.1 | 1.3.0 | 1.3.1 | 1.3.2 | 2.0.0) lists alternatives for currently supported versions of ODM. As new versions of the standard are published by CDISC, these versions will follow the specified versioning syntax (e.g. 2.0.1). Each ODM version has a corresponding specification and schema. The numbering scheme indicates the major, minor, and patch versions as shown in the x.y.z syntax. A major version indicates significant changes that are not compatiable with the previous version. A minor version adds functionality to the standard in a backwards-compatible manner. A patch version adds backwards-compatible bug fixes. If not present, no default odmversion value is implied. Encoding considerations: Same as application/xml - see section 9.1 of RFC 7303. Security considerations: As an XML-based type, this media type inherits the security considerations of XML- see RFC 7303 section 10. Xlink references in ODM documents may cause arbitrary URIs to be dereferenced. In this case, the security issues of RFC 3986, section 7, should be considered. ODM does not contain active or executable content. ODM does not employ compression or employ a container format, such as ZIP. The ODM standard does not provide privacy or integrity services, however, ODM may be used for storing and transferring sensitive information. When senstive data requires privacy or integrity services, those must be provided externally, for example by Transport Layer Security (TLS) or Secure Sockets Layer (SSL). For regulated research, specific regulations or guidelines may exist pertaining to data privacy and integrity. The government data protection regulations for your region should be consulted (e.g. Code of Federal Regulations Title 21 Part 11 Electronic Records; Electronic Signatures for the US). Interoperability considerations: See the ODM specification for guidance on ODM interoperability https://www.cdisc.org/standards/data-exchange/odm Published specification: https://www.cdisc.org/standards/data-exchange/odm Applications which use this media: The CDISC Operational Data Model (ODM) is a vendor-neutral, platform-independent format for exchanging and archiving clinical and translational research data, along with their associated metadata, administrative data, reference data, and audit information. ODM facilitates the regulatory-compliant acquisition, archival and exchange of metadata and data. It has become the language of choice for representing case report form content in many electronic data capture (EDC) tools. Fragment identifier considerations: None Restrictions on usage: None Additional information: 1. Deprecated alias names for this type: None 2. Magic number(s): None 3. File extension(s): .xml 4. Macintosh file type code: None 5. Object Identifiers: None General Comments: Person to contact for further information: 1. Name: Sam Hume 2. Email: shume&cdisc.org Intended usage: Common https://www.cdisc.org/standards/data-exchange/odm Author/Change controller: CDISC (https://www.cdisc.org/)