RPS R3 Glossary
About The Content Of This Page:
This page contains the definitions of the terms listed in the current RPS R3 Submission Message (SM) document plus the terms proposed for inclusion in the glossary. Each entry is labeled as a 'glossary definition' or a 'submission message definition'; if the definition of an SM term has not been considered yet it is additionally labeled as 'UNREVIEWED'.
Every artifact in the RPS R3 model is represented by a term in SM. If there is no definition in SM for the term, 'SM definition is:' appears with no following text. Where there is a proposed change to the SM definition it appears after 'Proposed SM Definition:'.
Open questions, if any, appear at the end of the entry.
Please feel free to edit or add definitions for the terms, but please do not change the term numbering because I'll never be able to get the changes back into the database.
If there are other terms you think should be included in the glossary please add them, unnumbered, at the end after 141.
Note Added 28 May 2011: This is being updated, entry by entry, to include: (a) the proposed changes, comments and questions distributed by Klaus Menges on May 6, and (b) proposed changes and comments by Keith Thomas based on decisions since this was last updated. Each of these changes is boxed and marked KM or KT as applicable.
1. agent
... Submission Message Definition -
SM definition is: If a person is the contact, it might be important to state which company they work for. For example, it might be important the person works for a CRO not the sponsor.
Glossary Definition (proposed): An Agent is an individual (a Person role in HL7) belonging to an Organization. The Agent class in the RPS message does not have any attributes, but provides a way of listing an Organization with a Person.
KM. Comment: An agent is an individual belonging to an organisation, e.g a CRO, which is acting on behalf of the sponsor or who is personally acting on behalf of the sponsor or who is as an employee of the sponsor authorised to and responsible for any communication between the applicant and the authority.
2. applicant
... Submission Message Definition - UNREVIEWED
SM definition is: The organization or entity that is responsible for the application.
2.1 applicant
Glossary Definition (proposed): An Applicant is contained within a Review object, and indicates the sponsor organization. The Applicant class in the RPS message does not have any attributes, but merely encloses an Organization element.
2.9. application
... Glossary Definition
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 regulated product, 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. An Application does not necessarily imply that something is being applied for, nor that it is approved, as it includes such topics as Investigational New Drugs and Master Files, which have no approval.
3. application
... Submission Message Definition
SM definition is: A request for approval to either market a product or to allow the applicant to start testing of a proposed product. Nevertheless, submission are for approvals. Applications organizes submissions (regulatory activities).
Proposed SM Definiton: An application is the highest level of organization of submission content. It is subdivided into submissions, which in turn may be subdivided into reviewable units.
KM. Comment: Seem to be sufficient as the standard concerns all regulated products and therefore several types of applications which may have slightly modified definitions in details.
4. application- id
... Submission Message Definition
SM definition is: id is a set and can be defined by many organizations for tracking purposes.
Glossary Definition (proposed): An Application must have at least one ID, consisting of a unique identifier -- a UUID or, preferably, an OID. A typical Application ID will use an OID mapped to a particular submission type at a regulatory authority, and use an extension to indicate the particular application number. An Application may have an additional ID generated by the applicant in cases where the ID has not yet been requested of the regulatory authority. If this is used, the applicant-generated ID must be maintained throughout the life of the Application, alongside the regulatory authority-supplied ID.
KM. Comment: Seem to be sufficient as the standard concerns all regulated products and therefore several types of applications which may have slightly modified definitions in details.
5. application - code
... Submission Message Definition
SM definition is:
Glossary Definition (proposed): The Application Code indicates the type of application. This value will be from a controlled list created by the regulatory authority.
6. Application life cycle
... Glossary Definition
to be defined
7. application – status code ?
... Submission Message Definition
SM definition is: Not currently in SM
Question:1. Do we need this to allow an application to be withdrawn (status = “null”)?2. Couldn’t we use the status code value of “new” to indicate a provisional application without an official id, rather than mood code? When it is assigned an official id the object would carry the status of “active”
8. application reference
... Submission Message Definition
SM definition is: The application that is being referred to by the Application. This is typically used in situations such as Drug Master Files or Active Substance Master Files. The Application ID of the referenced application is used.
9. application reference - id
... Submission Message Definition
SM definition is: The identifier of the application that is being referenced.
10. application reference - reason code
... Submission Message Definition
SM definition is: The reason why this application is being referenced. This will be a controlled list defined by the regulatory authority.
11. author
... Submission Message Definition
SM definition is: The organization/authority that is doing the review. This is a 'connector' object between the Review and Territorial Authority which contains no attributes of its own, and merely encloses the Territorial Authority object in the XML message.
