HL7 RCRIM Working Group Meeting Minutes
May 15, 2012
Tuesday Q1 Study Design Ballot Reconciliation
Attendees
First Name / Last Name / Affiliation / E-mail Address /Becky / Angeles / ScenPro /
Kathleen / Connor / Microsoft /
Smita / Hastak / Scenpro /
Ed / Helton / NCI /
Joyce / Hernandez / Merck /
Linda / King / Eli Lilly & Company /
Shy / Kumar / Datafarm /
Rebecca / Kush / CDISC /
Armando / Oliva / FDA /
Phil / Pochon / Covance /
Ed / Tripp / Edward S. Tripp and Associates /
Mead / Walker / Mead Walker Consulting /
Steve / Ward / Lilly /
Fred / Miller / Regulatory Informatics Consult. /
Behnaz / Minaei / FDA/CDRH /
Jean / Outeau / GPI /
I. Study Design Ballot Reconciliation Mead Walker
The summary of the balloting is in the table below.
Aff. / Neg. / Abst. / NVAffiliate / 0 / 0 / 14 / 2
Consultant / 0 / 1 / 3 / 2
Government/Non-Profit / 10 / 2 / 2 / 1
Payor / 0 / 0 / 0 / 0
Pharmaceutical / 3 / 12 / 0 / 2
Provider / 11 / 0 / 20 / 4
Vendor / 1 / 0 / 11 / 1
Totals / 25 / 15 / 50 / 12
% of Votes / 24.51% / 14.71% / 49.02% / 11.76%
Quorum / 88.24%
Approval / 24
The consolidated comments spreadsheet lists all votes cast and comments or reference to the uploaded comment spreadsheet.
The spreadsheet below is a consolidation of all comments uploaded via spreadsheet.
One Major Negative comment was discussed: study design not harmonized with BRIDG.
The expressed concern is that the study design model in BRIDG is not semantically equivalent to Study Design Structured Document that was created and balloted. A better approach would have been to start with BRIDG to design the RMIM, however this is not what the approved project scope statement had proposed. It started with the Study Design message, which is mostly in BRIDG.
Mead:FDA has provided a preliminary mapping to BRIDG. Although it was not part of the ballot, it was provided as a reference to the ballot. Jean-Henri performed the mapping as part of the Clinical Trials Repository (CTR) project, and he confirms that it adequately identifies the gaps. He also mentions that it doesn’t make sense tofully map this artifact to BRIDG; it makes more sense to harmonize a constrained implementation guide. The project did what it was supposed to do, according the scope statement.
Armando noted that the HL7 BRIDG Harmonization Process and Procedures document does not require BRIDG harmonization before the ballot. FDA has a concern that forcing harmonization before ballot will unacceptably slow down projects since BRIDG harmonization is not under the project team’sdirect control.
The group recognizes the benefits of harmonizing first with BRIDG and using BRIDG to define the RMIM. However, how do we move forward and not lose the work that has been performed to date?
The agreed resolution is to start with the existing BRIDG mapping document, update it as needed, and use that as the basis for conducting a BRIDG harmonization within the SCC, which will likely take a matter of weeks. This will be included in the DSTU package that gets published.
The text document below was submitted by Joyce Hernandez.
Comments from Joyce:
a) Can I use the path of TimePointEventCharacteristics to TimpointEventDefinition to define an activity occurring at the study level?
No you cannot use this path to define this activity, however there is another path in the model. There is an association between PlannedStudy and PlannedStudyActivity (component 3)
b) Should we had a priorityNumber that can be used to override the normal sequence of activitites given certain conditions?
We can and will consider.
c) ARM needs a code variable. The CDISC model contains both an ARM and ARMCD variables. We don't want to lose data we we transform from one format to another.
Yes we should add a code variable.
d) Have we addressed the overlapped between SD and SP. Can we define cohortgroups combinations in SD and reference them in SP?
There is no guidance that explains the overlap. We will look to Stage II group to address.
Yes. The SD message provides for groups.
e) Some miscellaneous questions:
a) Did we make repeatNumber optional? Not many activities repeat during a visit.
Yes
b) Can I use TimepointEventCharacteristic to link one or more activities in a visit?
Need to discuss with Stage II group.
c) Where is the link to the protocol (human readable) document? The human readable dpcument weill contain narratives which have not been broken down into the XML tagged entries.
The top level class has a text attribute that allows for insertion of an entire document and there are text sections that allow insertion or creation of text for these sections. Also can have a non XML body.
