Why Should You Attend:
This course is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC 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 Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this unique course. Effective and practical solutions to address real-world issues will be provided.
CDISC requirements to create SDTMs and ADaMs are not easy to understand or apply. There are many rules and standards that must be mastered and maintained across global studies. Pharmaceutical companies and CROs supporting global studies have a need to apply proven methods that reduce confusion and improve documentation. With new members joining the study team, there should be a system to help standardize and automate the FDA submission process. SDTM QC
Seasoned SAS programmers know how to leverage SAS for data science applications by taking advantage of metadata and SAS macro programming. Accessing metadata of datasets and SAS programs to automate and standardize processing of multiple files can be achieved without manual efforts. Combined with SAS macro programming, automation allows for more robust and advanced programming techniques to handle messy data as well as unexpected changes in data input. In a dynamic environment, this helps to assure confidence in processing large number and amount of data to convert data into meaningful information and action items.
Data Transfer Compliance
Since data is constantly transferred from vendors with different schedules based on the type of data, organizations must be proactive to control the acceptance of each data transfer. With each data transfer, organizations must be confident that all data received is correct by confirming full scope of all variables, attributes and records against the data transfer specifications. Often, missing variables or data truncation can occur due to faulty coding or values being set to missing.
The examples in this presentation are essential clinical data metadata for effective data transfers. The dictionary datasets, TABLES and COLUMNS, contain much of this information and can easily be accessed. Any metadata information outside of TABLES and COLUMNS data sets can be created as customized checks using SAS.
Upon completion of this training, you will be able to:
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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.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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