QA/QI Program: Auditing & Monitoring

CHA is dedicated to supporting safe, compliant, high quality research in compliance with state and Federal regulations and institutional policies. To help our researchers achieve that goal the CHA Office of Research Administration has recently revitalized its human research QA/QI program. The program’s concentration is on education and supporting investigators involved in the conduct of human subject research. Continuous QA, QI, and monitoring of ongoing research by members of the study team and internal and external monitors enhance the CHA research enterprise and promote a culture of compliance and subject safety.

The IRB and the QA/QI program are integrated components of the larger HRPP; they are separate entities with related, but different charges. The IRB is responsible for reviewing and overseeing human research to ensure it is designed and conducted ethically and is responsible for ensuring the protection, safety, and welfare of study participants. The QA/QI Program seeks to verify and promote the IRB’s mission by periodically monitoring research and through education and best practices.

QA/QI Program staff meets with researchers and reviews study documents and activities related to human research studies. They provide education and monitoring, recommend best practices, and verify the study is being conducted per the IRB-approved protocol. The following are typically performed as part of a QA/QI audit:

• Review study records.
• Review on-site record keeping.
• Review study procedures and ensure they are performed in accord with the IRB-approved protocol, Federal and/or state regulations, as applicable, and CHA policies.
• Observe the informed consent process.

The Principal Investigator (PI) and research team members are expected to implement a plan of their own to ensure that periodic monitoring, etc., occurs while the study is being conducted.

A “for cause,” or directed, audit is a review that is usually initiated at the request of the IRB, the Institution, or another oversight body. A for-cause audit is generally initiated because of a concern, complaint, or allegation that was brought to the attention of the CHA Research Administration regarding the conduct of a study or an investigator/research team member.

A “not-for cause,” or routine, audit is a service CHA provides to its researchers that is performed on a random basis and is conducted as part of overall effort to assure and/or improve the quality of research conducted at CHA. Feedback from this type of audit is shared with the research team in an effort to support the study conduct and practices, suggest potential areas of improvement, and strengthen the overall research enterprise at CHA.

QA/QI personnel are available to help with the following:

• Assist researchers with organizational and operational needs at the time of study start-up.
• Provide research education sessions.
• Help PIs develop and implement educational programs and tools to effectively train research team members in human research and related activities.
• Help PIs develop their own periodic study monitoring plans.
• Recommend education and process enhancements that will raise performance standards related to the conduct of human research.

Studies are selected from a list of all open studies in the IRB database. The following are among the criteria used to identify studies that are typically selected for review:

• Studies involving enrollment of human subjects, as opposed to strictly data or specimen analysis.
• Studies that involve a medical intervention or are subject to US Food and Drug Administration regulations.
• Investigator-initiated studies.
• Studies that enroll a vulnerable population(s).

Prior compliance issues associated with a study or investigator/research team member will also be a factor in selection.

After a protocol is identified and selected for a routine audit, the PI will be notified in writing and the Department Chair will be copied on the communication. The PI will then be contacted, typically within 1 week of the initial notification, to make arrangements for the audit, including scheduling a meeting date and time. Routine audits are scheduled at a mutually agreeable time, preferably within 1 month of the initial audit notification.

Prior to the audit, the PI/a study team member designated by the PI will be asked to provide a list of all study participants. To ensure subject confidentiality, the list is to be limited to the participants’ initials or unique identification number and their date of study enrollment.

From that list, the auditor will select several subject files for audit. The list of selected subjects will be given to the PI/study team so that all records containing information relevant to the study may be assembled, e.g., research records, clinic charts, hospital records. Access to all selected subjects’ records and associated documents should be provided to the auditor. At the time of the audit, additional records may be requested for review.

In preparation for an audit the PI and study team should:

• Ensure files, including individual subject files, and documents are present, organized, and available for review.
• Review the regulatory binder, and other study logs and records, to ensure all necessary documents are present and up-to-date.
• Ensure a copy of each research team member’s human research education certificate of completion is present.

The self-assessment tools developed by CHA QA/QI personnel, found elsewhere on the CHA IRB website, may also help the PI and study team prepare for the audit.

If an event that requires prompt reporting (e.g., a previously unreported serious adverse event or unanticipated problem) is discovered immediately contact the IRB office for guidance and to develop a plan, including a timetable, for submission to the IRB.

Issues such as missing or out-of-date documents should be addressed by the PI/research team without delay. In addition, the PI should document and implement a corrective and preventive action (CAPA) plan to ensure such issues do not reoccur. The CAPA should include a plan for the PI/research team to perform periodic monitoring of the study files to eliminate reoccurrence of the issue.

For other issues that are identified, contact the CHA QA/QI personnel for guidance.

The QA/QI auditor and PI/designated study team member will review various documents associated with the study. The following are among the things commonly reviewed:

• Study records, including eligibility criteria and screening procedures, IRB-approved documents, and verification that initial study applications, continuing review applications, and amendments submitted to the IRB are among the PI’s study files.
• IRB-related correspondence, including verifying the IRB approval letters are in the study files.
• Any management or monitoring logs used by the study team.
• Reports of serious adverse events and/or unanticipated problems.
• Study procedures to ensure they are performed in accord with the IRB-approved protocol, Federal regulations, and CHA policies.
• Observation of the informed consent process.
• On-site record keeping, including provisions for ensuring confidentiality and security of records.
• Electronic records, as applicable.
• Test article accountability, as applicable.

Yes, but not for the entire time of the on-site review of records. The QA/QI staff will meet with the PI or another senior member of the study team at the start of the on-site audit to review study practices and procedures. The PI or other qualified research team members may also need to be available during the audit to answer any questions that may arise during the conduct of the audit. As the person responsible for the conduct of the study, the PI is expected to be present at a brief close-out meeting at the end of the audit to review the findings and address any questions/issues.

Any event(s) identified during an audit that may represent serious non-compliance or continuing non-compliance or may be an unanticipated problem that may involve risks to human subjects or others are to be reported by the PI to the IRB immediately.

The QA/QI staff may suggest process improvements and/or make recommendations. Researchers may also be directed to the CHA education tools and resources.

A summary letter will typically be sent to the PI within 2 weeks of the on-site audit.

A summary of the results will be provided to the convened IRB.