Skip to main content
U.S. flag

An official website of the United States government

General Clinical Trial Process Outline: Text Version

Design and development

  • Protocol preparation
  • SOP identification or development
  • Partner identification
  • Project management planning

Approvals, permissions, and agreements

  • Submissions to oversight bodies
  • Agreements for data sharing, material transfer, etc.

Participant screening and enrollment

  • Data capture
  • Study team monitoring plus preparation of reports for other monitoring and oversight bodies

Data preparation, analysis and dissemination

  • Data quality review and cleaning
  • Scheduled and exploratory analyses
  • Final reports
  • Dissemination

Back to Considerations in Constructing Clinical Trial Budgets

Last Updated Date: