RCRIM Meeting Minutes

February 10, 2006 Teleconference

Attendees:

Name / Affiliation / E-mail Address
Phil / Anuta / Bryn Mawr Partners /
Anita / Benson / DataScene /
Bob / Birmingham / J&J /
Barry / Brown / Mortara Instrument, Inc. /
Julie / Evans / CDISC /
Pavla / Frazier / Management Systems Designers, Inc. /
Doug / Frisma / University of Pittsburgh (CDISC) /
Norman / Gregory / FDA /
Joyce / Hernandez / IBM /
Julie / Hurley / RWD /
Bron / Kisler / Duke Clinical Research Institute /
Randy / Levin / FDA /
Charlie / Mead / Oracle /
Don / Patrick
Phil / Pochon / Covance /
Jason / Rock / Global Submit /
Chris / Tolk
Ed / Tripp / Abbott Laboratories /
Mead / Walker / Mead Walker Consulting /
Diane / Wold / GSK

I.  Ballot Readiness

The Regulated Product Submission materials are ready to be sent to ballot as a DSTU. There is still an open question of domain for this standard. A motion to approve the RPS standard for ballot as a DSTU passed, with 15 affirmative and 0 negative votes.

The stability implementation Guide has addressed all issues from the last ballot. The team would like to post intent to ballot. A motion to approve Stability Implementation Guide for ballot as an informative document passed, with 15 affirmative and 0 negative votes.

CT Lab message intends to ballot as a DSTU. A motion to approve the CT Lab 2 message for ballot as a DSTU passed, with 16 affirmative and 0 negative votes.

GIN intends to ballot at committee level. A motion to approve the GIN message for committee ballot passed, with 9 affirmative and 0 negative votes.

II.  SPL Update

The SPL leadership met at the FDA White Oak Facility on February 3, 2006.

·  Lori Baranoski from Bristol Meyers Squibb will be leading the SPL team.

·  Steve Gitterman of FDA will lead the development of the implementation guide.

·  Keith Thomas of I4I and Leander Fontaine of Pharmiceutics will lead the technical team

The technical team anticipates that there may be 1-4 schema changes necessary to support compliance with Physician’s Labeling Rule (effective June 30, 2006). There is one known schema change that is required for packaging. Due to the pressing timeline for PLR implementation the team will focus on implementation issues and ballot the changes in the fall ballot cycle

·  Kris Spahr will continue to work on the team and will become the liaison to PhRMA ERS.

·  Bob Birmingham will be the HL7 liaison

Bob will update the SPL RCRIM project plan.

The version 2 standard is being sent to ANSI, however, the team believes it is best to wait for version 3 before applying for the standard to become an ANSI standard due to know changes that will need to be make to version 2. Randy will communicate the concern to Karen Van Hentenryck.

III.  Harmonization

Pavla sent out the harmonization proposal and Randy will upload the documents.

There is a proposal for body position codes for ECG messaging that are also useful for vital sign collection. A motion to send the body position codes to harmonization was amended to change the description to observable positions passed, with 18 affirmative and 0 negative votes.

IV.  ICSR CMET

The technical committee was asked to comment on the ICSR CMET extensions. Mead indicated that the issues should be discussed jointly between RCRIM and PSSIG.

Lise Stevens will cross post the both list serves to pull together a meeting of the appropriate interested parties from both groups.


HL7_Meeting_Minutes_2006-0210.doc