Clinical Trials Compliance

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Clinical Trials Compliance Directory

Get Help Contact Information

 

 

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Get Help With:
Adverse Events
Alachua General Hospital (Shands at AGH) - Ancillary Services Issues
Alachua General Hospital (Shands at AGH) - Ancillary Services Set-Up (Includes Individual Ancillary Departments); Registration Form (R99)
Alachua General Hospital (Shands at AGH) Clinical Trial Billing
Ancillary Departments: Shands at UF
Ancillary Departments: Shands at AGH
Anonymous Helpline - Report ethical or legal concerns regarding Clinical Trial Billing
Budgets
Clinical Trial Agreement Amendments
Clinical Trial Agreements/Contracts
Clinical Trial Budget Building
COM Clinical Trial submission process
Conflict of Interest
Contracts and Grants - Accounting Services
Contracts and Grants - Spending Regulations
Cost Accounting Standards (CAS)
Device Trial Set-up
Fiscal and Billing Compliance
Fiscal and Reporting Requirements
Gatorlink ID and Password
General Clinical Research Center (GCRC) Services
Human subjects
Human subject safety
IRB Closeout
IRB Continuing Review
Managed Care Contracts - Which ones do or do not have a Clinical Trials Policy
Notice of Awards (NOA)
Password, Gatorlink ID and Password
Professional Services (UFP) - Clinical Trial Billing
Professional Services (UFP) - Clinical Trial Pricing; Registration Form (R99)
Professional Services (UFP) - Participant’s Insurance Coverage Determination assistance
Registration Form (R99)
Regulatory requirements (DSR)
Research Administration and Compliance (RAC) Office
Service Department Contacts – Registration Form Contacts: Shands at UF
Service Department Contacts – Registration Form Contacts: AGH
Shands at UF Hospital - Hospital Clinical Trial Billing
Shands at UF Hospital - Hospital Clinical Trial Pricing
Shands at UF Hospital - Participant’s Insurance Coverage Determination assistance
Shands at UF Hospital - Services Issues
Shands at UF Hospital - Services Set-Up (Includes Individual Departments)
Signing Authority at Shands
Signing Authority at Faculty Group Practice
Sponsor negotiations
Sponsor or Agency policies
Subcontracts

Individual Contacts

For Help With:
Alachua General Hospital (Shands at AGH) - Ancillary Services Issues
Alachua General Hospital (Shands at AGH) - Ancillary Services Set-Up (Includes Ancillary Departments: Shands at AGH Individual Ancillary Departments); Registration Form (R99)
Service Department Contacts – Registration Form Contacts:

Alachua General Hospital (Shands at AGH) Services & Procedures; Ancillary

Cardiovascular Services
Cardiac Cath Lab
Neurological Functions
Respiratory: Russ Gay, Manager

Primary Contact Information:
Name: Harvey Norton
Email: nortohg@shands.ufl.edu
Phone: 352-372-4321
Fax:    352-338-6737
Box:    Name/Dept @ AGH

Gastroenterology and Endoscopy
Surgery/Anesthesia
Director:  Barbara McClenathan

Primary Contact Information:
Name:  Lavonne Simpson
Email:  simpsl@shands.ufl.edu 
Phone:  352-372-4321
Box:    Name/Dept @ AGH
Or
Name:  Tammy Phillips
Email:   phillt@shands.ufl.edu
Phone:  352-372-4321
Box:      Name/Dept @ AGH

Laboratory
Director:  Pam Core

Primary Contact Information:
Name:  Sue Davis
Email:  davissj@shands.ufl.edu 
Phone:  352-372-4321
Box:    Name/Dept @ AGH

Pharmacy
Primary Contact Information:
Name:  Peter Iafrate, Director
Email:  iafrate@shands.ufl.edu 
Phone:  352-372-4321
Box:   Name/Dept @ AGH

