Difference between revisions of "Regulated Product Submissions"
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[[Category:RCRIM]] | [[Category:RCRIM]] | ||
| + | [[Category:RPS]] | ||
Return to [[Regulated Clinical Research Information Management|RCRIM]] main page | Return to [[Regulated Clinical Research Information Management|RCRIM]] main page | ||
| + | ==Regulated Product Submission Release 3 == | ||
| + | |||
| + | ===Project Information=== | ||
| + | |||
| + | ====Project Scope==== | ||
| + | |||
| + | [[http://healthlevelseven.projectinsight.net/DL/FF4FA6B948DD4D6C96E8A8126304190C Project Scope Statement]] (Approved) | ||
| + | ====Project Plan==== | ||
| + | [[http://gforge.hl7.org/gf/download/docmanfileversion/5817/7477/RPSR3ProjectPlanv1-0.doc RPSr3 Project Plan]] | ||
| + | |||
| + | ====Project Notes==== | ||
| + | [[Link_to_2010_Biweekly_Meeting_Information_and_Minutes]] | ||
| + | |||
| + | ====Project Meetings==== | ||
| + | RPS R3 Project Leadership Team Meeting Minutes | ||
| + | |||
| + | The Storyboards as of March 15, 2011: [[Media:RPS_storyboard_Package_2011-03-15.zip]] | ||
| + | |||
| + | The presentation on Life Cycle from the 1-Jun-2010 Meeting is here: [[Media:RPS_Document_Life_Cycle.zip]] | ||
| + | |||
| + | Link to [[PLT Meeting Minutes: 2-Mar-2010]] | ||
| + | |||
| + | Link to [[PLT Meeting Minutes: 16-Mar-2010]] | ||
| + | |||
| + | [[Meeting Minutes 14-Dec-2010]] | ||
| + | |||
| + | [[Meeting Minutes 8 March 2011]] | ||
| + | |||
| + | [[Meeting Minutes 15 March 2011]] | ||
| + | |||
| + | [[Meeting minutes 22 March 2011]] | ||
| + | |||
| + | [[Meeting Minutes 29 March 2011]] | ||
| + | |||
| + | [[Meeting Minutes 5 April 2011]] | ||
| + | |||
| + | [[Meeting Minutes 12 April 2011]] | ||
| + | |||
| + | [[Meeting Minutes 19 April 2011]] | ||
| + | |||
| + | [[Meeting Minutes 10 May 2011]] | ||
| + | |||
| + | ====Wiki Versions Of Documents==== | ||
| + | |||
| + | RPS Harmonization Proposals For New Concept Domains | ||
| + | |||
| + | * Regulatory Category: [[media:HL7_RPS_Reg_Category_v2.doc]] | ||
| + | * Context Of Use: [[media:HL7_RPS_Conext_Of_Use_v2.doc]] | ||
| + | * Keywords: [[media:HL7_RPS_Keyword_v2.doc]] | ||
| + | * Regulatory Status: [[media:HL7_RPS_Reg_Status_v2.doc]] | ||
| + | * RPS Document Type: [[media:HL7_RPS_Document_Type_v2.doc]] | ||
| + | |||
| + | |||
| + | [[RPS R3 Glossary]] for review and edit. | ||
| + | |||
| + | |||
| + | [[RPS: Life Cycle & Object State Transitions]] includes link to background information document questions for members to respond to. | ||
| + | |||
| + | |||
| + | [[RPS: Additional Model Constraints]] includes background information on constraints and potential errors and questions for members to respond to. | ||
| + | |||
| + | |||
| + | RPS Keywords: Discussion And Proposed Changes 6 June 2011 [[media:RPS_Keywords_v1.doc]] | ||
| + | |||
| + | |||
| + | A page has been added with an alternative RMIM for RPS: [[RPS_R2D2_Alternative_RMIM]] | ||
| + | |||
| + | ====HL7 Working Group Meeting May 2011==== | ||
| + | The following presentation was given to the HL7 WGM in Orlando, May 16, 2011. | ||
| + | [[File:201105_RPS_Status_Report_-_Joel_Finkle_FINAL.ppt]] | ||
| + | |||
| + | ====Background Information About HL7 v3 Models ==== | ||
| + | The following document is a tutorial on HL7 Modeling methodology. It is intended | ||
| + | to help members read the RPS model by explaining the basic concepts and terminology | ||
| + | used in HL7 v3 models, and describing how the model relates to an XML implementation. | ||
