Meeting minutes 22 March 2011

Notes from RPS R3 WG Teleconference 22 March 2011

The 22-Mar RPS meeting focused on reviewing some of the critical ballot package documents which were circulated prior to the meeting. These documents are still 'in progress' and input is requested from all stakeholders to improve the clarity and focus of these documents prior to ballot. Any issues with these documents should be addressed prior to ballot so please review and provide comment now.

1. Review of Submission Message Modelv3 document

Keith reviewed the relationship between the RPS Reference Model (PORP_RM000001UV.html) and the Submission Message Model document.

Comments from telecon:

• submission is misspelled ("submisson") in a couple of places in the Reference Model

• not all 'subject' relationships are numbered in the Reference Model; there are specific references to subject relationships in the Message Model document which are not specifically shown in the Reference Model (e.g., subject1, subject2, subject7)

Action: RPS participants are requested to review this document and submit corrections/changes/requests for clarification to the RPS List Serve by 11-April-2011.

2. Review of R3 Glossary document

Keith reviewed the layout of the Glossary document and the purpose of each column. Column 2 displays the current descriptive note or attribute comment from the submission message definition of the Term in the RPS Model. Column 3 provides proposed revisions to some of these descriptions. Column 4 provides a definition to be used in the glossary. It is intended to be consistent with submission message definitions but framed in more general business terms to assist users of the standard in understanding the purpose and use of the term in the RPS message.

Action: RPS participants are requested to review this document and submit corrections/changes/requests for clarification to the RPS List Serve by 11-April-2011.

Action: Keith/Joel to evaluate whether the content of the Message Model document can be placed on the RPS wiki to enable easier collaboration among RPS team members (versus circulating 'track changes' Word files).

3. Review of Model Walkthrough document

Joe presented the current version of the Model Walkthrough document. The purpose of the document is to provide a more business-oriented review of the elements of the message standard and their intended usage. It was reaffirmed that the Model Walkthrough document, as well as the other documents discussed today, are intended to support all implementations of the message standard and are thus regulated product class agnostic. Implementation Guides (e.g., ICH Implementation Guide) would be developed to support the implementation of the message standard in a particular regulated product class.

Action: RPS participants are requested to review the Model Walkthrough documents and submit corrections/changes/requests for clarification to the RPS List Serve by the morning of 28-March-2011 for review at the next RPS Meeting on 29-March.