06-19-2014 minutes

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Laura Kaufman (laura.kaufman@pds-america.com); Dorsam, Robert <Robert.Dorsam@fda.hhs.gov>; William Houser (william.houser@bms.com); Jennifer Feldmann (Jennifer.Feldmann@instem.com); ; Nicola Robertson (nicola.j.robertson@gsk.com);Susan DeHaven (susan.dehaven@sanofi.com)


  • Reviewed SECTION 1.3 update from last meeting
  • Continued build of Nonclinical SDRG Template - work on SECTION 2: Study Description


  • Section 1.3 (Study Data Standards, Dictionaries and Conformance Tools) discussion: questioned value of repeating Trial Summary domain information for Standard and Versions used, where Controlled Terminology and Dataset standards are included in TS with TSPARMCDs. Agreed to leave in the table and recommend in guidance that the fields can be filled with a reference: "see Trial Summary domain for information."
  • Section 2 (Study Description) discussion:
  1. Decision to replace Protocol with Study
  2. Preference for a tabular representation of information in Section 2.1: Protocol Study Number, Protocol Study Title, Protocol Study Versions
  3. Study Design: discussion of value of this section. Preference for giving option to include text of "information meaningfully useful for reviewer", such as a sentence summarizing the design of the study - not just the controlled term for study design, which is included in the Trial Summary domain. Author can include a table, if desired. Generally agreed that content can be re-used from other sources (study protocol, report or other.) Using a diagram like the Trial Design diagrams from SEND IG, for a study was explored. This was determined to be more of a diagram of "Data set design" rather than "Study design." Some companies are against using color diagrams. We thought, if used, this diagram is more useful for the next section: 2.2 Trial Design Datasets.

We will resume with section 2.2 in next meeting.