12. authority
... Submission Message Definition
SM definition is: The name of the organization or authority that is doing the review. It may contain a name and an ID. The Authority object is enclosed by the TerritorialAuthority.
13. call back contact
... Submission Message Definition - UNREVIEWED
SM definition is: This is an HL7 message object used to enclose the Contact Party objects. They are found in the submission (regulatory activity) and submission unit. There may be 0 to many contacts in each submission unit and submission, each with a single Contact Party.
14. category event
... Submission Message Definition
SM definition is: The Category Event is a classification of a submission unit. For example, an amendment (submission unit.code) could be a 30 day waiver. The category event may have sub categories, each of which is a Category Event.
15. choice
... Submission Message Definition
SM definition is:
In the RPS model, a "Choice" box is used to indicate that a submission unit pertains to either a Submission or a Reviewable unit. There is no choice object or data in the model or the message.
16. code set
... Glossary Definition
code set: see shared controlled vocabulary
17. code system
... Glossary Definition
code system: see shared controlled vocabulary
18. component1
... Submission Message Definition
Relationship Between: [submission unit <> context of use]
SM definition is: The ContextOfUse Act contains most of the supporting information to help further the granting of an application. Two ContextOfUse Acts with the same Code can be sorted by priorityNumber. When the applicant administratively changes the status of the submission to obsolete, the applicant would create a submission unit message with no context of use.
Proposed SM Definiton: The Component1 is used to indicate that ContextOfUse items are found within the Submission Unit. It contains a Priority Number indicating precedence of items.
19. component 1 – priority number
... Submission Message Definition
SM definition is: The order of the context of use in an application.
Proposed SM Definiton: A value used to order (i.e. to sort) a context of use within the set of CoUs having the same code value and keywords in the same application. A real valued parameter allows new items to be interpolated anywhere in an existing list. The sort order between keyword, context of use code and priority will be subject to the implementation guide for each submission type, e.g. in Manufacturing, a Substance keyword may have the highest sort order, but within Nonclinical Studies, the Context of Use may have first sort sequence, then species, then priority number.
Question:Are keywords intended to have any role in as subheadings? Answer: Definition changed to include keywords.
20. component2
... Submission Message Definition
Relationship Between: [application <> document]
SM definition is: The document is first submitted in an application. Nevertheless, the document is considered universal. Meaning, the document can be associated to any context of use in any application.
Proposed SM Definiton: A Component2 object is used to show that each Document is enclosed by an Application. A document by default is associated with one application but it can be referenced from any context in any application known to the source and target databases.
21. component3
... Submission Message Definition
Relationship Between: [document <> document]
SM definition is: Can reference a Document by Id only.
Proposed SM Definiton: The component3 is used to reference one or more documents within another document. A document instance may have components only if it has no text attribute referencing a file.
22. contact
... Submission Message Definition - UNREVIEWED
SM definition is: The contact can either be a person or an organization.
23. contact party
... Submission Message Definition - UNREVIEWED
SM definition is: A person or department to call if there are any questions.
24. context of use
... Glossary Definition
A context of use associates one document with a position in a standardized table of contents defined by a controlled vocabulary (the code), plus optional Keywords. A context of use has a life cycle.
25. Context of use code
... Glossary Definition
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.)
26. Context of use, derivation:
... Glossary Definition
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.
27. Context of use, multiple application
... Glossary Definition
A context of use instance applies in each reviewable unit and/or submission to which the submission unit of which it is a component pertains.
28. Context of use, multiple application exclusions
... Glossary Definition
The application of a context of use may be excluded from an identified submission(s) in a multiple application situation.
29. Context of use life cycle
... Glossary Definition
To be defined
30. context of use
... Submission Message Definition
SM definition is: The ContextOfUse Act defines the use of the submitted document in the context of a submission unit. The document and its assignment to a particular code will be used to create a table of contents. This table of contents will be used by Regulatory Authorities to review an application. Based on regional guidance, a document can be submitted once and be referred to by other ContextOfUse's text attribute in the same submission unit, different submission unit for the same application, or different submission units in a different application. Codes for all ACTs will be different based on the Regulatory Authority and type of product. Regulatory authorities could have different codes than applicants.
Proposed SM Definiton: A context of use instance associates a document with a position in a pro forma table of contents defined by the controlled vocabulary specified in the code attribute. .
31. Context of use – id
... Submission Message Definition
SM definition is: The unique identifier that is used to refer to this act
32. Context of use – code
... Submission Message Definition
SM definition is: The code that specifies how the file is to be used within the submission process (e.g. Protocol, Summary Introduction). Note: ContextOfUse codes vary between different product types. If code is blank, the document code can be used.
