2006 SCDM Spring Tutorial

The site for the 2006 Spring Tutorial is the Washington Duke Inn & Golf Club. The Inn is located near the world famous Duke University Medical Center and just 15 minutes from Research Triangle Park and 20 minutes from Raleigh-Durham International Airport.

Database Archiving
March 19, 2006 at 1:00-5:00 PM EST

Presenter:
Curtis Campbell, CCDM
Duke Clinical Research Institute

Course Description
This training course provides a detailed discussion of the regulations, common practices and implementation considerations applicable to archiving Clinical Data Management documents. The instructor will identify minimum data management retention requirements for various organizations and trials, plus any differences at the document level of detail. The pertinent references of what should be retained and the record of retention timeframe related to the CFR and ICH regulations will be discussed. The contribution of data management documentation to a regulatory submission will be covered. For those attendees implementing archiving strategies, or evaluating their own practices, this course will highlight archiving cost considerations and a risk/benefit profile of those processes.

Recognizing the many ways organizations meet archival requirements, this course will include exercises and facilitated discussions using a fully developed training study. These discussions will highlight implementation practices during the lifecycle of a study to help the archival process run smoothly.

Participants completing the training should accomplish the following objectives:

• List the regulations that apply to records retention for clinical investigational sites, data coordinating centers and Sponsors for drug, biologic, and device trials
• Recognize requirement differences in pre and post marketing under both FDA and NIH regulations
• List the minimum document set required and the minimum records retention period
• Describe difference between electronic and paper archival requirements
• Outline a Clinical Data Management archival plan, and
• Discuss implementation options

Who should attend: The Database Achieve course is recommended for lead clinical trial data managers, project managers, those interested in QC and QA, statisticians with data management responsibilities or curiosity, those in clinical trial and registry, as well as those involved in clinical informatics in a research organization, and clinical research associates

Database Lock
March 20, 2006 at 8:00 AM-12:00 PM EST

Presenter:
Brian McCourt, CCDM
Duke Clinical Research Institute

Course Description The database lock milestone represents the culmination of months, more often years, of hard work and preparation; however, answering the question 'Will we be ready to lock?' isn't easy. This training course covers both the development of database lock requirements and strategies for smoothly reaching that milestone.

With a focus on understanding the end uses of a dataset the instructor will outline considerations for building a set of database lock requirements which represent all the data sources and contributing processes. Discussion on the lock requirements will include the importance of setting the acceptable threshold for considering the criteria accomplished - for example amount of outstanding data, number of patients with incomplete duration of follow-up, or status of reconciliation with overlapping datasets. The complexities of many data sources, stakeholders, and collaborative organizations will be addressed. Regulatory considerations will be reviewed. Additionally, workflow to support the defined requirements, for example 'freezing' patients, will be covered along with the tasks to remove user privileges and capturing the appropriate database lock documentation.

Participants completing the training should accomplish the following objectives:

• Identify database lock requirements for a clinical trial
• Discuss setting acceptance criteria for each required task
• Outline a decision making process to quickly move issues to completion and determine when a database is ready to be locked
• Define the documentation that is associated with lock tasks

Who should attend: Lead clinical trial data managers, programmers, clinical research associates, those interested in QC and QA, statisticians with data management resp. or curiosity, clinical trial and registry, clinical informatics in a research organization, project mangers and clinical research associates, programmers.

Registration Fee Information (Registration Deadline: March 10, 2006)

	(Postmarked or emailed by Feb. 24)	(Postmarked or emailed after Feb. 24 and on or before Mar. 10)
Member Price:
March 19, 2006 - Database Archiving	$395.00	$420.00
March 20, 2006 - Database Lock	$395.00	$420.00
Non-Member Price:
March 19, 2006 - Database Archiving	$420.00	$445.00
March 20, 2006 - Database Lock	$420.00	$445.00

Accommodations:
Rooms at the Washington Duke Inn are being held at a single or double rate of $169.00 per room per night. To reserve your room please call (800) 443-3853. In order to guarantee that space is available you must book your room by February 24, 2006.

Address:
3001 Cameron Blvd.
Durham, NC 27705
Telephone: (919) 490-0999
Fax: (919) 313-2164
www.washingtondukeinn.com

Cancellation Policy:
Registration may be cancelled and a refund received (minus a $25 cancellation processing fee), provided cancellation is received by SCDM at least 24 hours prior to program date. No refunds will be provided after this date, SCDM reserves the right to cancel any program at its sole discretion, whereupon all registration fees will be refunded.