Conference Information

DATES/LOCATIONS

September 25, 26, and 27, 2009 NASHVILLE, TENNESSEE, USA The Gaylord Opryland Resort and Convention Center 2800 Opryland Drive Nashville, Tennessee 37214 USA Hotel Phone: +1 615 883 2211 or 1 888 777 6779 Hotel Fax: +1 615 871 7441 SoCRA Room Block Rate $163 USD plus taxes and $10 resort fee is available until August 24, 2009 or until the room block is filled. Please contact the hotel directly for sleeping room reservations at 1-888-777-6779 or Click Here.

ANNUAL CONFERENCE REGISTRATION FEES

For Registrations Confirmed PRIOR to August 15:
Member Fee- $750
Non-Member Fee*- $825
* Non-Member Fees include a (non-refundable) one-year membership in SoCRA

For Registrations Confirmed AFTER to August 15:
Member Fee- $800
Non-Member Fee*- $875
* Non-Member Fees include a (non-refundable) one-year membership in SoCRA

Preconference Workshops- Add $175

CREDIT HOURS

SoCRA designates this educational activity for a maximum of 19* Continuing Education Credit Hours for SoCRA CE, Nurse CNE, and Physician Category 1 CME.
*The Annual Conference offers 15 CE. Pre-Conference Workshops offer an additional 4 CE.

Accreditation Statements:

• CME for Physicians – Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
• CNE for Nurses – Society of Clinical Research Associates is an approved provider of continuing nursing education by the Pennsylvania State Nurses Association an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation.
• PSNA (ANA) provider reference number 070-3-A-07

SoCRA Course # 09001

Back to Top

Program Description

WHO SHOULD ATTEND: Clinical research professionals including investigators, research coordinators, research associates, project managers, consultants, educators, and administrators. Such participants may be affiliated with medical centers; cooperative research groups; research consortia; pharmaceutical, device, and biotechnology companies; contract research organizations; site management organizations; and independent research firms.

LEARNING OBJECTIVES: Upon completion of this course the attendee should be able to:

• Discuss Current Policy and Initiatives at the Office of Human Research Protections
• Discuss the Good Clinical Practice Policy and Initiatives at FDA as they Relate to Clinical Researchers
• Describe how Academic Medical Centers can Integrate Science and Ethics
• Discuss FDA’s Perspective Regarding Research and Device Research
• Academic Research - Discuss Sponsor Monitoring / NIH Research - Non Drug/Non Device / and QA
• Discuss Sponsor and FDA Audits, and how to Develop a Monitoring Plan
• Discuss the Role Of The Clinical Information System and Building Reliability and Validity into Clinical Research
• Describe Data Safety Monitoring, Developing Data and Safety Monitoring Plans and Sample Size Considerations
• Discuss Issues related to Combination Products; Investigational Device Accountability; FDA Inspections
• Discuss Enrollment Challenges - Enrolling Minorities and Informed Consent
• Describe how to Develop an Understanding of Genetics by the Older Adult Population
• Discuss Legal Issues for Clinical Researchers and The Law and Investigational Site Responsibility
• Discuss Current Topics in Bariatric Surgery Research, Nutrition Research, Pediatric Obesity
• Discuss Psychological Considerations in the Treatment of Obesity and the Brain, Emotions, and Overeating
• Discuss Project Budgeting Tools and Resources: Coordination of Clinical Trial Sub-Sites/Multiple Projects
• Describe the effect of the European Union Clinical Trials Directive on Clinical Trials
• Discuss the Problems and Approaches in Designing Clinical Research in Complementary and Alternative Medicine
• Describe how to Succeed with a Clinical Trials Program in Private Practice vs. a Large Institution
• Discuss Adverse Drug Reactions: Understanding AEs; When Are The Risks Worth It?
• Discuss Site Management from Protocol Feasibility to Reimbursement
• Discuss Effectiveness Evaluation of Clinical Research Education / Current Trends and Successful Methodologies

Back to Top

Conference Schedule

SCHEDULE OF EVENTS:

