FAQs for Investigators

Start-Up Phase

I have a question regarding	Please Contact:
New Clinical Trial Agreement
Confidentiality Agreement	sb1382@nova.edu
Clinical Trial Agreement	sb1382@nova.edu
Service Agreements (Facility or Investigator)	sb1382@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	sb1382@nova.edu
Investigator binder	sb1382@nova.edu
Financial disclosure form	sb1382@nova.edu
Developmental of source documents (esource or paper)	ocr@nova.edu and cissuport@nova.edu
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	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
External (sponsor) budget:
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	sb1382@nova.edu
Establish research incentive account	Central Finance Office
Liability
Liability / Risk Management	sb1382@nova.edu

Active Phase

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
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	College Finance Officer
Re-budgeting	College Finance Officer and OCR
Ariba System
Setting Up Account	David Lippe (OIIT) dlippe@nova.edu
Training on Using Ariba	IZONE
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
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	Biosafety Officer
Audits	ocr@nova.edu
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
Sunshine Act
General Information	sb1382@nova.edu
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

Close Out Phase

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
Financial Disclosure Form	sb1382@nova.edu
Sunshine reporting	sb1382@nova.edu
Insure all invoices and expenses are reconciled	College Finance Officer and OCR
Final payment and hold back is received	College Finance Officer and OCR
Transferring unused balance after trial is complete	College Finance Officer and OCR