Centers for Medicare and Medicaid Services (CMS)
- CMS – Clinical Trials Policy History
- CMS – ClinicalTrials.gov NCT Number Required
- CMS – Coverage of Clinical Research Services
- CMS – Coverage of Investigational Device Studies
- CMS – Copays in Clinical Trials
- CMS – Indigent non-Medicare Patients
- CMS – Medicare Secondary Payer Rule and Mandatory Reporting Provisions
- CMS – Z00.6 and Q0/Q1 Modifiers
- CMS – 60 Day Rule: Reporting and Returning Overpayments
ClinicalTrials.gov
- ClinicalTrials.gov – History, Policies, and Laws
- FDA – Food and Drug Administration Amendments Act of 2007 (FDAAA)
- HHS-NIH – Clinical Trials Registration and Results Information Submission (09/21/16)
- ICMJE – Clinical Trials Registration
- Medicare – Mandatory Reporting of the 8-Digit National Clinical Trial Identifier Number
- NCI – Policy Ensuring Public Availability of Results from NCI-supported Clinical Trials
- NIH – Policy on the Dissemination of NIH-Funded Clinical Trial Information (09/21/16)
- WHO – International Clinical Trials Registry Platform (ICTRP)
Food and Drug Administration (FDA)
- FDA – Investigational New Drug Application (IND)
- FDA – Investigational Device Exemptions (IDE)
- 21 CFR 812 Subpart C
- 21 CFR 812.140
- 21 CFR 812.150
- Sponsor’s Responsibilities For Significant Risk Device Investigations (Nov. 1995)
- Investigators’ Responsibilities For Significant Risk Device Investigations (Nov. 1995)
- Recruiting Study Subjects – Information Sheet
- Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects – Guidance for Industry and FDA Staff (PDF – 26KB)
- Establishment and Operation of Clinical Trial Data Monitoring Committees (March 2006) (PDF – 774KB)
- Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (PDF – 163KB)
- FDA – Payment and Reimbursement to Research Subjects
Federal
- Affordable Care Act – Clinical Trial Coverage
- Anti-Kickback Statute (AKS)
- Civil Monetary Penalties Law (CMPL)
- False Claims Act (FCA)
- The Physician Self-Referral Statute (Stark Law)
UF
- UF – Billing Compliance Assurance
- UF – Electronic Signatures – EMR 21CFR Part 11
- UF – Epic Upload Required
- UF – Financial Language Assessment Required
- UF – Insurance Contingency Language in Clinical Agreements and Consents
- UF – Mandatory Research Billing Compliance Training and Certification
- UF – Professional Fees for Subject Injury
- UF – Professional Reading Exceptions
- UF – Research Billing Compliance Policy
- UF – Research Billing Process Follows Medicare Rules
- UF – Research Rates for Study-funded Services (Gatorlink login required)
- UF – Standard of Care
UF Health
- Shands – Research-Related Policies on UF Health Bridge (Gatorlink login required)
- UFHP – Clinic Research Visits