Difference between revisions of "Document (RPS)"
Joelfinkle (talk | contribs) (Definition of RPS Document) |
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| − | This is a Glossary page | + | This is a Glossary page. |
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''This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized'' | ''This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized'' | ||
==R1 Working Definition== | ==R1 Working Definition== | ||
| − | Content, typically a file, be it PDF or other data, provided as part of a [[Submission Unit (RPS)|Submission Unit]]. | + | Content, typically a file or collection of files, be it PDF or other data, provided as part of a [[Submission Unit (RPS)|Submission Unit]]. |
| − | Each document is assigned to one or more [[Context of Use (RPS)|Context of Use]] categories. | + | Each document is assigned to one or more [[Context of Use (RPS)|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 Relationship (RPS)|Document | + | |
| + | To express the life cycle of a document over time, a document may have one or more [[Document Relationship (RPS)|Document Relationship]]s. | ||
==ICH Equivalent== | ==ICH Equivalent== | ||
| − | Leaf | + | '''Leaf''' |
==BRIDG Term== | ==BRIDG Term== | ||
'''Document''' | '''Document''' | ||
| + | |||
A collection (physical or logical) of data with the following characteristics: | 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). | 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). | ||
| Line 23: | Line 26: | ||
==Additional Regional Definitions and Synonyms== | ==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''. | ||
[[Category:RPS Glossary]] | [[Category:RPS Glossary]] | ||
Latest revision as of 22:41, 10 November 2008
This is a Glossary page.
This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized
Contents
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.
