Clinical Data Quality Summit April 24-25, 2012 Loews Hotel, Philadelphia, PA PROGRAM CHAIRPERSON PROGRAM COMMITTEE Mathias Poensgen, PhD, MBA Aris Global LLC, Germany WHO SHOULD ATTEND Data managers Clinical project managers Clinical research coordinators Principal investigators Data standards personnel Monitors Quality assurance personnel Regulators Statisticians Clinical programmers This meeting will include a mix of plenary and breakout sessions designed to be highly interactive working sessions. You will: Troubleshoot, share processes and exchange ideas with colleagues from various clinical areas Explore new tools, technologies, and techniques for conducting remote-based and targeted monitoring Discuss how to partner with different research professionals, help studies improve quality, run more effectively and contain costs SPECIAL BREAKOUT TRACK SESSIONS Three concurrent tracks will repeat over the course of the two-day meeting. You will rotate through each of the tracks in order to participate in each breakout session. LEARNING OBJECTIVES At the conclusion of this conference, participants should be able to: Describe tools, technologies, and techniques that impact data quality Discuss best practices to ensure successful design of studies, while embracing standards Define who to include during the study start up phase to ensure that all elements are addressed Explain how research professionals can work effectively together during the conduct of a clinical trial Identify steps to successfully clean and lock a database by establishing partnerships with clinical and biostatistics Discuss regulatory expectations for quality data and recommendations for study start, conduct and closeout FEATURES Cross-functional, interactive breakout sessions dedicated to the different areas of interest Networking opportunities Question and answer sessions Case studies Presentation of best practices Table top exhibits This program has been developed by the eclinical, CLINICAL DATA MANAGEMENT and CLINICAL RESEARCH Special Interest Area Communities. Worldwide Headquarters Drug Information Association, Inc. 800 Enterprise Road, Suite 200 Horsham, PA 19044, USA Regional Offices Basel, Switzerland Tokyo, Japan Mumbai, India Beijing, China
2 CONTINUING EDUCATION Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102. As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer up to 1.1 CEUs for the conference. Participants must attend the entire conference, in order to be able to receive an IACET statement of credit. No partial credit will be awarded. If you would like to receive a statement of credit, you must attend the conference, sign-in at the DIA registration desk each day of the conference, and complete the on-line credit request process through My Transcript at www. diahome.org. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on May 9, 2012. Please Note: If you do not sign-in each day, you will not be able to request continuing education credits. The conference is part of DIA s Certificate Program and is awarded the following: Clinical Research Certificate Program: 8 Elective Units For more information go to www.diahome.org/certificateprograms Disclosure Policy It is Drug Information Association policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosures will be included in the course materials. Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda, and CE information are subject to change without notice. Recording of any DIA educational material in any type of media, is prohibited without prior written consent from DIA. To view DIA s Grievance Policy, please visit the CE page on DIA s website at www.diahome.org. Special Breakout Track Sessions There will be 3 concurrent breakout tracks, addressing the themes of Study Start Up, Study Conduct, and Study Closeout. Each breakout track will be repeated three times in order to allow all attendees to participate in and contribute to each track. Attendees will be assigned to one of the groups (Group 1, 2, or 3) at registration and will follow their group as it rotates through the breakout track sessions (please note that groups will be assigned randomly). Breakout Tracks: Track A Study Start Up Track B Study Conduct Track C Study Closeout Group Rotations: Group 1 Track A > Track B > Track C Group 2 Track B > Track C > Track A Group 3 Track C > Track A > Track B TUESDAY APRIL 24, 2012 7:15-8:15 AM REGISTRATION AND CONTINENTAL BREAKFAST 8:15-8:30 AM WELCOME AND OPENING REMARKS PROGRAM CHAIRPERSON 8:30-10:00 AM SESSION 1 PLENARY SESSION Expectations for Quality: Current State, Future Forward SESSION CHAIRPERSON Current State of Draft Guidance Document on esource Brief Overview of Draft Guidance Document on Risk-based Monitoring 10:00-10:30 AM REFRESHMENT BREAK
