In the United States, several agencies and organizations handle aspects of Clinical Trial Reports (CTR):

1. Food and Drug Administration (FDA)

• Role: The FDA is the primary regulatory body overseeing clinical trials for drugs, biologics, and medical devices. It reviews Clinical Trial Reports as part of regulatory submissions like New Drug Applications (NDAs), Biologics License Applications (BLAs), and Premarket Approval (PMA) applications.
• Website: FDA

2. Institutional Review Boards (IRBs)

• Role: IRBs review and approve clinical trial protocols and ensure the ethical conduct of trials. They are responsible for protecting participants' rights and welfare but are not directly involved in the handling of CTRs after the study is completed.
• Website: Office for Human Research Protections (OHRP)

3. National Institutes of Health (NIH)

• Role: The NIH supports and funds many clinical trials and requires the submission of study results for its funded research. It manages the ClinicalTrials.gov registry, where results and reports are often posted.
• Website: NIH

4. Centers for Medicare & Medicaid Services (CMS)

• Role: CMS may be involved in evaluating clinical trials that impact Medicare or Medicaid coverage. It is not directly involved in CTR handling but plays a role in assessing the relevance of trial results for healthcare coverage decisions.
• Website: CMS

5. Office for Human Research Protections (OHRP)

• Role: The OHRP oversees the protection of human subjects in research and provides guidance on ethical practices. It is involved in ensuring that trials comply with ethical standards but does not directly handle CTRs.
• Website: OHRP

These agencies and organizations collectively contribute to the oversight, approval, and dissemination of Clinical Trial Reports in the United States.