RCRIM Meeting Minutes

02-05 May 2005

Attendees:

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I. Monday Q3: Business meeting

a) Acceptance of WG minutes; teleconference decisions

Minutes from January WG meeting were approved.

Linda reviewed decisions and action items from teleconferences since last WG meeting (Word document—LQ)

b) Proposal for new project (Word document—BT)

Randy Levin and Barbara Tardiff presented a proposal for a project to develop a general purpose message to support submissions from sponsors to regulatory authorities. Linda Quade made a motion to approve, Don Kacher seconded. The motion carried unanimously.

There was considerable discussion about what to call the project. The agreed upon working name will be Regulated Product Submission. As other options are identified they will be brought forward and discussed.

The goal is to have a draft specification for discussion at the next WG meeting.

II. Monday Q4: Domain Space Analysis Model

c) Update on development of DAM; ODM-RIM mapping; DAM-RIM mapping project update. (PowerPoint-DF)

Doug Fridsma provided an update on the development of the domain analysis project. The CDISC problem space model/domain space analysis model, the HL7 Domain Analysis Model and the caBIG Structured Protocol Representation (caSPR) are all one and the same.

Have moved from Rational Rose XDE to Enterprise Architect. Has been beneficial in uncovering model defects and allowing for enhance collaboration.

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RCRIM adopted model as HL7 Domain Analysis Model for RCRIM in January 2005.

Doug presented a list of possible names. It was suggested that we use the HL7 term DAM as the generic term and then come up with a specific name that describes the RCRIM instance.

III. Tuesday Q1: SPL

d) R2 ballot reconciliation: Gunther reviewed the ballot results and comments to the ballot. [spreadsheet GS]

One negative ballot expressed concern that the ballot was not yet mature. The committee felt that the standard was robust and had been through considerable review and testing. A motion was made to consider this non persuasive. 16 affirm, 0 negative, 3 abstain.

A motion was made to adopt the proposed resolution discussed and move forward with requesting withdrawal of negative ballots.

ACTION ITEM: Gunther will upload the updated spreadsheet with comments to ballot web site and notify negative balloters as to resolutions, requesting withdrawal of negative ballots.

e) R2 implementation guide draft discussion;

Implementation guide will be updated to reflect R2 specification and any additional learning from pilot projects, testing, and early adopters. Plan is to ballot next cycle.

Expectation that there will quite of bit of discussion around implementation of section 6 when that occurs.

f) PIM to SPL translation guide

Deferred until Thursday session.

Gunther reviewed and walked through the SPL R-MIM. [PowerPoint-GS]

IV. Tuesday Q2: Drug Stability Reporting

g) Drug Stability Reporting:

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Ballot was approved with no negative ballots and will be submitted for approval as an ANSI standard.

h) Drug Stability Reporting Implementation Guide.

Norbert Bittner from uptodata will lead the team working on the implementation guide.

Organizations were asked to solicit involvement in this group to engage in piloting, authoring implementation guide.

ACTION ITEM: Norbert to launch implementation guide effort. This team will use the existing web site for communications. The plan is to ballot in the January

ACTION ITEM: Ed Tripp to work with PhRMA HL7 Task Force to reengage an industry group. He will report to the RCRIM list serve.

i) Periodic reporting of CT Lab data

Phil Pochon presented an update on progress on the Implementation Guide.

ACTION ITEM: Phil will distribute draft Implementation Guide via RCRIM web server. The plan will be to ballot in September cycle.

V. Tuesday Q3: Domain Space Analysis Model (cont.)

j) Model management

Doug Fridsma prevented some introductory comments and concerns. [PowerPoint-DF]

There was discussion regarding concerns, needs and issues around the DAM.

Doug proposed some suggestions as to how we might be able to move forward. Ed suggested that we represent the need for input from pharma and vendors.

ACTION ITEMS/AGREEMENTS:

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1. We will try process as described by Doug out and see how it works to support both model maintenance and continued development.

