Clinical Research for the Principal Investigator
A two-days comprehensive & interactive course***, case studies & workshop
Date: Oct 17 - 18, 2009 *** Limited spaces available ***
Place: Pelican Grand Beach Resort, Fort Lauderdale Florida, USA
Early registration ,extended to Sep 15th/09, is $975*, registration after Sep 15th, is $1,250*
Toll-free: 1-877-428-1427 Fax: 954-366-6011 E-mail: Info@CRIAmerica.com
In anticipation to the FDA critical path initiative to require formal clinical trial investigators training and potentially certification, the Clinical Research Institute of America provides now a two (2) full days, hands-on, interactive course and workshop, specially designed for the clinical investigator.
This workshop will provide principal investigators with formal training in
Clinical Research and Development. The topics selected are aimed at
fulfilling a learning need that is not provided by any program, taking into account practical issues that
can be learned and applied immediately. The entire program is designed to assist physicians
evaluate clinical trial protocols with safety and effectiveness purposes. Also will allow the investigator
to discriminate ethical and medical practice issues before a contract agreement is signed and an
Institutional Review Board is involved. The regulatory implications of running clinical studies together
with clinical practice will be discussed thoroughly.
The purpose of this workshop is to:- introduce Medical Investigators to the issues of running clinical studies
- give an introduction to the Drug Development Process
- explain the FDA Audit Process, and responses to inspectional findings
Course Outline
The following topics will be discussed in response to the question:
What a Medical Investigator should know before starting an industry or investigators sponsored clinical study?- Drug Development Process
- Good Clinical Practices and FDA/ EU/ Health Canada Regulations concerning Clinical Trials
- FDA Investigators responsibilities, the 1572
- IRB/ERB, Financial Disclosure (US), Patient Information and Consent forms and process
- Delegation of responsibilities at the Clinical Trial site
- Clinical Trials Documents: the protocol, the consent form, the investigators brochure, the case report forms
- Electronic systems in clinical research
- Clinical Study Audit (internal, regulatory audit)
- Response to an FDA 483 and Warning letters
- Obligations under contract agreement vs. Ethics and Medical Practice
- The sponsor/investigator, IND application process
Who should Attend
This two-day course is valuable for all participants with daily responsibilities in the following areas:- Physicians,
- Medical Specialist
- Surgeons
- Any other Medical Professional who plans to participate or presently runs clinical trials
*Registration fee includes: steps to popular Las Olas beach, in Fort Lauderdale, Florida - Presentation, Reference and Study Materials( printed, also electronic copy)
- Breakfast, Luncheon and Refreshments
- Each participant will receive a copy of the book:
"Good Clinical Practice (GCP) Audit Preparation: A Guide for the Pharmaceutical Industry",
by: Mihajlovic- Madzarevic, Vera ( to be published in January 2010 - ISBN: 9780470248850 -Wiley)
Not Included:- Airfare
- Transportation to/from the airport
- Parking, tips...
- **Hotel accommodation:
To reserve your room, call Chris Rowe at
954-556-7598 or 1-800-525- 6232 and mention the
Clinical Research Institute of America's special rate for the room.
You may also want to send an e-mail to: chrisrowe@pelicanbeach.com- Tax is not included, please add 6% to the price of the course
Please, be advised that Pelican Beach Resort is completely non-smoking resort.
Upon Completion of the course:
- ***CME: 12 Elective credits by the American Academy of Family Physicians will be available to qualifying participants and
- All participants will receive a Certificate of Attendance
Special group rates for this course:- 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 Academy reserves the right to cancel the course, if insufficient number of students are enrolled.
For more information on our professional clinical research training programs, please visit us at http://www. CRIAmerica.com/
Contact Us:
Phone: 1-877-428-1427 (toll free USA & Canada) or +954-975-0860 Fax: 954-366-6011
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