SoCRA 19th Annual Conference
Innovation and Integrity:
Shaping Tomorrow’s Clinical Trials Today

Dallas, Texas - September 24, 25, and 26, 2010
Preconference Workshops- September 23, 2010

Conference Information

DATES/LOCATIONS

September 24, 25, and 26, 2010 DALLAS, TEXAS, USA Sheraton Dallas Hotel 400 North Olive Street Dallas, Texas 75201 USA Hotel Phone: +1 214 922 8000 or 1 866-716-8134 SoCRA Room Block Rate $179 USD plus taxes is available until August 16, 2010 or until the room block is filled. Please contact the hotel directly for sleeping room reservations at 1-866-716-8134 or Click HERE.

ANNUAL CONFERENCE REGISTRATION FEES

For Registrations Confirmed PRIOR to August 13:
Member Fee- $750
Non-Member Fee*- $825
* Non-Member Fees include a (non-refundable) one-year membership in SoCRA

For Registrations Confirmed ON or AFTER August 13:
Member Fee- $800
Non-Member Fee*- $875
* Non-Member Fees include a (non-refundable) one-year membership in SoCRA

Preconference Workshops- Add $175

Continuing Education Credit Hours:

SoCRA designates this educational activity for a maximum of 19* Continuing Education Credits for SoCRA CE and Nurse CNE. SoCRA designates this educational activity for a maximum of 19 (15 credits Annual Conference, 4 credits pre-conference) AMA PRA Category 1 Credit(s)™. Physicians should claim credit commensurate with the extent of their participation in the activity.
* The Annual Conference offers 15 credits (maximum). Pre-conference Workshops offer an additional 4 credits (maximum).

Accreditation Statements:
CME for Physicians: The 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. ANCC/PSNA Provider Reference Number: 205-3-A-09

SoCRA Course # 10001

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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

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Conference Schedule

SCHEDULE OF EVENTS:

Certification Preparation and Review Course and Certification Examination

Wednesday, September 22
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 23
Certification Examination (requires separate registration - Click Here for more details)
Registration Deadline for application to the exam is August 11, 2010
7:30 AM to Noon - Examination Registration and Session

Annual Conference Events

Thursday, September 23
Pre-conference Seminars - Ten pre-conference seminars are planned. Click Here for pre-conference workshop descriptions.

12:30 PM to 5:15 PM Pre-conference seminar registration and sessions

• How to Prepare for an FDA Audit
• IRBs and the Informed Consent Process
• Clinical Research Administration, Budgeting, Contract Negotiation and Finance: A Site’s Perspective
• GCP 101 for Sites - New Study Coordinator Workshop
• Presentation Skills 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

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 24

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 10:00 PM (approximate times) - Optional Event (Prepaid reservations required)
Night Out at the famous Gilley’s Dallas

Saturday, 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 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 26

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

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Conference Agenda

Click Here for the 2010 Annual Conference Agenda.

Click Here for the preconference workshop descriptions.

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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 September 3.
• 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.

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Poster Program

• Special Recognition Award Competition (LInked below)
• Guidelines for Submitting Poster Abstracts (Linked below)
• Explanation of Special Recognition Award Review and Evaluation Process (Linked below)
• Guide to Writing a Poster Abstract for the SoCRA Annual Conference (Linked below)
• Submit Your Poster Abstract

Special Recognition Award Competition

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.

Guidelines for Submitting Poster Abstracts

• 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, (not including figures, tables, or graphs) and must be presented on a single page/poster. Poster boards are limited in size to four feet high by eight feet wide (4’x8’).
  ▪ Abstracts must present new data. The author must certify that no prior copyright or ownership applies to the abstract or poster.
• Once an abstract is accepted, it may not be revised prior to publication. Updated material may be presented in the poster or during the presentation.
• Award winners will be encouraged to give an oral presentation at a future annual conference.
• Authors of posters must be registered attendees for the conference at the time of submission in order to be considered for the poster program and competition and to have the abstract published.
• Authors should check the box for Poster Competition on their Annual Conference Registration Form
• At least one author must be a SoCRA member prior to abstract submission in order to qualify for the Special Recognition Award.
• 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.
• Poster sessions will be conducted as a distinct part of the program.

Explanation of Special Recognition Award Review and Evaluation Process

• Abstracts are submitted and scored prior to the annual conference
• The displayed posters are scored by the evaluation committee during the first day (Friday) of the conference
• The highest combination of the abstract score and poster score determines ten finalists, five in each category of submission
• The ten finalists are notified on Friday evening of conference week and invited to a question and answer session that is scheduled for the next day (Saturday)
• Saturday morning, the ten finalists gather along with their posters (a projected photograph or PowerPoint slide), in a session and track devoted to the poster program
• Finalists are affforded two to three minutes to present a brief review of their poster, followed by a question and answer session with interested attendees and the selection committee
• The highest aggregate score among abstract, poster, and Q&A session for each of the two categories (management and clinical trials) is awarded $500 and a fee waived registration
• Special recognition awards will be announced (and awarded) during the Sunday morning closing plenary session

Guide to Writing a Poster Abstract for the SoCRA Annual Conference

Poster abstracts submitted to SoCRA should serve as the initial report of knowledge, experience, or best practices in the field of clinical research. Submissions participate in a peer-review process and are evaluated by a committee of experts. A well-written abstract is more likely to be considered as a finalist, and ultimately for the special recognition award. To expedite the review process, to assure effective communication, and to elevate the work toward the special recognition award, abstracts should follow a standardized format.

