Mary Checovich – Regulatory Specialist – 3830 Alumni Hall, 608-263-2653
- Develop and monitor a standardized mechanism for IRB submissions that will:
- Provide advice for department faculty;
- minimize faculty effort;
- provide training opportunities;
- and incorporate administrative preparation and review of protocols, applications, amendments, changes to protocols, one-time use requests, and adverse events.
- Develop and prepare clinical research protocols, applications, amendments, changes to protocols, one-time use requests, and adverse events for submission to the HS-IRB, MR-IRB, and the VA Research Committee
- Guide faculty investigators, research coordinators, and staff to ensure compliance with expectations, human subjects requirements, and institutional and regulatory requirements.
- Submit serious adverse event reports, Data Safety Monitoring Board findings, Investigator Brochure updates, and protocol deviations as required.
- Assist investigators with federal applications such as Investigational New Drug, Investigational Device Exemption, and Certificates of Confidentiality.
- Assist investigators with Collaborative Institutional Training Initiative training.
- Develop patient-oriented materials, such as study subject recruitment flyers, letters, and advertisements.