RCRIM Meeting Minutes
March 10, 2006 Teleconference
Attendees:
Name
Phil
Greg
Landen
Bob
Barry
Carol
Julie
Doug
Anuta
Anblin
Bain
Birmingham
Brown
Creech
Evans
Frisma
Margaret
Bron
Haber
Kisler
Randy
Peggy
Phil
Jason
Alex
Ed
Mead
Levin
Leizear
Pochon
Rock
Ruggieri
Tripp
Walker
Cara
Willoughby
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Affiliation
E-mail Address
Bryn Mawr Partners
panuta@brynmawrpartners.com
CDISC
J&J
Mortara Instrument, Inc.
lbain@topsailtech.com
rbirming@prdus.jnj.com
barry.brown@mortara.com
CDISC
University of Pittsburgh
(CDISC)
NCI
Duke Clinical Research
Institute
FDA
FDA
Covance
Global Submit
Amgen
Abbott Laboratories
Mead Walker
Consulting
Lilly
jevans@cdisc.org
fridsma@cbmi.pitt.edu
mhaber@mail.nih.gov
bkisler@cdisc.org
randy.levin@fda.hhs.gov
peggy.leizear@fda.hhs.gov
Phil.Pochon@covance.com
jason.rock@globalsubmit.org
alex.ruggieri@amgen.com
edward.tripp@abbott.com
dmead@comcast.net
willoughby_cara_e@lilly.com
I.
Ballot Readiness
The CTLab ballot has been submitted for posting. There is now an
officially accepted CMET from Clinical Genomics
Regulated Product Submissions material has been submitted to Julie
Evans for the ballot preview. Phil Anuta has been identified to lead the
DSTU testing. Within the FDA Peggy Leizear has been working across the
centers to obtain input and support for the message. The Device and
Pharmaceutical representatives have harmonized the model and
terminology.
GIN is working to complete the ballot reconciliation package. Following the
meeting, the package was completed on Tuesday, March 14, 2006.
II.
HL7 RCRIM Out-of-Cycle Meeting
The April 25, 2006 Out-of-Cycle meeting in Berlin, Germany is enrolled to
capacity. Landen will attempt to arrange for a larger room that could
accommodate up to 50 participants. It was agreed that there would be no
teleconference for this meeting. The agenda for the meeting is attached
below.
III.
SPL Project Documents
Bob Birmingham had previously routed for comments the RCRIM Project
Roster and the SPL Project Description. It was agreed that Ed Tripp would
take responsibility for updating the project roster. Bob will incorporate
comments he has received to date on the Project Description. He will post
it to the RCRIM listserve and the document will be reviewed for
acceptance at the next teleconference.
IV.
Harmonization
Harmonization proposals have all been submitted.
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