The NIH conducts quality clinical research for a number of diseases and conditions, including cancer, Alzheimer's disease, allergies, infectious diseases, and neurological disorders. You can find other clinical trials on conditions and diseases by visiting ClinicalTrials.gov.
Provides links to clinical investigators who have participated or are participating in clinical trials of pharmaceuticals and regulatory correspondence and restrictions resulting from non-compliance observed during Biological Research Monitoring Inspections (BIMO).
Good Clinical Practices incorporate established ethical and scientific quality standards for the design, conduct, registration, and reporting of research involving human subjects.
OHRP develops educational programs and materials, provides guidance and clarification, maintains regulatory oversight, and provides advice on ethical and regulatory issues in behavioral and biomedical research.
If you or someone you know would like to take part in a clinical study, we provide up-to-date information about clinical research studies to patients, their families and caregivers, healthcare professionals, and the public. Each study record includes a summary of the study protocol, including purpose, enrollment status, and eligibility criteria.
Human drug studies can begin only after the FDA and a local institutional review board review an investigational new drug. The board is a panel of scientists and non-scientists at hospitals and research institutions that oversees the clinical trial.
Modern advances in human health and wellness ultimately depend on research studies involving humans. Well-controlled studies with human subjects are essential to verify any conclusions about normal physiology, disease mechanisms, the efficacy of new treatments, learning, or behavior.
A Case Record Form or CRF is a document designed by the Protocol to record data and other important information about each test subject. The CRF must be in a format that allows accurate entry, submission, verification, audit, and inspection of the data recorded. CRFs may be in paper or electronic format, both of which are acceptable under Good Clinical Practice guidelines.