Difference between revisions of "Regulated Product Submissions"
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==RPS Release 2 DSTU Testing== | ==RPS Release 2 DSTU Testing== | ||
Revision as of 01:57, 29 March 2011
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- 5 Iteration 2 - SUPERSEDED BY DSTU INFORMATION ABOVE
- 6 Iteration 1 - SUPERSEDED BY DSTU INFORMATION ABOVE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
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)
