Effective CDISC Clinical Data Acceptance Testing and Compliance

Why Should You Attend:

This course will focus on isolating and cleaning data issues to assure that correct, consistent and reliable SDTMs and ADaMs are reproducible. Discussions will focus on proven techniques to address real-world issues. Get your SAS technical and validation questions answered and learn efficient tips for accepting and locking the clinical study data base in a timely manner. Selected edit check macros and acceptance testing guide will be included in the course.

Learning Objectives:

• Identify and prevent unexpected data issues.
• Apply proven strategies for effective communication and documentation of results and use methods to monitor improvements in data quality.
• Run SAS macros to display data values for clinical data and protocol issues.

Areas Covered in the Webinar:

Module 1: Analysis of clinical data issues

• Identifying and quantifying the impact of bad clinical data
• Establishing protocol criteria for clinical data acceptance testing
• Checking for data compliance at all three levels: general, CDISC domain, and study protocol specific

Module 2: Effective methods and SAS macros to identify data issues

• Developing and testing edit check macros
• Applying standard edit check macro parameters

Module 3: Communicating and monitoring improvements in clinical data issues

• Timely and effective communication of results with clinical data management
• Managing metrics on clinical data acceptance testing for quicker data base lock

Who Will Benefit:

This course is intended for anyone directly or indirectly responsible for the creation, content or validation of SDTMs, ADaMs, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be 21 CFR Part 11 compliant in relation to the SAS programming environment will benefit from this unique course. Effective and practical solutions to address real-world issues will be provided. This course is recommended for:

• SAS Statistical Programmers
• Quality Assurance Specialists
• SAS Statistical Managers
• Medical Writers
• Statisticians
• Regulatory Affairs Associates
• Clinical Data Managers
• Directors, Statistical Programming
• CRO Professionals
• Health Care Professionals
• Research University Specialists

Instructor Profile:

Sunil Gupta is an international speaker, best-selling SAS author, and a global corporate trainer. He is the principal SAS/CDISC consultant at Gupta Programming since 1994. Most recently, he taught both of his CDISC online classes with the University of California at San Diego and SAS Institute India. Mr. Gupta will start to teach the new Sharpening Your SAS Skills online class for UCLA Extension in 2016. In 2011, he launched his unique SAS resource blog, SASSavvy.com, for smarter SAS searches. Currently, SAS Savvy’s membership consists mostly of SAS programmers, university students and pharmaceutical corporate accounts.

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