Studies Approved by the Research Subjects Review Board (RSRB)

The Office for Human Subject Protection implements a program for conducting both routine and "directed" audits of studies approved at this institution. The purpose of the program is to assure that the rights and well being of human subjects are protected and that the study is being conducted is in compliance with the currently approved protocol and Good Clinical Practice (GCP) standards. In compliance with the Federal Office of Human Research Protections (OHRP) guidelines, the auditing function provides the RSRB a vehicle to achieve verification from sources other than the investigator that no material changes have occurred since the previous RSRB approval. Studies can become candidates for audit according to a number of various criteria; projects that receive only minimal or no monitoring by the sponsor; complex projects involving unusual levels or types of risk to the subjects; projects where concern about material changes occurring without RSRB approval that have been raised based upon information provided in continuing review reports or from other sources. The audits are conducted in a collegial manner and provide recommendations on how to improve processes.

Overview

The Quality Improvement (QI) Program of the OHSP seeks to assist Investigators and their staffs by identifying areas within research programs that are or may be susceptible to non-compliance with regulatory standards. The auditing program is similar to the monitoring techniques used by governmental organizatons such as the FDA and the NIH. The main difference is that the QI program goal is to provide education and feedback, when necessary, to prevent situations that might place additional risks on human subjects or lead to regulatory citations if the research were to be reviewed by an outside entity. The QI program is conducted under strict confidentiality guidelines and the issuance of audit reports and correspondence are limited to the Principal Investigator (PI) and other individuals who may be responsible for action on audit observations.

What the QI Program Reviews:

For Non-FDA regulated studies e.g. behavioral and social science studies, the QI program measures compliance to protocol. The parameters that may be examined in these types of studies include, but are not limited to:

• Study File for required elements including: Presence of required documentation: protocol and amendments, approved consent forms and IRB documentation
• Subject eligibility
• Informed Consent Documentation
• Unanticipated event reporting
• Site specific SOP's (if applicable)
• Confidentiality

For FDA regulated research studies, the QI program conducts reviews to establish that the research data being collected is accurate and that compliance to protocol are being maintained. The scope of the reviews is based on considerations such as the trial objective, purpose, design, complexity, blinding, size and endpoints of the trial. Depending on the size of the trial, sampling may be an acceptable method for selecting the data to be verified. Parameters to examine include, but are not limited to:

• The study file (for required elements)
• Subject eligibility
• Subject history
• Informed Consent documentation
• Concomitant medications / therapy
• Laboratory data
• Accuracy and completeness of CRF's
• Adverse Event Reporting
• Confidentiality of records
• Site specific SOP's (if applicable)
• Drug and Device handling and accountability

How the Program Works:

Audit Process: When a study is selected for review, the PI will receive a memo indicating the intention for the review and requesting that the PI select a time and place for the review to be conducted. Investigators may assign a person to arrange access to the records and obtain a suitable workspace for the audit. It is encouraged that the investigator meet with the reviewer at the start of the audit to have any questions answered. Some investigators like to be periodically updated on any preliminary findings throughout the course of the review; this is also encouraged. If deficiencies are found during the course of the review, they will be brought to the attention of the investigator and/or study staff. If possible, immediate corrective actions may be implemented.

Audit Conclusion: Once the review has been completed, the reviewer will conduct an exit interview with the PI and appropriate study staff. During the exit interview, the preliminary findings will be discussed as well as any recommendations the QI reviewer(s) may have. This interview provides opportunity for immediate dialogue, feedback and/or clarification.

Audit Report: If unresolved audit observations exist at the conclusion of the review, a draft audit report will be generated and sent to the PI within ten working days from the conclusion of the review. The PI is requested to respond in writing to each audit observation in the draft report and, provide a corrective action plan. As necessary, QI reviewers will assist the investigator and study staff, by providing consultations, in the development of satisfactory corrective actions. Once a satisfactory corrective action plan is determined and implemented, the QI reviewers will issue a final report. If necessary, the report may include additional recommendations for process improvement.