Certification Preparation and Review Course and Certification Examination

Wednesday, September 23
CCRP Certification Preparation and Review Course (requires separate registration - Click Here for more details)
8:00 AM to 4:30 PM - Course Registration and Session

Thursday, September 24
Certification Examination (requires separate registration - Click Here for more details)
Registration Deadline for application to the exam is August 14, 2009
7:30 AM to Noon - Examination Registration and Session

Annual Conference Events

Thursday, September 24
Pre-conference Seminars - Nine pre-conference seminars are planned - Click Here for pre-conference workshop descriptions.
12:30 PM to 5:00 PM Pre-conference seminar registration and sessions

• How to Prepare for an FDA Audit
• IRBs and the Informed Consent Process
• Presentation Skills Workshop
• Research Project Management and Budgeting
• GCP 101 for Sites - New Study Coordinator Workshop
• SOP Development and Implementation
• Legal Issues Involving Researchers, Including Fraud and Misconduct
• Grant Writing and Protocol Development Workshop
• Statistics in Clinical Research - Understanding Protocols and Statistical References
• Device Basics for Device Research and Regulations

Welcome Reception and Registration
6:00 PM to 7:00 PM - Reception and Registration for Attendees, Speakers, Exhibitors, Poster Presenters and SoCRA Board of Directors

Friday, September 25

General Session

• 7:30 AM to 5:00 PM Registration
• 8:00 AM to 8:30 AM Continental Breakfast
• 8:30 AM to 12:15 PM Welcome, Introduction and Opening Plenary Session
• 10:00 AM to 10:45 AM Morning Break with Exhibitors
• 10:00 AM to 5:00 PM Exhibits and Poster Session
• 12:15 PM to 1:30 PM Luncheon / Exhibit and Poster Session
• 1:30 PM to 5:00 PM Breakout Sessions
• 3:00 PM to 3:30 PM Afternoon Break with Posters and Exhibitors

Night-Out Event
6:30 PM to 10:30 PM - Optional Event (Prepaid reservations required)
Night Out at the Wild Horse Saloon - Click here for details

Saturday, September 26

General Session

• 7:30 AM to 5:00 PM Registration
• 8:00 AM to 8:30 AM Continental Breakfast
• 8:30 AM to 5:00 PM Breakout Sessions
• 10:00 AM to 10:45 AM Morning Break with Exhibitors
• 10:00 AM to 5:00 PM Exhibits and Poster Session
• 12:15 PM to 1:30 PM Luncheon / Exhibit and Poster Session
• 3:00 PM to 3:30 PM Afternoon break with Exhibitors

Sunday, September 27

General Session

• 8:00 AM to 8:30 AM Continental Breakfast
• 8:30 AM to Noon Closing Plenary
• 10:00 AM to 10:30 AM Morning Break
• 12:00 Noon Program Adjourns

Back to Top

Conference Agenda

Click HERE for the Pre-Conference Workshop Descriptions.

Click HERE for the 2009 Annual Conference Agenda, including Session Descriptions.

Back to Top

How to Register for the Conference

Click Here to register online.

Click Here to download the Registration Form (PDF).

*SoCRA Registration Policies/Information:

• Non member fees include a one year membership in SoCRA.
• Membership fees are processed immediately and are not refundable. Fees are in U.S. dollars.
• Please make checks payable to “SoCRA”
  Checks must be drawn on a U.S. bank or marked “Pay in U.S. Funds”.
  Written cancellation requests received by SoCRA at least 10 business days prior to start of course may receive a $525 refund ($125 for pre-conference).
• We regret that refunds cannot be issued for cancellations on or after 10 business days prior to start of course.
• Taping (audio or video) is prohibited unless SoCRA’s written permission has been acquired.
• ADA - This program is accessible to persons with disabilities. Please list any special needs in the area indicated in the registration form.
• If for any reason this conference cannot be held, SoCRA is not responsible for costs incurred by attendees, such as airfares, or hotel or other reservations.
• SoCRA is an educational non-profit membership organization (corporation) - Federal Tax ID #61 1208981.

