Contents

- Investigational New Drug
- Human Research Participants
- Protection of Human Participants Training
- Clinical Conduct
- Other Links

Registering Clinical Trials

• Registering with ClinicalTrials.gov

Investigational New Drug

• Investigatonal New Drug Regulations (21 CFR 312)

Human Research Participants Policy and Guidance

• Office of Behavioral and Social Science Research - Protection Of Participants In Behavioral And Social Science Research
  
  
• Guidance on Including Women and Minorities
  
  
• Policy on Including Children in Research Involving Human Subjects
  
  
  • Infant, Child, & Adolescent Workgroup
    
    
• Research Involving Individuals with Questionable Capacity to Consent
  
  
• Guidance on Approving Research Involving Prisoners
  
  
• Policy On Reporting Race And Ethnicity Data: Subjects In Clinical Research
  
  
• Office for Human Research Protection

Protection of Human Participants

• Procedures for Registering IRBs and Filing Federal-Wide Assurances of Protection for Human Subjects (FWAs)
  
  
• OHRP Federal-Wide Assurance Application (FWA)
  "Assurance" of protection for human subjects. The Assurance formalizes the institution's commitment to protect human subjects. The requirement to file an Assurance includes both "awardee" and collaborating "performance site" institutions.
  
  
• Institutional Review Boards and Informed Consent (46 CFR)
  The IRB should ensure that all human subject research that is regulated by the Food and Drug Administration (FDA), and for which the IRB provides review and oversight, complies with FDA regulations at Title 21 Code of Federal Regulations Parts 50 and 56 (21 CFR 50 and 56).
  
  
• Certificates of Confidentiality
  
  
• Data and Safety Monitoring: Guidelines for NIDA Grantees
  
  
• Draft Guidelines for Establishing and Operating a Data and Safety Monitoring Board
  
  
• Required Education in the Protection of Human Research Participants
  
  
• NACDA Guidelines for the Administration of Drugs to Human Subjects
  
  
• NACDA Guidelines for Substance Abuse Research Involving Children and Adolescents
  
  
• NACDA Provision of Marijuana and Other Compounds For Scientific Research
  
  
  • NIDA Drug Supply Program (Chemistry & Physiological Systems Research Branch) provides chemicals and research probes that are either unavailable, difficult to obtain, or very expensive to buy to researchers. In addition, this program also provides analytical services for the analysis of researchers experimental samples.
  
  
• For Reporting Serious Adverse Events (SAEs) and Adverse Events (AEs)
  
  
  • Investigational New Drug Safety Reports (21 CFR 312.32)
    
    
  • E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting - ICH Guidance
    
    
  • FDA Regulation 21 CFR 312.33 - Annual Reports