Interorganizational SEND Minutes 2013-07-08

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

Discussion in this meeting

  • Welcome to our new members:
    Eric Sun (Sanofi) - 24 years of clinical data experience.
    Pamela Hills-P. (Pfizer) - working with Kathy Powers.
    Nancy Gongliewski (GSK) - GLP QA group joined at Connie Marvel's request.

Discussed in this meeting:

  • In last meeting we discussed how the Clinical experience shows that clear expectations need to be established between CROs and sponsors. We decided we need to develop something the help with this for nonclinical studies. But ran out of time.
  • SEND version
  • CT version
  • Which domains to include
  • Which variables to include
  • Use of SUPPQUAL (e.g., instrument used for lab tests)
  • Sample study data package including sample define file.
  • EX record for each dose, or one for each constant dosing interval.
  • How vehicle only doses appear in EX records.
  • RELRECs between PC and PP.
  • All use of RELREC
  • USUBJID naming convention
  • STUDYID naming convention
  • Conventions for creating trial design (ARM,
  • Trial summary (TSPARMCD) and trial set (TXPARMCD) and subject characteristics parameters
  • Desired extensions to SEND CT (i.e. Sponsor's required terminology)
  • File format for exchange (samples maybe very helpful *.xml, *.xls, *.csv, etc.)
  • Data exchange intervals (at end or interim and/or draft too.)
  • Define file format (xml or something else)
  • How the define file will be assembled with some measurements collected at different facilities.
  • Who will merge each dataset that is collected by multiple organizations (LB, CO, RELREC, etc)
  • Process for integrating sponsor and/or subcontractor generated data in SEND format
  • Costs
  • Inclusion in master service agreement for all applicable study types or contracted study by study
  • QA expectations
  • GLP validation status of system producing SEND datasets
  • Data standards validation rules used by each party
  • To learn from our experiences that we are testing this year, Troy will add to the questionnaire a couple questions:
  • What was discussed before transfers
  • At the end, what did you wish you had discussed earlier
  • Does CDASH make sense for non-clinical? It provides data acquisition standards and facilitates flow of data into SDTM.
  • CDASH is a standard for "case report forms".
  • Why is CDASH not needed for nonclinical?
  • Case Report forms are not submitted.
  • Each test is typically conducted all within one facility.
  • Protocol specifies what is needed.

Additional topic discussed:

  • Isaac has heard SEND is not being chosen for storage format, yet that it is used for mining and visualization. What are companies really doing?
  • Kenje - is adopting SEND in warehouse.
  • Troy expects slow movement toward SEND. Database table storage is often one big findings table instead of the multiple findings domains.
  • Bill - Some data types are not yet supported by SEND.
  • Peggy - many are using "SEND-like" formats.
  • Carolyn - SEND files are stored as they are for submissions and archival.

Action Items

  • Everyone send Debra and Bill list of items for pre-SEND exchange checklist (may separate out some items for business partner selection & engagement checklist).
  • Troy will respond to the questionnaire for the scenarios 1 and 2. - 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)