This is a Glossary page.
Content, typically a file or collection of files, be it PDF or other data, provided as part of a Submission Unit.
Each document is assigned to one or more Context of Use categories, with each file component of a multiple-file document associated to a different associated Context of Use.
To express the life cycle of a document over time, a document may have one or more Document Relationships.
A collection (physical or logical) of data with the following characteristics: 1) Stewardship, 2) Potential for authentication, 3) Wholeness, 4) Human readability, 5) Persistence, 6) Global vs local context (the person that signs it is the author of all sections unless otherwise noted).
For example, regulatory processes require the submission of documents from the Applicant to the Regulatory Authority. These documents are varied in focus and are often defined by the field of study or by the regulatory application requirements of the region or Regulatory Authority (e.g., Integrated Summary of Safety, Pharmacokinetics Written Summary).
For example, Adverse Event Report, Expedited Adverse Event Report, IRB Report, X-Ray Report, Lab Summary Report, Autopsy Report, etc.
NOTE: This class is an abstract concept that contains attributes common to all types of study documents.
CDISC: An ordered presentation of XML elements, possibly including text and tabular analyses, description, and figures.
General for Devices: Each file currently printed and sent to a regulatory agency is a document.
Japan, Human Pharmaceuticals: Similar to bunsho in Japanese. If a bunsho is in an electronic format, it can be a file or a collection of files, which in either case can have a single semantic unit. If a bunsho is composed of multiple files, then each component, which is a file, does not have a semantic unit as bunsho.
This page was last modified on 10 November 2008, at 18:41.