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FAQs for Investigators

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.eduwsmith@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

sb1382@nova.eduocr@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
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