HL7 RCRIM Working Group Meeting Minutes



Tuesday Q1 RPS

Attendees

|First Name |Last Name |Affiliation |E-mail Address |

|Louis |Boulay |Health Canada |Louis.boulay@nc-sc.gc.ca |

|Isabelle |Davias |Sanofi Aventis |isabelle.davias@sanofi- |

|Frank |Faunce |Abbott Laboratories |frank.faunce@ |

|Myron |Finseth |Medtronic |myron.finseth@ |

|William |Friggle |Sanofi Aventis |William.Friggle@sanofi- |

|Scott |Getzin |Eli Lilly and Company |sgetzin@ |

|Gary |Ginsinger |FDA |gary.gensinger@fda. |

|Mark |Gray |FDA |mark.gray@fda. |

|Norman |Gregory |FDA |norman.gregory@fda. |

|Ed |Helton |NCI |heltone2@mail. |

|Jared |Lantzy |FDA/CDER |jared.lantzy@fda. |

|Behnaz |Minaei |FDA/CDRH |behnaz.minaei@fda. |

|Armando |Oliva |FDA |armando.oliva@fda. |

|Terrie |Reed |FDA |terrie.reed@fda. |

|Mitra |Rocca |FDA |Mitra.Rocca@fda. |

|Karin |Sailor |Medtronic |karin.sailor@ |

|Ed |Tripp |Edward S. Tripp and Associates |edward.tripp@ |

|Marti |Velezis |Sonrisa Consulting |marti.velezis@ |

|Mike |Ward |Health Canada |mike.ward@hc-sc.gc.ca |

I. RPS update and IG status Mark Gray

Mark presented the following slides.

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During ballot reconciliation (on teleconference) there were a number of items marked as “Referred and Tracked”, although these items are usually marked for handing off to another work group, in this case these are to be tracked during DSTU testing to determine if these comments need to be addressed by changes in the specification.

It is expected that an implementation guide will be developed in reference to the material that will be balloted as normative. It may be a high level IG that indicates areas where localization should occur for specific products or Health Authorities.

II. IMDRF work plan and outstanding issues TBD

Mike Ward Presented the following

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It was suggested that once a device specific TOC is developed it would be appropriate to develop an associated storyboard and test for the DSTU.

Tuesday Q2 Joint Meeting with O&O

O&O is hosting see O&O Minutes for attendance.

Tuesday Q3 PSUR (Joint with Patient Safety

|First Name |Last Name |Affiliation |E-mail Address |

|Jamie |Cash |Abbott Nutrition |jamie.cash@ |

|Isabelle |Davias |Sanofi Aventis |isabelle.davias@sanofi- |

|Frank |Faunce |Abbott Laboratories |frank.faunce@ |

|Myron |Finseth |Medtronic |myron.finseth@ |

|William |Friggle |Sanofi Aventis |William.Friggle@sanofi- |

|Scott |Getzin |Eli Lilly and Company |sgetzin@ |

|Gary |Ginsinger |FDA |gary.gensinger@fda. |

|Hugh |Glover |Bluewave |hugh@blue-wave.co.uk |

|Mark |Gray |FDA |mark.gray@fda. |

|Norman |Gregory |FDA |norman.gregory@fda. |

|Kosuke |Haneda |PMDA Japan |haneda-kosuke@pmda.go.jp |

|Ed |Helton |NCI |heltone2@mail. |

|Jared |Lantzy |FDA/CDER |jared.lantzy@fda. |

|Behnaz |Minaei |FDA/CDRH |behnaz.minaei@fda. |

|Armando |Oliva |FDA |armando.oliva@fda. |

|Mitra |Rocca |FDA |Mitra.Rocca@fda. |

|Shohko |Sekine |PMDA |sekine.shohko@pmda.go.jp |

|Koji |Shomoto |JPMA |koji.shomoto@ |

|Lise |Stevens |FDA |lise.stevens-Hawkins@fda. |

|Kenji |Suzuki |PMDA Japan |suzuki-kenji@pmda.go.jp |

|Ed |Tripp |Edward S. Tripp and Associates |edward.tripp@ |

|Mead |Walker |Mead Walker Consulting |dmead@ |

|Crystal |Wolfe |Abbott Nutrition |crystal.wolfe@ |

I. BRIDG Update Ed Helton

Ed reviewed the status of BRIDG based on the following information on the BRIDG website.

