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

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 training issue? Once the “why” is determined, the plan must address ways to prevent it from happening again Additional education/training is virtually always appropriate The IRB will make the final determination regarding the sufficiency of the CAPA Reporting at Continuing Review All instances of minor noncompliance should be summarized for the IRB at the time of continuing review on the Form 5R. When applicable, the summary may be a simple brief statement that there have been no protocol deviations or other instances of noncompliance. HRPP Review Inquiry The HRPP Compliance Manager, HRPP Director, an IRB Chair or Manager, or other qualified designee will initially assess a report/allegation of noncompliance and make a preliminary determination as to the seriousness or continuing nature of the noncompliance. Next, a fact-finding inquiry will be conducted which may include: examination of study records; and discussions with the research team, other personnel, research participants, witnesses, the complainant (if applicable and not anonymous), and others, as appropriate. If the inquiry suggests that the incident may constitute serious or continuing noncompliance, then the matter will be referred to a fully-convened IRB. Actions By IRB The IRB has the authority to take whatever action it deems appropriate, up to and including suspending or terminating approval of r