RPS R3 Glossary

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3 Application

Note that the term application is not used here with the same meaning as given in the HL7 glossary. In RPS an application is a collection of documents and metadata concerning a product regulated by approval, both submitted to a regulatory authority, and returned by the regulator as responses. An application is the highest level of content organization recognized in RPS. It is subdivided into submissions, which may themselves be further subdivided into reviewable units.

Submission Message Term: application

6 Application life Cycle

[tbd]

Submission Message Term: application – status code ?

15 code set

see shared controlled vocabulary

16 code system

see shared controlled vocabulary

18 Filing order

documents are virtually filed under specified headings in a standardized table of contents for the particular application type. (By virtually filed, we mean displayed under those headings by the software tools used to access and manage the document databases). The heading is specified by a context of use that also references the document. Since more than one document may file under the same heading, a secondary sorting order may be specified by, first type and value of any keywords associated with the document or context of use (?), and then by a numerical position value associated with the context of use. The numerical position is specified as a positive real number so that a context of use may <p>Submission Message Term: component 1 – priority number

23 Context of use

a context of use associates one document with a position in a standardized table of contents defined by a controlled vocabulary. A context of use has a life cycle.

Submission Message Term: context of use

24 Context of use, derivation

:a context of use is said to be derived from a document in that the attribute values and associated keywords used when processing it may be inherited from the document.

26 Context of use code

the context of use code is a value taken from a shared controlled vocabulary representing the ordered headings of a standardized table of contents for a given kind of application. The code determines the heading under which the document is virtually filed. (A given document can be virtually filed in multiple locations by reference from different context of use instances.)

Submission Message Term: Context of use – code

28 Context of use life cycle

[tbd]

Submission Message Term: Context of use – status code

34 Document

a document is the unit of content managed by RPS. A document object is created once with a unique id and may be referenced from any number of other documents or context of uses . A document has a life <p>Submission Message Term: document

35 Document, simple

a simple document comprises exactly one file, which must accompany the RPS message in which the document object is submitted; the file is referenced by path and name in the document object. Each file accompanying an RPS message must be referenced from exactly one simple document object.

36 Document, compound

a compound document comprises one or more simple and/or compound document, which are referenced by id as components.

39 Document type

documents may be assigned a type from a shared controlled vocabulary. It is expected that a controlled vocabulary will be published by ICH for study documents; other regulators may develop controlled vocabularies for other purposes.

Submission Message Term: Document – code

42 Document life cycle

[tbd]

Submission Message Term: Document – status code

46 File

The actual content of submissions is provided electronically in named digital files of various formats, as dictated by the regulator’s policies. Files are submitted in batches along with an RPS message. Each file is to be submitted exactly once, and referenced from exactly one document object in the

50 Keyword application

<p> keywords are applied to (i.e. used on) document or context of use instances by associating either a keyword definition by reference to its id, or a keyword name and value directly from a controlled vocabulary by using the appropriate code.

Submission Message Term: keyword

53 Keyword, use life cycle

when a keyword used on a document or context of use is to be replaced or dropped then a new version of the document or context of use instance is submitted, including the whole new set of keywords applied to that instance.

Submission Message Term: keyword - status code

54 Keyword

a keyword is a name-value pair, where the name identifies the type of keyword, and the value is a text string to be used on a document or context of use to which that keyword is applied. Keywords are applied to (i.e. used on) document and content of use instances as additional metadata to modify their retrieval, <p>Submission Message Term: keyword definition

55 Keyword sources

keywords may be invoked directly from a shared controlled vocabulary, or may be defined in and for an application. Keywords that are defined in and for an application are subject to a managed life cycle.

58 Keyword definition life cycle

once a keyword has been defined in and for an application, it may be replaced (i.e. assigned a new type and/or value) or it may dropped entirely from further use. In either case a new keyword definition is submitted with a reference to the keyword definition being replaced.

Submission Message Term: keyword definition - status code

59 Keyword definition

a keyword may be defined in and for an application by specifying its type from a controlled vocabulary and assigning it a text string value.

Submission Message Term: keyword definition – value

68 Context of use, multiple application

a context of use applies in each reviewable unit and/or submission to which the submission unit of which it is a component pertains.

Submission Message Term: pertinent information3

69 Context of use, multiple application exclusions

the application of a context of use may be excluded from an identified submission(s) in a multiple application situation.

101 Shared controlled vocabulary

a shared controlled vocabulary is an encoded knowledge representation that is used to classify RPS information objects in some domain. It is sometimes also called a code set or a code system. Within the HL7 formalism a given vocabulary must be identified by an OID, and contain a set of entries, each with a code value and a display text string. A given vocabulary may have other information associated with each entry to assist its users in applying and managing codes, including information concerning the ordering, nesting and/or association of entries.It is shared by virtue of its being published and available from an authoritative source. Shared vocabularies needed for RPS include context of use code sets, document type code sets, user-definable keyword type code sets, and pre-defined keyword code sets.

Submission Message Term: Shared controlled vocabulary

109 Submission

a submission is a organizational subdivision of an application, usually associated with a specific regulatory activity or purpose.

Submission Message Term: submission

112 Submission, withdrawal

when a sponsor wishes to withdraw a submission they submit a empty submission unit pertaining to a submission with the same id value and the status code set to null.

Submission Message Term: submission – status code

117 Submission unit

a submission unit is the portion of an RPS message that carries the organizational and management metadata applicable to the batch of files accompanying the unit or to documents previously submitted. It may be sent as a submission by the applicant or as a response form the regulator.

Submission Message Term: submission unit

121 Submission unit, withdrawal

when a sponsor wishes to withdraw a submission unit they submit an empty submission unit with the same id value and the status code set to null

Submission Message Term: submission unit - status code

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