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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 human subject research objective is twofold:

  1. To support institutional regulatory compliance
  2. To assist investigators in the human clinical research process

QA/QI's animal research objective is twofold:

  1. To support institutional animal welfare regulatory compliance
  2. To assist investigators in the humane use of animals in their research

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.

QA/QI has free, unlimited and unrestricted access to all books, records, files, 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 and to monitor the implementation of approved recommendations and has the duty to report findings to the appropriate compliance committee when deemed applicable.

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.

QI 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.

Contact Information

Karen Skinner, MSN, RN, NHA, CCRP
Director of Quality Assurance/Quality Improvement
Office: 215-255-7883
Fax: 215-255-7874
QA/QI Research

Kirtanaa Voralu, MStat, MSCR
Analyst, QA/QI (Human Subject Research)
Office: 215-255-7878 
Fax: 215-255-7874
QA/QI Research

Michelle McCarthy, BA, CPIA
Analyst, QA/QI (Animal Research)
Office: 215-255-7892
Fax: 215-255-7874
QA/QI Research

Office of Research

1601 Cherry Street   Suite 10444
3 Parkway
Philadelphia, Pa 19102