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 purpose of this course and workshop is to update and provide expertise to the process of monitoring clinical trials from phases I to III. Updates on regulatory requirements for monitoring clinical trials will be studied in detail as per Good Clinical Practices. New monitoring strategies will be discussed (e-monitoring or internet real time monitoring). Monitoring management procedures and project management will be discussed to help streamline the process of reducing errors and omissions. New and challenging case studies will be performed to practice monitoring procedures on site. Safety monitoring and monitoring adverse experiences and reporting will be studied in detail to make it a focal point of the monitoring activity. This program also includes a review of the newest technologies of EDC (Electronic Data Capture), transfer and electronic systems in clinical research. This is a fully interactive course where the participants will share different experiences and analyze them together with the instructor to encourage resolution of issues that may hinder monitoring activities at different sites.
Course Outline
| Introduction to Good Clinical Practices |
Monitoring strategies : fax monitoring, site monitoring, phone contacts, e-monitoring |
| Clinical Trial monitoring, responsibilities of the sponsor/monitor |
Understanding the study design and case report forms layouts
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| Understanding the protocol and case report forms |
Advanced Monitoring: Costs analysis and Planning of monitoring activities (multiple site monitoring)
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| Planning of monitoring activities (multiple site monitoring) |
Monitoring forms, review and update |
Monitoring forms, and reports. Standardization
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Site selection, Site placement, Site initiation, Site monitoring, Site Close-up purpose, process, reporting |
Monitoring Stages of a Clinical Trial: Site selection, Site placement, Site initiation, Site monitoring,
Site termination, Site Close-up; purpose, process, reporting |
Site termination, process, reporting
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| Patient Information and Consent forms. Patient files, and confidentiality |
Monitoring Strategies. Implementation of monitoring procedures |
Case report forms monitoring & Source documentation
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Monitoring Pharmaceutical and biotech products Monitoring a Medical Device study Paper monitoring vs. Electronic monitoring Case studies, monitoring a phase II study, Case studies, monitoring a phase III study, Case studies, monitoring a phase VI study, minimum requirements
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Data resolution and monitoring activities
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Source documentation, validity, availability and legibility (case study) |
Monitoring vs. site/study audit
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Monitoring Adverse Drug Reactions (Adverse events), Reporting Adverse Events, and Serious Adverse Events |
| Case studies, monitoring a phase II study |
Safety surveillance, safety monitoring. Safety reports, health authorities and IRB/ERB |
Case studies, monitoring a phase III study
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Monitoring global studies, strategies and coordination |
Case studies, monitoring a phase VI study, minimum requirements
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Preparing the site for an internal Audit |
Safety surveillance, and safety monitoring
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Contract Research Organizations and monitoring studies. Selecting a CRO, SMO. Cost/timelines and effectiveness of the process |
Reporting Adverse Events, and Serious Adverse Events
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The Monitor and the Investigator (management of the interaction, successful cooperation, conflict management and problem solving on the site)
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Contract Research Organizations and monitoring studies
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The Monitor and the coordinator (management of the interaction, successful cooperation, conflict management and problem solving on the site)
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Who Should Attend
This two-day course is valuable for Monitors, regulatory personnel and participants with daily responsibilities in the following areas:
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- Documentation and Medical Writing
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- Others who interact together to launch a product
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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 2 of 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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- 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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