Page History

Other File Attributes

As implied above, most ODM documents will contain only part of the total information (current and historical) held in the source database.

The information that is sent in a given document can vary along several dimensions. Some examples of the contents of a document are:

• just metadata,
• just clinical data,
• just domain data (SDTM),
• a series of updates of a single value for a single subject,
• the current state of the entire study,
• the current state of a subset of a study (particular subjects, particular forms, etc),
• the changes to the study since the last communication, or
• a full history of all changes ever made to the study.

Because of this variability, it is also important that each document describe itself, so that the consumer of the document knows what to expect of it. To address these needs, the ODM element has several attributes for describing the current document.

The CreationDateTime attribute tells when the ODM document was created. In contrast, the AsOfDateTime attribute tells when the document content was accurate by specifying the date/time at which the source database was queried to create the ODM document. This is of particular importance when a series of files is used to give an evolving view of a changing database.

The FileType and Granularity attributes allow the document sender to define the scope, across time and data, that a particular document spans. The Archive attribute allows the sender to assert that the contents of the document meet a specific set of criteria that qualifies it as an electronic record defined in the FDA 21 CFR 11 regulation. Finally, the Description attribute provides the sender a text string in which to give details, as elaborately as necessary, to supplement the other attributes in describing the document. This section details the values these attributes can take, and discusses the use of the values in a single document and in a series of documents.