Radiology
Name:  Marian Speed
Email:  speedma@shands.ufl.edu 
Phone:  352-372-4321
Box:   Name/Dept @ AGH

Rehabilitation Services
Name:  Kathryn Zeppieri
Email:  zeppik@shands.ufl.edu  
Phone:  352-733-0111 Ext. 30328
Box:    Name/Dept @ AGH

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For Help With:
Clinical Trial Budget Building
Fiscal and Billing Compliance

COM Clinical Trials Compliance Office
Contact Information:
Name: Idella Philman
Email: dphilman@ufl.edu
Phone: 352-273-5946
Fax:    352-273-5960
Box:     100215

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For Help With:
Contracts and Grants - Accounting Services
Contracts and Grants - Spending Regulations
Cost Accounting Standards (CAS)
Fiscal and Reporting Requirements

Contracts and Grants
See Contact Information

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For Help With:
Clinical Trial Agreements/Contracts
Clinical Trial Agreement Amendments
Conflict of Interest
Notice of Awards (NOA)
Regulatory requirements
Sponsor negotiations
Subcontracts

Division of Sponsored Research
See Contact Information

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For Help With:
Gatorlink ID and Password
Password, Gatorlink ID and Password

Gatorlink ID and Password
See Contact Information

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For Help With:
General Clinical Research Center (GCRC) Services
           
General Clinical Research Center
Contact Information:
Name:  Ann Coutu
Email:  coutua@gcrc.ufl.edu
Phone:  352-265-8909

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For Help With:
Professional Services (UFP & Shands at AGH) - Clinical Trial Billing
           
Faculty Group Practice Billing
Contact Information:
Name:  Stephanie Jones
Email:   jonsta@shands.ufl.edu
Phone:  352-265-0111 ext 8-5986
or
Name:  Maggie Phillips
Email:  philma@shands.ufl.edu
Phone:  352-265-0111 ext 8-6622

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For Help With:
Professional Services (UFP) - Participant’s Insurance Coverage Determination assistance
Professional Services (UFP) - Clinical Trial Pricing; Registration Form (R99)
Signing Authority at Faculty Group Practice

Faculty Group Practice
See Liaisons Contact Information

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For Help With:
Anonymous Helpline - Report ethical or legal concerns regarding Clinical Trial Billing

Gator Compliance Hotline
Contact Information:
Phone: 1-866-574-2867

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For Help With:
Adverse Events
Human Subjects
Human Subjects safety
IRB Closeout
IRB Continuing Review

Institutional Review Board (IRB)-01: Gainesville Health Science Center
See Contact Information

Institutional Review Board (IRB)-02: UF Campus Non Medical
Contact Information:
Name: Ira S. Fischler, PhD, Chair
Email: irb2@ufl.edu
Phone: 392-0433

Institutional Review Board (IRB)-03: Jacksonville Health Science Center
Contact Information:
Name: Sheila A. Heim, CIP, Administrative Coordinator, IRB-03
Email: sheila.heim@jax.ufl.edu
Phone: 904-244-3155

Institutional Review Board (IRB)-04: Western IRB  (WIRB)
Contact Information:
Name: Michael Mahoney, Local WIRB liaison, 846-1706
WIRB Email: wirb@wirb.com
WIRB Phone: 800-562-4789

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For Help With:
Budgets
COM Clinical Trial submission process
Research Administration and Compliance (RAC) Office
Sponsor or Agency policies

Research Administration and Compliance (RAC)
See Contact Information
Phone:  273-5398

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For Help With:
Shands at UF Hospital - Participant's Insurance Coverage Determination assistance

Shands: Case Management
Contact Information:
Phone: 265-0224

Contact Information:
Name: Frank Bellamy, RN, MSN, CCRN, ACM
Email: bellaf@shands.ufl.edu
Phone: 265-0111 ext 42900
Fax:    265-0469 