2. Doug will be accountable for overseeing the process and clarifying where there is confusion as to handle or proceed with a given issue.

3. We will use the RCRIM list serve (Domain Analysis Model/RIM project list) for communications. An agenda item for a model update will be included as regular item on the RCRIM teleconferences.

4. We will proceed with normalization of existing messages. Anita Benson/Lise Stevens will take the lead on ICSR. Linda Quade will take the lead on the Periodic Reporting of CT Lab data.

5. We will start building a list of guiding principles, objectives—what does a well-functioning future look like.

6. We are proceeding with message development in the content of the DAM.

a. The NCI under the early adopter program is developing an eCRF message.

b. RCRIM per project approved yesterday is developing a message for regulatory submissions. This message will require development of this subdomain within the DAM.

7. Agenda items for next WG meeting: check of process (what is working and what is not working), review of guiding principles, and discussion of results of mapping/harmonization efforts.

VI. Tuesday Q4: Vocabulary (Joint with Clinical Genomics and Patient Safety SIG)

k) Update of progress of group [PowerPoint-SB]

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Susan Bassion presented an update of the meetings and progress of the terminology team. This team is a joint effort of CDISC, FDA and HL7 and within HL7, RCRIM, Patient Safety SIG and Clinical Genomics SIG.

There are concern that the rush to get terms defined for SDTM we may not realize opportunities to harmonize across related standards.

Susan encouraged folks to contact her to get involved.

They are working on a terminology web site. It was suggested that this be at a minimum linked and at best coordinated through the HL7 web site.

VII. Wednesday Q1: Joint with Clinical Genomics

l) Report of Clinical Genomics RCRIM project

Amnon Shabo presented an update on HL7 Clinical Genomics Current Work [PowerPoint—AS]

Genotype shared model: ongoing work to develop storyboards and use case in tissue typing, cystic fibrosis, pharmacogenomics, and BRCA.

Amnon reviewed the genotype model that was recently balloted.

Genotype CMET approved on second DTSU ballot. Main comments: harmonize with clinical statement, need to register CMET with common domains so that family history, OO/Lab, and RCRIM models can use it.

Discussed time frame for comment as DTSU. Given interest in balloting Pharmacogenomics message at normative level starting around end of year it may be useful to limit comment period to 6 months.

Will be presenting at PHIN (public health information network).

m) Clinical Genomics RCRIM message update [PowerPoint—PP]

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Phil Pochon reviewed the options for approaching the PG message and the potential issues that may need to be worked through.

Key clinical genomics additions: Genetic profile act—allows multiple gene analyses; allows some redundancy between expression data (MAGE) and HL7.

May need to modify basic CT lab message to ensure flexible enough to handle early stage and animal studies, May need involvement of additional domain expertise.

A number of groups have been identified to work on use cases to accommodate: lab to sponsor, biotech to lab, sponsor to regulatory authority, cancer research center to caBIG, etc. Use cases are differentiated by genetic test method, therapeutic area, etc.

Final object model is union of use cases; regulatory submission is probably minimal model. Object model should fit CDISC CT Domain model as well as rendered into HL7 R-MIM. Will need to fill vocabulary holes.

Target is a draft for review at next WG meeting to be balloted at committee level in December.

VIII. Wednesday Q2: Joint with Clinical Decision Support (see earlier presentation)

Doug Fridsma presented an overview of the work done on the Domain Analysis Model.

Discussion focused on understanding how CDS and RCRIM were approaching understanding and implementing protocols.

Ross Martin described what CDS is doing to support prior authorization associated with ePrescribing as a simpler process example.

One approach might be to build a common model across all of the representations.

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Has been very useful brainstorming and sharing ideas and perspectives across two groups. Next joint session should be focused on a few key areas; these could include both process and well as message structure issues.

ACTION ITEM: Samson Tu, Doug Fridsma, Don Kacher and an additional representative from CDS will form a small task force to discuss and determine agenda for next meeting. We will plan to meet again Wednesday Q2 with RCRIM hosting.