Click Here for information regarding the Prep and Review Course.

Click Here for information regarding the CCRP Certification Examination.

Back to Top

E-mail Your Poster Abstract

Special Recognition Award Competition Offers $500 grant + Fee Waived Annual Conference Registration*

Please consider contributing to this very important meeting through the poster program. Abstracts of approximately 500 words are requested for identification, evaluation, and publishing of poster presentations.

There are two categories of submission.

• Clinical Trials: Scientific papers reporting on findings of treatment, intervention, or survey studies.
• Clinical Research Management: Critical reviews, position papers, or descriptive case reports dealing with issues associated with implementation, coordination, or management of clinical research or programs.

*Papers to be considered for a special recognition award will be accepted through July 15. Submissions will be subject to blinded review by a panel of experts in clinical research. The author of the abstract receiving the highest score in each of the above categories will receive a $500.00 award and a fee waived registration to the annual conference.

In submitting this poster abstract, the primary author has reviewed and agreed to the following:

Guidelines for The Submission of Posters
SoCRA - 18th Annual Conference
September 25 - 27, 2009 - The Gaylord Opryland Resort and Convention Center - Nashville, TN, USA

• Primary author must be a SoCRA member prior to abstract submission in order to qualify for the Special Recognition Award.
• Authors of posters are expected to attend the conference as registered attendees in order to participate in the poster session and to have the abstract published.
• Only registered attendees to the conference will be considered for the Poster Competition.
• Only authors listed in the abstract will be recognized in subsequent publications.
• If the submission is a research project, the first sentence must state the purposes or specific objectives of the study. Methods should describe the study design, subjects, and evaluative procedures. Clear documentation of statistical methodology should accompany the methods/results section. A summary of the results must be stated in the abstract to support the final conclusions. Please do not include statements about providing further data or conclusions at the time that the abstract is presented.
• If the submission is an overview or a theoretical position paper, state the purpose and methodology if appropriate. The body of the abstract should include the main points that are to be made as well as the conclusion(s).
• Abstracts of posters are limited to 500 words in length and must be presented on a single page.
• Poster boards are limited in size to four feet high by eight feet wide (4’x8’).
• Posters must present new data of professional or scientific interest to the clinical research professional.
• The author must certify that no prior copyright or ownership applies to the abstract or poster.
• Once an abstract is accepted, content may not be significantly revised prior to the annual conference. Updated material may be presented in the poster or during the presentation.
• Poster sessions will be conducted as a distinct part of the program.
• Award winners will be expected to give an oral presentation at some time in the future.
• Abstract applications received postmarked after July 15 will not be included in the abstract/poster evaluation and award process, but will be accepted for the poster sessions at the Annual Conference.
• Posters will be on display from 9AM Friday until 5PM on Saturday. Poster presenters should be available during the afternoon breaks on Friday and Saturday.
• Submissions and supporting documentation will not be returned.

All poster authors must be registered attendees to the conference. Click Here to register for the conference.

Copy and paste the following bolded text into your poster abstract submission e-mail, provide the requested information, attach your Microsoft Word poster abstract to the e-mail, and send the e-mail.

By this submission, I certify that my submitted abstract and poster are an original work and have no prior ownership or copyright restrictions. I certify that the abstract and poster are not previously copyrighted. I give SoCRA authority to reproduce and publish my abstract in their annual conference program, the SoCRA SOURCE journal, and proceedings of the meeting. If any other individual or organization asks for or receives copyright privileges for this work, I will promptly notify SoCRA of any such situation. I shall hold SoCRA harmless from any breach of this warranty.

Primary Author (for contact purposes):

Primary Author email address:

Primary author phone number:

Title of Abstract:

Poster subject area:
______ 1. Clinical Trials _____ 2. Clinical Research Management

Click Here to E-mail Your Poster Abstract.