Or Contact Your Department Clinical Care Liaison

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For Help With:
Shands at UF Hospital - Hospital Clinical Trial Pricing
Signing Authority at Shands

Shands Financial Planning & Analysis
Primary Contact Information:
Name: Theresa O’Connell
Email: OCONTA@shands.ufl.edu
Phone: 352-265-7965 Ext 86465
Fax:   352-548-4062
Box:    100336

Secondary Contact Information:
Name: Denny Speed
Email: SPEEDDC@shands.ufl.edu
Phone: 352-265-7965 Ext 86465
Fax:    352-265-7966
Box:    100336

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For Help With:
Ancillary Departments: Shands at UF
Shands at UF Hospital - Services Set-Up (Includes individual departments); Registration Form (R99)
Service Department Contacts - Registration Form Contacts: Shands at UF
Shands at UF Hospital - Services Issues

Shands at UF Hospital Services & Procedures; Ancillary

Bone Marrow Transplant Clinic:
Primary Contact Information:
Name:  Diann Fisk
Email:  fiskdd@shands.ufl.edu
Phone: 352-265-0232
Fax:     352-338-9817
Box:     100403

Secondary Contact Information:
Name:  Helen Welsh, Manager
Email:  welshho@shands.ufl.edu
Phone:  352-265-0247
Fax:     352-265-0533
Box:     100335

Burn Clinic:
Primary Contact Information:
Name:  Linda Dodgen
Email:  dodgel@shands.ufl.edu
Phone:  352-265-0127
Fax:      352-265-0125
Box:      100335

Secondary Contact Information:
Name:  Robert Nappo, Manager
Email:  nappor@shands.ufl.edu
Phone:  352-265-0200
Fax:      352-265-0125
Box:      100335

Cardiovascular Services:
Primary Contact Information:
Name:  Marti Penfold
Email:  penfoma@shands.ufl.edu
Phone:  352-265-0047
Fax:      352-338-9883
Box:     100395

Secondary Contact Information:
Name:  Brad Green, Manager
Email:  greenbe@shands.ufl.edu
Phone:  352-265-0119
Fax:      352-265-0314
Box:     100395

Cardiac Cath Lab:
Primary Contact Information:
Name:  Betsy Chandler
Email:   chandbj@shands.ufl.edu
Phone:  352-265-0119
Fax:     265-0314
Box:     100395

Secondary Contact Information:
Name:  Brad Green, Manager
Email:   greenbe@shands.ufl.edu
Phone:  352-265-0119
Fax:      265-0314
Box:     100395

Billing Contact:
Name:  Patricia Davis
Email:  davispa@shands.ufl.edu
Phone:  352-265-0680 x 44210

Scheduling or Account Set Up Contact:
TBD

CardioPulmonary Services:
CardioPulmonary R99 Order Form
Primary Contact Information:
Name:  Rich Russin
Email:   russira@shands.ufl.edu
Phone:  352-265-0078
Fax:     265-1112
Box:     100373

Secondary Contact Information:
Name:  Tim Coons, Manager
Email:   coonstj@shands.ufl.edu
Phone:  352-265-0078
Fax:      265-1112
Box:     100373

ECG Services
Primary Contact Information:
Name:  Cheryl Ondrako
Email:  ondraca@shands.ufl.edu
Phone:  352-265-0047
Fax:     352-265-1106

Secondary Contact Information:
Name:  Marti Penfold
Email:  penfoma@shands.ufl.edu
Phone:  352-265-0047
Fax:      352-338-9883
Box:     100395

Billing Contact:
Name:  Cheryl Ondrako
Email:  ondraca@shands.ufl.edu
Phone:  352-265-0047
Fax:     352-265-1106

Scheduling or Account Set Up Contact:
Name:  Linzi Wilson or Jessica Booth-Burley
Phone:  352-265-0047

ECHO Lab
Primary Contact Information:
Name:  Cheryl Ondrako
Email:  ondraca@shands.ufl.edu
Phone:  352-265-0047
Fax:     352-265-1106

