The Quality Improvement Unit (QIU) within Phronetik's Office of Human Subjects Research (OHSR) provides post-approval monitoring and internal oversight, education and training to research professionals to assure that all OHSR operations effectively support Phronetik's mandate to protect the rights and welfare of research participants. The QIU also reviews and assesses OHSR operations. Based on the outcomes of these activities targeted educational outreach is developed and improvements are made in the overall program to protect human research.
The program includes but is not limited to the following investigator-related components:
Review of all post approval event reports, including but not limited to adverse events, protocol deviations and/or incidents, subject complaints, and allegations of non-compliance.
Post approval monitoring of studies that are minimal risk or more than minimal risk. Monitoring may be routine or requested by the IRB, a department or Federal agency or in response to a subject or other complaint. Post approval monitoring may also be conducted on studies where the Phronetik IRB is relying on another IRB.
Assistance with questions about compliance with federal regulations, state laws, and Phronetik policies and guidelines as well as about Good Clinical Practices.
Assistance with questions about compliance with HIPAA requirements.
QIU Policy, Procedure & Guidance: