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Study Data Reviewers’ Guide – Nonclinical Assessment

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

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Study Data Reviewers’ Guide – Nonclinical Assessment

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

  2. 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!

  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. Propose a Team Charter

  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.

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