| + | [[Media:RPS_Modeling_Methodology_And_Terminology_v1.doc]] | ||
| + | |||
| + | ==RPS Release 2 DSTU Testing== | ||
| + | This section contains centrally-shared information relating to the DSTU Testing intitiative | ||
| + | |||
| + | ===Informational Documents (i.e. Plans, Rosters, Reference info, etc.)=== | ||
| + | |||
| + | [http://gforge.hl7.org/gf/download/docmanfileversion/5573/7151/RPS2DSTU-Sub-teamsRoster.xls DSTU Sub-team Roster] Last updated April 27, 2010 | ||
| + | |||
| + | [http://wiki.hl7.org/images/1/1b/RPSSchemas.zip Schema files] Zip file includes informational README file. | ||
| + | |||
| + | [http://gforge.hl7.org/gf/download/docmanfileversion/5604/7187/RPSTechnicalWalkthrough-JRock29-Apr-2010.pptx RPS Technical Walkthrough (J Rock, April 28, 2010)] Last updated May 5, 2010 | ||
| + | |||
| + | [http://gforge.hl7.org/gf/download/docmanfileversion/5625/7210/RPSR2ImplementationGuidedraft-Apr2010.doc RPS Release 2 Implementation Guide (draft)] Last updated May 13, 2010 | ||
| + | |||
| + | [http://gforge.hl7.org/gf/download/docmanfileversion/5626/7211/RPSTestBLA.zip Sample RPS R1 messages - Multiple BLA SubmissionUnits] Last updated May 13, 2010 | ||
| + | ''(NOTE: Recommend downloading and unzipping this zip file (which contains several folders and sub-folders) to your desktop for use.'' | ||
| + | |||
| + | ===Technical Team Information=== | ||
| + | [[RPS R2 DSTU Technical Team]] Meeting Information and Discussions | ||
| + | |||
| + | ===Controlled Vocabulary Team Information=== | ||
| + | [[RPS R2 DSTU Controlled Vocabulary Team]] Meeting Information | ||
| + | |||
| + | Phase 1 Controlled Vocabulary '''FINAL''' | ||
| + | *[http://gforge.hl7.org/gf/download/docmanfileversion/5773/7398/eCTD_RPS_R2_DSTU_codes20100719-v3.xls RPS R2 DSTU Controlled Vocabulary] <font color="red">'''UPDATED!''' July 20, 2010</font> | ||
| + | |||
| + | Phase 2 Controlled Vocabulary '''DRAFT''' | ||
| + | *[http://gforge.hl7.org/gf/download/docmanfileversion/5901/7629/eCTD_RPS_R2_DSTU_codes20101008-v1.xls RPS R2 DSTU Controlled Vocabulary] <font color="red">'''UPDATED!''' October 10, 2010</font> | ||
| + | |||
| + | |||
| + | Phase 1 Controlled Vocabulary '''DRAFT''' | ||
| + | *[http://gforge.hl7.org/gf/download/docmanfileversion/5645/7237/eCTD_RPS_R2_DSTU_codes20100520.xls RPS R2 DSTU Controlled Vocabulary (May 20, 2010)] SUPERSEDED | ||
| + | |||
| + | *[http://gforge.hl7.org/gf/download/docmanfileversion/5585/7166/eCTD_RPS_R2_DSTU_codes20100506.xls RPS R2 DSTU Controlled Vocabulary (May 6, 2010)] SUPERSEDED | ||
| + | |||
| + | ===Test Case Team Information=== | ||
| + | [[RPS R2 DSTU Test Scenario Team]] | ||
| + | |||
| + | [[Image:Test Scenario Remit.doc Test Case Team Remit]] May 17, 2010 | ||
| + | |||
| + | [http://gforge.hl7.org/gf/download/docmanfileversion/5640/7230/PhaseIScenarios.doc Phase 1 Scenarios '''FINAL'''] Last updated May 18, 2010 | ||
| + | |||
| + | [http://gforge.hl7.org/gf/download/docmanfileversion/5853/7556/Sept1_Phase2Scenarios.doc Phase 2 Scenarios (Draft)] Last updated September 22, 2010 | ||
| + | |||
| + | [http://gforge.hl7.org/gf/download/docmanfileversion/5644/7234/17May_RPSR2DSTUv1.xls Detailed Testing Scenario Spreadsheet] Last updated May 18, 2010 | ||
| + | |||
| + | [http://gforge.hl7.org/gf/download/docmanfileversion/5852/7555/Sept8_Phase2_details.xls Phase 2 Details] Last updated September 22, 2010 | ||
| + | |||
| + | [http://gforge.hl7.org/gf/project/rcrim/docman/?subdir=268 Link to DSTU Testing Files] Last updated September 23, 2010 | ||
==Regulated Product Submission Release 2== | ==Regulated Product Submission Release 2== | ||
