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- 15:45, 20 April 2011 diff hist +231 RPS R3 Glossary →96. related context of use – version number
- 15:38, 20 April 2011 diff hist +118 RPS R3 Glossary →95. related context of use - id: proposed def
- 15:36, 20 April 2011 diff hist +966 RPS R3 Glossary →94. related context of use: Proposed def, answered question.
- 19:32, 19 April 2011 diff hist +112 RPS R3 Glossary →93. reference3: Proposed def
- 19:18, 19 April 2011 diff hist +155 RPS R3 Glossary →92. reference2: Proposed def
- 19:14, 19 April 2011 diff hist +166 RPS R3 Glossary →91. reference1: Proposed Def
- 19:12, 19 April 2011 diff hist +149 RPS R3 Glossary →90. product category: Proposed def
- 18:49, 19 April 2011 diff hist +186 RPS R3 Glossary →89. product: Proposed def
- 18:46, 19 April 2011 diff hist +172 RPS R3 Glossary →88. primary information recipient: Added proposed def
- 16:57, 19 April 2011 diff hist +98 RPS R3 Glossary →77. organization
- 16:57, 19 April 2011 diff hist +185 RPS R3 Glossary →78. person: added definition
- 16:54, 19 April 2011 diff hist +430 RPS R3 Glossary →77. organization: Added a definition
- 16:50, 19 April 2011 diff hist +341 RPS R3 Glossary →74. links
- 16:31, 19 April 2011 diff hist +146 RPS R3 Glossary →57. information recipient
- 16:28, 19 April 2011 diff hist +181 RPS R3 Glossary →56. holder: Original is not readable
- 16:25, 19 April 2011 diff hist +241 RPS R3 Glossary →54. file
- 16:15, 19 April 2011 diff hist +97 RPS R3 Glossary →40. Document: added the two types of document
- 16:10, 19 April 2011 diff hist +29 RPS R3 Glossary →24. context of use: added mention of keywords. Do we also need to mention the "filter" objects for submissions and territories, or are their own definitions sufficient?
- 16:06, 19 April 2011 diff hist +83 RPS R3 Glossary →20. component2: Added definition, in addition to relationship.
- 15:54, 19 April 2011 diff hist +110 RPS R3 Glossary →18. component1: Added definition - I disagree that the CoU definition is sufficient.
- 15:47, 19 April 2011 diff hist +67 RPS R3 Glossary →21. component3: provided definition instead of just exception
- 20:50, 11 April 2011 diff hist +177 RPS R3 Glossary →15. choice
- 20:47, 11 April 2011 diff hist +36 RPS R3 Glossary →14. category event
- 20:46, 11 April 2011 diff hist +159 RPS R3 Glossary →13. call back contact
- 20:43, 11 April 2011 diff hist -13 m RPS R3 Glossary →11. author
- 20:43, 11 April 2011 diff hist +89 RPS R3 Glossary →12. authority
- 20:41, 11 April 2011 diff hist -6 RPS R3 Glossary →11. author
- 20:39, 11 April 2011 diff hist +208 RPS R3 Glossary →11. author
- 20:32, 11 April 2011 diff hist +65 RPS R3 Glossary →10. application reference - reason code
- 20:31, 11 April 2011 diff hist +171 RPS R3 Glossary →8. application reference
- 20:23, 11 April 2011 diff hist +9 RPS R3 Glossary
- 20:18, 11 April 2011 diff hist +142 RPS R3 Glossary changed structure to use Wiki headlines for easier editing of sections
- 20:16, 11 April 2011 diff hist -282 RPS R3 Glossary
- 20:09, 11 April 2011 diff hist +2 m RPS R3 Glossary
- 20:08, 11 April 2011 diff hist -3 m RPS R3 Glossary
- 22:00, 1 April 2011 diff hist +444 N Talk:RPS R3 Glossary Created page with "--~~~~ There is a question on the page as to whether the Application needs a Status element. Personally, I don't think so: It's the individual Submissions that are approved, with..." current
- 21:54, 1 April 2011 diff hist +783 RPS R3 Glossary Added Application ID, Application Code
- 21:43, 1 April 2011 diff hist +189 RPS R3 Glossary Updated the Application note (2.9)
- 21:31, 29 March 2011 diff hist +236 RPS R3 Glossary Applicant proposed definition
- 21:28, 29 March 2011 diff hist +236 RPS R3 Glossary Agent proposed definnition
- 19:23, 31 March 2010 diff hist +1 RPS Ontology current
- 19:23, 31 March 2010 diff hist +26 RPS Ontology
- 19:22, 31 March 2010 diff hist 0 N File:RPSOntology.zip current
- 19:20, 31 March 2010 diff hist +167 N RPS Ontology New page: This page is reserved for information about RPS Ontologies and controlled vocabularies. The file listed below is a stub, and does not have any content as of 4/1/2010.
