Are Your Investigative Sites GCP Compliant?

GCP compliance is currently being scrutinized, and the Investigator Meeting is an optimal place to ensure that your teams are in compliance. Bring Barnett Educational Services’ GCP Training on-site to your next Investigator Meeting! Enhance your trial and thank your Investigators with ACPE-accredited coursework while they attend! We will work with you to customize content to parallel your study protocol and meet your exact training needs. Our interactive training addresses topic areas of most concern to the regulatory agencies:

Regulatory officials have been speaking openly about a reassessment of the GCP compliance program. As quoted in Barnett’s Global GCP Compliance Report 2006:

Mike Rashti, FDA Bioresearch Monitoring Specialist and Field Investigator:
“At [the Principal Investigator meeting], the Principal Investigators should be thoroughly trained in good clinical practices, the protocol, and the regulations.” “99.9 percent of the Principal Investigators I visit are entirely qualified to conduct the study. But how much they know about the study protocol or the GCP regulations is another story.” “The responsibility falls squarely on the sponsor/monitor to train the site staff during the PI meeting and the monitoring visits.” “The monitors should come to the sites and train and/or retrain the site staff during the monitoring visits. This training and retraining should go on continuously during the monitoring visits…I review the monitor’s CV as well as their training records.”

Joanne Rhoads, MD, MPH, Director, CDER Division of Scientific Investigations (DSI):
“We are concerned about how monitoring is being done during clinical trials. There are certainly times when the monitoring done by the sponsor is not adequate to detect even obvious problems at a site, and there are other times when the monitoring detects and reports significant problems that are not acted on by the sponsor. We plan to look at these problems in a systematic fashion with the goal of improving effective and efficient monitoring during trials.” “The clinical investigator is responsible for the conduct of the trial at his or her site, and cannot delegate his or her study-related responsibilities.”

Bernard Schwetz, PhD, DVM, Director, US HHS Office for Human Research Protections (OHRP):
“Training of investigators is an issue for me. If a future research tragedy is linked somehow to a lack of investigator training, Congress would most likely make such training mandatory.”

• Principal Investigator Role and Responsibility Training
• Conducting Clinical Trials Under ICH GCP
• Adverse Events and Pharmacovigilance for Pharmaceuticals and Devices
• Patient Recruitment and Retention
• Auditing Techniques for Clinical Research Professionals
• Clinical Project Management
• Global GCP Monitoring for Drugs and Devices
• CRA and CRC Roles and; Responsibilities Training
• The CRA Manager Course
• Developing Clinical Study Budgets
• eClinical Trials and Data Management
• Introduction to Clinical Data Management
• Working with CROs
• Conducting Clinical Trials in Developing Regions

Exclusive Bonus Materials: When you partner with Barnett for your training needs, your attendees will receive complementary copies of Barnett Educational Services industry-leading publications, written by 20-year industry analyst and author, Mark Mathieu.
Good Clinical Practice: A Question and Answer Reference Guide 2006. Developed with input from over 100 industry and government clinical trial and GCP experts, this new reference guide answers well over 400 of the most common and difficult questions regarding the day-to-day interpretation and implementation of GCP requirements for drug, biologics, and device trials.
2006 CFR/ICH GCP Reference Guide. Our 2006 CFR/ICH GCP Reference Guide contains the FDA Code of Federal Regulations, Good Clinical Practice Parts 11, 50, 54, 56, 58, 312, & 314 plus ICH Guidelines, Good Clinical Practice (E6), Clinical Safety Data Management (E2A), and the European Union Clinical Trials Directive.

For more information contact:Rachel Meyers Associate Director, Barnett Educational Services
Telephone: (413) 527-3056
Fax: 413-527-3057
E-Mail: rachel.meyers@parexel.com