Proposed SM Definiton: The code specifies the controlled vocabulary (i.e. code set) providing the pro-forma table of contents and the specific value to be used.Different controlled vocabularies may be used depending on the application type and regulator.
Question:How could a code for document type take the place of a code specifying the position in the overall application TOC?
33. Context of use - title
... Submission Message Definition
SM definition is: The title for the document in the associated assignment. If title is blank, the document title can be used.
Proposed SM Definiton: The context of use may have a title.
34. Context of use – status code
... Submission Message Definition
SM definition is: See section "Document Identification, Revisions, and Addenda"
Question:In the case where a CoU is being dropped does the instance carrying the null status code have the same id as its predecessor or a new id? The first way seems to be the proper way under RIM rules, but it applies only to the specified object; there seems to be no defined way to end a sequence of versions.
35. Context of use – set id
... Submission Message Definition
SM definition is: See section "Document Identification, Revisions, and Addenda"
36. Context of use – version number
... Submission Message Definition
SM definition is: See section "Document Identification, Revisions, and Addenda"
37. dedicated service delivery location
... Submission Message Definition - UNREVIEWED
SM definition is: The manufacturing site is based on the organization creating such a product. In other words, if a different organization buys a manufacturing site, it is possible that sites needs to be approved again.
38. derived from
... Submission Message Definition
Relationship Between: [context of use <> document reference]
SM definition is: The context of use is derived from the document. Meaning that the context of use specialized the document it reference or inherits all of the attributes of the document. For example, if the code or title value is not present in the context of use, the code or title will be inherited from the document.
Question:Are keywords inherited by type? Does a document with components also ‘inherit’ keywords from its components?
39. device
... Submission Message Definition - UNREVIEWED
SM definition is:
40. Document
... Glossary Definition
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 cycle. A document may consist of either a reference to a single file, or to a set of additional documents.
41. Document, simple
... Glossary Definition
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.
42. Document, compound
... Glossary Definition
A compound document comprises one or more simple and/or compound document, which are referenced by id as components.
43. Document life cycle
... Glossary Definition
To be defined
44. Document type
... Glossary Definition
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.
45. document
... Submission Message Definition
SM definition is: The ContextOfUse Act defines the use of the submitted document in the context of a submission unit. The document and its assignment to a particular code will be used to create a table of contents. This table of contents will be used by Regulatory Authorities to review an application. Based on regional guidance, a document can be submitted once and be referred to by other ContextOfUse's text attribute in the same submission unit, different submission unit for the same application, or different submission units in a different application. Either text or component is used, but not both.
Proposed SM Definiton: A document instance represents either a simple document, comprising exactly one file y means of a text attribute, or a compound document, comprising one or more simple and/or compound documents referenced as components.
46. Document – id
... Submission Message Definition
SM definition is: The unique identifier that is used to refer to this act
47. Document – code
... Submission Message Definition
SM definition is: The code that specifies how the file is to be used within the submission process (e.g. Protocol, Summary Introduction). Note: ContextOfUse codes vary between different product types. If code is blank, the document code can be used.
Proposed SM Definiton: A document may have a type assigned from a controlled vocabulary. It is expected that a controlled vocabulary of document types, corresponding to the file tags defined in the ICH study tagging specification, will be specified by ICH. Individual regulators may define other document types for other uses.
48. Document - title
... Submission Message Definition
SM definition is: The title for the document in the associated assignment. If title is blank, the document title can be used.
Proposed SM Definiton: A document may have a title.
49. Document - text
... Submission Message Definition
SM definition is: The location of the document.
Proposed SM Definiton: The text attribute is present only if the document instance represents a simple document, in which case the text attribute carries information about the file:- reference URL (path to the file including the file name), plus optionally, - language- integrity check- integrity check algorithm
50. Document – status code
... Submission Message Definition
SM definition is: See section "Document Identification, Revisions, and Addenda"
51. Document – set id
... Submission Message Definition
SM definition is: See section "Document Identification, Revisions, and Addenda"
52. Document – version number
... Submission Message Definition
SM definition is: See section "Document Identification, Revisions, and Addenda"
53. document reference
... Submission Message Definition
SM definition is: A document can be used many times. Each time the document is used, that document has a different context of use. Accordingly, each context of use must refer to one document.
Proposed SM Definiton: A context of use must reference exactly one document.
54. file
... Submission Message Definition
SM definition is:
Proposed SM definition: A file is a block of arbitrary information, or resource for storing information, which is available to a computer program and is usually based on some kind of durable storage.[1]
55. Filing Order
... Glossary Definition
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 ‘insert’ a document in an existing filing sequence under a heading.
