Document (RPS)

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This is a Glossary page.

This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized

R1 Working Definition

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.

ICH Equivalent

Leaf

BRIDG Term

Document

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.

Additional Regional Definitions and Synonyms

  • ISO 15489: Recorded information or object which can be treated as a unit
  • CDISC: An ordered presentation of XML elements, possibly including text and tabular analyses, description, and figures.
  • CDISC: (Clinical Document) A documentation of clinical observations and services. This loses credibility for using clinical and document in the definition
  • 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.