RCRIM Meeting Minutes

October 30, 2007 Teleconference

Attendees:

First Name / Last Name / Affiliation / E-mail Address
Greg / Anglin / Eli Lilly Canada /
Constanze / Coon / MSD, Inc. /
Julie / Evans / CDISC /
Gabriele / Fischer / Pfizer /
Scott / Getzin / Eli Lilly and Company /
Ed / Helton / CDISC / SAS /
Joyce / Hernandez / Merck /
David / Iberson-Hurst / CDISC /
Don / Kacher / Oracle /
Bron / Kisler / Duke Clinical Research Institute /
Rebecca / Kush / CDISC /
Peggy / Leizear / FDA /
Randy / Levin / FDA /
Jay / Levine / FDA / .
Charlie / Mead / Booz Allen Hamilton/NCI /
Jennifer / Neat / City of Hope /
Armando / Oliva / FDA /
Phil / Pochon / Covance /
Theresa / Quinn / NCI /
Jason / Rock / Global Submit /
Lise / Stevens / FDA /
Ed / Tripp / Abbott Laboratories /
Marti / Velezis / Booz Allen Hamilton /
Mead / Walker / Mead Walker Consulting /
Robert / Wallace / Amgen /
Steve / Ward / Lilly /
Cara / Willoughby / Eli Lilly and Company /
Diane / Wold / GSK /
Mark / Gray / FDA /
Saurin / Mehta / Novartis /
Steve / Sandburg / Mayo Clinic/Foundation
Richard / Furr / SAFE-Biopharma Association /
Pierre Yves / Lastic / Sanofi Aventis /

I.Intent to Ballot

Notification of Intent to Ballot was completed for:

a)CT lab message abnormality assessment DSTU

b)CMET for abnormality assessment DSTU (by M&M)

c)Clinical Research Functional Query SFM DSTU

d)eDCI DSTU

e)SPL r4 Committee

Action Item: Ed Helton will verify that the CR HER Profile intent to ballot was posted.

Subsequent to the meeting Armando Oliva informed the chairs that he heard from Suzanne Bishop from the EHR-CR Functional Profile working group and they are not going to make the January ballot. They are now shooting for the spring ballot.

II.Service Functional Model Specification: Clinical Research Functional Query

Marti walked the committee through a quick overview of the sections of the document.

III.First brief review and discussion of new CDISC HL7 Message Project Document (with closure of CDISC Content to Exploratory Message

A question was raised if people want to participate on the work on the project. Cara Willoughby expressed a desire to participate on the project.

It was proposed that a teleconference be established for the project and the small team prepares the materials to address the items outlined in the document above. The small work group would review the material prepared with the larger group prior to bringing it to RCRIM TC.

There was insufficient time left for the call to discuss in depth the proposed project plan "CDISC-HL7 Project Document". Armando Oliva introduced the plan described in the draft document, stating that the FDA had done Stage IA already and that the purpose of the document was to describe the results of the exploratory project so as to conclude that project at this time and provide a transition to an active HL7 project. Steve Ward pointed out that the document did not fully address the four deliverables that were requested at the 9/19/2007 meeting. Becky Kush mentioned that Stage IB was intended to address the requests for further information to wrap up the Exploratory Project such that it would no longer be Exploratory. Armando pointed out that this set of deliverables was not part of the original exploratory project scope statement.
Steve Ward expressed concern that a development project has not been 'approved' by RCRIM. Becky Kush recalled that RCRIM voted at the September Working Group meetings (Day 1) to move this beyond the exploratory stage, but that there were requests on Day 4 for the additional information that should be provided through the work described in Stage IB in the document. The minutes from that meeting did not reflect this view. Hence, it was acknowledged that these were semantic issues and various members disagreed how to interpret the Atlanta decision. Steve Ward stated that he felt Stages IA and IB represented the work authorized by the committee and should proceed but that the message development should not begin until a development project is approved. This exploratory project was initiated in 2006, however, and message development has already started. The draft Project Document proposes:

“Stages IB and II will occur in parallel. We see an iterative approach in conducting these two steps. The existing requirements in BRIDG will support initial stage II work. As stage IB progresses, additional requirements will support future stage II activity. Stage II will take into account the outputs of Stage IB."

The draft Project Document proposes, based upon action items from the September Working Group meetings, that a small group be convened by CDISC and FDA to conduct the work in Stage IB. The members of the group, along with 'sponsors' for this group, are listed in the document. The proposed group is comprised of representatives from those considered stakeholders. The document also proposes that this group report back regularly to RCRIM. Several on the telecon expressed an interest in getting the original parties who had expressed interest in this project together to have a regular call, as for the other RCRIM projects. Lise Stevens suggested that this open project-specific teleconference be held at regular intervals through HL7 and that the small group report back to this group on these calls. Mead clarified that the small work group would work on the tasks detailed in Stage IB and Steve agreed that work should proceed. Lise Stevens asked for input from those on the call. Hearing none, she stated that she stated that this indicated agreement to initiate the open project-specific teleconference calls and the small group. No disagreement was heard from the attendees on the call.

Action Items:

Jay Levine and Dave Iberson-Hurst will initiate the small group as described in the Project Document to perform the activities of Stage IB.
The HL7 RCRIM co-chairs will set up a regular project call for this project. (Post-teleconference - Armando Oliva and Ed Helton will facilitate this call.)

IV.SPL

The Government Projects SIG Co-Chairs would like to have a call with the RCRIM TC Co-Chairs to discuss the desire and feasibility of changing the stewardship of the HL7 SPL Standard to the HL7 Government Projects SIG for the purposes of facilitating a next version of SPL to meet additional requirements and further international regulatory implementation.

V.RCRIM Publishing Facilitator

Julie Evans is stepping down as RCRIM Publishing Facilitator.

RCRIM is looking for volunteers for this position. Those interested should contact the RCRIM co-chairs.