3 10:30-12:30 PM SESSION 2 BREAKOUT TRACKS (WORKING SESSIONS) TRACK A STUDY START UP TRACK B - STUDY CONDUCT TRACK C STUDY CLOSEOUT Missing Data Data Quality - Is It an Oxymoron? Kari B Kastango, PhD Senior Biostatistician Sunovion Pharmaceuticals, Inc. Remote Monitoring: Key to Improved Data Quality and EDC Optimization Vikas Gulati Vertex Pharmaceuticals Inc. Delight the Sites: The Impact of Site/Sponsor Relationships on Site Performance Paul Ivsin Vice President, Consulting Director CAHG Evaluating Two Approaches to Centralized Remote Data Review Nicole D. Baker Clinical Operations Director Kforce Clinical Research, Inc. The Two Levels of Database Quality Auditing Clinical Trial Database and CDISC Datasets Scott Brand, PhD Director of Strategic Planning and Quality Assurance KAI Research Inc. Providing an Inspection-Ready Database to the FDA Jan Holladay Pierre, MPH Quality Principal Leader Dynport Vaccine Company 12:30-2:00 PM LUNCHEON 2:00-4:00 PM SESSION 3 - BREAKOUT TRACKS (REPEATED) TRACK A STUDY START UP TRACK B - STUDY CONDUCT TRACK C STUDY CLOSEOUT Missing Data Data Quality - Is It an Oxymoron? Kari B Kastango, PhD Senior Biostatistician Sunovion Pharmaceuticals, Inc. Remote Monitoring: Key to Improved Data Quality and EDC Optimization Vikas Gulati Vertex Pharmaceuticals Inc. 4:00 PM END OF DAY 1 Delight the Sites: The Impact of Site/Sponsor Relationships on Site Performance Paul Ivsin Vice President, Consulting Director CAHG Evaluating Two Approaches to Centralized Remote Data Review Nicole D. Baker Clinical Operations Director Kforce Clinical Research, Inc. The Two Levels of Database Quality Auditing Clinical Trial Database and CDISC Datasets Scott Brand, PhD Director of Strategic Planning and Quality Assurance KAI Research Inc. Providing an Inspection-Ready Database to the FDA Jan Holladay Pierre, MPH Quality Principal Leader Dynport Vaccine Company 4:00-5:00 PM NETWORKING RECEPTION
4 WEDNESDAY APRIL 25, 2012 7:30-8:30 AM REGISTRATION AND CONTINENTAL BREAKFAST 8:30-10:30 AM SESSION 4 - BREAKOUT TRACKS (REPEATED) TRACK A STUDY START UP TRACK B - STUDY CONDUCT TRACK C STUDY CLOSEOUT Missing Data Data Quality - Is It an Oxymoron? Kari B Kastango, PhD Senior Biostatistician Sunovion Pharmaceuticals, Inc. Remote Monitoring: Key to Improved Data Quality and EDC Optimization Vikas Gulati Vertex Pharmaceuticals Inc. Delight the Sites: The Impact of Site/Sponsor Relationships on Site Performance Paul Ivsin Vice President, Consulting Director CAHG Evaluating Two Approaches to Centralized Remote Data Review Nicole D. Baker Clinical Operations Director Kforce Clinical Research, Inc. The Two Levels of Database Quality Auditing Clinical Trial Database and CDISC Datasets Scott Brand, PhD Director of Strategic Planning and Quality Assurance KAI Research Inc. Providing an Inspection-Ready Database to the FDA Jan Holladay Pierre, MPH Quality Principal Leader Dynport Vaccine Company 10:30-11:00 AM REFRESHMENT BREAK 11:00 AM-12:30 PM SESSION 5 - PLENARY SESSION Solving the Quality Equation with Data-Driven Decisions SESSION CHAIRPERSON Benchmarking Clinical Data Quality Jeffrey S. Handen, PhD Vice-President, Clinical Solutions The Clinical Trials Eligibility Database (CTED): Automating the Clinical Trials Process for Patient Identification, Screening and Tracking Lynne Penberthy, MD, MPH Director Cancer Informatics Core Massey Cancer Center at Virginia Commonwealth University Using CDISC Standards in Study Start-up to Optimize the End-to-End Clinical Trial Process Mark Wheeldon Chief Executive Officer Formedix 12:30-2:00 PM LUNCHEON 2:00-4:00 PM SESSION 6 PLENARY SESSION Summaries from Breakout Tracks and Next Steps The Track Chairpersons will each give a summary of the discussion points from their breakout track sessions. 4:00 PM MEETING ADJOURNED
Real Training Real Skills Real Results experience the difference of Real-world, Hands-on Training www.diahome.org/training Good Clinical Practices for Clinical Research Professionals March 30 Horsham, PA Development of a Clinical Study Report March 29 Horsham, PA Essentials of Project Management April 16-18 Horsham, PA Advanced Clinical Statistics for Nonstatisticians July 16-24 Online Introduction to Clinical Data Management September 12-21 Online Clinical Project Management August 8 Horsham Fundamentals of Clinical Research Monitoring March 19-April 2 Online Proven Strategies for Creating an Effective Clinical Research Program April 16-27 Online
