New Clinical Trial Agreement
Confidentiality Agreement
jmagnum@nova.edu
Clinical Trial Agreement
Service Agreements (Facility or Investigator)
Consultation for general help and start-up
ocr@nova.edu
Feasibility of Clinical Research Trial
General questions
Database query
cissuport@nova.edu
Site qualification/feasibility survey
Site qualification on site meeting
Regulatory
Essential Documents
Investigator binder
Financial disclosure form
Developmental of source documents (esource or paper)
IRB
IRB Submission
irb@nova.edu; wsmith@nova.edu
CITI Training
irb@nova.edu
Budget Development and Negotiations
Internal budget:
Review billing codes and fees
Determine what banner expense code to use
Suppliers, Vendors & Purchasing equipment
External vendor agreements & sub awards
External (sponsor) budget:
Negotiating budget and F&A with sponsor
Hiring a new employee
Hiring a student employee
Request banner account
Establish research incentive account
Central Finance Office
Liability
Liability / Risk Management
Vendor Supplies
Office of Procurement Management
Monitoring Day to Day Expenses of a Budget
College Finance Officer/ PI
Creating Invoices
College Finance Officer/ SC or PI
Paying Invoices from Vendor or Sub Award
Tracking Wire Transfer
sb1382@nova.edu
Accessing Banner System
College Finance Officer
Paying Research Subjects-check, gift card
sb1382@nova.edu, ocr@nova.edu
Training on Using Banner
Re-budgeting
College Finance Officer and OCR
Ariba System
Setting Up Account
David Lippe (OIIT) dlippe@nova.edu
Training on Using Ariba
IZONE
Blackboard, Banner, Ariba, Go to Training and Kronos
Access the OI2T Support Portal to submit a ticket
Technical Support
Client Support Services
Compliance
HIPPA
irb@nova.edu and ocr@nova.edu
Research Misconduct
jmedina1@edu.com
Human Subject Research
wsmith@nova.edu , irb@nova.edu
Financial Conflict of Interest
jmedina1@nova.edu
Biosafety
Biosafety Officer
IATA Training
Audits
Protocol Deviations / Violations
PI and irb@nova.edu
Recruitment / Advertising
General Help with Marketing and ideas
Electronic Marquee
univrel@nova.edu
Coordination / Regulatory Requirements
Investigational product / device
Storage
Accountability logs
Dispensing logs
Deconstruction logs
Adverse Event Reporting
Adverse event
PI reports to irb@nova.edu
Unanticipated events
Serious Adverse events
Sunshine Act
General Information
REDCAP Establish Account
redcap@nova.edu
Clinicaltrials.gov
Interpreting F & A Cost Recovery Policy
Interpreting Procurement Policies
Interpreting Terms and Conditions of Contract
Extensions / Amendments
Date Management, Storage and Open Access Display
NSU Works
Iron Mountain
IRB study closure report
Financial Disclosure Form
Sunshine reporting
Insure all invoices and expenses are reconciled
Final payment and hold back is received
Transferring unused balance after trial is complete