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Meeting Minutes

CDISC-HL7 Stage II

March 31, 2010

9:30 am – 10:30am (EST)

Attendees / Affiliation

Jason Rock/GlobalSubmit (Chair)

Patty Garvey/FDA (Facilitator)

Joyce Hernandez/Merck

Marcelina Hungria/ISI

Mary Lenzen/Octagon Research

Mitra Rocca/FDA

Chris Tolk/CDISC

Steve Ward/Eli Lilly

Gary Walker/

Diane Wold/GSK

Julia Zhang/Genzyme

Background

FDA wishes to receive, in regulatory submissions, standard clinical study information content developed by the Clinical Data Interchange Standards Consortium (CDISC) in a Health Level 7 (HL7) message exchange format. This is key to the FDA strategic initiatives to improve public health and patient safety.

This project is currently broken into two stages: requirements analysis and message development. Stage IB team was developed and tasked with the requirements analysis responsibilities. Stage II team was developed and tasked with the message development responsibilities.

The purpose of the meeting is to discuss the next steps for testing the study participation, study design and subject data.

Discussion

  • Discuss the Regulate Product Submission (RPS) testing subteams that have been established for the project testing.
  • Controlled vocabulary
  • Technical
  • Test case

Not sure at this time if this project test team should be modeled after the RPS testing team.

  • Jason indicated that a lot of work can still be accomplished prior to the FDA Implementation Guide (IG) is completed. Mitra hopes to complete the IG end of April.
  • Start by developing test cases
  • Start from the story boards but provide more details then the story boards i.e. investigator’s name and address, expected results, etc.
  • Use XL template to create XML and determine what other information is needed
  • Make sure that it will go through without stylesheet or system at this time
  • For the first phase will develop test cases for human trial
  • Diane will develop test cases for Study Design and Marcelina will be the primary reviewer for these test cases
  • Test Plan
  • Jason will develop a test plan and put it on the wiki
  • Will provide the group with the RPS test plan

ACTION ITEMS:

  1. Jason to provide a test plan and put it on the wiki.
  2. Jason or Patty will provide a RPS test plan.

ADDENDUM to ACTION ITEMS:

  1. Link to sample test plan:
  2. RPS test plan: waiting to receive it from Bob Birmingham.

Drafted: PGarvey/04-07-10