## Principles of Good Clinical Practice (GCP) ### Principle 1: Trials should be conducted with ethical principles that come from the Declaration of Helsinki. ### Principle 2: Risks, benefits and alternative procedures need to be weighed prior to designing and beginning a trial. They should also be discussed in detail with the prospective research participant. ### Principle 3: The rights, safety and welfare of the research participant override the interests of the study, society and science. The advancement of medicine is never the most important factor in research; therefore investigators must never sacrifice the interests and rights of study subjects to ensure completion of a trial. ### Principle 4: The proposed study should be based on sound scientific data. ### Principle 5: Trials should be described in a clear and detailed protocol. ### Principle 6: Trials should be conducted in accordance with the protocol that has received prior approval by an Institutional Review Board or ethics committee. ### Principle 7: Medical care within the context of a trial should be the responsibility of a qualified physician, dentist or other health care provider. ### Principle 8: Each individual on the study team should be qualified by education, training and experience to perform their designated study responsibilities. ### Principle 9: Freely given informed consent should be obtained from every participant prior to their participation. ### Principle 10: All trial information should be recorded, handled, and stored in a way that allows accurate reporting, interpretation and verification. ### Principle 11: The confidentiality of participants' records and their privacy should be protected in accordance with all applicable federal and local regulation. ### Principle 12: Systems with procedures that assure quality of every aspect of the trial should be considered and implemented. ## Commonly Required IRB requirements ### Objectives ### methods ### QA/QI ### Ethics ### Data management ### Background/significance ### Risks/management