Who receives the audit report?
The audit report is provided to the principal investigator (PI), the study coordinator (SC), the PI’s department/division chair, the Vice President of Research, Associate Vice President for Clinical Research (if School of Medicine), the HAC Chairman or CRRI representative. If the PI is a department chair, the audit findings will be sent to the Dean of the School. The report will list both positive findings as well as areas that may need improvement. The investigator may be requested to provide clarifications in writing to any questions raised and to develop a plan of corrective actions to eliminate future reoccurrences of the problem. In cases where major deficiencies are identified, a meeting with the Principal Investigator, the study coordinator, the HAC Chairman or CRRI contact, the OHRP Director, and the Clinical Trials Auditor (CTA), will be called. At the meeting, the PI and SC will be given an opportunity to clarify discrepancies and deficiencies.
The audit report is provided to the principal investigator (PI), the study coordinator (SC), the Vice President of Research, the HAC Chairman and HAC Vice-Chair or CRRI representative. The report will list all findings as well as areas that may need improvement. The investigator will be requested to provide responses in writing to any questions raised and to develop a plan of corrective actions to eliminate future reoccurrences of the problem. In cases where major deficiencies are identified, a meeting with the Principal Investigator, the study coordinator, the HAC Chairman or CRRI contact, the OHRP Director, and the Clinical Trials Auditor (CTA), will be called. At the meeting, the PI and SC will be given an opportunity to clarify discrepancies and deficiencies.
