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Article Title:
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Developing a Quality Assurance and Compliance Program Within Your Organization

Article Description:
====================

Many sponsor organizations, clinical research sites and contract
research organizations (CROs) are developing and implementing
Quality Assurance and Compliance Programs to assure adherence to
company and institutional standard operating procedures,
compliance with FDA Regulations, GCP Guidelines and protection of
human research subjects. Implementation of such programs can
improve the conduct of clinical trials and assure accurate,
compliant data prior to submission to the FDA. This article will
discuss the reason for increased growth in this area, the common
types of QA audits and why and how organizations are implementing
these programs.


Additional Article Information:
===============================

932 Words; formatted to 65 Characters per Line
Distribution Date and Time: 2008-03-12 11:24:00

Written By: Lisa Mazurka
Copyright: 2008
Contact Email: mailto:lisa.mazurka@...



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Developing a Quality Assurance and Compliance Program Within Your Organization
Copyright (c) 2008 Lisa Mazurka
Clinical Research Consulting, Inc.
http://www.eclinicalresearchconsulting.com



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




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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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