高清不卡日本v二区在线,天天综合网天天综合,激情丁香五月天婷婷水蜜桃视频,91精品免费久久久久久久久,手机看片久久久久久久久,日日夜夜嫩草,日本不卡 在线视频,欧美亚洲日韩,高潮歹无毛免费观看视频,天天综合网7799日日夜夜永,欧美日本国产日韩激情视频 ,久久久无码精品亚洲日韩蜜桃,日夜夜天天人人综合网,91蜜桃长长久久,国产精品精品一区在线发布,一级a毛片免费观看久久精品

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.