BRIDG Release 3.2

last modified 2012-09-06 12:25

BRIDG release version 3.2 can be found at the following location: majority of the changes represented in Release 3.2 are due to the harmonization of the following projects:

• CDISC Statistical Analysis Domain Analysis Model - The Statistical Analysis Domain Analysis Model includes concepts describing the planning and performance of the statistical analysis of data collected during clinical trial research and their relationships. This sub-domain will eventually include the semantics for the entire Statistical Analysis lifecycle. For BRIDG 3.2, only the Statistical Analysis Plan semantics are included.

• Hematopoietic Cell Transplant (HCT) Database – This project is designed to produce a BRIDG-compatible model and database (with associated Common Data Elements (CDEs)) covering the scope of federally-mandated data submission from all transplant centers to the Stem Cell Transplant Outcomes Database (SCTOD). In association with integration engines to be developed in tandem but outside the scope of this project, the application will support direct connection between center databases of varying types and the SCTOD. The feasibility of this design has already been demonstrated at MD Anderson using a non-BRIDG compatible data model but caDSR-curated CDEs. Successful implementation will demonstrate high-volume clinical data transmission using the GRID for sharing of center-generated standardized clinical outcome data. It will also support intra-center data exchange and transmission of data to the CTRP and the .gov databases without data transcription. The harmonization of the HCT concepts has occurred in phases, the first of which was included in release 3.1 and covered concepts related to donor and recipient information. The second phase harmonized HCT concepts that are related to product processing and storage. Because HCT is an emerging field, we anticipate further changes to BRIDG to harmonize that content in later releases.

• NCI Case Report Form (CRF) Harmonization and Standardization Initiative: This project is an NCI Clinical Trial Work Group initiative focused on the improvement of enterprise clinical trials through the use of a library of harmonized data collection forms (Case Report Forms, aka CRFs) created through stakeholder consensus. Running since 2006, this effort is projected to run through an estimated five consecutive rounds of community review and consensus-building to produce a set of wider community vetted and approved variables that will be used to create Standard CRF modules that will be used to build CRF collection instruments. The core set of elements and associated forms will be registered in the cancer data standards registry and repository for public review and use. The main concepts covered in the harmonization of the NCI CRFs include Concomitant Medication, End of Form, Footer, Header, Prior/Post Therapy Agents, Staging/Extent of Disease, and Study Agent Administration. The NCI CRF project is taking a phased approach so additional concepts will be harmonized in subsequent releases of BRIDG.

• FDA Clinical Trials Repository (CTR)/Janus: The Clinical Trial Repository (CTR) is a standards-based repository of subject level clinical trial data to support regulatory review and patient centered outcomes research. The conceptual model captures FDA’s requirements for clinical trial data. The model is informed by the Biomedical Research Integrated Domain Group (BRIDG) Domain Model and is designed to receive data in CDISC SDTM format and emerging HL7 v3 study data exchange standards.

• HL7 Clinical Trial Registration and Results (CTRR) - This effort is focused on the development and maintenance of a Health Level 7 (HL7) V3 message in support of the information requirements brought about by the increasing number of national, regional and global clinical trial registries and trial results databases. In doing so, this project will provide an important element in the electronic exchange of both the protocol-related descriptive information needed to register a clinical trial, as well as a capability to define the exchange of information summarizing trial result outcomes. The project is intended to address the exchange of clinical trial summary-level data and will not be used to transport individual patient-related data.

• NCI Clinical Trials Reporting Program (CTRP): NCI's Clinical Trials Reporting Program (CTRP) is a web-based program that is designed to serve as a single, definitive source of information on all NCI-supported cancer-related clinical trials. The CTRP system receives submissions and updates from hospitals and cancer centers and from systems maintained within the Cancer Therapy Evaluation Program (CTEP), the Division of Cancer Prevention (DCP) and the Center for Cancer Research (CCR). CTRP captures information covering all key aspects of a clinical trial -- including study design, sponsors, investigators, participating sites, eligibility criteria, trial status, and accrual. The data collected in CTRP is used by NCI to coordinate research efforts and facilitate effective clinical trial prioritization. To learn more about CTRP, please visit the NCI Wiki: .

• FDA HL7 Study Design Structured Document (partial) - The Study Design Structured Document specification describes a research study protocol. This specification will transport the human-readable protocol and machine-readable trial design and eligibility criteria information in a standardized format, with particular emphasis on communicating the following as structured items: arms, epochs, subject assignment, planned encounters (visits), planned interventions, planned observations (assessments), eligibility criteria and other study characteristics. Release 3.2 contains a subset of the semantics of this project. The remaining semantics are expected to be included in a future release of BRIDG.