- 17:32, 28 January 2010 diff hist +253 Regulated Activity Structure Hierarchy current
- 17:29, 28 January 2010 diff hist +20 N File:RASH Proposal Overview.pdf RASH Proposal slides current
- 17:24, 28 January 2010 diff hist +55 Regulated Activity Structure Hierarchy
- 17:21, 28 January 2010 diff hist +31 N File:RASH Project Scope Statement 20091214.doc RASH Scope Statement (proposed) current
- 17:20, 28 January 2010 diff hist +458 N Regulated Activity Structure Hierarchy New page: The Regulated Activity Structure Hierarchy (RASH) is a proposed structured document format to accompany Regulated Product Submissions (RPS). It is designed to be a ''machine-readable i...
- 17:18, 28 January 2010 diff hist +62 Regulated Clinical Research Information Management →RCRIM Projects
- 15:28, 4 January 2010 diff hist +173 m Regulated Product Submissions →1. Project Information
- 02:28, 16 December 2009 diff hist +1 m RPS Hyperlinking →RPS Hyperlinking current
- 02:25, 16 December 2009 diff hist +1,667 N RPS Hyperlinking New page: == RPS Hyperlinking == Hyperlinking between documents in electronic submissions is done wihin PDF (Portable Document Format) documents. RPS release 1 and 2 do not propose any changes to t...
- 02:10, 16 December 2009 diff hist +93 RPS Glossary →Glossary of Abbreviations and Terms
- 02:01, 16 December 2009 diff hist +931 N RPS Threaded Discussions New page: This would entail providing the ability to keep track of individual questions or issues, and the responses and comments from all interest parties. Example – and this may be more detail ...
- 02:01, 16 December 2009 diff hist +104 Regulated Product Submissions →Future Scope Discussions Topics
- 13:18, 4 December 2009 diff hist +227 Regulated Product Submissions →7.RPS Resources
- 12:59, 4 December 2009 diff hist 0 m Regulated Product Submissions →7.RPS Resources
- 12:58, 4 December 2009 diff hist -6 Regulated Product Submissions →7.RPS Resources
- 12:58, 4 December 2009 diff hist +88 Regulated Product Submissions Added resource links to R1 information
- 12:55, 4 December 2009 diff hist +477 Regulated Product Submissions
- 12:37, 15 September 2009 diff hist +59 m RPS Structure and Linking Discussion →Example Implementations
- 12:36, 15 September 2009 diff hist +1,241 RPS Structure and Linking Discussion →Hyperlinking
- 18:43, 19 August 2009 diff hist +547 RPS Master Files
- 22:33, 16 July 2009 diff hist +1,751 N RPS Structure and Linking Discussion Discussion of hyperlinking and file/folder structure
- 22:23, 16 July 2009 diff hist +1 m RPS R2 Project →Domain Analysis Links
- 22:23, 16 July 2009 diff hist +213 RPS R2 Project →Domain Analysis Links
- 16:40, 27 January 2009 diff hist +1 m RPS Glossary →Glossary of Abbreviations and Terms
- 16:43, 31 December 2008 diff hist +88 Common Product Model →Storyboards
- 16:37, 31 December 2008 diff hist +34 Common Product Model →Ambitions & Scope
- 22:41, 10 November 2008 diff hist +449 Document (RPS) →Additional Regional Definitions and Synonyms current
