Why and How Do Clinical Trial Submissions Differ from Other Clinical Research Project Submissions?

Clinical trials and large epidemiologic studies that exceed yearly direct costs over $500,000 require approval before submission and are encouraged to contact the Clinical Research Liaison or the appropriate Program Director. There are additional requirements for applications requesting $1 million or more in the direct costs in any year. Once a study has been through the review process, there are additional NINDS requirements before an award can be made.

• NINDS Requirements
  • NINDS Terms of Award for Clinical Research
  • Conversion of Grant to Cooperative Agreement
  
  
• NIH Requirements
  • Inclusion of Women and Children
  • NIH Data Safety Monitoring Plan Guidance
    • NIH Policy for Data and Safety Monitoring(released on June 10, 1998)
    • Further Guidance on Data and Safety Monitoring for Phase I and Phase II Trials (released on June 5, 2000)
    • NIH Policy of Reporting Race and Ethnicity Data: Subjects in Clinical Research
      
      
• Other Federal Agency Requirements:
  • Office for Human Research Protections
  • Food and Drug Administration