Clinical Research Office: Services From To of a Clinical Research Study C LINICAL AND T RANSLATIONAL S CIENCE A WARD (CTSA)
NIH Definition of Clinical Research • Pat ient -orient ed research. Research conduct ed wit h human subj ect s (or on mat erial of human origin such as t issues, specimens and cognit ive phenomena) for which an invest igat or (or colleague) direct ly int eract s wit h human subj ect s. Excluded from t his definit ion are in vit ro st udies t hat ut ilize human t issues t hat cannot be linked t o a living individual. Pat ient -orient ed research includes: a. Mechanisms of human disease, b. Therapeutic interventions, c. Clinical trials, or d. Development of new technologies. • Epidemiologic and behavioral st udies • Out comes research and healt h services research C LINICAL AND T RANSLATIONAL S CIENCE A WARD (CTSA)
NIH definition of Clinical trials • A research study in which one or more human subj ects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. C LINICAL AND T RANSLATIONAL S CIENCE A WARD (CTSA)
Clinical Research Office March 8, 2016 C LINICAL AND T RANSLATIONAL S CIENCE A WARD (CTSA)
Clinical Research Office Staff Number of Staff Function Assigned Oversee Operations (RNs) 2 Contract negotiation 2 Budget design and negotiation 2 Coverage analysis 2 Regulatory review and support 2* IRB pre review (clinical research facilitators) 2* Accounts receivable/ accounts payable 2 Research coordinators 7 CTMS “ S uper Users” trained 5 IT , data entry, data “ extraction” support 2* *S upported by CTS A C LINICAL AND T RANSLATIONAL S CIENCE A WARD (CTSA)
C LINICAL AND T RANSLATIONAL S CIENCE A WARD (CTSA)
CRO: Initiatives • Developing new workflows incorporat ing S t udy Regist rat ion • Depart ment al/ S chool S cient ific Review • Research facilit at or • • Policies and Procedures (Invest igat or Handbook/ Websit e redo) • CTMS (OnCore) Implement at ion • Collect ion of met rics • Cent ral IRB for mult i-sit e Clinical Trials • Accelerat ed Confident ial Disclosure Agreement s (ACDA) • Accelerat ed Clinical Trial Agreement s (ACTA) • S UNY Int egrat ed Clinical Trial Infrast ruct ure C LINICAL AND T RANSLATIONAL S CIENCE A WARD (CTSA)
Scientific Review • Not a Top Down approach • Recognize diversity of Clinical Research • Biomedical research • S ocial and Behavioral research • Two working groups • Initial drafts (policy and form) substantially modified based on input from working groups • Currently working on integration into CLICK C LINICAL AND T RANSLATIONAL S CIENCE A WARD (CTSA)
Scientific Review: Final Products C LINICAL AND T RANSLATIONAL S CIENCE A WARD (CTSA)
Proposed Workflow Study Scientific Facilitator IRB Review Registration Review Review Add Docs Parallel Processing when feasible: PI • Contract negotiation • Budget negotiation • Affiliate agreements CLICK Environment • Conflict of interest • Coverage analysis C LINICAL AND T RANSLATIONAL S CIENCE A WARD (CTSA)
IRB Turnaround Time 80 60 Days Aug 2014- 40 S ept 2015 Nov 2015- 20 Feb 2016 Nat’ l Average 0 Full Board Expedited Exempt Review Review C LINICAL AND T RANSLATIONAL S CIENCE A WARD (CTSA)
One year goals: Clinical Study Activation Reduce IRB t urnaround t ime Implement scient ific review • Fully implement pre review by facilit at ors • Mult i cent er indust ry sponsored t rials t o be reviewed • by cent ralized IRBs Follow met rics in real t ime and be responsive • S ign and use IRBrely Mast er Common Reciprocal IRB Aut horizat ion Agreement Reduce t ime for cont ract s, budget s and coverage analysis. Adopt and use Accelerat ed Clinical Trials Agreement (ACTA) C LINICAL AND T RANSLATIONAL S CIENCE A WARD (CTSA)
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