Post-Conference Workshop

Thursday December 10 2009

CDISC CDASH standards are set to shape the future of data management as the industry moves towards a more consistent approach to managing the vast amount of data generated during a trial. However developing an effective implementation strategy that incorporates in-house processes is a huge challenge.

Through a combination of lectures and hands-on exercises, this workshop will provide an interactive environment for you to discuss the various challenges of implementation. Attendees are encouraged to bring a sample Concomitant Medications CRF and the associated database structure in order to conduct a real mapping exercise. The workshop is intended to enable practitioners to share experiences with peers on how best to move forward in making processes fit the CDASH model and speed up data submissions.

Students will receive:

1. Slide deck of the presentation materials
2. Tools for performing the mappings

Workshop learning objectives:

1. Understand the content of CDASH
2. Understand the data structure philosophies behind the standard
3. Learn how to map CDASH into SDTM, including each field existing in CDASH and not in SDTM
4. Learn how to map sponsor CRFs into CDASH with results that are both CDASH and SDTM conforming

Registration

An overview of CDISC CDASH standards - The relationship between CDASH and SDTM

How to map from CDASH to SDTM – Session One

Refreshments

How to map from CDASH to SDTM – Session Two

Kit Howard has 25 years of experience in the industry, and extensive experience in the design, implementation and maintenance of cross-functional clinical data standards.  She is a member of the CDASH Core management team, the CDISC Devices team, and the CDASH ODM development team, and is a long-term member of the Society for Clinical Data Management’s Editorial Board.  She has spoken and published extensively on topics related to standards and data quality, and is passionate about the potential for standards to revolutionize the way we bring treatments to patients.

Kestrel was established in 2003, and specializes in clinical data standardization and clinical data quality.  With a select network of consultants, Kestrel provides both consulting and educational services to the biopharma and medical devices industries, especially in the area of CDASH implementation.
www.kestrelconsultants.com

Dorothy Dorotheo has over 27 years of clinical development experience including clinical and data management, project management, CRO outsourcing and oversight. She has extensive experience in spearheading the establishment of company standard data collection instruments through creation, implementation and maintenance.

Dorothy is a member the CDASH Core management team, leading one of the first CDASH domain streams, Prior and Concomitant Medication domain as well as the CDASH ODM development team. She is a certified clinical data manager (CCDM). Over the years, she has acquired additional training in clinical trial management, CDISC (SDTM & ODM), GCP, document management, project management, eCTD submission, communications and other clinical development related topics. Dorothy is a member of DIA and SCDM.
www.intermune.com