Secondary Contact Information:
Name:  Marti Penfold
Email:  penfoma@shands.ufl.edu
Phone:  352-265-0047
Fax:      352-338-9883
Box:     100395

Billing Contact:
Name:  Cheryl Ondrako
Email:  ondraca@shands.ufl.edu
Phone:  352-265-0047
Fax:     352-265-1106

Scheduling or Account Set Up Contact:
Name:  Linzi Wilson or Jessica Booth-Burley
Phone:  352-265-0047

General Clinical Research Center (GCRC):
Contact Information:
Name:   Ann Coutu
Email:   coutua@gcrc.ufl.edu
Phone:  352-265-8909
Fax:      265-8910
Box:     100322

GI-Endoscopy and EEG:
Instructions for GI-R99 Order Form
Primary Contact Information:
Name:   Felicia DeSue
Email:   moself@shands.ufl.edu
Phone:  352-265-0048
Fax:     265-0163
Box:     100396

Secondary Contact Information:
Name:   Esther Hardy
Email:   hardyer@shands.ufl.edu
Phone:  352-265-0334
Fax:     265-0163
Box:     100396

Heart Station
Primary Contact Information:
Name:  Cheryl Ondrako
Email:  ondraca@shands.ufl.edu
Phone:  352-265-0047
Fax:     352-265-1106

Secondary Contact Information:
Name:  Marti Penfold
Email:  penfoma@shands.ufl.edu
Phone:  352-265-0047
Fax:      352-338-9883
Box:     100395

Billing Contact:
Name:  Cheryl Ondrako
Email:  ondraca@shands.ufl.edu
Phone:  352-265-0047
Fax:     352-265-1106

Scheduling or Account Set Up Contact:
Name:  Linzi Wilson or Jessica Booth-Burley
Phone:  352-265-0047

Shands Infusion Center:
Infusion Center-Patient Referral Process
Primary Contact Information:
Name:  Cindy Lasley
Email:  laslec@shands.ufl.edu
Phone: (352) 258-0501
Fax:     265-7038  

Laboratory/Pathology including Rocky Point:
R99 Lab Ordering Process-Reference Tool for Investigators/Study Coordinators
Process for Obtaining R99 Price Quotes
Example of Lab R99 Order Form
Primary Contact Information:
Name:  Georg Suzuki, IS Specialist
Email:  suzukg@shands.ufl.edu
Phone:  352-265-0680 Ext 72245
Fax:     265-0585
Box:     100344

Secondary Contact Information:
Name:  Kara White  
Email:   whitkd@shands.ufl.edu
Phone:  352-265-0172
Fax:     265-0585
Box:    100344

Neurological Functions-EEG:
Contact Information:
Name:  Peter Tharpe
Email:  tharpp@shands.ufl.edu
Phone:  352-265-0334 Ext. 45784
Fax:     265-0003
Box:    100365

Obstetrics & Gynecology:
Contact Information:
Name:  Rutha Harrison 
Email:   harrirm@shands.ufl.edu
Phone:  352-265-6200 x 40274

Otolaryngology:
Contact Information:
Name:  Carrie Reed
Email:   carrie.reed@ent.ufl.edu
Phone:  352-273-5199
Fax:     352-392-6781
Box:     100264

Pharmacy:
Primary Contact Information:
Name:  April Ellis
Phone:  352-265-0404 x 43975

Secondary Contact Information:
Name:  Jason Czaplewski
Email:  czapja@shands.ufl.edu
Phone:  352-265-0404 Ext. 44233

Radiation Oncology:
Primary Contact Information:
Name:  Audrey Mardook
Email:   mardoa@shands.ufl.edu
Phone:  352-265-0316
Fax:     265-0546
Box:     100385

