Regulated Product Submissions

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Regulated Product Submission Release 3

Project Information

Project Scope

[Project Scope Statement] (Approved)

Project Plan

[RPSr3 Project Plan]

Project Notes

Link_to_2010_Biweekly_Meeting_Information_and_Minutes

Project Meetings

RPS R3 Project Leadership Team Meeting Minutes

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

• RPS R2 DSTU Controlled Vocabulary (May 20, 2010) SUPERSEDED

• RPS R2 DSTU Controlled Vocabulary (May 6, 2010) SUPERSEDED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