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===ICH eCTD Requirements=== | ===ICH eCTD Requirements=== | ||
| − | To go to the ICH eCTD Requirements, click here [[Media: | + | To go to the ICH eCTD Requirements, click here [[Media:ICH_eCTD_NMV_Requirements-V4-0.pdf]] |
To go to ICH Requirements Discussions: [[RPS_ICH_Requirements]] | To go to ICH Requirements Discussions: [[RPS_ICH_Requirements]] | ||
| Line 48: | Line 174: | ||
To go to the Threaded Discussions discussion: [[RPS_Threaded Discussions]] | To go to the Threaded Discussions discussion: [[RPS_Threaded Discussions]] | ||
| − | ==Iteration 2== | + | ==Iteration 2 - SUPERSEDED BY DSTU INFORMATION ABOVE== |
To go to update Domain Analysis Model, click here [[RPS R2 Iteration 2 - DAM]] | To go to update Domain Analysis Model, click here [[RPS R2 Iteration 2 - DAM]] | ||
| Line 57: | Line 183: | ||
To go to updates to previous storyboards, click here [[RPS R2 Iteration 2 - Updated Storyboards]] | To go to updates to previous storyboards, click here [[RPS R2 Iteration 2 - Updated Storyboards]] | ||
| − | ==Iteration 1== | + | ==Iteration 1 - SUPERSEDED BY DSTU INFORMATION ABOVE== |
To go to the '''Business Scenarios''', click here [[Regulated Product Submission Release 2 (RPS R2) Business Scenario Development]] | To go to the '''Business Scenarios''', click here [[Regulated Product Submission Release 2 (RPS R2) Business Scenario Development]] | ||
| Line 67: | Line 193: | ||
To go to the '''Terminology Mapping Document''', click here [[Media:RPS Terminology revised 081105.doc]] | To go to the '''Terminology Mapping Document''', click here [[Media:RPS Terminology revised 081105.doc]] | ||
| − | === | + | ===Development Subgroup Information=== |
[[Media:RPS_Model.zip]] | [[Media:RPS_Model.zip]] | ||
| − | === | + | ===Testing Subgroup Information - SUPERSEDED BY DSTU INFORMATION ABOVE=== |
The Testing Subgroup goals and objectives are to ensure that R2 as developed meets both the requirements and the objectives set out by the team and uncovers any specific new requirements or implementation enhancements for future releases of RPS. The objective is to ensure enough varied stakeholder participation to ensure specific stakeholders get (sufficient) experience with the implementation of the RPS R2 model in order to validate that the model was implemented correctly and works for their specific needs as well as to make decisions on future requirements. | The Testing Subgroup goals and objectives are to ensure that R2 as developed meets both the requirements and the objectives set out by the team and uncovers any specific new requirements or implementation enhancements for future releases of RPS. The objective is to ensure enough varied stakeholder participation to ensure specific stakeholders get (sufficient) experience with the implementation of the RPS R2 model in order to validate that the model was implemented correctly and works for their specific needs as well as to make decisions on future requirements. | ||
| − | ====REVISED FINAL TEST CASE DOCUMENTS==== | + | ====REVISED FINAL TEST CASE DOCUMENTS - SUPERSEDED BY DSTU INFORMATION ABOVE==== |
[[Image:RPS_R2_Test_Case_PRE_SUB_MTG_RESPONSE_D2_Example_4_FDA_Comments.doc]] | [[Image:RPS_R2_Test_Case_PRE_SUB_MTG_RESPONSE_D2_Example_4_FDA_Comments.doc]] | ||
| Line 97: | Line 223: | ||
To come.... communication and educational material | To come.... communication and educational material | ||
| − | == | + | ==Regulated Product Submission Release 1== |
