Course offering number:0903-701
Course ID:
2250
Effective Clinical Data Acceptance Testing
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This course is intended for anyone directly or indirectly responsible for the creation, content or validation of summary data sets, 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.
• SAS Statistical Programmers
• Quality Assurance Specialists
• SAS Statistical Managers
• Medical Writers
• Statisticians
• Regulatory Affairs Associates
• Clinical Data Managers
• Directors of Statistical Programming
• CRO's
• Health Care Professionals
• Research University Professionals
Description
This intense 90-minute accredited online course focuses on isolating and cleaning data issues to assure that correct, consistent and reliable
analysis data sets 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 are included in the course.
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
Question and Answer Session