Developing a Quality Assurance and Compliance Program Within Your Organization

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Article Title:

==============

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:

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Distribution Date and Time: 2008-03-12 11:24:00

Written By: Mazurka

Copyright: 2008

Contact Email: mailto:lisa.mazurka@...

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Developing a Quality Assurance and Compliance Program Within Your Organization

Copyright © 2008 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, " 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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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.