OCR FAQ for Investigators

Here are answers to investigator frequently asked questions for each phase of a trial.

I have a question regarding	Please Contact:
New Clinical Trial Agreement
Confidentiality Agreement	ocr@nova.edu
Clinical Trial Agreement	ocr@nova.edu
Service Agreements (Facility or Investigator)	ocr@nova.edu
Consultation for general help and start-up	ocr@nova.edu
Feasibility of Clinical Research Trial
General Questions	ocr@nova.edu
Database Query	cissuport@nova.edu
Site Qualification/feasibility survey	ocr@nova.edu
Site Qualification on site meeting	ocr@nova.edu
Regulatory
Essential Documents	ocr@nova.edu
Investigator binder	ocr@nova.edu
Conflict of Interest Disclosure	jmedina1@edu.com
IRB
IRB Submission	irb@nova.edu; wsmith@nova.edu
CITI Training	irb@nova.edu
Good Clinical Practice Training	irb@nova.edu
Budget Development and Negotiations
Internal budget:
Review billing codes and fees	Clinical Operation
Determine what banner expense code to use	College Finance Officer and ocr@nova.edu
Suppliers, Vendors & Purchasing equipment	Office of Procurement Management
External vendor agreements & sub awards	ocr@nova.edu
Negotiating budget and F&A with sponsor	ocr@nova.edu
Personnel
Hiring a new employee	College Finance Office/ HR Compensation Dept.
Hiring a student employee	College Finance Office/ Student Employment (Patricia Chin)
Requesting a Banner Index Number After IRB Approval
Request banner account	ocr@nova.edu
Establish research incentive account	Central Finance Office
Liability
Liability/Risk Management	ocr@nova.edu

I have a question regarding	Please Contact
Expenses
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	College Finance Officer/ PI
Accessing Banner System	College Finance Officer
Paying Research Subjects-check, gift card	nsumerch@nova.edu
Training on Using Banner	College Finance Officer
Re-budgeting	College Finance Officer and OCR
Ariba System
Computer/ Software Support
Blackboard, Banner, Ariba, Go to Training and Kronos	Access the OI²T Support Portal to submit a ticket
Technical Support	Client Support Services
Compliance
HIPAA Authorization	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	Biosafety Officer
Protocol Deviations / Violations	PI and irb@nova.edu
Recruitment / Advertising
General Help with Marketing and ideas	ocr@nova.edu
Electronic Marquee	univrel@nova.edu
Coordination / Regulatory Requirements
Investigational product / device
Storage	PI/SC
Accountability logs	PI/SC
Dispensing logs	PI/SC
Deconstruction logs	PI/SC refer to Biosafety officer for drug destruction
Adverse Event Reporting
Adverse event	PI reports to irb@nova.edu
Unanticipated events	PI reports to irb@nova.edu
Serious Adverse events	PI reports to sponsor and irb@nova.edu within 24 hours
Databases
REDCAP Establish Account	redcap@nova.edu
Clinicaltrials.gov	sb1382@nova.edu
Other Questions
Interpreting F & A Cost Recovery Policy	Vice President Research & Tech Transfer
Interpreting Procurement Policies	Office of Procurement
Interpreting Terms and Conditions of Contract	ocr@nova.edu
Extensions / Amendments	ocr@nova.edu

I have a question regarding	Please Contact
Date Management, Storage and Open Access Display
NSU Works	University Archivist
Iron Mountain	jlong2@nova.edu
IRB study closure report	irb@nova.edu
Financial Reconciliation
Insure all invoices and expenses are reconciled	College Finance Officer and PI/Designee
Final payment and hold back is received	College Finance Officer and PI/Designee
Transferring unused balance after trial is complete	College Finance Officer and PI/Designee