Interorganizational SEND Minutes 2013-06-24

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Participant Attended
Pranav Agnihotri, PointCross
Kenjie Amemiya, Genentech
Kathryn Brown, Sanofi x
Susan DeHaven, Sanofi x
Steven Denham, MPI Research x
Jennifer Feldmann, Instem
Jeff Foy, Celgene
Geoff Ganem, Genentech
Isaac Hatzell, Johnson & Johnson
William Houser, Bristol-Myers Squibb x
Jyotsna Kasturi, Johnson & Johnson
Laura Kaufman, Preclinical Data Systems x
Lou Ann Kramer, Eli Lilly
Wayne Kung, Genentech x
Connie Marvel, Bristol-Myers Squibb x
Carolyn McGary, Bristol-Myers Squibb
Shree Nath, PointCross
Louis Norton, Covance
Debra Oetzman, Covance
Kathy Powers, Pfizer x
Gerard Randoph, Roche x
William Reinholt, MPI Research
Lynda Sands, GlaxoSmithKline x
Paul Sidney, Charles River Laboratory x
Troy Smyrnios, Zoetis x
Nathan VanSweden, MPI Research
Audrey Walker, Charles River Laboratory
Heather Williamson, PointCross x
Steven Wilson, MIP Research x
Peggy Zorn, INDS

Discussion in this meeting

  • Welcome to our new members:
    Kathy Powers
    Paul Sidney
  • Clinical experience
  • (Gerard) Biggest problem Clinical (SDTM) has is that the CROs don't provide what is expected by the sponsor (their own interpretation). This emphasizes the need for clear communication (with examples or template to fill-out) showing what is needed.
  • (Laura) SDTM datasets are assembled once for each submission not for each multiple interim update.
Question: is there a conflict between CTD filings and SEND datasets?
  • The eCTD structure data used for nearly all submissions to the FDA includes both.
  • Reviewed timing of other's testing

For discussion in our next meeting:

  • Since Clinical experience shows clear expectations need to be established between CROs and sponsors, we should develop a list or other guidance to facilitate these discussions. What should we do? Ideas discussed today:
  • Create a Wiki to enable a list to grow as we get experience
  • Look through SENDIG for multiple ways of reporting the same information. (i.e. Clinical Chemistry reported is LBCAT or ?; and creating RELRECs between PC and PP.)
Does CDASH make sense for non-clinical? It provides data acquisition standards and facilitates flow of data into SDTM.

Action Items

  • Troy will respond to the questionnaire for the scenarios 1 and 2.
  • Peggy will adjust her document to reference numbers that has been added to the flow charts. - Done.
  • Connie will submit question for September conference with OECD of if/when they will want eData and in what format.

Potential Scenario Changes

  • Establishing SEND contract
  • Troy's Scenario 1: add to the diagram more explicitly: "Establish capabilities of CRO, logistics, and expectations" which would include a listing of what domains will be and which domains will not be provided.
  • Scenario 1
  • Box 4: Troy- add "zoom-in" lines since everything under box 4 is an expanded view of what is in box 4.
  • Box 13: Troy- relabeled "are datasets acceptable" -> "Is dataset reportable?".
  • Box 19: Troy- relabeled "CRO generates final datasets" -> "CRO generates final data package"
  • Scenario 2
  • Box 13-14: Troy- conversion of SEND datasets to match the rest of the study’s data may be needed (e.g. translating STUDYID and USUBJID)