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

2. Membership Sue DeHaven susan.dehaven@sanofi.com
Laura Kaufman
Debra Oetzman
Please contact us to join our project!

3. 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

4. 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.

5. 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

6. 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.

7. 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?

8. 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.