To link to content for '''Release One''' of the Regulated Product Submission Standard, click here | To link to content for '''Release One''' of the Regulated Product Submission Standard, click here | ||
[[https://gforge.nci.nih.gov/plugins/wiki/index.php?Regulated%20Product%20Submission&id=234&type=g]] | [[https://gforge.nci.nih.gov/plugins/wiki/index.php?Regulated%20Product%20Submission&id=234&type=g]] | ||
| − | ==How To | + | ==How To== |
How to view the RPS Listserve Forum and a thread of discussion, see attached [[Media:List Serve Forum Instructions.doc]] | How to view the RPS Listserve Forum and a thread of discussion, see attached [[Media:List Serve Forum Instructions.doc]] | ||
| Line 114: | Line 240: | ||
3. Download EA files from RPS R2 DAM page and open with viewer. | 3. Download EA files from RPS R2 DAM page and open with viewer. | ||
| − | == | + | ==RPS Resources== |
This section links to resources for RPS not found otherwise on this wiki: | This section links to resources for RPS not found otherwise on this wiki: | ||
Note that some HL7 links may require HL7 membership or paid subscription to ballot. | Note that some HL7 links may require HL7 membership or paid subscription to ballot. | ||
| Line 121: | Line 247: | ||
*[http://www.hl7.org/v3ballot/html/processable/multicacheschemas/schemas.htm HL7 Schemas] (scroll down to "Domain: Regulated Products") | *[http://www.hl7.org/v3ballot/html/processable/multicacheschemas/schemas.htm HL7 Schemas] (scroll down to "Domain: Regulated Products") | ||
*[http://nciterms.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C79148 NCI Thesaurus RPS Codes] (this frustratingly does not include a nice table of the codes, you have to browse them one-at-a-time) | *[http://nciterms.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C79148 NCI Thesaurus RPS Codes] (this frustratingly does not include a nice table of the codes, you have to browse them one-at-a-time) | ||
| + | |||
| + | RPS Codes for Testing | ||
| + | *http://gforge.hl7.org/gf/download/docmanfileversion/5406/6804/eCTD_RPS_codes.xls Posted by [[User:Martijames|Martijames]] 19:00, 11 January 2010 (UTC) | ||
| + | *http://gforge.hl7.org/gf/download/docmanfileversion/5405/6803/OIVD_510k_RPS_codes.xls Posted by [[User:Martijames|Martijames]] 19:00, 11 January 2010 (UTC) | ||
Latest revision as of 13:20, 3 January 2012
Return to RCRIM main page
Contents
- 1 Regulated Product Submission Release 3
- 2 RPS Release 2 DSTU Testing
- 3 Regulated Product Submission Release 2
- 4 Future Scope Discussions Topics
- 5 Iteration 2 - SUPERSEDED BY DSTU INFORMATION ABOVE
- 6 Iteration 1 - SUPERSEDED BY DSTU INFORMATION ABOVE
- 7 Regulated Product Submission Release 1
- 8 How To
- 9 RPS Resources
Regulated Product Submission Release 3
Project Information
Project Scope
[Project Scope Statement] (Approved)
Project Plan
Project Notes
Link_to_2010_Biweekly_Meeting_Information_and_Minutes
Project Meetings
RPS R3 Project Leadership Team Meeting Minutes
The Storyboards as of March 15, 2011: Media:RPS_storyboard_Package_2011-03-15.zip
The presentation on Life Cycle from the 1-Jun-2010 Meeting is here: Media:RPS_Document_Life_Cycle.zip
Link to PLT Meeting Minutes: 2-Mar-2010
Link to PLT Meeting Minutes: 16-Mar-2010
Wiki Versions Of Documents
RPS Harmonization Proposals For New Concept Domains
- Regulatory Category: media:HL7_RPS_Reg_Category_v2.doc
- Context Of Use: media:HL7_RPS_Conext_Of_Use_v2.doc
- Keywords: media:HL7_RPS_Keyword_v2.doc
- Regulatory Status: media:HL7_RPS_Reg_Status_v2.doc
- RPS Document Type: media:HL7_RPS_Document_Type_v2.doc
RPS R3 Glossary for review and edit.