56. holder
... Submission Message Definition - UNREVIEWED
SM definition is: The sponsor is the requesting a review.
Proposed SM Definition: The holder is an HL7 object used to connect an Application or Review to an Applicant object, referring to the product sponsor requesting a review or approval.
57. information recipient
... Submission Message Definition - UNREVIEWED
SM definition is: An application can be targeted to only one regulatory authority.
Proposed SM definition: The Information Recipient is an HL7 object used to optionally connect an Application or Review with a Territorial Authority.
58. ingredient
... Submission Message Definition - UNREVIEWED
SM definition is: An ingredient is a substance that forms part of a product.
59. Keyword
... Glossary Definition
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, ordering (?) and display.
60. keyword
... Submission Message Definition
SM definition is: A Keyword is a reference to the KeywordDefinition Act. One or more Keywords can be associated to documentation.
Proposed SM Definiton: A keyword instance represents the association of a keyword with a document or with a context of use. A keyword instance either invokes a keyword type and value directly from a controlled vocabulary or it references by id a keyword type and value defined in and for an application.
Question:When the keyword is attached to a context of use (or inherited from the derived document) are tools expected to ensure that the keyword id is defined for each application to which the CoU pertains?
Question 2: How can a sponsor control the presentation order of a particular keyword? e.g. study sequence, manufacturers, substances, species. The 'priority' value determines the order within all other sorting, but there is currently no means of specifying the priority of a list.
61. keyword – id
... Submission Message Definition
SM definition is: Reference to the KeywordDefinition.id. This field should only be used if there is not coding system equivalent
Proposed SM Definiton: An id attribute is present in a keyword instance only when it is intended to reference a keyword name and value defined in and for an application.
62. keyword – code
... Submission Message Definition
SM definition is: Used if the keyword is from a coding system not from keyword definition.
Proposed SM Definiton: A code attribute is present in a keyword instance only when it is intended to invoke a keyword type and value directly from a controlled vocabulary.
63. keyword - status code
... Submission Message Definition
SM definition is: Being able to remove a keyword for a context of use.
Question:Shouldn’t this be removed because it serves no purpose? A keyword used on a document or a context of use cannot be updated without submitting a new version of the document or context of use including its whole set of associated keywords, because it is not possible to refer to a keyword instance that directly applies a keyword name and value from a code set, since it carries no id.
64. Keyword application
... Glossary Definition
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.
65. Keyword application life cycle
... Glossary Definition
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.
66. Keyword application sources
... Glossary Definition
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.
67. keyword definition
... Glossary 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.
68. keyword definition
... Submission Message Definition
SM definition is: A keyword definition contains name value pairs that are used within the context of an application. Each keyword is an item of information that provides context for the document(s). Keywords are used only to further define the context of documents, and the Keywords, by themselves, have no intrinsic value. Since one of the goals of this message was to create one message structure that can be used for all regulated product types, we decided not model individual keywords as classes and relate these classes to specific document types.
69. keyword definition – id
... Submission Message Definition
SM definition is: The unique identifier that is used to refer to this act
Proposed SM Definiton: A unique id for this keyword definition.
70. keyword definition – code
... Submission Message Definition
SM definition is: The type of Keyword (e.g., Manufacture, Dosage Form, Route of Admin)
Proposed SM Definiton: A code attribute is required to specify the keyword (type) name from a controlled vocabulary.
71. keyword definition - status code
... Submission Message Definition
SM definition is: Active or nullified.
Question:In the case where a keyword is being dropped, does the instance carrying the null status code have the same id as its predecessor or a new id? The first way seems to be the proper way under RIM rules, but it applies only to the specified object; there seems to be no defined way to end a sequence of versions.
72. keyword definition – value
... Submission Message Definition
SM definition is: The value of the KeywordDefination.code
Proposed SM Definiton: A value (text string) is required to complete the keyword definition, unless the keyword definition instance has a null status code.
73. Keyword definition life cycle:
... Glossary Definition
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.
74. links
... Submission Message Definition
SM definition is: This allows two link correspondences together to make a threaded communication.
Proposed SM definition is: This permits a ContextOfUse to be related to other ContextOfUse items.
Question:What does this mean and how is it supposed to work? Answer: I thought we ditched threaded communications. However, this may be useful in responses to permit a question to point to a document, or a revised file to point to a question. If this is done, though, it probably needs a reason code.
75. manufactured product
... Submission Message Definition - UNREVIEWED
SM definition is: The product that is the subject of the review.
