Managing Protocol Deviations: Identifying and reporting protocol deviations and developing effective corrective and preventive action plans (CAPA)
Audrey Williams, PhD., Sr IRB Coordinator, UTHealth Committee for the Protection of Human Subjects Office
Carolyn McKinney, RN, BSN, CCRP, Sr Research Compliance Specialist, UTHealth Clinical TrialsProgram Description:
The purpose of this education activity is to demonstrate and discuss knowledge in the area of Protocol Deviations related to subject protection by using a Corrective and preventative action plans (CAPA) in an effort to protect research patients per stated objectives. Upon completion of this session, participants should be able to:
- Learn to identify minor and major protocol deviations.
- Outline the reporting requirements for protocol deviations.
- Discuss best practices for developing an effective corrective and preventive action plan.
1.0 Contact hours have been applied for through ACRP. Contact hour credit can be purchased at www.acrpnet.org under the Greater Houston Area Chapter. Contact hours are free for ACRP local Chapter members, $15 ACRP Members/ Non-Chapter and $30 for non-ACRP members.Target Audience:
Research Managers / Administrators, Regulatory personnel, Clinical Research Coordinators, Clinical Trial Nurses, (Principal/Sub) Investigators, Clinical Research coordinators (CRAs), Project Managers (PMs), AuditorsRegistration:
Registration will be done on-line through ACRP and sign-in on the day of the event beginning at 11:15PM CST.
Please contact Kathy Franco with any questions or concerns: 281-731-8871 or Kathy.d.franco@uth,tmc.edu