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About Us

• Overview
  Mission Statement | Code of Conduct | Clinical Trials Compliance Responsibilities | Join the CTC Email Listserv
• CTC Office
  Find Us | CTC Team | Join the CTC Email Listserv
• UF CTC Committee
  Membership | Purpose & Responsibilities

Starting Out Right

• CTC Process - Start to Finish
  Study Initiation: Pre-Award Phase | Ready to Enroll: Post-Award Phase | Wrap Up: Closeout Phase
• Defining Clinical Trials
• Triad of Clinical Trial Documents
  Clinical Trial Agreement & Budget | Protocol & Schedule of Events | IRB & Informed Consent Form
• Policy & Standards
  CTC Policy | Standards | Laws and Regulations

Study Initiation: Pre-Award Phase

• Overview
• First Steps
  DSR Preliminary Review of CTA (Optional) | IRB Submission
• Medicare Coverage
  Medicare Clinical Trial Rules - Determine Type of Trial | All Clinical Trials except Device Trials | Device Trial | Medicare Coverage Analysis - National Coverage Decision
• Budget Building
  Clinical Services Billing Plan | Clinical Trial Agreement Checklist | Detailed Budget | Negotiations - Can we afford it?
• RAC & DSR - What to Send
  Study Initiation Checklist | DSR 1 Form
• Final Steps
  Signing CTA | DSR Account Set-Up | Device Approval | NOA
• Frequently Used Forms & Resources
  Phase I: Pre-Award | Phase II: Post-Award | Phase III: Closeout

Ready to Enroll: Post-Award Phase

• Overview
• Study Participants
  Participant Registration | Participant Tracking
• Study Procedures/Services
  Charges | Allowable Costs
• Third Party Payors
  Overview | Insurance Pre-approval | Physician & Hospital Medicare Billing - Clinical Trials | Denial of Claims/Services
• Frequently Used Forms & Resources
  Phase I: Pre-Award | Phase II: Post-Award | Phase III: Closeout

Wrap Up: Closeout Phase

• Overview
• Budget
  Payment Sources | Errors in Payment
• Final Steps
  Evaluate Budget Performance | Study Closeout Checklist
• Document Management & Storage
• Frequently Used Forms & Resources
  Phase I: Pre-Award | Phase II: Post-Award | Phase III: Closeout

Frequently Used Forms & Resources

Education & Training

• Classes
  Phase I: Pre-Award | Phase II: Post-Award | Phase III: Closeout | Directions
• Online Training
• Videotaped Lectures
  Currently Available | Check-out DVD/VHS
• Certification

Conducting Compliance Reviews

• Process
• Investigation Guidelines
• Billing Compliance Assurance Information

Getting Help

• Contact: Who Can Help?
• CTC Office
  Find Us | CTC Team | Join the CTC Email Listserv
• FAQs
• Links of Interest
  UF Compliance Organizational Chart | Other UF Sites | Other Regulatory Sites
• Gatorlink Password
• Join the CTC Email Listserv
• Helpline - Reporting Concerns

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Last modified: July 27 2009.