Regulated Product Submissions
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Contents
Regulated Product Submission Release 3 (Proposed)
Project Information
Project Scope
RPS R3 Project Scope Statement (proposed) - The project scope statement is being discussed at several January meetings (RPS and RCRIM meetings on January 5,2010; Phoenix WGM - Tuesday, January 19, 2010)
Pending Project Approval - stay tuned for more details.
Project Notes
Link_to_2010_Biweekly_Meeting_Information_and_Minutes
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-V1-0.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
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
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
3. Development Subgroup Information
4. Testing Subgroup Information
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
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
6.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.
7.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)
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:
