The RSAs will periodically review protocols using the CRC to ensure that the research is being conducted according to the protocol, and that the approved data and safety monitoring plan is being followed. The RSAs will randomly select protocols to be reviewed, usually those that are moderate to high risk, or those that have limited monitoring.

The CRC research subject files will be reviewed for:

• Consistency between the physician orders and the labs tests and procedures listed in the protocol
• Eligibility criteria
• Adherence to study procedures and schedules
• Reporting of adverse events
• Informed consent issues

A written Quality Assurance report will be submitted to the PI of the study at the completion of the review. The report will list the findings and recommendations from the RSAs. If concerns arise during a continuing protocol, the investigator may be contacted before the final report is completed.

The confidentiality of all research subjects will be maintained during the review, and the QA reports will be kept confidential by keeping copies in a locked file cabinet in the RSA’s office. The reports will only be shared with the PI and the CRC Advisory Committee.