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Planning Clinical Trials and Navigating Regulatory Requirements

National and regional regulatory authorities have heightened the level of oversight and regulation required for clinical trials in recent years. So, when trials are conducted in more than one country, the differing regulations can be complicated and difficult to navigate. This checklist explains the requirements for collaborating with U.S.-based groups.

 

  • Agree to OHRP Guidelines
    Your institution must agree to the requirements set up by the U.S. Department of Health and Human Services (DHHS), Office of Human Research Protections (OHRP).
  • Complete an FWA
    Each institution participating in research sponsored by the U.S. DHHS must apply for a Federal-Wide Assurance (FWA) to certify that the institution meets international ethical standards.
  • Set up and Register an IRB
    An independent ethics committee, also known as an Institutional Review Board (IRB), must be set up to comply with U.S. DHHS policy on patient safety. Policies and procedures for establishing an IRB vary by region and country. All institutions collaborating in clinical trials with NCI must register their IRB.
  • Apply to Join Cooperative Group (if applicable)
    If you plan to join an NCI-sponsored Clinical Trials Cooperative Group, your institution must apply. These applications provide proof that your institution is committed to academic clinical trials, that you have sufficient numbers of cancer patients to participate in clinical trials, and that you have the necessary multidisciplinary collaboration and commitment to participate in academic clinical trials effectively.  Applications can be found on each cooperative group's Web site. A list of NCI-sponsored cooperative groups is available on the NCI Web site.
  • Complete FDA 1572 Forms
    Each investigator must complete an FDA 1572 form and return that form to NCI.