Tuesday Q2 Joint session with Patient Safety
First Name / Last Name / Affiliation / E-mail Address /Becky / Angeles / ScenPro /
Elaine / Ayres / NIH Clinical Center /
William / Gregory / Pfizer /
Nicholas / Halsey / European Medicines Agency /
Joyce / Hernandez / Merck /
John / Kiser / Abbott Laboratories /
Wayne / Kubick / Phase Forward /
Fumika / Kubota / PMDA /
Rebecca / Kush / CDISC /
Fred / Miller / Regulatory Informatics Consult. /
Behnaz / Minaei / FDA/CDRH /
Scott / Moss / EPIC /
Armando / Oliva / FDA /
Phil / Pochon / Covance /
Shonko / Sekine / Pharmaceuticals & Medical Devices /
Rik / Smithies / NPROGRAM Ltd /
Ed / Tripp / Edward S. Tripp and Associates /
Mead / Walker / Mead Walker Consulting /
Steve / Ward / Lilly /
Nat / Wong / HL7 Australia /
Julia / Zhang / Genzyme /
I. Study Design Mead Walker
Reconciliation continued so that all negatives could be addressed. See consolidate spreadsheet with disposition comments below:
II. PSUR Nick Halsey
Nick presented the following information on PSUR EU Process.
Tuesday Q3 PSUR – Joint Session with Patient Safety
First Name / Last Name / Affiliation / E-mail Address /Becky / Angeles / ScenPro /
William / Gregory / Pfizer /
Margaret / Haber / NCI /
Ed / Helton / NCI /
John / Kiser / Abbott Laboratories /
Fred / Miller / Regulatory Informatics Consult. /
Behnaz / Minaei / FDA/CDRH /
Shree / Nath / Pointcross Life Sciences /
Tomoko / Okudaira / PMDA /
Armando / Oliva / FDA /
Shohko / Sekine / PMDA /
David / Sperzel / Apelon, Inc /
Ed / Tripp / Edward S. Tripp and Associates /
Mead / Walker / Mead Walker Consulting /
Steve / Ward / Lilly /
Julia / Zhang / Genzyme /
Vivienne / Zhu / Regenstrief Institute, Inc. /
I. PSUR - Continued Mead Walker
The workgroup wants to determine if BRIDG can be used for a DAM or as a start of a DAM.
Nick walked the group through his high level model.
Becky and Smita reviewed the BRIDG Adverse Event subdomain, to identify if there is potential for use to expedite DAM development.
Patient Safety will consider hosting work sessions (on Wednesdays) with RCRIM members invited. Updates and announcement of work sessions will occur at the Tuesday RCRIM teleconference.
Tuesday Q4 SPL Ballot Reconciliation
First Name / Last Name / Affiliation / E-mail Address /Lee / Coller / Oracle /
William / Gregory / Pfizer /
Ed / Helton / NCI /
Behnaz / Minaei / FDA/CDRH /
Armando / Oliva / FDA /
David / Sperzel / Apelon, Inc /
Marti / Velezis / Sonrisa Consulting /
Steve / Ward / Lilly /
Julia / Zhang / Genzyme /
I. SPL Ballot Reconciliation TBD
The summary of the balloting is in the table below.
Aff. / Neg. / Abst. / NVAffiliate / 0 / 0 / 24 / 1
Consultant / 2 / 1 / 1 / 1
Government/Non-Profit / 3 / 9 / 1 / 1
Payor / 0 / 0 / 0 / 0
Pharmaceutical / 1 / 6 / 0 / 3
Provider / 14 / 0 / 15 / 4
Vendor / 0 / 3 / 14 / 3
Totals / 20 / 19 / 55 / 13
% of Votes / 18.69% / 17.76% / 51.40% / 12.15%
Quorum / 87.85%
Approval / 30
The consolidated comments spreadsheet lists all votes cast and comments or reference to the uploaded comment spreadsheet.
The spreadsheet below is a consolidation of all comments uploaded via spreadsheet.
Ballot comment uploaded via Word document:
There were 2 co-chairs and 7 members, one member short of quorum. The ballot reconciliation could not proceed. The principal negative comment is the lack of backwards compatibility between R2 and R1. The proposed solution is an SPL schema that supports both R1 and R2 datatypes. What should a stakeholder do if they wish to use R2 dataypes?
The proposed plan is to:
a) Schedule a joint resolution meeting with the appropriate representatives from the following work groups: InM, MnM, Publication, RCRIM and CPM in the week following the May WGM
· Determine what will be supported for backwards compatibility
· Determine if both R1 and R2 datatypes will be supported by the solution
· Plan for reconciling the supporting materials (e.g., schemas) in the publication materials that are included in the HL7 v3 Normative Edition
b) Debrief back to RCRIM
· Add an agenda item to the RCRIM meeting following the joint resolution meeting
· Debrief RCRIM WG members on the results of the joint resolution meeting
· Determine the next steps for the Ballot Reconciliation - will the negative votes be removed by the recommended resolution or will another ballot cycle be required to bring SPL R5 to a Normative status?
We plan to have a brief meeting tomorrow Q2 to review their plan of action to move this forward.
End of Document
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