Introductory Course for Those Who are New to Writing or Reviewing Integrated Clinical Study Reports

This fast-track course will teach you the latest strategies for preparing clear, well-organized, and ICH-compliant clinical study reports.

WHAT YOU WILL LEARN

·          Structure and format of an integrated clinical study report in accordance with ICH guidelines

·          Investigational plan through statistical methodology

·          Study population and protocol deviations

·          Placement and presentation of study information and data in various report sections, including tables, appendices, and supporting documentation

·          Safety and efficacy results

·          Pharmacokinetic and/or pharmacodynamic endpoints

·          Acceptability of abbreviated study reports

At the conclusion of this course, participants should be able to:

• Recognize key regulatory requirements for integrated and abbreviated clinical study reports
• Describe the structure and format of a clinical study report and its relationship to the clinical study protocol
• Explain the format and structure of a clinical study report
• Discuss various approaches to solving problems related to preparation, protocols, patient disposition, compliance, and changes to statistical methods
• Develop a comprehensive and easily reviewable clinical study report

For detailed program information including faculty and topics, please contact:
Colleen Buckley
Tel. +1-215-442-6108
Email Colleen.Buckley@diahome.org

If you have not received confirmation within 5 business days, please contact:
DIA
Tel. +1-215-442-6100
Fax +1-215-442-6199
Email confirmationservices@diahome.org

TRAVEL AND HOTEL INFORMATION
Hotel reservations should be made ONLY after receipt of written registration confirmation from DIA.

TRAINING COURSE LOCATION
DIA Worldwide Headquarters
800 Enterprise Road; Suite 101
Horsham, PA 19044

HOTEL LOCATION
Joseph Ambler Inn
1005 Horsham Road
North Wales, PA 19454-1413 USA

Travel Information
Tucked away on 12 acres of rolling countryside, the Joseph Ambler Inn offers the exceptional features expected of a great country inn including an award-winning Pennsylvania restaurant and 52 pampering B&B guestrooms. Surrounded by peaceful meadows and comprising 5 historic buildings, the inn’s facilities and grounds are unmatched in all of Bucks and Montgomery counties.
Just 45 minutes from Philadelphia, the Joseph Ambler Inn is centrally located to the attractions and activities of the area.  Valley Forge National Park, New Hope, and Bucks County are just a one-hour drive. Day trips can be made to Atlantic City casinos, Lancaster County Amish Country, and Reading, the shopping outlet headquarters.

Hotel Information
A limited block of rooms has been reserved at the Joseph Ambler Inn at a low rate per night until the release date of March 31, 2010. We urge you to make your hotel reservations early and plan on staying at the hotel in order to facilitate interactive discussion with faculty and fellow participants.

Single $127 Double $127

Attendees must make their own hotel reservations. To reserve your room, contact the Joseph Ambler Inn by telephone at 215-362-7500 and mention the DIA Training Course.

Participants with disabilities: DIA meeting facilities and overnight accommodations are accessible to persons with disabilities. Services will be made available to sensory-impaired persons attending the meeting if requested at least 15 days prior to meeting. Contact the DIA office to indicate your needs.

• Sep 16 2010 10:00AM - Sep 30 2010 12:00PM