- 22:34, 10 November 2008 diff hist +1 m Context of Use (RPS) →R1 Working Definition current
- 22:33, 10 November 2008 diff hist +17 Context of Use (RPS) →Additional Regional Definitions and Synonyms
- 22:31, 10 November 2008 diff hist +248 Reviewable Unit (RPS) →Human Pharmaceuticals current
- 22:30, 10 November 2008 diff hist +78 Submission Unit (RPS) →Human Pharmaceuticals current
- 22:30, 10 November 2008 diff hist -164 Submission Unit (RPS) →Japan
- 22:25, 10 November 2008 diff hist +183 Submission (RPS) →Europe
- 22:24, 10 November 2008 diff hist +217 Application (RPS) →Human Pharmaceuticals
- 14:21, 28 October 2008 diff hist -1 Reviewable Unit (RPS)
- 14:21, 28 October 2008 diff hist -74 Submission Unit (RPS)
- 14:20, 28 October 2008 diff hist -114 Submission (RPS) Removed Japanese Device Definitions
- 14:20, 28 October 2008 diff hist -60 Application (RPS) Removed Japanese Device Definitions
- 16:40, 20 October 2008 diff hist 0 Submission Unit (RPS) →Human Pharmaceuticals)
- 16:39, 20 October 2008 diff hist +587 Submission Unit (RPS) →Additional Regional Definitions and Synonyms
- 16:08, 20 October 2008 diff hist +1,607 RPS Glossary/doc →Creating New Definition Pages current
- 16:02, 20 October 2008 diff hist +106 Reviewable Unit (RPS)
- 15:57, 20 October 2008 diff hist +1,497 Submission (RPS) →Additional Regional Definitions and Synonyms
- 15:48, 20 October 2008 diff hist +164 Submission (RPS) →R1 Working Definition: - updated to match terminology map more closely
- 15:41, 20 October 2008 diff hist +1,128 Application (RPS) →Additional Regional Definitions and Synonyms
- 20:14, 14 October 2008 diff hist +1,628 N Keyword (RPS) New page: 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== A '''Keyword''' is a pi... current
- 20:04, 14 October 2008 diff hist +666 N File (RPS) New page: 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== A single electronic fil... current
- 19:56, 14 October 2008 diff hist +1,853 N Context of Use (RPS) new definition
- 19:46, 14 October 2008 diff hist +21 RPS Glossary →Glossary of Abbreviations and Terms
- 14:21, 14 October 2008 diff hist -201 m Regulated Product Submission Release 2 (RPS R2) Storyboards →Example 2: Send Submission Unit to Regulated Industry
- 14:21, 14 October 2008 diff hist -217 Regulated Product Submission Release 2 (RPS R2) Storyboards →E.1 Additional Information about a Submission Unit: - moved Submission Unit Type and Contact Type definitions to RPS Glossary
- 14:12, 14 October 2008 diff hist +61 N Package (RPS) Redirecting to Submission Unit (RPS) current
- 14:11, 14 October 2008 diff hist +720 N Submission Unit Type (RPS) New page: 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== The type of [[Submissio... current
- 14:09, 14 October 2008 diff hist +14 RPS Glossary →Glossary of Abbreviations and Terms
- 14:08, 14 October 2008 diff hist +93 RPS Glossary →Glossary of Abbreviations and Terms
- 14:06, 14 October 2008 diff hist +60 Contact Type (RPS) →R1 Working Definition current