RPS: Life Cycle & Object State Transitions includes link to background information document questions for members to respond to.
RPS: Additional Model Constraints includes background information on constraints and potential errors and questions for members to respond to.
RPS Keywords: Discussion And Proposed Changes 6 June 2011 media:RPS_Keywords_v1.doc
A page has been added with an alternative RMIM for RPS: RPS_R2D2_Alternative_RMIM
HL7 Working Group Meeting May 2011
The following presentation was given to the HL7 WGM in Orlando, May 16, 2011. File:201105 RPS Status Report - Joel Finkle FINAL.ppt
Background Information About HL7 v3 Models
The following document is a tutorial on HL7 Modeling methodology. It is intended to help members read the RPS model by explaining the basic concepts and terminology used in HL7 v3 models, and describing how the model relates to an XML implementation. Media:RPS_Modeling_Methodology_And_Terminology_v1.doc
RPS Release 2 DSTU Testing
This section contains centrally-shared information relating to the DSTU Testing intitiative
Informational Documents (i.e. Plans, Rosters, Reference info, etc.)
DSTU Sub-team Roster Last updated April 27, 2010
Schema files Zip file includes informational README file.
RPS Technical Walkthrough (J Rock, April 28, 2010) Last updated May 5, 2010
RPS Release 2 Implementation Guide (draft) Last updated May 13, 2010
Sample RPS R1 messages - Multiple BLA SubmissionUnits Last updated May 13, 2010 (NOTE: Recommend downloading and unzipping this zip file (which contains several folders and sub-folders) to your desktop for use.
Technical Team Information
RPS R2 DSTU Technical Team Meeting Information and Discussions
Controlled Vocabulary Team Information
RPS R2 DSTU Controlled Vocabulary Team Meeting Information
Phase 1 Controlled Vocabulary FINAL
- RPS R2 DSTU Controlled Vocabulary UPDATED! July 20, 2010
Phase 2 Controlled Vocabulary DRAFT
- RPS R2 DSTU Controlled Vocabulary UPDATED! October 10, 2010
Phase 1 Controlled Vocabulary DRAFT
Test Case Team Information
RPS R2 DSTU Test Scenario Team
File:Test Scenario Remit.doc Test Case Team Remit May 17, 2010
Phase 1 Scenarios FINAL Last updated May 18, 2010
Phase 2 Scenarios (Draft) Last updated September 22, 2010
Detailed Testing Scenario Spreadsheet Last updated May 18, 2010
Phase 2 Details Last updated September 22, 2010
Link to DSTU Testing Files Last updated September 23, 2010
Regulated Product Submission Release 2
1. Project Information
RPSr2 Project Scope Statement This document is accessed from an external site which requires a username and password. Read-only access is permitted with username of "anonymous" and a blank password
This is the page that we will add RPS specific information RPS Meeting Calendar
The RPS Glossary contains a list of terms, abbreviations and definitions used by the RPS project.
The RPS Project Management page contains the project plan and risks/issues/change management logs.