IX. Wednesday Q3: Joint session with PSSIG

n) ICSR: status and scope of Implementation Guide

Formally approved as ANSI standard 25 April 2005.

o) Changes to mission and charter

Mission and charter update to reflect RCRIM as parent TC.

ACTION ITEM: Lise Stevens will forward updated mission and charter to ARB. Pending final approval will ensure HL7 web site updated to reflect new charter.

p) Generic Incident Notification (GIN)

Chris provided an overview of the GIN.

There are three areas of activity: Looking across the three models (GIN, ICSR, and Case Notification Report), looking for pieces that can be replicated, and creating an analysis model and incorporating in the RCRIM DAM. Charlie suggested that the last effort be done first within the domain space covered by these three messages and then integrate this analysis model into the RCRIM DAM.

There were 43 votes with substantive comments. Plan is to respond to the comments but not ask for retraction of negatives.

Comments fell into three general categories: scoping, technical comments, typographical corrections. [spreadsheet listing comment.]

Chris reviewed the comments. Are adopting most of comments.

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Plan is to incorporate comments, clarify the differences in scope between the three messages, look across the messages for structural consistency and opportunities to encapsulate common elements. It was emphasize that it would be helpful to create an analysis model for the “notification” business process area that could be incorporated into/harmonized in the RCRIM HL7.

ACTION ITEM: Plan is to ballot at Committee level this coming cycle.

X. Wednesday Q4: Unfinished business. Planning for next working group meeting

XI. Thursday Q1: SPL to PIM

q) SPL to PIM

Lori Baranoski presented an overview of the SPL and the work that the SPL Working Group has done. [PowerPoint—LB]

Question revolved around clarification of difference between SPL and PIM.

Tim Buxton presented an overview of PIM [PowerPoint—TB]

Steve Gitterman proposed that is the elements are harmonized across then the coded data elements could be used by both and gain advantages of both.

ACTION ITEM: Steve Gitterman, Tim Buxton, and Mukesh Mehta will explore representation of PIM data elements and components into SPL. Tim is occupied until November 2005 in release of PIM but much of the work can be done from available documentation.

XII. Thursday Q2: Stability

r) RCRIM eStability Early Adopter program

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Norbert Bittner presented an overview of the up to data participation in the early adopter program. [PowerPoint—NB]

Took RCRIM stability specification and incorporated in to iStudyReporter v2 to allow creation of HL7 eStability from any LIMS.

Norman demonstrated the iStudyReporter.

Could create separate message to support use case of transfer of data from CRO to sponsor that is more complete than current message. Both would operate off of the same R-MIM.

ACTION ITEM: Norbert and Norman will pursue development of Implementation Guide and engagement with Ed with PhRMA.

XIII. Thursday Q2

s) Discussion of opportunities to engage more diverse domain expertise and perspective including European community (vendors, regulators, pharma reps based in EU, research organizations).

Meeting in Europe very important (usually 90% US 10% ROW at HL7, this meeting around 50%/50% with approx. same total attendance).

Having out of cycle meetings in Europe proposed as one approach.

Proposal for out of cycle meeting this summer in Europe.

Could be joint with another meeting. CDISC may be willing to be recognized as cosponsor

Agenda could be focused on RCRIM DAM and launch of HDF process for new messages (eCRF, regulated product submission). Would include invitation to participate in message development projects.

Suggested logistics: 2-3 days, could get organization to donate room, ask HL7 board for support for meals and refreshments, early July probably optimal time this summer (late July and August conflict with European holiday times).

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If in Paris, Charlie Mead might be able to participate and present DAM.

ACTION ITEMS:

Randy Levin will on board approval process for out of cycle meeting.

Landen Bain will check on CDISC interest in co-sponsoring/hosting.

Randy and Tim Buxton will approach regulators for participation.Landen will work on identifying possible hosts and potential dates.

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