Quality Assurance/Quality Improvement
The Quality Assurance/Quality Improvement Program (QA/QI) is a unit within the Office of Research independent of the Institutional Review Board ( IRB), the Institutional Animal Care and Use Committee ( IACUC), and all research related departments. The objectives of this group in no way conflicts with those of IRB, The Office of Human Research Protection (ORHP), IACUC, U.S. Department of Agriculture (USDA), or the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC, Intl).and/or other regulatory agencies.
The QA/QI aims to promote a culture of compliance with the highest legal and ethical standards for the conduct of research. It is also committed to education of the Drexel and affiliates research community and outreach to collaborating institutions striving for research excellence.
QA/QI has free, unlimited and unrestricted access to all books, records, files, equipment, materials, property, systems and personnel of Drexel University and its subsidiaries during reviews of research related activities. To the degree that audit rights have been established, affiliates, partnerships, joint ventures, licensees, contractors, vendors, distributors, third parties or other operations are also subject to quality assurance/quality improvement review. The QA/QI team has the authority to recommend improvements, to monitor the implementation of approved recommendations and has the duty to report findings to the appropriate compliance committee, Institutional Official, and/or regulatory oversight agencies when deemed applicable.
QA/QI's human subject research objective is twofold:
- To support institutional regulatory compliance
- To assist investigators in the human clinical research process
The primary goal of the QA/QI program is to ensure a human subject safety, to maintain regulatory and institutional compliance, and support the strive for research excellence. QA/QI supports the Human research protection program and complements regulatory oversight. Associated with this, the QA/QI will facilitate the science by serving as a resource to the researchers. The QA/QI review process is positioned to convey IRB policies, identify opportunities for improvement and make recommendations on how to achieve improvement. Ultimately, the QA/QI review will confirm that the manner in which research is conducted under an approved protocol is consistent with what the IRB approved.
Human Research Support and Ensuring Institutional Regulatory Compliance by:
- 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.
- 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.