Clinical research regulations. Stay informed on clinical trial standards and practices.

Clinical research regulations. Tabs within the page describe why we have regulations to protect research participants; what the principal regulations that protect research participants are; which Federal office oversees and enforces the HHS regulations; what research is not be regulated by the Federal Regulations and Requirements Governing Clinical Trials In addition to human subject protection regulations, there are regulations that govern the approvals and oversight required before a drug or device can be tested and approved for market. Guidance documents listed below represent the agency's current thinking on the conduct of clinical trials, good clinical practice and human subject protection. These include guidance documents and frequently asked questions (FAQs) addressing various topics, findings in the form of OHRP letters addressing regulatory issues, and other media including decision tree Information Not Yet Incorporated Into Country Profile: CRO Registration Requirement Effective April 1, 2025, the New Drugs and Clinical Trials (Amendment) Rules, 2024 requires registration of Clinical Research Organizations (CROs) with the Central Licensing Authority, which is the Drugs Controller General of India (DCGI), prior to conducting clinical trials or bioavailability or bioequivalence May 21, 2025 · Read guidelines for high-quality, safe, and ethical clinical research from the NIH, FDA, OHRP, and other Federal agencies. Welcome to Clinical Research Resources, home of the popular CFR/ICH Guidelines books and more. . Jan 21, 2021 · The documents posted below include the various publications that contributed to the development of final rules related to FDA's regulations on good clinical practice and clinical trials. As new ways of conducting Jun 5, 2024 · FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and good clinical practice (GCP) regulations. Sep 19, 2025 · FDA Rules governing human research are primarily found in Title 21 of the Code of Federal Regulations (CFR). Oct 16, 2023 · This page provides an overview of the laws and regulations that project volunteers participating in clinical research studies. 33 - Annual Reports Clinical Conduct Principles And Guidelines For Recipients Of NIH Research Grants And Contracts On Obtaining And Disseminating Biomedical Research Resources: Final Notice (PDF, 149KB) Dec 29, 2024 · David Peloquin discusses the development and future directions of clinical research regulations. je9rfgn bqxb 2oi brtux habwtlt 4c087s 6rnin5 nbaljn ojv9i 9qqa5w