A 1.5-DAY COMPREHENSIVE & INTERACTIVE COURSE, CASE STUDIES & WORKSHOP

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Training Program for Institutional/Ethics Review Board Members

IRB01(RESORT): Fall-Spring 2011 US $ 750.00 IRB01(CRUISE): Fall-Spring 2011 US $ 1,350.00

Course Overview

Institutional Review Boards (Ethics committees) have been involved in clinical trial reviews for more than 30 years. These boards have the responsibility of deciding the ethical implications on running clinical trials at a clinical trial site.  IRB reviews protocols, consent forms and other clinical trial documents for studies sponsored by the academia as well as the industry. All clinical investigations conducted on human volunteers have to be reviewed by an IRB before initiation.

The majority of IRB members do not have any formal training on IRB regulatory requirements for clinical trials or drug development; however they play the most important role on assessing the potential risks and benefits of patients enrolled in a study in function to the information provided by investigators. Continuing evaluation of a clinical trial is also an IRB responsibility, and new guidelines have been setup just recently to highlight the importance of IRB involvement.

IRBs are now more than ever under tight scrutiny, and it is time that every member, regardless of the professional background has the knowledge of all information regarding their responsibilities and functions.

This 2 full day course and workshop is aimed at members of IRBs in the US and globally, who are responsible for the initial and continuous review on clinical trial protocols, informed consent forms and safety information. The 2 day course and hands on workshop will allow the participant to understand the responsibilities of the institutional review boards (IRB) or ethics committees as well as the clinical investigator and the sponsor. A complete background analysis of requirements for medical research is presented with the analysis of the Declaration of Helsinki and the Belmont report.

The objective if this course is to provide participants from different professional backgrounds the necessary knowledge to perform as an IRB member in a compliant and well-informed manner. This course also involves a workshop where warning letters issued by the FDA are analyzed and violations are identified as well a possible action to avoid non compliance is discussed.

Content of the program

• An introduction to Clinical Research and Drug Development
• Ethics of clinical trials, Declaration of Helsinki, The Belmont Report
• Good Clinical Practices /ICH – Responsibilities of an Instituional Review Board/Ethics Committees
• FDA 21 CFR 54
• FDA - IRB registration
• 101 – The review process
• Additional safeguards for pediatric studies
• Local vs. Central IRBs
• Payments to subjects
• Emergency setting studies
• IRB continuing review after approval
• Records and documentation
• Inspections of IRBs globally
• Workshop – Analysis of FDA warning letters, and potential remedial actions

Who Should Attend

This course is aimed at all institutional Review Board members who are actively participating in the review of clinical trials or intend to participate in clinical trial review process.

Also clinical trial coordinators and monitors as well as investigators are encouraged to participate to acquire the basics on IRB submissions, review and decisions.

CERTIFICATE OF ATTENDANCE AND COURSE MATERIAL

• From 1-2 people from the same facility/clinic - as advertised
• From 3 and up to 5 - 10% discount for the entire group
• From 6 and up to 10 - 15% discount for the entire group
• More than 10 people per group - please call Vesna at 1-877-428-1427

Upon registration, you will receive a complete agenda and detailed information.

At the time of registration, please notify us of any special dietary requirements.

Enrolment to the course is accepted until one (1) week before the starting date.

Clinical Research Institute of America reserves the right to cancel the course, if insufficient number of students are enrolled.

For more information please Contact Us at:

Phone: 1-877-428-1427 (toll free USA & Canada) or +954-975-0860 Fax: 954-366-6011

E-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

*CANCELLATION POLICY (% fee is based on a regular price of the course)

Cancellation from date of signing up to 30 days prior to event...........full refund

Cancellation from 30 days to 20 days prior to event.............................10% fee

Cancellation from 20 days to 10 days prior to event….. ……............. 20% fee, after that......... 30% fee

Note: Tax is not included - please add 6% to the price of the course.

PRIVACY POLICY

Any of the information we collect from you, in this form, will be used solely for the purpose of registering for this course. We do not sell, trade or otherwise transfer to outside parties any part of your personal information.

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