Regulatory Affairs & Quality Assurance
Regulatory Affairs and Quality Assurance provides support for investigators, sponsors, and study teams navigating the regulatory process for Investigator Initiated Trials (IITs).
Services provided to investigators include:
- Investigational New Drug (IND) and Investigational Device Exemption (IDE) application assistance and submission to FDA
- Multi-center trial management consultations
- Data and Safety Monitoring Plans consultations
- Auditing and Monitoring Services
- Assists with FDA inspection and external audits
Director, Regulatory Affairs and Quality Assurance
Quality Assurance Program
The Quality Assurance Program is charged with ensuring the compliance of clinical research conducted or reviewed by KUMC and its Institutional Review Board. The QA program offers a wide variety of services to the KUMC research community including collaborative reviews of clinical trials, education and training, and external audit preparation.
Internal Reviews and External Audit Preparation
The QA Program conducts routine reviews of clinical research conducted or reviewed by KUMC and its IRB. The QA staff work closely with investigators and study teams providing information regarding the review and educational/training opportunities for the investigator and study team. Additionally, the QA Program can assist in preparing for an audit conducted by an external agency or company as requested by the Principal Investigator.
FDA Inspection Preparation
The QA Program supports investigators notified that they, or one of their protocols, are the subject of an FDA inspection. QA staff will work with the investigator and their study team to assist in preparing for the inspection and host/co-host the inspection.
Quality Assurance Associate
Monitoring is the process of overseeing the progress of a clinical trial; and ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP). Study monitoring is important to ensure the rights and well-being of participants is protected, proper and accurate collection and documentation of study data, and the study is conducted in compliance with the approved protocol and applicable regulations.
It includes the development of monitoring plans that describe the monitoring strategy that will be followed and the responsibilities of the different parties involved.
Examples of items the Clinical Research Monitor will review during a monitoring visit include:
- Participant eligibility
- Documentation of informed consent
- Adherence to protocol requirements and protocol defined endpoints
- Data collection and source documentation review
- Adverse events, serious adverse events and unanticipated problems
- Protocol deviations
- Investigational product accountability and pharmacy documents
- Delegation logs, training documents and regulatory documentation
Clinical Research Monitor
Sponsor Investigator Support
Support provided to investigators holding an IND or IDE includes:
- Provides support for IND and IDE application process
- Submits IND and IDE application to FDA
- Supports additional submissions (e.g., annual report or protocol amendment) to FDA