76. mode
... Submission Message Definition - UNREVIEWED
SM definition is: The high-level handling of the information submitted as part of variation(s) and extension applications. The mode should only be used in variation or line extension regulatory activities and must be included in every sequence of that activity. The following are the valid modes: a single regulatory activity (e.g. a Type II variation), a grouped activity (e.g. several variations grouped into a single submission or a periodic report of type IA variations applicable to one or more marketing authorisations), and an activity subject to a worksharing agreement (e.g. a Type II variation applicable to more than one marketing authorisation)
77. organization
... Submission Message Definition - UNREVIEWED
SM definition is:
Proposed SM definition: An Organization is an HL7 entity indicating a sponsor or regulatory authority. It is used in four ways: (a) As a contact party (associated with a Submission Unit), (b) to indicate the group to which an individual (Person) is an Agent in a contact party, (c) as the Sponsor Organization of an Applicant on a Review, and (d) as the recognizing organization of a Dedicated Service Delivery Location in a Review. The organization information includes names, addresses and telecommunications contact information
78. person
... Submission Message Definition - UNREVIEWED
SM definition is:
Proposed SM definition: A Person is an individual that may be referenced as a Contact Party in a Submission Unit, and includes names, addresses and telecommunications contact information.
79. pertinent information1
... Submission Message Definition
Relationship Between: [submission <> reviewable unit]
SM definition is: Organizes information for a single submission. In modular reviews there could be many reviewable units in one submission.
Proposed SM Definiton: Relates a reviewable unit to a submission.
80. pertinent information2
... Submission Message Definition
Relationship Between: [submission unit choice <> either reviewable unit or submission]
SM definition is: A submission unit either pertains to one or more Submissions or pertains to one or more Reviewable Units. For example, an annual report submission unit can apply to multiple applications. Therefore, the applicant will create one submission unit and associate that unit to multiple submissions.
Proposed SM Definiton: Relates a submission unit to either a reviewable unit or a submission. A submission unit must pertain to at least one submission or reviewable unit, and may pertain to many.
81. pertinent information2 – sequence number
... Submission Message Definition
SM definition is:
Proposed SM Definiton: This is the integer sequence number assigned to this submission unit within the specific reviewable unit or submission to which it pertains via this relationship instance.
82. pertinent information3
... Submission Message Definition
Relationship Between: [context of use <> submission reference]
SM definition is: Used to state that certain documentation do not belong to certain submissions.
Proposed SM Definiton: This is used with a context of use only to exclude the associated document from inclusion in the referenced submission.
83. pertinent information3 – negation indicator
... Submission Message Definition
SM definition is:
Proposed SM Definiton: Always set to true to indicate that this document is to be excluded from the referenced submission.
84. pertinent information4
... Submission Message Definition
Relationship Between: [application <> submission]
SM definition is: A submission unit either pertains to one or more Submissions or pertains to one or more Reviewable Units. For example, an annual report submission unit can apply to multiple applications. Therefore, the applicant will create one submission unit and associate that unit to multiple submissions.
Proposed SM Definiton: Each submission must pertain to exactly one application; however, the same application object may be repeated in a given message as many times as different submissions within the application are referenced.
85. pertinent information5
... Submission Message Definition
Relationship Between: [submission <>submission group]
SM definition is: A way to link multiple submissions to one group for a regulatory decision.
86. place
... Submission Message Definition - UNREVIEWED
SM definition is: The location of authority (e.g. France)
87. previous keyword definition
... Submission Message Definition
SM definition is: PreviousKeywordDefinition is used to replace an existing KeywordDefination. Once a KeywordDefinition is replaces, that KeywordDefination can no longer be associated with a context of use.
Proposed SM Definiton: PreviousKeywordDefinition is used to replace an existing KeywordDefination. Once a KeywordDefinition is replaced, that KeywordDefination can no longer be associated with a document or context of use.
88. primary information recipient
... Submission Message Definition - UNREVIEWED
SM definition is: A context of use can be targeted to only one regulatory authority.
Proposed SM definition: The Primary Information Recipient is used to relate a context of use to a Territorial Authority, used for limiting who should review a Context of Use.
89. product
... Submission Message Definition - UNREVIEWED
SM definition is: The product that is the subject of the review
Proposed SM definition: The Product is the proprietary name of a Manufactured Product. There will be one name per product (per review), and each Product may have zero or more Ingredients.
90. product category
... Submission Message Definition - UNREVIEWED
SM definition is: Whether the product is new or the reason for the change to the product to be reviewed.
Proposed SM definition: The Product Category contains a controlled vocabulary term indicating the reason for the change to the product to be reviewed.
91. reference1
... Submission Message Definition - UNREVIEWED
Relationship Between: [keyword definition <> application]
SM definition is:
Proposed SM Definition: The Reference1 object is used to connect an Application to the Keyword Definitions it contains. Each Reference1 contains one KeywordDefinition.
