Study Data Reviewers’ Guide – Nonclinical Assessment 2013-2014 PhUSE Nonclinical WG Project Co-Leads: Susan DeHaven & Laura Kaufmann

Membership Sue DeHaven susan.dehaven@sanofi.com Laura Kaufman laura.kaufman@pds-america.com Debra Oetzman Debra.Oetzman@covance.com Please contact us to join our project!

Study Data Reviewer’s Guide Call for New Team New Project agreed at PhUSE 2013 Proposed Goals: Assess use of SDRG in Nonclinical and justify outcome pilot the use of SDRG, which was developed with Clinical Study focus, on a Nonclinical Study provide assessment on applicability and useability how well does the SDRG help identify gaps between report and SEND dataset? Call for membership need sample reports + the associated SEND dataset determine if that is enough Nice to have: Familiarity with a tox study reports SEND familiarity (you can just jump in if you are that kind of person!) Define files Looking for 3-6 assessments for the project Timeline: October to Feb, report out at March PhUSE 2014. Other topics to consider… Familiarity with data source systems identification of gaps in SEND that are the result of system, process…. Link to SDRG in PhUSE Wiki

Meeting Plan Kick-off meeting Nov 22 @11am US Eastern time Biweekly meetings from then on meeting day and time can be optimized for attendees Complete assessment by March CSS meeting, with Poster or White paper to distribute at meeting.

Nonclinical Pilot of SDRG Propose a Team Charter Nonclinical Pilot of SDRG Team Members Mission Benefits Collaboration partners Team characteristics Scope Operating Model CSS deliverables

Background A project of the “Optimizing the use of data standards” define.XML does not adequately document SDTM mapping decisions, sponsor-defined domains, sponsor-defined controlled terminology, and sponsor extensions to CDISC controlled terminology. A standardized Data Guide would help to address this documentation gap. The content of the Data Guide should be standardized and developed jointly between CDER, Industry, and CDISC.

Approach Option 1 – Test of requirement for source system knowledge With one study – generate two guides test facility writes SDRG external (naïve) author for SDRG on same study Answers what question? differences in source knowledge do you need to describe why there is a differences?

Approach 2 Does SDRG cover/describe… important differences between SEND and Report things in the report that are not in SEND things in SEND that don’t fit the validator things in SEND that don’t match the report Answers: what is different, but does not provide why.