Most organizations involved in clinical research today, have internal standard operating procedures (SOPs) and guidelines relating to how clinical trials are conducted and monitored. In addition, as outlined in the ICH GCP Guidelines, sponsors are responsible for assuring that clinical studies are adequately monitored to assure the safety of subjects.1 But what about the larger picture? Who is responsible for assuring these tasks are performed and are in compliance with both federal regulations and organization standards? What if organizations are not in compliance with what they defined? Is there harmonization between these two functions?
These questions are becoming more common within industry organizations. Upon exploration, such organizations are surprised at what they may find. A self-auditing exercise conducted at Kaiser Permanente Southern California (KPSC) found their researchers were not reporting adverse events (AEs) in compliance with the organization's standard operating procedures (SOPs). Interestingly, the researchers were in compliance with federal guidelines and regulations however, KPSC's SOPs were more stringent in the adverse events reporting compliance.2
As a result of these inconsistencies, many clinical research industry sponsors and clinical sites are developing compliance and quality assurance programs to address this issue. Instead of waiting until the FDA comes knocking on the door for an audit, and waiting to see what they may find, organizations are proactively using internal self-auditing or outsourced auditing methods to assure compliance with organization standards and FDA regulations and guidelines. By instituting compliance and quality assurance programs, issues which may be cited during an FDA inspection are identified and can be corrected prior to an FDA visit through such compliance programs. Further, identification of compliance issues early on in a clinical program can help prevent recurrence of noncompliance findings and vastly improve the overall conduct of clinical trials.
The Center for Clinical Research of University Hospitals Case Medical Center in Cleveland, OH has developed an internal compliance program which uses prospective monitoring to review and audit a selection of internal protocols to identify compliance issues, how to resolve these issues and set realistic compliance goals. In addition, this program helps identify needed areas for improving staff education and training. The Center feels that this program has been a great success and feels the program was instrumental in a recent successful FDA audit. 3
The following types of quality assurance audits are commonly seen in the clinical industry; Sponsor/Monitor Audits, Investigator/Site Audits and Contract Research Organization Audits.
• Sponsor/Monitor Audits consist of the internal auditing of a sponsors internal operations and conduct of its monitoring program. Items reviewed may consist of; internal standard operating procedures, investigator/site central files, personnel files including CVs and training records and adverse event collection and reporting procedures.
• Investigator/Site Audits consist of audits where a clinical trial is currently or has previously been conducted. Items reviewed may consist of; verification of source documentation and data collected on Case Report Forms (CRFs), informed consent process and documentation, essential/regulatory documents, personnel files including CVs and training records and delegation of staff responsibilities.
• Contract Research Organization (CRO) Audits consist of auditing of the outsource provider if the sponsor delegates to outsource tasks to such an entity. The content and breadth of these audits is very similar to the Sponsor/Monitor Audit. The audit may also include an on site audit of the clinical site to assess the quality of monitoring conducted by the CRO.
Sponsors, clinical sites and CROs may have their own internal QA departments with an identified QA officer, departmental personnel and defined program. If organizations do not have the infrastructure, staff or financial capacity to manage an internal program the QA function can be outsourced to organizations specializing in such services. Both capacities are commonly utilized in the clinical research industry today.
Clinical Research Consulting, Inc. (CRCI) is a contract research organization which specializes in conducting QAC audits (Quality Assurance and Compliance Audits). CRCI clients feel the QAC audits are very helpful and effective. Ms. Lucy Tennant, Clinical Affairs Director at NewLink Genetics Corporation (NLG) located in Ames, Iowa states; "We hired CRCI to conduct a quality assurance audit because we are a fairly young organization conducting Phase I immunotherapy trials. We wanted to know whether we were compliant but we also wanted to know if are conducting our clinical trials in the most efficient manner possible. This information would prove to be extremely valuable as we move into larger Phase II and Phase III trials. We found as an organization that this audit was extremely worth while. CRCI was able to identify any areas where improvement was needed and also confirmed our areas of strength and efficiency. The audit helped our department to take the time and initiative to look at our internal processes and make improvements and changes that will enable us to conduct our trials more efficiently. We would recommend this process to other organizations"
Whether you are a clinical research site, sponsor or CRO, quality assurance programs are becoming standard practice in our industry today. These programs can be beneficial and instrumental to the success of clinical research programs. If your organization does not currently have a QAC function, developing a program should be on the forefront of your organization planning and structuring.
_______________________________________________________________________ References:
1. Guidance for Industry, E6 Good Clinical Practice Consolidated Guideline; ICH, April 1996
2. "Organization Finds Self-auditing Helps Develop Better Standard Operating Procedures for Trials," Thompson Guide to Good Clinical Practice, January 2008, Volume 15, No.4
3. "Research Center's Compliance Program Makes Use of Prospective Monitoring," Clinical Trials Administrator, AHC Media, LLC, January 2008, Volume 6, No. 1
4. Lucy Tennant, "Personal Communication," February 8, 2008
Copyright: Copyright © 2008 Lisa Mazurka
About the Author:| Lisa K. Mazurka is Founder and President of Clinical Research Consulting, Inc., a niche Clinical Research Organization (CRO) which provides clinical monitoring, project management, quality assurance and compliance (QAC) audits, education and training services to the clinical research industry. Ms. Mazurka has been instrumental in the development of CRCI's QAC auditing program and has served an active role in numerous audits conducted for the agency
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