92. reference2
... Submission Message Definition - UNREVIEWED
Relationship Between: [application <> application reference]
SM definition is: The Reference2 object is used to connect an Application to the Application References it contains, in order to list related applications such as Master Files.
93. reference3
... Submission Message Definition - UNREVIEWED
Relationship Between: [keyword <> document | context of use]
SM definition is:
Proposed SM definition: The Reference3 object relates a Keyword Definition to the Context of Use that contains it.
... Submission Message Definition
SM definition is: Provides a relationship between a ContextOfUse and ContextOfUse that was recorded previously. See section "Document Identification, Revisions, and Addenda"
Proposed definition: The Related Context of Use provides a relationship between a ContextOfUse and ContextOfUse that was recorded previously. See section "Document Identification, Revisions, and Addenda".
Question:Now that we have a robust independent document construct why do we need this? We could do all content life cycle tracking on the document, and leave the sequence of versions in a set as the track of a CoU life cycle.
Answer: The Related Context of Use is used to indicate replacement within a submission. Merely changing the document doesn't tell the submission that it's current. You need both: A document is updated, then a submission uses it. For instance, let's say that the tablets and gel-caps use a common manufacturing method, then it's found that the gel caps can use a different set of steps, or an ingredient is provided by a different vendor closer to the plant. A new document is created, perhaps as a sub-document of a larger document, but until a Submission Unit says that it is using that new document, it isn't part of the submission. That Context of Use needs to say, "I'm replacing the old one." But the old one may still be valid for other submissions.
... Submission Message Definition
SM definition is:
Proposed SM definition: The Related Context of Use ID is used to identify which Context of Use element is being replaced.
... Submission Message Definition
SM definition is:
Proposed SM definition: The Related Context of Use Version Number is used to identify the version number of the item being replaced.
Question: Is this even useful? The ID should be sufficient to identify the CoU being replaced.
... Submission Message Definition
SM definition is: Provides a relationship between a Document and Document that was recorded previously. See section "Document Identification, Revisions, and Addenda"
... Submission Message Definition
SM definition is:
Proposed SM Definition: The Related Document ID is used to indentify which document is changed (replaced, deleted, etc.).
... Submission Message Definition
SM definition is:
Question:Isn’t this is redundant? (Yes I know that CDA doe it this way but our documents are not the same as theirs so I don’t see why we should adopt the same conventions, especially when they’re problematic.)
100. replacement of
... Submission Message Definition
Relationship Between: [keyword definition <> previous keyword defintion]
SM definition is: One can only replace another KeywordDefinition. When the KeywordDefinition is replaced, that KeywordDefinition is obsolete; therefore, that KeywordDefinition cannot be used in a context of use.
Proposed SM Definition: The Replacement Of object is used to connect a Previous Keyword Definition with the Keyword Definition that contains it.
101. review
... Submission Message Definition - UNREVIEWED
SM definition is: Products or manufacturing locations can be the subject of the regulatory decision.
Proposed SM definition: Review objects are used by Regulatory Authorities to indicate different review statuses, including product details (e.g. formulations or doses) or manufacturing locations, among the many Regulatory Authorities that may be reviewing this Submission. This is designed for use in EU submissions, where different territories may have different review statuses.
102. review - id
... Submission Message Definition - UNREVIEWED
SM definition is: The unique identifier
Proposed definition: The Review ID is the unique identifier used on each Review object.
103. review - status code
... Submission Message Definition - UNREVIEWED
SM definition is: If the review is active, completed or withdrawn
Proposed SM definition: The Review Status Code indicates the status of the Review of the Submission for a given Territorial Authority, e.g. Active, Completed or Withdrawn.
104. review – effective time
... Submission Message Definition - UNREVIEWED
SM definition is: The time period of the review in this state
Proposed SM Definition: The Review Effective Time is the date and time at which the review status, product, and/or location changed.
105. review choice
... Submission Message Definition - UNREVIEWED
SM definition is:
Proposed Definition: The subject of each Review is a choice of either a Manufactured Product or a Dedicated Service Delivery Location. This is expressed as a "Review choice" in the model.
106. review procedure
... Submission Message Definition - UNREVIEWED
SM definition is: Defines the procedure in used to review the regulatory activity. The procedures are Centralised, National , Mutual Recognition and Decentralised.
Proposed SM Definition: The Review Procedure defines the procedure in used to review the regulatory activity. The procedure is a coded value representing such terms as "Centralised", "National", "Mutual Recognition and Decentralised". This is only required for some regions and submission types.
