Research Monitoring and Oversight
In April 2004, the Monitoring and Oversight Program was established at Wake Forest University Health Sciences as part of the Office of Research, which oversees human studies conducted at Wake Forest University School of Medicine and North Carolina Baptist Medical Center.
The goal of the program is to help fulfill the institution’s responsibility for ensuring compliance with Federal and State regulations governing human research, and to promote an environment in which human subject research will be conducted according to the highest standards.
CareCast Access for External Monitors
Ethical Principals, Regulations, and Guidelines
The Monitoring and Oversight Program is governed by the following:
The Belmont Report
Code of Federal Regulations (CFR) governing human research
DHHS 45 CFR 46 (The Common Rule)
DHHS 45 CFR 164 (Health Insurance Portability and Accountability Act
of 1996 (HIPAA)
Search FDA regulations for guidance in conducting human research
· FDA 21 CFR 11 (Electronic Records; Electronic Signatures)
· FDA 21 CFR 50 (Protection of Human Subjects)
· FDA 21 CFR 54 (Financial Disclosure by Clinical Investigators)
· FDA 21 CFR 56 (Institutional Review Boards)
· FDA 21 CFR 312 (Investigational New Drug Application)
· FDA 21 CFR 812 (Investigational Device Exemptions)
ICH Good Clinical Practice (GCP) Guidelines
Wake Forest University Health Sciences Institutional Review Board Policy
Wake Forest University Health Sciences Operational Policy and Procedures
Standard Operating Procedures
Selection of Studies for Routine Monitoring and Oversight Review
Authority
The Monitoring and Oversight program is independent of the Wake Forest University Health Sciences IRB. The focus of the program is to assist with monitoring of ongoing studies and education of investigators and study staff.
The Monitoring and Oversight Specialist reports to the Associate Dean for Research
Monitoring and Oversight Specialist:
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Conducts random, not for cause reviews on any study that has been approved by the Wake Forest University Health Sciences IRB.
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Conducts directed (for cause) audits at the request of the IRB or institutional official.
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Conducts Conflict of Interest (COI) reviews on studies with an approved COI plan established by the CIRC (Conflict of Interest Review Committee).
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Responds to findings of non-compliance from on-site reviews by:
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Identifying corrective actions, which may include mandatory re-assessment in the future.
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Reporting major findings of noncompliance to the IRB.
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Provides investigators with quality improvement recommendations to ensure that research is conducted according the Good Clinical Practice guidelines.
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Recommends action to the IRB, based on on-site observations during a for-cause audit.
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Reports serious or continuing non-compliance to appropriate regulatory authorities
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Helps to prepare study sites for external audits.
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Assists study sites responding to external audit findings
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Provides consultation and continuing education for investigators and study staff.
Are you in compliance with the regulations governing clinical research?
Do you know that non-compliance can result in penalties such as limitations of your research activities or even disqualification as an investigator?
The Monitoring and Oversight Program is available to help investigators and their research teams understand and comply with the regulations and avoid such sanctions. Specializing in regulatory compliance and quality assurance and improvement, the M/O specialist can:
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Conduct an on-site review of your study files to ensure regulatory compliance and good clinical practice
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Provide on-site consultation as you set up new studies or monitor ongoing studies
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Provide an annotated study binder to facilitate proper documentation
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Assist study sites as they prepare for upcoming audits by FDA, NIH, or other external agencies
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Provide regulatory advice, including assistance in preparing responses to Form FDA- 483 or FDA warning letters, and development of specific plans to prevent future non-compliance