Back to Top

Exhibit Program

EXHIBIT HOURS: Friday, September 25: 10AM - 5PM Saturday, September 26: 10AM - 5PM
Exhibit Details: SoCRA will supply 8’ high blue drape, 3’ high blue side dividers, one 6’ x 30” white draped table, two side chairs, one wastebasket, black carpet, and a 7” x 44” identification sign Exhibitors may also bring a display system which may utilize (up to) a 10’x10’ footprint. Exhibits will be open from 10AM Friday until 5PM on Saturday. Exhibitors should be available during the morning and afternoon breaks on Friday and Saturday. The drayage company will supply other furniture/material that you require as well as drayage, signage and labor for your booth. Electrical & communications will also be coordinated through them. They will include the electrical and communications forms in their service kit for quick access and to facilitate your ordering procedures. ▪ All attendee breaks are held in the exhibit hall Separate (optional) exhibit staff luncheon is offered during the afternoon session Other details will be provided to the exhibitor upon registration. Exhibit Fees: First Exhibitor registration: $1,050 Two additional exhibit staff may register at $400 each. Registration must be confirmed by August 14 in order to be listed in program materials. Exhibit Registration: Click Here to register online. Click Here to download the Exhibitor Registration Form (PDF). Exhibit Service Contractor Information: FREEMAN 1701 Lebanon Pike Circle Nashville, TN 37210 Phone: (615) 884-5785 Exhibitor Move-In: Thursday, September 24, 2009 - 1PM to 5PM (with assistance from Freeman) 5PM to 11PM (NO assistance - must show photo ID to security) Exhibitor Move-Out: Saturday, September 26, 2009 - 5PM to 9PM (all materials must be removed by 9PM on Saturday) Click Here for a downloadable PDF of FREEMAN “QUICK FACTS” Information Sheet. Additional Exhibit Advertising As an exhibitor for the 2009 SoCRA Annual Conference, you have the opportunity to mail announcements or promotional materials to the annual conference registrants, prior to the conference. This opportunity is available through our mail house, who would receive your materials and coordinate mailing with you. The mail house is: Mailcrafters, Inc. Contact - Mr. John McNulty 813 W Main St Lansdale, PA 19446 (215) 368-6200 mailcrafters@verizon.net The cost of any assembly, as well as mail preparation and mailing, would be coordinated and resolved by you and Mr. McNulty. The cost of this program will be paid directly to Mailcrafters. At this time, we would suggest that you consider preparing 1,000 mailers. SoCRA will give Mailcrafters our attendee/participant address list on September 9. We appreciate your support, and are looking forward to your participation at our conference. Additional sponsorship opportunities (including breaks, reception, lunch, breakfast, speaker travel, and an Internet Cafe) are still available. Please contact Janis Skarbowski at 800 762 7292 to discuss the mailing program or the sponsor program. We appreciate any comments or suggestions.

Back to Top

Sponsorship Opportunities

Program Sponsor Categories:

• Bronze Sponsor $3,000 (includes one fee waived registration)
• Silver Sponsor $5,000 (includes two fee waived registrations)
• Gold Sponsor $7,000 (includes three fee waived registrations)
• Platinum Sponsor $ 9,000 (includes four fee waived registrations)

Sponsorship Suggestions:

• Program Tracks (Sponsor of Speakers)
• Commemorative Registration Bags
• Commemorative Travel Mugs or Water Bottles
• Welcome Reception
• Coffee Break
• Internet Cafe
• Luncheon

Please note: If you don’t see an opportunity that fits your needs, SoCRA will consider customized sponsorships.
Please contact the SoCRA office for more details.

Click Here to download a printable version of the Sponsorship Opportunites.

QUESTIONS? Call the SoCRA office at 1-800-762-7292

Back to Top

Advertising Opportunities

Pricing for Ads:

• Full Page Color Ad - $900
• Full Page Black & White Ad - $600
• Half Page Black & White Ad - $500

If your ad requires resizing or typesetting, please add $100.

Deadline for Submissions:
Ads must be submitted by August 10 to be considered for the Program Ad.