107. review procedure - code
... Submission Message Definition - UNREVIEWED
SM definition is: The procedure type
Proposed SM definition: The Review Procedure code represents such terms as "Centralised", "National", "Mutual Recognition and Decentralised".
108. reviewable unit
... Submission Message Definition
SM definition is: The reviewable unit is a way to organize a submission into discrete units. Each reviewable unit can have a status. A reviewable unit performs similar to submission.
Proposed SM Definiton: A reviewable unit is a subdivision of a submission, used in some but not all submission types.
109. reviewable unit - id
... Submission Message Definition
SM definition is: The unique identifier that is used to refer to this act
Proposed SM definition: The Reviewable Unit ID is a unique identifier used to refer to the Reviewable Unit.
110. reviewable unit – code
... Submission Message Definition
SM definition is: The code specifying the particular kind of reviewable unit (e.g. CMC, Administration, Tox).
Proposed SM Definition: The Reviewable Unit Code is a value specifying the particular kind of reviewable unit (e.g. CMC, Administration, Toxicology). The available values will be determined by each regulatory authority for submissions that include reviewable units.
111. reviewable unit – status code
... Submission Message Definition
SM definition is: A submission is either active, completed or null.
Proposed SM Definition: The Reviewable Unit Status Code indicates that the reviewable unit is "active", "completed" or null ("").
112. sequel to 1
... Submission Message Definition
Relationship Between: [context of use <> related context of use]
SM definition is: A context of use reference one file. In the case that a context of use is being made obsolete, there is no need for a document reference.
Proposed SM Definition: The Sequel To 1 is used to connect a Related Context of Use to the Context of Use that contains it. In the case that a context of use indicates that it is being made obsolete, there is no need for a reference to a related context of use.
Question:Isn’t the succession of versions of a CoU within a set a sufficient record of its history? Answer: Please see Related Context of Use for discussion.
113. sequel to 2
... Submission Message Definition
Relationship Between: [document <> related document]
SM definition is: A document reference one document. In the case that a document is being made obsolete, there is no need for a file reference.
Proposed SM Definiton: The Sequel To 2 is used to connect a Related Document to the Document that contains it. In the case of a document being made obsolete, there is no need for a Document Reference.
[remove, place comment on related document class]?
... Glossary Definition
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.
115. subject 1
... Submission Message Definition - UNREVIEWED
Relationship Between: [submission unit <> category event]
SM definition is:
Proposed SM definition: The Subject 1 is used to connect a Category to the Submission that contains it.
116. subject 2
... Submission Message Definition - UNREVIEWED
Relationship Between: [category event <> category event]
SM definition is:
Proposed SM Definition: The Subject 2 is used to connect a category to another category within it, providing the capability for sub-categories.
Question: Is this really needed? Wouldn't the coding for a category be sufficient to understand that category 4.5.6 is within 4.5 which is within category 4? Joelfinkle 18:37, 20 April 2011 (UTC)
117. subject3
... Submission Message Definition - UNREVIEWED
Relationship Between: [submission <> review]
SM definition is:
Proposed SM definition: The Subject 3 is used to connect each Review object to the Submission which contains it.
118. subject4
... Submission Message Definition - UNREVIEWED
Relationship Between: [review <> product category]
SM definition is: One submission can have many approvals for one submission. This is true in Europe where one submission is expecting approvals from many countries at different times.
Proposed SM definition: The Subject 4 is used to connect each Product Category to the Review object that contains is.
119. subject5
... Submission Message Definition - UNREVIEWED
Relationship Between: [review <> review choice]
SM definition is: The approval is either related to a product or a manufacturing site.
Proposed SM definition: The Subject 5 is used to connect each Manufactured Product or Dedicated Service Delivery Location to the Review object that contains it.
120. subject 6
... Submission Message Definition - UNREVIEWED
Relationship Between: [application <> review procedure]
SM definition is:
Proposed SM definition: The Subject 6 is used to connect the Review Procedure to the Application which contains it.
121. subject7
... Submission Message Definition - UNREVIEWED
Relationship Between: [submission <> mode]
SM definition is:
Proposed SM definition: The Subject 7 is used to connect the optional Mode to the Submission which contains it.
122. Submission
... Glossary Definition
a submission is a organizational subdivision of an application, usually associated with a specific regulatory activity or purpose.
Proposed SM Definition: A Submission is a collection of Submission Units within an Application, usually associated with a specific regulatory activity or purpose, e.g. initial approval, variation or supplement, annual report, etc. The submission may be grouped with other submissions, may have reviews, may have a mode, may have contact parties, and may be subdivided into Reviewable Units.
123. Submission, life cycle
... Glossary Definition
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.