To link to content for the Regulated Product Submission Release 2, click here RPS R2 Project
2. Requirements Subgroup Information
Meeting Schedule: RPS_Requirements_Subgroup_Meetings
Future Scope Discussions Topics
The following scope topics should be considered for the next release/lifecycle of RPS:
Hyperlinking
To go to the Hyperlinking Discussion: RPS_Structure_and_Linking_Discussion
ICH eCTD Requirements
To go to the ICH eCTD Requirements, click here Media:ICH_eCTD_NMV_Requirements-V4-0.pdf
To go to ICH Requirements Discussions: RPS_ICH_Requirements
Master Files
To go to the Master Files Discussion: RPS_Master_Files
Multi-Regulator Submissions
To go to the Multi-Regulator Discussions: RPS_MultiRegulator_Submissions
Threaded Discussions
To go to the Threaded Discussions discussion: RPS_Threaded Discussions
Iteration 2 - SUPERSEDED BY DSTU INFORMATION ABOVE
To go to update Domain Analysis Model, click here RPS R2 Iteration 2 - DAM
To go to the Multi-Product Submission "DRAFT" Scenarios, click here RPS R2 Iteration 2 - Multi-Product Submissions
To go to the Multi-Regulator/Multi-Applicant Submission "DRAFT" Scenarios, click here RPS R2 Iteration 2 - Multi-Regulator Submissions
To go to updates to previous storyboards, click here RPS R2 Iteration 2 - Updated Storyboards
Iteration 1 - SUPERSEDED BY DSTU INFORMATION ABOVE
To go to the Business Scenarios, click here Regulated Product Submission Release 2 (RPS R2) Business Scenario Development
To go to the conceptual modeling discussion, click here Regulated Product Submission Release 2 (RPS R2) Conceptual Model
To go to the Storyboards, click here Regulated Product Submission Release 2 (RPS R2) Storyboards
To go to the Terminology Mapping Document, click here Media:RPS Terminology revised 081105.doc
Development Subgroup Information
Testing Subgroup Information - SUPERSEDED BY DSTU INFORMATION ABOVE
The Testing Subgroup goals and objectives are to ensure that R2 as developed meets both the requirements and the objectives set out by the team and uncovers any specific new requirements or implementation enhancements for future releases of RPS. The objective is to ensure enough varied stakeholder participation to ensure specific stakeholders get (sufficient) experience with the implementation of the RPS R2 model in order to validate that the model was implemented correctly and works for their specific needs as well as to make decisions on future requirements.
REVISED FINAL TEST CASE DOCUMENTS - SUPERSEDED BY DSTU INFORMATION ABOVE
File:RPS R2 Test Case PRE SUB MTG RESPONSE D2 Example 4 FDA Comments.doc
File:RPS R2 Test Case PMA BUNDLED QUESTIONS D1 Example 1 FDA Comments.doc
File:RPS R2 Test Case PMA BUNDLED ACTION D1 Example 2b FDA Comments.doc
File:RPS R2 Test Case IND HOLD D1 Example 2a FDA Comments.doc
File:RPS R2 Test Case BLA CBE to PAS C2 Example 2 FDA Comments.doc
5. Communications Team Subgroup Information
Meeting Schedule: RPS_Communications Team_Subgroup_Meetings
Communication Documentation
To come.... communication and educational material
Regulated Product Submission Release 1
To link to content for Release One of the Regulated Product Submission Standard, click here [[1]]
How To
How to view the RPS Listserve Forum and a thread of discussion, see attached Media:List Serve Forum Instructions.doc
How to download EA Lite - the Enterprise Architect Viewing tool:
1. Go to: Sparx Systems [2]
2. At the bottom of the page - you will see a link for EA Lite (under the zip icon); or download EA Lite[3], the FREE read-only version of Enterprise Architect. Registered users can distribute EALite when sharing UML models with customers and colleagues.
3. Download EA files from RPS R2 DAM page and open with viewer.
RPS Resources
This section links to resources for RPS not found otherwise on this wiki: Note that some HL7 links may require HL7 membership or paid subscription to ballot.
- RPS R1 Implementation Guide
- RPS R1 Ballot Information
- HL7 Schemas (scroll down to "Domain: Regulated Products")
- NCI Thesaurus RPS Codes (this frustratingly does not include a nice table of the codes, you have to browse them one-at-a-time)
RPS Codes for Testing
- http://gforge.hl7.org/gf/download/docmanfileversion/5406/6804/eCTD_RPS_codes.xls Posted by Martijames 19:00, 11 January 2010 (UTC)
- http://gforge.hl7.org/gf/download/docmanfileversion/5405/6803/OIVD_510k_RPS_codes.xls Posted by Martijames 19:00, 11 January 2010 (UTC)