Secondary Contact Information:
Name:  Steve Ritz, Manager
Email:   ritz@shands.ufl.edu           
Phone:  352-265-0316
Fax:     265-0546
Box:     100385

Radiology:
Primary Contact Information:
Radiology R99 Order Form
Radiology Quote Form
Name: Andrew Baldwin
Email:  baldwa@radiology.ufl.edu
Phone:  352-273-8347
Fax:     265-0279
Box:     100374

Secondary Contact Information:
Name:  Anne D’Amico
Email:   damicag@shands.ufl.edu
Phone: 352-265-0290 Ext. 45957
Fax:     265-0292
Box:     100374

Rehabilitation Services:    
Primary Contact Information:
Name:   Amy Ellis
Email:   Ellisac@shands.ufl.edu
Phone:  352-265-0295
Fax:     265-6980
Box:     100341

Secondary Contact Information:
Name:   Pat O'Connor or Kevin McDonald, Managers
Email:   oconnpd@shands.ufl.edu or mcdonk@shands.ufl.edu
Phone:  352-265-0295
Fax:      265-6980
Box:      100341

Sleep Center:
Primary Contact Information:
Name:  Tiffany Cellon  
Email:   cellogtg@shands.ufl.edu
Phone:  352-371-8321
Fax:     371-1321
Box:     100373

Secondary Contact Information:
Name:  Neerav Jadeja  
Email:   jadejn@shands.ufl.edu
Phone:  352-371-8321
Fax:     371-1321
Box:     100373

Surgery/Anesthesia:
Surgery Order Form
Primary Contact Information:
Name:  Michele Scanlan
Email:  scanlma@shands.ufl.edu
Phone:  352-265-0680 Ext. 45382
Fax:      265-0507
Box:     100364

 Vascular Lab
Primary Contact Information:
Name:  Cheryl Ondrako
Email:  ondraca@shands.ufl.edu
Phone:  352-265-0047
Fax:     352-265-1106

Secondary Contact Information:
Name:  Marti Penfold
Email:  penfoma@shands.ufl.edu
Phone:  352-265-0047
Fax:      352-338-9883
Box:     100395

Billing Contact:
Name:  Cheryl Ondrako
Email:  ondraca@shands.ufl.edu
Phone:  352-265-0047
Fax:     352-265-1106

Scheduling or Account Set Up Contact:
Name:  Linzi Wilson or Jessica Booth-Burley
Phone:  352-265-0047

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For Help With:
Managed Care Contracts - Which ones do or do not have a Clinical Trials Policy

Shands Managed Care
Shands Hospital Agreements
Shands and UF Physician Agreements

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For Help With:
Device Trial Set-up
Shands at UF Hospital - Hospital Clinical Trial Billing
Alachua General Hospital (Shands at AGH) Clinical Trial Billing 

Shands Patient Financial Services
Contact Information:
Name: Heather Cavin or Marian Orton
Email: cavinhm@shands.ufl.edu or ORTONMP@shands.ufl.edu
Phone: 352-265-0680 x42126 or x42263
Fax:    265-9044
Box:    100334

Contact Information:
Name: Kathie Poole
Email: poolkaj@shands.ufl.edu
Phone: 352-265-0680 x42383
Fax:     265-9044
Box:    100334

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Overview, CTC Office, Clinical Trials Compliance Steering Committee, CTC Newsletter , CTC Information Management Project

CTC Process - Start to Finish, Defining Clinical Trials, Triad of Clinical Trial Documents, Policy & Standards

Overview, First Steps, Medicare Coverage, Budget Building, RAC & DSR - What to Send, Final Steps, Frequently Used Forms & Resources

Overview, Study Participants, Study Procedures/Services, Third Party Payors, Frequently Used Forms & Resources

Overview, Budget, Final Steps, Document Management & Storage, Frequently Used Forms & Resources

Classes, Online Training, Videotaped Lectures, Certification

Process, Investigation Guidelines, Billing Compliance Assurance Information