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Regulatory Resources

Clinical Research Institute (CRI) is closely regulated with an emphasis on the protection of human subjects. As you will learn in training courses, there have been times when studies have been performed without regard for the safety of the subjects, who often were forced to participate under duress. The Institutional Review Board (IRB) functions as defined under regulations to endure that studies are designed within the constraints of the regulations and to guarantee confidentiality for the subjects. It is the final responsibility of the principal investigator to ensure adherence to the regulations during the conduct of a study, but this responsibility is shared by all members of the study team. Thus, it is critical for all team members to be totally familiar with regulations, adequately trained, and qualified for the tasks assigned to them.

The regulations can be obtained in the following Titles/Sections on the FDA website:

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