Question:When a regulator approves a submission might they send the approval documents in a submission unit that pertains to a submission instance with the same id and a status code of completed?
124. submission
... Submission Message Definition
SM definition is: The submission is a way to organize an application into discrete units. Most typically the submission will be used to organize information based on a review clock. Receipt date from the regulatory authority is important for a submission. Since the message, at this time, is only from applicant to regulatory authority, submission does not have a date attribute.
[See #122 instead of this]
125. submission - id
... Submission Message Definition
SM definition is: The unique identifier that is used to refer to this act
Proposed SM Definition: The Submission ID is a unique identifier provided for each Submission. This value remains constant throughout the Submission life cycle.
126. submission - code
... Submission Message Definition
SM definition is: The code specifying the particular kind of submission (e.g. Original, Supplement, Annual report).
Proposed SM definition: The Submission Code indicates the particular kind of submission (e.g. Original, Supplement, Annual report).
127. submission – status code
... Submission Message Definition
SM definition is: A submission is either active or null. Additional status can be found in the approval.
Proposed SM definition: The Submission Status code is either "active" or null (""). Additional status may be recorded within the Review object.
128. submission – effective time
... Submission Message Definition
SM definition is: The time of review
Proposed SM definition: The Submission Effective Time contains the date and time at which the Submission status changed. [Is this correct?]
129. submission – value
... Submission Message Definition
SM definition is: This information is used to determine review timelines and goals and should be captured when the activity is submitted.
[say what?]
130. submission group
... Submission Message Definition
SM definition is:
Proposed SM definition: The Submission Group is an optional label used to associate several submissions as a group.
131. submission reference
... Submission Message Definition
SM definition is: The submission reference is a pointer to the submission.
Proposed SM definition: The Submission Reference is optional for a Context of Use to indicate that that Context of Use is only valid for particular Submissions, rather than for all Submissions pertaining to the Submission Unit.
132. Submission unit
... Glossary Definition
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.
Proposed SM definition: A Submission Unit is a single RPS message that carries the organization and management metadata applicable to the batch of documents accompanying the message or to documents previously submitted. Submission Units may be sent from applicant to regulatory authority or from regulatory authority to applicant. A submission unit may pertain to multiple submissions or reviewable units, and are composed of Context of Use items indicating the type of content being sent.
133. Submission unit, withdrawal
... Glossary Definition
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
134. submission unit
... Submission Message Definition
SM definition is: A collection of documents submitted at a particular point in time in order to further the granting of a submission. Both applicants and regulatory authorities?send submission units
Proposed SM Definiton: A submission unit contains 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.
[Repeat -- see #132]
135. submission unit – id
... Submission Message Definition
SM definition is: The unique identifier that is used to refer to this act
Proposed SM definition: The Submission Unit ID is a unique identifier that is used to refer to the particular Submission Unit.
136. submission unit – code
... Submission Message Definition
SM definition is: The code specifying the particular kind of submission unit (e.g. Original, Amendment, Supplement).
Proposed SM definition: The Submission Message Code is a controlled term indicating type particular kind of submission unit. [[[User:Joelfinkle|Joelfinkle]] 19:14, 20 April 2011 (UTC): Is this correct? The terms listed in the original definition refer to Submissions, and Submission Unit has the Category to describe the type]
137. submission unit – title
... Submission Message Definition
SM definition is: Short description of the submission unit
Proposed SM definition: The Submission Unit Title is a short description of the submission unit.
138. submission unit - status code
... Submission Message Definition
SM definition is: A submission unit is either active or null.
Proposed SM definition: The Submission Unit Status code indicates that the submission unit is "active" or null ("").
[Is this correct? When is a submission unit not active? Withdrawing requires another submission unit! Joelfinkle 19:17, 20 April 2011 (UTC)]
139. substance
... Submission Message Definition - UNREVIEWED
SM definition is: The unique identifier that is used to refer to this act
Proposed SM definition: A Substance is a description of an Ingredient (used with the Review object). It contains a name.
140. territorial authority
... Submission Message Definition - UNREVIEWED
SM definition is: The regulatory authority has authority of a region (e.g. country) and is an organization.
Proposed SM definition: A Territorial Authority is a regulatory authority associated with a set of governing authorities and/or places. It is used in three ways in an RPS message: As the territorial recipients of an Application, as the authors of a Review, and as the Primary Information Recipient limiting who should review a Context of Use.
141. A Device Act Definition
... Submission Message Definition
SM definition is:
Proposed SM definition: A Device Act Definition is a subset of the Common Product Model used to describe a Device-type product associated with the Dedicated Service Delivery Location option of a Review.
