INTRODUCTION
This course provides a solid understanding of Good Clinical Practice (GCP) requirements and clinical quality assurance in detecting fraud and misconduct in clinical trials. Attendees will learn methods and techniques for detecting, correcting and preventing clinical study misconduct and fraud at domestic and international clinical sites. The course will also address how to uncover misconduct, as well as methods for dealing with its consequences, while identifying proactive solutions to prevent further problems. Included in the coursework are practical examples and a roadmap for evaluating study conduct, source documents, case report forms and other study documentation.
PROGRAM OBJECTIVES
- Identifying and defining the principles and requirements for GCPs
- Defining the basic roles and responsibilities of the sponsor, monitor, investigators
- Understanding the GCP audit process for sponsors
- Knowing when to conduct audits of vendors, sites, IRBs and laboratories
- Ensuring data and supporting documentation are accurate and presentable for inspection
- Gaining knowledge concerning common outcomes and findings in clinical trials
WHO SHOULD ATTEND?
- Those involved in the monitoring and/or QA of clinical trials.
- Professionals involved in the pharmaceutical or biotechnology sectors
- Professionals who work in Contract Research Organizations (CRO),
- Those involved with the supervision and oversight of clinical trial practices will find this course to be highly beneficial.
PROGRAM OUTLINE
Introduction and Overview
- Terminology and definitions
- Overview of clinical compliance laws
- FDA, ICH, ISO and global requirements
- Understanding the role of the FDA, OHRP and IRBs
- Significance of GCP guidelines for effective studies
- Understanding the roles and responsibilities of the clinical research team
- Group discussion of interpreting regulatory requirements for GCP
Industry Overview –Regulatory Requirements
- Understanding regulatory obligations
- Identifying key documents
- Differences and similarities for drugs and device audits
- Compliance issues
The Different Types of Audits
- When and why to audit
- Who and what is inspected
- Audit problems and issues
- What to avoid
- Data quality and integrity issues & solutions
Role of Monitoring in Detecting Misconduct
- Defining the difference between auditing and monitoring
- What are the big items that must be in place
- Common problems and ways to dissolve them
- Knowing what questions to ask in monitoring a site
- Pointing out site performance deficiencies
- Identifying solutions to deficiencies
- What to do if misconduct is suspected
Conducting GCP Audits
- Different types of audits
- Key activities during an audit
- What to expect and common findings
- Audit reports and follow-up
Preventing Fraud and Scientific Misconduct
- Maintaining accurate records
- How to detect fraud in case report forms and clinical trial materials
- Misleading data and results
- Examples of fraud
- Key findings from recent cases
- Types of problems and possible preventive actions
- Case examples of misconduct and fraud
Permintaan Brosur penawaran Training
( Harga, Waktu dan Tempat)
silahkan Menghubungi kami.
Cs1 : +62812 2554 2418
Cs2 : +62857 2459 5005
