A TWO-DAY COMPREHENSIVE & INTERACTIVE COURSE, CASE STUDIES & WORKSHOP
 REGISTER
- To Register On-line: select the course date below, then click on Pay Now (securely processed by PayPal
- To Register by FAX: download form (PDF)
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Locations to choose from:
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Contact Us :
Tel: +954-957-3957;
Fax: +954-366-6011;
E-mail:
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Early registration for the RESORT is $975 +tax, if paid in full 30 days or more before the start, after that is $1250 + tax.
Early registration for the CRUISE is $1350 +tax, if paid in full 75 days or more before the start, after that is $1550 + tax. |
To Register On-line:
Click on the arow below, select the course date, and then click on Pay Now (securely processed by PayPal)
Course Overview
The Patient Information and Consent Process is the cornerstone for patient protection.
This course was designed to provide the most in depth information of the consent process for studies under an IND and any other GCP compliant study. Every investigator site must ensure that proper compliant informed consent was obtained and that all reasonable risks were disclosed to the subject.
The program
- The course Patient Information and Consent Process, is based on 21 CFR 50, 56 and 312, and GCP ICH and the most important FDA auditable findings were included to understand the requirement as well as the process as well as the Declaration of Helsinki and the Belmont report.
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- This course and workshop will discuss in depth the consent form content, as well as the language and interpretation. It is still a matter of discussion on how to ensure that the subject "understood" the consent information, therefore methods to verify that the patient understood will also be part of this course.
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- The process of writing the consent according to IRB's and regulatory requirements will be presented to allow the participant understand compliance.
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- Discussion will be provided for the most important issues in consenting as is:
- who can act as consenter
- how much time is enough time to provide to the subject before signing
- the signing of the consent
- consent in emergency situations
- the legal representative, the witness
- consenting special populations (children, elderly, infirm, subjects that need special protection)
- the asent
- the verbal consent
- when consent is not possible
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Who Should Attend
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- Clinical Research Associates
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- Clinical Trial Coordinators
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- Institutional Review Board members
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CERTIFICATE OF ATTENDANCE AND COURSE MATERIAL
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
- Also, after completion of the course, participant may decide to take a comprehension exam. If the exam is passed successfully, participant will receive the Certificate of Completion (step 3 of CCP Certification / CCRP Certification).
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Registration fee for the RESORT includes:
- 2 whole days of training in a beautiful ocean-front hotel,steps to popular Las Olas Beach, in Fort Lauderdale, Florida
- Presentation, Reference and Study Materials( printed, also electronic copy)
- Breakfast, Luncheon and Refreshments
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Registration fee for the CRUISE includes:
- 2 whole days of training on a luxury Friday to Monday All-Inclusive CRUISE
- Presentation, Reference and Study Materials( printed, also electronic copy)
- All meals and Refreshments
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- Each participant will receive a copy of the book:
"Good Clinical Practice (GCP) Audit Preparation: A Guide for the Pharmaceutical Industry", by: dr Mihajlovic- Madzarevic, Vera (to be published in April 2010 - ISBN: 9780470248850-Wiley)
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Not Included
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- Transportation to/from the airport
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- **Hotel accomodation: (Pelican Beach resort is completely non-smoking)
To reserve your room, call Amanda Mohler at Direct - 954.556-7560, Hotel-954.568.9431 or (800) 525-OCEAN and mention the "Clinical Research Institute of America's" special rate for the room (valid up to 1 month before course starts). You may also want to send an e-mail to:
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- Tax is not included, please add 6% to the price of the course.
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Special group rates for this course (% off the regular price of the 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 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:
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*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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