VCU Clinical Research/Trial Quality System

The mission of the Quality System is to:

  1. Support uncompromising research integrity in the conduct of clinical trials and clinical research protocols which includes the protection of the rights, safety, and welfare of research participants.
  2. Strive for accuracy and reliability of clinical research and clinical trial data.
  3. Assess for compliance with Federal, State, and Institutional regulations and policies governing the conduct of clinical research.
  4. Evaluate the effectiveness of the clinical research/ trial system and provide an opportunity to improve it through education and process improvement.

Quality Improvement (definition adopted from the CDC) is a continuous and ongoing effort to achieve measurable improvements in the efficiency, effectiveness, performance, accountability, outcomes, and other indicators of quality services or processes.

Definitions (ICH-E6, April 1996)

Quality Assurance (QA) is defined as “all those planned and systematic actions that are established to ensure that the trial is performed and data are generated, documented, (recorded), and reported in compliance with GCP and the applicable regulatory requirements (s) {ICH1.46}

Quality Control (QC) is defined as “the operational techniques and activities undertaken within the quality assurance system to verify that the requirements for the quality of the trial-related activities are fulfilled” {ICH 1.47}

Monitoring is defined as “the act 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), GCP and the applicable regulatory requirements(s). {ICH 1.6}

Audit is defined as a “systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), GCP, and the applicable regulatory requirement(s)” {ICH 1.6}

VCU Clinical Research/Trial Quality Control (QC) Systems

VCU’s Clinical Research Quality System is composed of several quality control programs and is overseen by a quality assurance program that is an independent, top down, systematic evaluation of processes and quality control.

  1. Individual Investigators and their study teams: Principal investigators on human subject research protocols and medically responsible individuals, as appropriate, are ultimately responsible for the conduct of clinical research and clinical trials. This includes: 1) receiving and maintaining IRB approval, 2) maintaining adequate and accurate records, 3) assuring consent/assent/parental permission of participants according to the process outlined in the protocol, 4) adherence to the approved protocol, 5) monitoring the safety and risk to human subjects, and 6) maintaining communication with the IRB and other university and regulatory authorities. Principal Investigators are responsible for assuring that all staff working on the research protocol have the training required to effectively complete their responsibilities on the study.
  2. Programs within VCU entities: Quality Control systems exist in a number of Individual Schools and Centers. Examples include, but are not limited to:
    • Protocol Review and Monitoring System in the Massey Cancer Center
    • Protocol Review and Auditing through the Center for Clinical and Translational Research
    • Post Approval Monitoring and Quality Improvement Program through the Office for Research Subject Protections in the Office for Research and Innovation.

Quality Assurance and Improvement

VCU provides clinical research/trial quality assurance within the Office of the Vice President for Research and Innovation under the guidance of the Senior Associate Vice President for Research Administration and Compliance and the Clinical Research Compliance Officer.

There are two main components of this quality system:

  1. Audits of individual studies. The goal for audits is: 1) To provide an independent assessment of the protection of the rights, safety, and welfare of subjects involved in clinical trials; 2) To verify the accuracy and reliability of clinical trial data in support of research findings; and 3) To assess compliance with regulations governing the conduct of clinical trials. Determination of clinical trials chosen for audits will utilize a risk based approach.
  2. Quality Oversight to determine needed process changes or educational needs. QC reports which may include monitoring reports and/or monitoring follow up letters, and protocol self-assessments are centrally reviewed by a panel comprised of the Clinical Research Compliance Officer, the Director of Research Subjects Protection, the Director of Research Integrity and Ethics, the Executive Director of the CRS, and the Associate Director for Clinical Research at Massey Cancer Center or their designees. This committee will track trends and assess deficiencies and educational needs. These activities will be focused on Quality Improvement.

Documentation

Documentation of internal audit/monitoring reviews is achieved through the CTMS (OnCore). Access to audit/monitoring results is limited to individuals charged with Quality Oversight (as above) as well as the principal investigator and designated research personnel for individual studies.