Quality Assurance - Human Subject

The Office of Research Compliance is responsible for evaluating the conduct of clinical research within the VAMHCS. This is done through audits of individual studies and investigators as well as audits of institutional procedures. Specific areas include:

• Study conduct: source documentation and regulatory documents
• Study conduct: Informed consent process and documentation
• Interface with the clinical side: research notes in CPRS, scanning of consent documents into CPRS, Research Subject Clinical Warnings in CPRS
• Investigational Drug Service (IDS)

The ORC is also apprised of VAMHCS research activities through R&D Committee meetings, IRB meetings, DSMB reports, exit meetings with external monitors and auditors, SAE reports and reports on "Unanticipated Problems Involving Risks to Subjects and Others". Additionally, the ORC handles complaints and allegations of noncompliance from subjects, families, and staff.

The Research Compliance Officer reports QA activities to the R&D Committee, the IRB, and the Executive Performance Improvement Committee (EPIC). Audit findings often are the impulse for making improvements to the Human Research Protection Program.

There are Standard Operating Procedures (SOPs) which describe QA activities in more details:

Please note that forms listed below are to be printed and manually completed.

Standard Operating Procedures (SOPs)
SOP Number	Title	Appendixes/ Attachments
02.01	Overview of Quality Assurance Activities	UMB Self-Assessment Tool: Subject Records Checklist UMB Self-Assessment Tool: Investigator Records Checklist UMB Self-Assessment Tool: Investigator/Staff Interview Checklist UMB Self-Assessment Tool: Informed Consent Form Review Checklist Documents Typically Subject to Audit
02.02	Audit Triggers	Sample Audit Notification Letter Determination of Audit Sample Documents Typically Subject to Audit Problem Resolution Worksheet Table of Contents of Research Service SOPs
02.03	Auditing Source Document Charts	Sample Audit Notification Letter Determination of Audit Sample Documents Typically Subject to Audit Internal Source Documents Audit Internal Source Documents Guidelines Problem Resolution Worksheet Chart Audit Log
02.05	Auditing the Investigational Pharmacy	Study Subject Worksheet Pharmacy Audit Form A: Investigational Drug Dispensing Tool Companion Tool for Pharmacy Form A Pharmacy Audit Form B: Investigational Drug Log Tool Companion Tool for Pharmacy Form B Pharmacy Audit Form C: Investigational Pharmacy Audit Report VAMHCS Investigational Pharmacy Drug Log
	VA Monitoring Visit Policy

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QA audit tools are also available. Investigators are welcome to use Research Service tools in order to perform their own self assessments.

Due to limited resources, the ORC will not routinely include data integrity as an integral part of its Quality Management Program. It will instead focus its attention on matters that more directly impact subject rights and safety (such as informed consent, eligibility criteria and adverse event reporting) and regulatory compliance. However, investigators are now required to notify the Office of Research Compliance when they host external monitors for site visits. Monitors are now required to sign-in at the Research Service Office and, if problematic results are uncovered as a result of the visit, the ACOS/R&D, AO/R&D, or designee (the Research Compliance Officer), must attend the exit interview.

Potential triggers for audits of studies are listed below:

• Routine (scheduled) spot audit
• For-cause audits
• Principal Investigator / study personnel request
• Investigator initiated studies
• Scheduled follow-up to routine audits
• PIs with high numbers of protocols
• PIs with vulnerable populations (elderly, children, psychiatric patients, persons with impaired decision-making)
• Unanticipated Problems Involving Risk to Subjects or Others - numerous or interesting
• Protocol deviations/exceptions - numerous or interesting
• Research participant/family member complaint
• Participant death
• Appearance of lack of staff support/resources/high staff turnover
• Lapses in continuing review/studies administratively closed by IRB
• Ongoing concerns about the quality of IRB or R&D Submissions
• Ongoing concerns of IRB or R&D about document processing
• ACOS/AO/R&D, Chief of Staff, VA/Director, VA/Administrator/Department Chair, IRB Chair has concerns
• Scheduled follow-ups to Resolution Plans

For questions about the Quality Assurance program or for assistance with internal QA activities, investigators or staff should contact the Research Compliance Officer at 410-605-7000 x6512, or Research Compliance Specialists Jessica Mendoza (jmend001@umaryland.edu) or Phyllis Slade (pslad001@umaryland.edu).

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