Difference between revisions of "Regulated Product Submissions"

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1 Regulated Product Submission Release 3
- 1.1 Project Information
2 RPS Release 2 DSTU Testing
3 Regulated Product Submission Release 2
- 3.1 1. Project Information
- 3.2 2. Requirements Subgroup Information
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5 Iteration 2 - SUPERSEDED BY DSTU INFORMATION ABOVE
6 Iteration 1 - SUPERSEDED BY DSTU INFORMATION ABOVE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 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.)

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

RPS R2 DSTU Controlled Vocabulary (May 20, 2010) SUPERSEDED

RPS R2 DSTU Controlled Vocabulary (May 6, 2010) SUPERSEDED

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

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.

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)

@@ Line 10: / Line 10: @@
 [[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====
@@ Line 16: / Line 18: @@
 ====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==
@@ Line 50: / Line 158: @@
 ===ICH eCTD Requirements===
-To go to the ICH eCTD Requirements, click here [[Media:ICH eCTD NMV Requirements-V1-0.pdf]]
+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]]
@@ Line 66: / Line 174: @@
 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]]
@@ Line 75: / Line 183: @@
 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]]
@@ Line 85: / Line 193: @@
 To go to the '''Terminology Mapping Document''', click here [[Media:RPS Terminology revised 081105.doc]]
-=== 3. Development Subgroup Information===
+===Development Subgroup Information===
 [[Media:RPS_Model.zip]]
-===4. Testing 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====
+====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]]
@@ Line 115: / Line 223: @@
 To come.... communication and educational material
-==6.Regulated Product Submission Release 1==
+==Regulated Product Submission Release 1==
 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]]
-==How To:==
+==How To==
 How to view the RPS Listserve Forum and a thread of discussion, see attached [[Media:List Serve Forum Instructions.doc]]
@@ Line 132: / Line 240: @@
 .  Download EA files from RPS R2 DAM page and open with viewer.
-==7.RPS Resources==
+==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.
@@ Line 143: / Line 251: @@
 *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)
-==8. 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: http://gforge.hl7.org/gf/download/docmanfileversion/5573/7151/RPS2DSTU-Sub-teamsRoster.xls
-  Schema Files (Zipped, includes informational README file): http://wiki.hl7.org/images/1/1b/RPSSchemas.zip
-  RPS Technical Walkthrough (J Rock, April 28, 2010):   http://gforge.hl7.org/gf/download/docmanfileversion/5604/7187/RPSTechnicalWalkthrough-JRock29-Apr-2010.pptx
-  RPS Release 2 Implementation Guide (draft): http://gforge.hl7.org/gf/download/docmanfileversion/5625/7210/RPSR2ImplementationGuidedraft-Apr2010.doc
-  Example RPS Code:  BLA Multiple Sequence: http://gforge.hl7.org/gf/download/docmanfileversion/5626/7211/RPSTestBLA.zip
-  ''(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
-*[http://gforge.hl7.org/gf/download/docmanfileversion/5585/7166/eCTD_RPS_R2_DSTU_codes20100506.xls RPS R2 DSTU Controlled Vocabulary (May 6, 2010)]
-*[http://gforge.hl7.org/gf/download/docmanfileversion/5645/7237/eCTD_RPS_R2_DSTU_codes20100520.xls RPS R2 DSTU Controlled Vocabulary (May 20, 2010)]
-===Test Case Team Information===
-[[RPS R2 DSTU Test Scenario Team]]
-Test Case Team Remit  [[Image:Test Scenario Remit.doc]]
-Phase 1 Scenarios '''FINAL''':[http://gforge.hl7.org/gf/download/docmanfileversion/5640/7230/PhaseIScenarios.doc]
-Phase 2 Scenarios DRAFT_May17th: [http://gforge.hl7.org/gf/download/docmanfileversion/5641/7231/Phase2Scenarios.doc]
-Detailed Scenario Spreadsheet  [http://gforge.hl7.org/gf/download/docmanfileversion/5644/7234/17May_RPSR2DSTUv1.xls]
-Test Documents:
-Application A:  DMF files [http://gforge.hl7.org/gf/project/rcrim/docman/?subdir=272]
-Application B Sequence 0000 [http://gforge.hl7.org/gf/project/rcrim/docman/admin/?subdir=274]
-Application B Sequence 0003 [http://gforge.hl7.org/gf/project/rcrim/docman/?subdir=275]