Society of Urologic Oncology – Clinical Trials Consortium
in conjunction with
The Society of Urologic Oncology
and
Large Urology Group Practice Association

“The Clinical Research Landscape: Challenges and Opportunities
in Building and Managing a Compliant Clinical Research Program”

Thursday 11/3/11
8:30 AM – 5:00PM
Lunch & breaks included

The program committee is finalizing this program and looking forward to a successful program that meets and exceeds your expectations. Please check back often for updates on the scientific program, accreditation and other meeting-related information. To register early for the meeting, please click here.

Download a printable Registration Brochure (pdf)!

Course Description:

Fundamentals of Clinical Research is a formal classroom presentation for all healthcare professionals engaged in the conduct of clinical trials. This includes physicians, nurses, PAs and research coordinators interested in clinical research and/or investigators who would like to increase productivity and efficiency of their existing program.

Speakers will provide participants with an introduction to research, reviewing legislation and regulations that govern clinical research; providing insight into drug, biologic, and device development for a changing research environment. Instructors will highlight differences between device and drug/biologic studies; identify differences between industry sponsored research and investigator initiated trials.

Course participants will acquire a thorough knowledge base of Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines (E6, E2A); gain an understanding of clinical trial development and management; insight into essential elements of resource allocation, site infrastructure, management tools, marketing and promotion, recruitment and retention strategies, budget and contracts and indemnification. The role of Medical Monitor, DSMB and CRO interface will be mentioned along with role of investigator in safety analysis.

The afternoon session will focus on corporate structure, practice interface, budgeting, research cash-flow, organizational structure, monitoring, study management activities, site development and audit preparation. During the course, speakers will discuss GCP issues, recent FDA findings.

Course Curriculum:

1. The Food and Drug Administration Past and Present
2. Overview of Investigational Product Research and Development
3. Good Clinical Practice (GCP)
4. Clinical Trial Development and Implementation
5. Clinical Trial Management
6. Investigator Site Perspective: Review and acceptance process, CTA, Financial Disclosure
7. Sponsor’s Perspective: Managing a Clinical Trial
8. Monitoring Obligations and Methods
9. Developing a Successful Clinical Research Program

Upon Completion of the Training Course, the participant will be able to:

• Describe the regulatory path to investigational product approval.
• Identify the GCP/ICH and FDA obligations in protecting the rights of study subjects.
• Distinguish the different roles and obligations of Investigator, Sponsor, the IRB, CRO and study monitor.
• Explain the ‘ideal’ elements used in coordinating a clinical trial.
• Demonstrate the ability to perform effective trial management activities and detect GCP deficiencies.
• Identify the critical elements that lead to failure or success of a clinical research program.
• List at least three tools that can develop a clinical research center of excellence

GENERAL MEETING INFORMATION

Registration/Information Desk Hours are as follows:
Thursday November 3rd, 2011
7:00 AM – 12:00 noon

HOTEL INFORMATION

Drake Hotel - Since the 1920s, no other Chicago hotel has inspired more legendary acclaim.
140 East Walton Place
Chicago, IL 60611-1501
Main (312) 787-2200
Fax: (312) 787-1431
Website: www.thedrakehotel.com

Room Rate
A block of rooms have been reserved at the Drake Hotel at a discounted rate of $229.00. per night for Wednesday 11/2/11 and Thursday 11/3/11.

Reservations
To make your hotel reservations at The Drake Hotel, please send the Reservation Form to katie@wjweiser.com. If you are planning on attending the LUGPA Meeting, we ask that you do not make your hotel reservation at this time.  You will be able to reserve a room upon your LUGPA Registration. 

Hotel Deposit & Cancellation Policy
A deposit equal to one night’s stay is required to hold a reservation. These deposits are fully refundable if the hotel is notified 72-hours prior to arrival and a cancellation number is obtained.

Hotel Deadline
The deadline to receive the group rate is October 7th, 2011. We encourage you to make your reservation early, as the hotel and discount block may sellout before this date. After this date, reservations will be accepted on a space-available basis and higher rates may apply.

TRAVEL & TRANSPORTATION

Airport Information
Both Chicago O’Hare International Airport (ORD) and Chicago Midway Airport (MDW) are within close proximity to the Drake Hotel. Driving time is approximately 35 minutes and 25 minutes respectively.

Public Transportation
Both Chicago airports offer easy access to the Chicago Transit Authority’s “L” System. From O’Hare International Airport, a one-way fare downtown on the Blue Line costs $2.25. From Midway Airport, a one-way fare downtown on the Orange Line costs $2.25. Please visit the following link for detailed directions: http://www.transitchicago.com/travel_information/trip_planner.aspx

Taxi Cab Services
Several Taxi companies work with both Chicago O’Hare International Airport and Midway Airport. A few options are as follows:

Parking
The Drake Chicago Hotel offers Valet Parking ($50 per day); self parking is available on Walton Street. Please note that rates are subject to change.

MEETING REGISTRATION

The deadline for discounted early registration is 09/01/11.
After 09/01/11 , regular registration fees will apply to online & on-site registration.

Additional Registration Information:

Early Registration Deadline
Meeting registration forms must be received by the SUO-CTC Executive Office by 09 /01/11 to receive the discounted early registration rate. All forms received after this deadline will be assessed the regular registration fee.

Registration Cancellation & Refund Policy
Registration refund requests must be submitted in writing to the WJWeiser Executive Office by 09/15/11.
All refund requests will be subject to a $100 processing fee. No refunds will be made after 09/15/11.

Special Needs
For accommodations on the basis of disability or special dietary needs, please call (847) 517-7225.

Questions
Please feel free to contact the SUO-CTC Executive Office by:
Phone: (847) 264-5901
Fax: (847) 517-7229
Email: info@suoctc.org