Other major changes in BRIDG R3.2 include:

• Inclusion of the OWL Perspective – The BRIDG SCC has now committed to publishing a representation of BRIDG semantics in OWL. For this release, the scope of the OWL content is limited to the information found in the BRIDG UML model.

• Addition of an html representation of the BRIDG Model – The BRIDG SCC is providing the html version of the BRIDG model.

• Addition of new instance diagrams – These new instance diagrams should help BRIDG users understand how to use BRIDG semantics to represent:

o Contingent Eligibility Criteria, e.g., asking an eligibility criteria question that is contingent on the answer to one or more previous eligibility criteria questions.

o Hematopoietic Stem Cell Transplant concepts, e.g., how various CDEs are linked to one another through a series of commonly referenced complex activities.

• Removal of the SME perspective subdomain models from the BRIDG release package – Because the content of these subdomain diagrams do not differ significantly from the comprehensive domain diagrams and there was no known use of these subdomains, these files have been removed from the release package.

Following the discussion Mitra provided the following SCC Schedule presentation.

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I. JANUS CTR Update Ed Helton and Armando

Oliva

Ed Helton is the PO on the NCI side of the JANUS project. This project is funded by AHRQ. The contract for this ends September 30 2013. The concept is to build a repository to support FDA review and approval of clinical data. The model is BRIDG informed and uses SDTM. The project has completed the first release of a functional clinical trial repository. There is data for 5 major disease categories. Main focus is on Diabetes. The project is performing user acceptance testing using the repository to look across pharmacological classes. One area of interest is in performing Comparative Effectiveness Research.

Armando’s role is to identify and document the requirements for the repository. The most recent activity has been generating useful reports from the warehouse, using modified SDTM data. There are 8 diabetes pivotal trials loaded with reports generated. The next step will be to have the reviewers utilize these reports and review tools to analyze the data.

II. PSUR Mead Walker

Mead presented following document

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Mead walked through the model on page 2 in the document above.

EMS has also worked to create a TOC for a PBRER

The business requirements are going to be solidified from ICH (Step 4) in November of this year.

There is a question as to whether or not we map to BRIDG. The safety is from all sources including clinical studies, premarket.

We should post a request for a volunteer modeler to review and comment on the PBRER model. See

There is concern that the PS WG may be at risk. One co-chair is no longer active in HL7 and Nick Halsey will not be running in this election, leaving Mead Walker as the only co-chair. There is only 2 active projects (both related); Project 713 “Risk Management Plans” and 714 “Periodic Safety Reporting”. The group discussed two possible approaches.

1. PS WG continuing low level until January and then assess its long term viability

2. Fold the PS WG into RCRIM. PS originated as a SIG of RCRIM and if there is a need to identify a home for ICSR and the current projects, RCRIM would make logical sense.

This will be revisited during the business meeting Q2 Wednesday.

Tuesday Q4 Patient Narrative Ballot Reconciliation

|First Name |Last Name |Affiliation |E-mail Address |

|Isabelle |Davias |Sanofi Aventis |isabelle.davias@sanofi- |

|Frank |Faunce |Abbott Laboratories |frank.faunce@ |

|Myron |Finseth |Medtronic |myron.finseth@ |

|William |Friggle |Sanofi Aventis |William.Friggle@sanofi- |

|Scott |Getzin |Eli Lilly and Company |sgetzin@ |

|Norman |Gregory |FDA |norman.gregory@fda. |

|Ed |Helton |NCI |heltone2@mail. |

|Behnaz |Minaei |FDA/CDRH |behnaz.minaei@fda. |

|Armando |Oliva |FDA |armando.oliva@fda. |

|Mitra |Rocca |FDA |Mitra.Rocca@fda. |

|Karin |Sailor |Medtronic |karin.sailor@ |

|Leslie |Tompkins |FDA |leslie.tompkins@fda. |

I. Patient Narrative Ballot Reconciliation Mitra Rocca

The following slides were presented

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Mitra Rocca reviewed the outstanding comments for the CDA R2 Implementation Guide for patient narratives.

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There was discussion surrounding one comment, which requested that the I.G. add planned arm, in addition to actual arm, as structured entries. The proposed disposition was persuasive and planned arm had been added to the I.G. The discussion centered around the notion that planned arm is not needed to evaluate the effect of the actual treatment on the reason the narrative was generated. There was consensus that planned arm is not needed in the patient narrative I.G. The disposition was changed to non-persuasive and Mitra will inform the commenter.

Attached is the revise IG.

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The W.G. voted 11-0 with 1 abstention to accept the ballot reconciliation spreadsheet.

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