Quality Assurance/Quality Improvement
The Quality Assurance/Quality Improvement Program (QA/QI) is a unit within the Office of Research independent of the IRB and all human research related departments.
QA/QI's objective is twofold:
- To support institutional regulatory compliance
- To assist investigators in the human clinical research process
QA/QI is independent of the IRB. QA/QI supports the Human Research Protection Program. The objectives of this group in no way conflict with those of IRB and/or other regulatory agencies. The QA/QI functions independently.
The QA/QI aims to promote a culture of compliance with the highest legal and ethical standards for the conduct of human research. It is also committed to education of the Drexel and affiliates research community and outreach to collaborating institutions striving for research excellence.
Support Institutional Regulatory Compliance
- Conducting Random on site reviews to assess for regulatory compliance and subject safety.
- Conducting Directed (for-cause) Audits at the request of the IRB or authorized Institutional Officials. Directed Audits focus on areas of concern that have been identified by a variety of entities, i.e., federal, state or institutional.
- Recommending action to the IRB, based on onsite observations during Directed (for-cause) Audits.
- Investigating allegations and findings of non-compliance.
- Reporting potential serious or continuing non-compliance to the IRB and/or Drexel University Institutional Officials and proposing corrective actions.
QIP ensures institutional regulatory compliance by:
- Providing general guidance or study specific services at study startup or throughout the course of a study. These services can include On-site Reviews, Study Consultations, In-services, IRB Submission Assistance, External Audit Preparation, and Study Management Tools
- Providing investigators with quality improvement recommendations to ensure that research is conducted in accordance with best practices.
Karen Skinner, MSN, RN, NHA, CCRP
Director of Quality Assurance/Quality Improvement
Office of Research
1601 Cherry Street Suite 10444
Philadelphia, Pa 19102
QA/QI Research email@example.com