Clinical trials are a cornerstone in search for medical advances. There has been progress in the design and conduct of a clinical trial. This led to an increased awareness of ethical issues and safety monitoring. It is the Policy of National Institutes of Health (NO) that a system should be there to ensure the safety of participants. The establishment of Data safety monitoring boards is required for multi site clinical trials involving potential risks to the patient. A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
This topic describes: Good clinical practice (gcp), Safety monitoring in different phases of clinical trial, Data and safety monitoring board, Functions of DSMB, Composition of DSMB, Meetings, Responsibilities in monitoring safety, Pharmacovigilance, Adverse event, Methods of collecting adverse events in clinical trial.