Writing an effective abstract is best learned with guidance by an experienced mentor. If such a person is not available, we suggest seeking input from a colleague who would review and critique the poster abstract prior to its submission.

General suggestions

The following are some suggestions about poster abstracts that assist in increasing the readability and quality of the submission.

• Check for proper spelling and grammar.
• Use a standard typeface such as Times Roman with a font size of 12.
• Begin sentences with words (not numbers).
• Standard abbreviations may be used without definition, but nonstandard abbreviations/acronyms should be placed in parentheses after the first use of the terminology. It is important to keep nonstandard abbreviations/acronyms to a minimum, to allow for readability and understanding.
• Use generic names when referring to medications.
• Do not include tables, figures, or graphs in the abstract. Such content is appropriate for the poster.
• Limit the abstract to 500 words.
• Try to organize the abstract with the following headings where appropriate, as explained below; purpose, methods, results, conclusions.

Title

The abstract title conveys the content/subject of the poster. The title should not be misleading and should pertain to the purpose, methods, results and conclusions. The title may be written as a question or the title may be written to suggest the conclusions, if appropriate. A short concise title may more easily catch a reader’s attention. Try to not use abbreviations or acronyms in titles.

Purpose

The introductory sentence(s) may be stated as a hypothesis, a purpose, an objective, or state the current evidence for a particular finding.

• Hypothesis is a supposition or conjecture used as a basis for further investigations
• Purpose is a statement of the reason for conducting a particular project or reporting on a particular program, process or activity
• Objective is the end result that the author is trying to achieve by conducting a particular project, program, process or activity

Methods

Briefly describe the methods of the project to define the data or population, outcome variables, and analytic techniques, as well as data collection procedures and frequencies. A description of statistical methods used may be included if appropriate.

Results

The results should be stated succinctly to support only the purpose, objectives, hypothesis, or conclusions.

Conclusions

The conclusion(s) should highlight the impact of the project, and follow the methods and results in a logical fashion. This section should not restate results. Rather, the utility of the results and their potential role in the management of the project should be emphasized. New information or conclusions not supported by data in the results section should be avoided.

Important note

Poster program finalists are determined following evaluation of each actual poster by the review committee. Finalists will be notified by a call to their cell phone on the Friday evening of the Annual Conference. Authors should assure that they include a cell phone number on their application, as they will be asked to give an oral presentation on Saturday morning. On-site contact information is critical to participation as a finalist in the annual conference poster program.

Benefiting from a good outcome

Presenting a poster at a SoCRA meeting is a noteworthy way to share expertise or accomplishment in a specific area while contributing to clinical research. Poster finalists may be asked for permission to convert their work into an article for a future edition of the internationally recognized SoCRA Source journal. A quality poster abstract is the first step to making that happen.

In submitting this poster abstract, the primary author has reviewed and agreed to the following Guidelines for Submitting Posters.

Submit Your Poster Abstract

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.

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Exhibit Program

EXHIBIT HOURS: Friday, September 24: 10AM - 5PM Saturday, September 25: 10AM - 4PM
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” one-line identification sign Exhibitors may also bring a display system which may utilize (up to) a 10’x10’ footprint. Exhibits will be open from 10AM to 5PM on Friday and 10AM to 4PM 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 13 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: Click Here for a downloadable PDF of FREEMAN “QUICK FACTS” Information Sheet. FREEMAN Phone: 214-634-1463 Exhibitor Move-In: Thursday, September 23, 2010 - 1PM to 5PM (with assistance from Freeman) 5PM to 11PM (NO assistance - must show photo ID to security) Exhibitor Move-Out: Saturday, September 25, 2010 - 4PM to 5:30PM (all materials must be removed by 5:30PM on Saturday)

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Sponsorship Opportunities

Click Here for the Sponsor Opportunities Flyer.

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.

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

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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 13 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.

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Night Out Event

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Travel/Tourism

Dallas Tourism: Dallas Tourism Website

Travel by Air: Dallas/Fort Worth International Airport is approximately 30 miles from the hotel. Taxi fare from the airport to the hotel is estimated at $45USD.

Super Shuttle Service is available at a discounted rate to SoCRA attendees for $14USD/one-way or $26/ round trip only when reservations are made in advance. Click HERE for more information and to reserve your shuttle.

Parking: Valet parking rates are $26 USD/day and self parking is available for $17 USD/day (in and out privileges for hotel guests only) at the Sheraton Dallas. Surface parking lots are also available near the hotel with prices starting at $6/day. These prices are approximate and are subject to change. Therefore, please confirm current pricing with the hotel prior to your arrival in Dallas.

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Become a Speaker

SoCRA is accepting Speaker Abstracts for the 20th Annual Conference!

SoCRA 2011 Annual Conference

Dates: September 23-25, 2011

Location: San Diego, CA – Town and Country Resort and Convention Center

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, 2010 for consideration.
• Successful applicants will be contact in the winter of 2010/2011.

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.

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