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FAQs for Investigators

I have a question regarding  Please Contact:    

New Clinical Trial Agreement

Confidentiality Agreement

jmagnum@nova.edu

Clinical Trial Agreement

jmagnum@nova.edu

Service Agreements (Facility or Investigator)

jmagnum@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 qaulification/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.eduwsmith@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

jmagnum@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

Tracking Wire Transfer

sb1382@nova.edu 

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

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

Strategic Support Services (sss@nova.edu)

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 , jmagnum@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

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 recieved

College Finance Officer and OCR

Transferring unused balance after trial is complete

College Finance Officer and OCR
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