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.
- Apply auditing standards 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 electronic medical records
- Identify the differences between monitoring and auditing and how to integrate auditing techniques into monitoring procedures
- Select investigators and 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
- 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
The course will be led by one of the following instructors:
Jeanne Morris, B.S., MT, (ASCP)
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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
Day 2: 8:30 a.m. – 5:00 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 manage a regulatory authority inspection; FDA’s Application Integrity Policy
- Summary of Auditing and QS Processes: Audit Planning, Notifications, Conduct, Reporting; Root Cause Analysis; developing and implementing CAPAs
- 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
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.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
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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# 0778-0000-13-028-L01-P. Released: 8/13.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.