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Developing a Quality Assurance & Compliance Program within your
Organization
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:
- Guidance for Industry, E6 Good Clinical Practice Consolidated Guideline; ICH, April 1996
- “Organization Finds Self-auditing Helps Develop Better Standard Operating Procedures for Trials,” Thompson Guide to Good Clinical Practice, January 2008, Volume 15, No.4
- “Research Center’s Compliance Program Makes Use of Prospective Monitoring,” Clinical Trials Administrator, AHC Media, LLC, January 2008, Volume 6, No. 1
- Lucy Tennant, “Personal Communication,” February 8, 2008
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