Clinical Research Operations

FDA Guidance Documents

FDA (Food and Drug Administration)

List of FDA Clinical Trials Guidance Documents

Continuing Review 

• Continuing Review after Clinical Investigation Approval
• IRB Continuing Review After Clinical Investigation Approval

Development and Approval Process -- IDE

• Draft Guidance FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
• Factors to Consider when Making Risk Benefit Determinations for IDEs
• IDE Guidance
• IDE Policies and Procedures
• Significant Risk and Nonsignificant Risk Medical Device Studies

Development and Approval Process -- IND

• Content and Format of IND Application for Phase 1
• Final Rule: IND Safety Reporting
• How to Put Together an Application (pdf)   
• Individual Patient IND under Expanded Access for Non-emergency or Emergency Use
• IND Application Overview
• IND Applications for Clinical Treatment with Investigational Drugs in Emergency Situations
• Draft Guidance IND Applications Prepared and Submitted by Sponsor Investigators 
• IND Meetings for Human Drugs and Biologics
• Investigator-Initiated Investigational New Drug (IND) Applications
• "Off Label" and Investigational Use of Marketed Drugs, Biologics and Medical Devices
• Overview of the IND Process CBER 101 -- An Introduction to CBER (pdf)
• Safety Reporting Requirements for INDs and BA/BE Studies
• Safety Reporting Requirements for INDs and BA/BE Studies - Small Entity Compliance Guide
• Submitting an IND -- what you need to know (PowerPoint) 
• Submitting IND Applications

Expanded Access (21 CFR parts 312 and 316)

• Expanded Access to Investigational Drugs for Treatment Use  

Form Guidance

• FAQ Statement of Investigator (Form FDA 1572)
• Guidance for Submitting Form FDA 3674  

Frequently Asked Questions (FAQs)

• FAQ about Medical Devices  
• FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions

 Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards

• Adverse Event Reporting to IRBs 

Guidance for Industry

• Chemistry, Manufacturing, and Controls (CMC) for Phase 2 and 3 Studies  
• Collection of Race and Ethnicity Data in Clinical Trials
• Data Retention when Subjects Withdraw from FDA-Regulated Clinical Trials
• Drug Master Files (pdf)
• E2F Development Safety Update Report (DSUR)
• E6 Good Clinical Practice: Consolidated Guidance
• E14 Clinical Evaluation of QT/Qtc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
• Exemptions for Studies of Lawfully Marketed Drug or Biological Products
• FDA Definition of Disease Prevalence for Therapies Qualifying under the Orphan Drug Act  

Guidance for the Public, FDA Advisory Committee Members, and FDA Staff

• Public Availability of Advisory Committee Members' Financial Interest Information and Waivers

Informed Consent Elements

• Elements of Informed Consent  
• FDA New Requirements Informed Consent  
• Questions and Answers on Informed Consent Elements, 21 CFR § 50.35 (c)

Inspections and Monitoring

• Compliance Program Guidance Manual
• FDA Inspections of Clinical Investigators  
• Draft Guidance Oversight of Clinical Investigations -- A Risk-Based Approach to Monitoring

Investigator Responsibilities

• Financial Disclosures by Clinical Investigators
• Investigator Responsibilities