In the course of the conduct of clinical research, it is inevitable that noncompliance will occur. In some cases, noncompliance can be serious and jeopardize the rights and welfare of research participants. More commonly, however, noncompliance is minor and involves relatively insignificant documentation problems. Investigators, research staff, sponsors and IRBs are obligated to minimize the occurrence of noncompliance as much as possible. This session will define noncompliance in accordance with federal regulations for the protection of human subjects, describe how to investigate allegations of noncompliance using due process, present incident based options institutions and IRBs can take if noncompliance is verified, and discuss FDA and OHRP reporting requirements. Finally, the possible legal consequences of wrongful dismissal or sanctions based upon incomplete and/or faulty determinations of noncompliance will be discussed.
Define serious or continuing noncompliance.
Describe how to investigate allegations of noncompliance using due process.
Explore the possible legal consequences of wrongful dismissal or sanctions based upon incomplete and/or faulty determinations of noncompliance using examples of actual litigations.
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