REGISTRATION FORM Register online or fax this page to +1.215.442.6199 Clinical Data Quality Summit Event #12004 April 24-25, 2012 Loews Hotel, Philadelphia, PA Registration Fees If DIA cannot verify your membership, you will be charged the nonmember fee. Registration fee includes refreshment breaks, luncheons, and reception (if applicable), and will be accepted by mail, fax, or online. Member Early-bird Opportunity On or before After Available on nondiscount member fee only APR. 3, 2012 APR. 3, 2012 Member Fee US $1340 US $1490 Join DIA now to qualify for the early-bird member fee! www.diahome.org/membership MEMBERSHIP US $175 To qualify for the early-bird discount, registration form and accompanying payment must be received by the date above. Does not apply to government/academia/nonprofit members. Nonmember Fee US $1665 A one-year membership to DIA is available to those paying a nonmember registration fee. If paying a nonmember fee, please indicate if you do, or do not, want membership. I want to be a DIA member I do NOT want to be a DIA member Discount Fees MEMBER NONMEMBER Government (Full-time) US $595 US $770 Charitable Nonprofit/Academia (Full-time) US $745 US $920 *If paying a nonmember fee, please check one box above, indicating whether you want membership. TO RECEIVE AN EXHIBIT APPLICATION, PLEASE CHECK TRAVEL AND HOTEL The most convenient airport is Philadelphia International Airport and attendees should make airline reservations as early as possible to ensure availability. Lowes Hotel is holding a block of rooms at the reduced rate below until April 2, 2012 for the DIA event attendees. Room availability at this rate is guaranteed only until this date or until the block is filled. Single $219 / Double $219 Attendees must make their own hotel reservations. Contact the Loews Hotel by telephone at +1.888.575.6397 and mention the DIA event. The hotel is located at 1200 Market Street, Philadelphia, PA 19107, USA. CANCELLATION POLICY: On or before APRIL 17, 2012 Administrative fee that will be withheld from refund amount: Member or Nonmember = $200 Government or Academia or Nonprofit (Member or Nonmember) = $100 Preconference Workshop (if applicable) = $50 Cancellations must be in writing and be received by the cancellation date above. Registrants who do not cancel by that date and do not attend will be respons ible for the full registration fee paid. Registrants are responsible for can celling their own hotel and airline reservations. You may transfer your registration to a colleague at any time but membership is not transferable. Please notify DIA of any such substitutions as soon as possible. Substitute registrants will be responsible for nonmember fee, if applic able. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants. Participants with Disabilities: DIA event facilities and overnight accommodations are accessible to persons with disabilities. Services will be made available to sensory-impaired persons attending the event if requested at least 15 days prior to event. Contact the DIA office to indicate your needs. GROUP DISCOUNTS* Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia. To take advantage of this offer, please make a copy of this registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA. Please indicate that this form is part of a group registration by checking this box and list below the names of the other three registrants from your company. 1. 2. 3. TABLETOP EXHIBIT INFORMATION Attendees may visit the tabletop exhibits during the event and receptions. Contact Jeff Korn, Exhibits Associate, Phone +1.215.442.6184 Fax +1.215.442.6199, email Jeff.Korn@diahome.org EVENT INFORMATION For registration questions, please contact Elizabeth Espich by phone at +1.215.293.5802 or by email at Elizabeth.Espich@diahome.org. For agenda details, please contact Victoria Graves, Program Manager by phone at +1.215.919.9863 or by email at Victoria.Graves@diahome.org Please check the applicable category: Academia Government Industry CSO Student (Call for registration information) Last Name Payment options: Register online at www.diahome.org or check payment method. First Name M.I. CREDIT CARD number may be faxed to: +1.215.442.6199. You may prefer to pay by check or bank transfer since non-u.s. credit card payment will be subject to the currency conversion rate at the time of the charge. Visa MC AMEX Exp Date Card # Name (printed) Degrees Dr. Mr. Ms. Job Title Company Signature CHECK drawn on a US bank payable to and mailed along with this form to: Drug Information Association Inc, P.O. Box 95000-1240, Philadelphia, PA 19195-1240, USA. Please include a copy of this registration form to facilitate identification of attendee. BANK TRANSFER When DIA completes your registration, an email will be sent to the address on the registration form with instructions on how to complete the Bank Transfer. Payment should be made in US dollars. Your name and com pany, as well as the Event I.D. # must be included on the transfer document to ensure payment to your account. Address (As required for postal delivery to your location) Mail Stop City State Zip/Postal Country email Required for confirmation Phone Number Fax Number Required for confirmation