Guidelines for Program Ads:

• Please supply a PDF or camera-ready copy of the appropriate size (paper slick)
• To submit other digital files contact the SoCRA office to discuss options
• Full-page ads must fit a 7 1/4” x 9” layout; half-page ad may be 3 1/2” x 9” or 7 1/4” x 4 1/2”

QUESTIONS? Call the SoCRA office at 1-800-762-7292.

Click Here to download a printable version of the Advertisement Opportunities handout.

Back to Top

Travel/Tourism

Nashville Tourism: Nashville has so much to offer! Visit the city’s tourism website for more information: www.visitmusiccity.com or visit the hotel website at www.gaylordhotels.com/gaylord-opryland/

Travel by Air: If you are traveling by air, Nashville International Airport is approximately 8 miles from the hotel. Taxi fare from the airport to the hotel is estimated at $25USD. Gaylord operates airport shuttle service available to SoCRA attendees for $12USD/one-way ($24USD/round trip). To reserve this discounted rate, please book online HERE.

Travel By Car: Please visit the hotel website for more information at www.gaylordhotels.com/gaylord-opryland/.

Parking: Valet parking rates are $25USD/day and self parking is available for $18USD/day (in and out privileges for hotel guests only). These prices are approximate and are subject to change. Therefore, please confirm current pricing with the hotel prior to your arrival in Nashville.

Back to Top

Become a Speaker

SoCRA is accepting Speaker Abstracts for the 19th Annual Conference!

SoCRA 2010 Annual Conference

Dates: September 24-26, 2010

Location: Dallas, TX - Sheraton Dallas Hotel

Right-click HERE and Save file for a speaker enrollment form. Please complete this form and email to socramail@aol.com.

Please note:

• *All topics related to regulatory and operational areas of clinical research as well as study related experience will be considered.
• Successful Applicants Will Receive a Fee Waived Annual Conference Registration
• Enrollment forms must be received by July 31, 2009 for consideration.
• Successful applicants will be contact in the winter of 2009/2010.

Please direct any questions to the SOCRA office by phone at 215-822-8644 or 1-800-762-7292 or by email to socramail@aol.com.

Back to Top

Night Out Event

OPTIONAL EVENT at the 18th Annual Conference Friday, September 25, 2009 from 7:00PM-10:00PM The famous Wild Horse Saloon Dinner (and optional "Line" Dancing) in Downtown Nashville! NOTE: Only preregistered guests will be accepted. Availability is limited. Don't delay in reserving your place! To register, please complete the form below (one per person) and fax or email with credit card payment or mail with a check.
Registration Includes: Taste of Tennessee Dinner Buffet Wildhorse Salad - mixed greens, fresh tomatoes, chopped boiled eggs, mushrooms, alfalfa sprouts & bacon bits served with choice of dressing Barbecue Pulled Pork Shoulder - award winning smoked shoulder, hand pulled Tequila lime Breast of Chicken Southern succotash with oven roasted corn, peppers, onions, black beans, lima beans, bacon and hominy Oven-roasted new potatoes with onions and peppers Broccoli, zucchini and squash medley Yeast rolls and cornbread Fresh fruit cobbler Coffee/Tea and decaffeinated coffee Live Entertainment and Dance Lessons ($8 cover charge WAIVED with event registration) Bus transportation will shuttle you to and from downtown Nashville ($18 value) Cash Bar will be available
FEES: Dinner, Transportation, Entertainment, Total $49 USD includes Taxes, and Gratuities How to Register for the Night Out Event: Click Here to register online. Click Here to download the Registration Form (PDF). *SoCRA REGISTRATION POLICIES/INFORMATION: Fees are in U.S. Dollars. Please make checks payable to "SoCRA". Check must be drawn on a U.S. Bank or marked "Pay in U.S. Funds". Confirmations will be emailed within three business days. We regret that refunds cannot be issued for cancellations on or after Sept. 18. Written cancellation requests received by SoCRA prior to Sept. 18 will receive a $30 refund. If for any reason this conference cannot be held, SoCRA is not responsible for costs incurred by attendees, such as airfares, hotel, or other reservations. SoCRA is a non-profit (membership organization) corporation - Federal Tax ID #61 1208981

Back to Top