Auditing Techniques June 2010

Course Description

This workshop teaches practical, immediately usable techniques that top-notch Good Clinical Practice (GCP) auditors and FDA investigators employ. They include techniques that are useful when auditing clinical trials that employ Electronic Medical Records (EMR) and/or Electronic Data Capture (EDC). When monitors and auditors apply these techniques, they can better detect, correct, and prevent clinical study performance deficiencies at clinical sites and within their organizations. Significant updates to the seminar focus on the development and utilization of Quality Systems (QS) at clinical sites to improve their performance. The workshop will emphasize Simple Efficient & Effective QS processes that clinical site personnel can utilize and how monitors and auditors can help them develop and implement them.

Learning Objectives

Apply auditing standards that are solidly based in current law, regulations and guidelines
Utilize special, not often taught, auditing techniques as part of your daily monitoring or auditing activities
Develop Simple, Efficient, and Effective Quality Systems (SEEQS – pronounced See Q’s)
Utilize SEEQS for detecting root causes of performance deficiencies and developing and implementing effective Corrective and Preventative Action (CAPA)
Employ techniques for auditing and monitoring the electronic clinical trial (e.g., e-trials in which electronic medical records and/or Electronic Data Capture are utilized)
Identify the differences between monitoring and auditing and how to integrate auditing techniques into monitoring procedures
Select investigators and patient records for auditing or special monitoring emphasis
Conduct clinical investigator and Sponsor-Monitor-CRO audits
Detect, prove, and prevent scientific fraud and misconduct
Write audit plans and reports

Who Should Attend

Clinical Quality Assurance Professionals who audit the quality of clinical trials
Clinical Research Associates (CRAs) and Managers, Project Leaders, and Medical Monitors who want to enhance their effectiveness
Regulatory Affairs Professionals responsible for GCP regulatory compliance
Investigators, Study Coordinators and Trial Center Managers who want to learn how to prepare for FDA and sponsor audits and to improve the quality of their research activities

Instructors

Carol Cox-McClave

Barry Renaud

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Course Outline

Day 1: 8:30 a.m. – 5:00 p.m.

The Standards: Important aspects of GCP-related law and regulations: Food, Drug, and Cosmetic Act, Title 18 Criminal Statutes, HIPAA, 21CFR 11, 50, 54, 56, 312, and 812; Corporate standards
Trial Center Auditing Methods: Selecting centers to audit, auditing and inspection procedures and methodology, including special procedures for “e-trials”; differences between auditing and monitoring; Defining and determining the adequacy of source documentation; developing and implementing Simple, Effective, and Efficient Quality Systems to improve clinical site performance
Fraud and Misconduct: Motives; discovering, reporting, and preventing fraud and misconduct, including special techniques for e-trials
Data Trend Analysis: Definition and description of this special auditing technique; multiple examples; how to practically use this technique; Special subsection on detecting the signs and symptoms of impeding failure at a trial center

Day 2: 8:30 a.m. – 4:30 p.m.

Data Trend Analysis: Definition and description of this special auditing technique; multiple examples; how to practically use this technique; Special subsection on detecting the signs and symptoms of impeding failure at a trial center
Auditing Techniques Exercise: Perform data trend analysis; audit to determine document validity and data accuracy; perform root cause analysis; build a CAPA;work individually and within a group of your peers
Essential Documents: Define and prioritize; auditing the essential document binder or files; the legal and regulatory basis behind the EDs
Enforcers & Enforcement: The compliance organizations in CDER, CBER and CDRH; FDA inspection results and consequences of adverse findings; How to conduct “in-house” audits; how to manage a regulatory authority inspection; FDA’s Application Integrity Policy
Summary of Auditing and QS Process: Audit Planning, Notifications, Conduct, Reporting; Root Cause Analysis; developing and implementing CAPAs

There will be a 15 minute morning break, 1 hour lunch break, and 15 minute afternoon break on each training day.

Interactive Activities

Perform Data Trend Analysis
Prepare for a Trial Center Audit
Accomplish an Audit of Source Documents and CRFs
Work on an Audit Team to Discuss and Present Findings

Course Dates and Locations

June 24-25, 2010

Philadelphia, PA

Course # SFCA0610

Renaissance Philadelphia Airport

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Registration Fees

$1,595 by May 21

$1,795 after May 21

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

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Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 778-000-07-006-L01-P. Released 6/07.