That Wasn’t Supposed to Happen - Yale University：这是不应该发生的事情-耶鲁大学.pptVIP

What corrective actions are necessary? Issue may warrant consideration of substantive changes in the research protocol or informed consent process/document or other corrective actions in order to protect the safety, welfare or rights of the subjects or others. The PI must include a proposed corrective and preventive action (CAPA) plan with the report of noncompliance. Corrective and Preventive Action Plan In crafting an effective plan, the investigator needs to really think about why the event occurred. Is it a system problem? Problem with procedure or something in the protocol? A tra