Clinical Trial Disclosure: Towards a More Transparent World
Oct 1 2013 8:30AM - Oct 2 2013 3:30PM | Hyatt Regency Bethesda
One Bethesda Metro Center,
Bethesda, MD 20814-5326
Tutorials: September 30, 2013
Meeting: October 1-2, 2013
Transparency of clinical trial information is taking on new dimensions including the release of participant-level data. Discussion is now focused on the different mechanisms for transparency, their scope, objectives, and audiences. This increased transparency changes availability and use of information from clinical trials, and brings with it new data use opportunities and operational challenges for industry and academia.
The continuing proliferation of national and industry sponsored registries leave many sponsors considering disclosure strategy, developing operational measures, and looking for efficient ways to manage dissemination of clinical trial protocol information and results data. The audience for registers containing clinical trial information is expanding from patients to readers of the medical literature to clinical investigators and researchers.
In collaboration with the Clinical Trial Disclosure Community
Who Should Attend
Professionals involved in:
- Clinical Operations
- Clinical Research
- Clinical Trial
- Government Agencies
- Medical Research
- Patient Advocacy
- Registry Management
- Regulatory Affairs
- Research and Development
At the conclusion of this meeting, participants should be able to:
- Identify the current clinical trial disclosure requirements in the US and EU
- Discuss the interrelationships between medical writing, regulatory affairs, and clinical trials disclosure teams to maintain consistency for protocol registration and results reporting
- Describe the impact of greater transparency in the clinical trial disclosure environment on industry and academia
- Discuss the advantages and implications of availability of clinical trial disclosure databases
Enroll in the meeting, choose one tutorial and receive up to $100 off your total registration.*
Hotel & Travel
Hyatt Regency Bethesda
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until September 17, 2013, or until room block is filled). Attendees can follow this link to make their hotel reservations, or by calling +1.212.532.1660 or in the USA at 1.800.221.3531. If making your hotel reservation by phone, please select option 1 for “Hotel Reservations,” inform the phone agent that it is a DIA event, and provide them with the date and title of the meeting. Please Note: In order to receive the reduced room rate, hotel reservations must be made as noted above and not directly with the hotel.
Standard Room Rate $229
Hotel Address: One Bethesda Metro Center (7400 Wisconsin Ave) Bethesda, Maryland, USA, 20814
The most convenient airport is Baltimore Washington Airport and attendees should make both airline and hotel reservations as early as possible.
Additional concessions for guests: Complimentary access to health club
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 up to 1.9 CEUs for this program and tutorials. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.
These programs are part of DIA’s Certificate Program and are awarded the following:
• Clinical Research Certificate Program: X Elective Units
>• Regulatory Affairs Certificate Program: X Elective Units
For more information go to www.diahome.org/certificateprograms
|Clinical Trial Disclosure Tutorial 2
|Clinical Trial Disclosure Tutorial 1
|Clinical Trial Disclosure
It is DIA 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. Disclosure statements will be included in the course materials.
Statement of Credit:
If you would like to receive a statement of credit, you must attend the program and tutorial(s), if applicable, scan your name badge at the DIA registration desk each day of the program/tutorial, and complete the on-line credit request process through My Transcript at www.diahome.org. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. 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 October 16, 2013.
To view DIA’s grievance policy, please visit the CE page on the DIA website at www.diahome.org/CE
The Clinical Trial Disclosure meeting offers interested companies the opportunity to exhibit with a tabletop display.
Tabletop Fee: $1,500
- One six-foot skirted table
- One chair
- Standard electricity
Each tabletop rental requires at least one registered attendee to staff the table. All tabletop staff must be registered conference attendees.
Tabletop Exhibit Dates:
October 1-2, 2013
- Charitable Nonprofit/Academia Member
- Member Government
- Member Standard
- Member Standard (As of 09/10/2013)
- Charitable Nonprofit/Academia Nonmember
- NonMember Government
- NonMember Standard
Registration Fees for Additional Offerings
- Clinical Trial Disclosure Tutorial 1 - Standard Rate
- Clinical Trial Disclosure Tutorial 2 - Standard Rate
Printable Registration Form
*Receive $100 off your total registration by enrolling in the Clinical Trial Disclosure meeting and Tutorial 1, a full-day tutorial or receive $50 off your total registration by enrolling in the Clinical Trial Disclosure conference and Tutorial 2, a half-day tutorial.
Meeting and tutorial enrollment must occur in the same transaction to be eligible for discount. Promotion ends May 31, 2013.
Register three individuals from the same company and receive complimentary registration for a fourth! All four 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 the 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.
CANCELLATION POLICY: All cancellations must be received in writing two weeks before
the start of the event. Administrative fee that will be withheld from refund amount:
- Member or Nonmember = $200
- Government or Academia or Nonprofit (Member or Nonmember) = $100
- Tutorial (if applicable) = $50
Cancellations must be in writing and be received two weeks before the start of the event. Registrants who do not cancel two weeks before the start of the event and do not attend the event will be responsible for the full registration fee. Registrants are responsible for cancelling their own hotel and airline reservations. 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.
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.
Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.