Quality Improvement Program
The Office of Research Compliance and Assurance supports and promotes ethical and compliant research practices at the University of South Alabama through the Quality Improvement Program (QIP). We offer a variety of education and study related services and activities designed to ensure investigators, research staff, and the IRB are compliant with regulations, guidance, institutional policies, and best practices for human research protections. Our staff is available to help address issues and questions that may arise during the conduct a study, as well as to provide quality improvement recommendations on the best practices for conducting a research study.
The Office of Research Compliance and Assurance provides research templates and resources to ensure human subjects protection and overall data integrity. In addition, our staff is willing to tailor existing services to meet your study's needs (i.e. reviewing specific study documents, preparing for an audit, etc.).
Please feel free to contact us if you have any research-related questions or would like to request any study related services:
Stefanie White, CCRP
Associate Director, Research Quality Assurance and Improvement
Phone: (251) 460-7573
1. On Site Reviews - The focus of the review includes as assessment of the roles, responsibilities and training of research team members, suitability of the facility to conduct research including pharmacy operations, regulatory, and IRB compliance, recruitment, eligibility and consenting process, case review for protocol adherence through source documentation and data collection, adverse events, file security, and other relevant aspects of the study.
2. Informed Consent Review - This review helps researchers in assuring that adequate informed consent is provided to participants in studies and can be performed in conjunction with other reviews. Auditors may observe the consenting process; verify that the person the subject is qualified and designated by the PI; verify that the consent document is appropriately signed and dated, and a copy was given to the participant
3. For Cause Review - This type of review is performed at the request of the IRB and/or Compliance Officer. Reasons for this request may include: specific concerns regarding compliance, protocol adherence, or subject safety. The review may be either scheduled or unscheduled and may involve full review or focus on specific concerns.
It is the policy of USA that the Office of Research Compliance and Assurance should be notified whenever an audit has been scheduled. This policy applies to any type of audit: sponsor, FDA, or other regulatory agencies. It is important to contact the Office of Research Compliance and Assurance as soon as you are notified of a pending audit.
A reviewer will conduct a comprehensive review of all study related records including pharmacy, regulatory, subject binders, etc. Any observations will be noted in a formal report to the Principal Investigator.
The Office of Research Compliance and Assurance provides training for new research personnel. Additionally, continuous education opportunities are provided throughout the year for research coordinators and investigators.
Contact the Office of Research Compliance and Assurance to schedule training sessions or to inquire about planned educational sessions.