Clinical Research Office: Services From To of a Clinical Research - - PowerPoint PPT Presentation

CLINICAL AND TRANSLATIONAL SCIENCE AWARD (CTSA)

Clinical Research Office: Services

From To

• f a Clinical Research Study

CLINICAL AND TRANSLATIONAL SCIENCE AWARD (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

CLINICAL AND TRANSLATIONAL SCIENCE AWARD (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.

CLINICAL AND TRANSLATIONAL SCIENCE AWARD (CTSA)

Clinical Research Office March 8, 2016

CLINICAL AND TRANSLATIONAL SCIENCE AWARD (CTSA)

Clinical Research Office Staff

Function

Number of Staff 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

CLINICAL AND TRANSLATIONAL SCIENCE AWARD (CTSA)

CLINICAL AND TRANSLATIONAL SCIENCE AWARD (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

CLINICAL AND TRANSLATIONAL SCIENCE AWARD (CTSA)

Scientific Review

• Not a Top Down approach
• Recognize diversity of Clinical Research
• Biomedical research
• S
• cial 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

CLINICAL AND TRANSLATIONAL SCIENCE AWARD (CTSA)

Scientific Review: Final Products

CLINICAL AND TRANSLATIONAL SCIENCE AWARD (CTSA)

Proposed Workflow

Study Registration Scientific Review Facilitator Review IRB Review

PI CLICK Environment

Add Docs

Parallel Processing when feasible:

• Contract negotiation
• Budget negotiation
• Affiliate agreements
• Conflict of interest
• Coverage analysis

CLINICAL AND TRANSLATIONAL SCIENCE AWARD (CTSA)

20 40 60 80 Days

Full Board Review Expedited Review Exempt

IRB Turnaround Time

Nat’ l Average Aug 2014- S ept 2015 Nov 2015- Feb 2016

CLINICAL AND TRANSLATIONAL SCIENCE AWARD (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)