HASUG MEETING ANNOUNCEMENT AND DIRECTIONS
Our next meeting is Thursday, February 14th, 2013 at
The Hartford Main Office
One Hartford Plaza
Hartford, Connecticut 06155 from 9:00am to noon
Refreshments to be served, and time for conversation, beginning at 8:30 AM
NOTE: The Hartford security requires that every attendee must RSVP with a response by Feb 13th noon by using the Online HASUG Registration Form
Our Topics and Speakers will be:
Dropping Sparsely Populated Variables, Craig Dickstein, Tamarack Professional Services, LLC
In the Clinical trials data analysis and reporting work, though the Data Management works hard to ensure high quality data as per the Good Clinical Practices, data issues still can exist. The study programmers extract data for the study and checks for potential data issues to ensure the data integrity by executing edit check programs. This paper demonstrates how to effectively integrate all different edit checks into one output file. Also, this article talks about some important and very common edit checks. This paper incorporates the use of ODS tagset feature that is available in SAS® 9.1.3 and later versions.
Craig Dickstein, an independent Consultant, works with clients and select project teams to implement customized business solutions for the healthcare industry. He has significant past experience managing and developing SAS applications and has been a SAS user since 1978. With an MS in Statistics and meaningful work experience in medical research, health insurance, and large database structures, he adds value to the resolution of specific client business needs. Craig has a long history of SAS user group involvement as both an organizer and invited speaker.
Could Have, Would Have, Should Have! Adopting Good Programming Standards, Not Practices, to Survive An Audit.
Vincent J. Amoruccio, M.A., Alexion Pharmaceuticals, Inc., Cheshire, Connecticut
The primary purpose of a Pharmaceutical is to develop and market drugs which treat or prevent disease safely and efficaciously. A major step in the licensing of a drug, in particular in the United States, is the inevitable audit by the FDA. While the FDA suggests that adherence with Good Clinical Practices (“GCP”) is a critical requirement, it falls short in providing programming standards for the SAS® deliverables of a submission. SDTM and ADaM are solutions to standardizing the review of data, but not the programs themselves. The lack of regulations leaves programmers unmanaged and exposed to risk when asked to deliver SAS® Programs to the FDA during a submission. While many programmers are addressing this through groups, papers, websites, and blogs there are no formal Good
Programming Practices (“GPP”). Until there is, programmers must create, manage, and defend their own programming choices during an audit. It is not enough to establish programming „practices? since auditors only care about what was done rather than what could have, would have or should have been done. This paper will first discuss the importance for GPP and common practices appearing in current GPP discussions. It will then discuss the difference between practices and standards and suggest ways to select practices to manage as standards. It will suggest ways to check and document compliance with Good Programming Standards (“GPS”), not GPP, and prepare for a successful FDA Audit. Finally, it will end with a call to the FDA for established programming standards.
Vincent J. Amoruccio, Director of Clinical & Statistical Programming at Alexion Pharmaceuticals has experience providing direct project, team and staff oversight, a strong Senior Programming background, a Master’s Degree in Biostatistics, CDISC SDTM training and 8 solid years of SAS experience including SAS/BASE, SAS/ACCESS, SAS/MACRO, SAS/STAT, SAS/SQL and SAS/GRAPH. He is highly proficient in using SAS statistical procedures to produce tables, listings, figures, statistical analyses and modeling including simultaneous modeling of discrete and continuous variables. Also experienced in all aspects and phases (I-IV) of Clinical Trials, epidemiology studies and authoring parts of SAPs and SOPs. Therapeutic experience includes autism, cardiovascular, diabetes, gastrointestinal, infectious diseases, rare fatal diseases, obstetrics and gynecology, oncology and sexual
health.
Please register before 2/13/2013. Directions can be found on the HASUG website at www.hasug.org and the most current FLASH is available for your reading pleasure.
Look forward to seeing you at the meeting, and invite your SAS colleagues to join you at this meeting.
Hartford Area SAS User Group Steering Committee |
