Here's a great opportunity to learn CDISC from CDISC at Public Courses being held in Audubon, Pennsylvania at Bioclinica's eHealth Headquarters on March 2-12. (Other dates and locations are available).
Why take CDISC Training?
As the pharmaceutical industry uses CDISC standards to represent clinical data, this is great foundational training to have under your belt. Having a good grasp of the CDISC standards and how they apply to the collection and submission of clinical data is beneficial to anyone involved with clinical data - especially data managers, programmers, biostatisticians and clinical operations folks.
The best way to learn about CDISC standards, and how they to apply to your situation, is to attend a CDISC training session. The training team travels all over the world providing in-person sessions by qualified industry professionals vetted by CDISC. These individuals have extensive real-world experience implementing these standards. Many of the instructors served as volunteers on teams that developed them, providing you with a wealth of knowledge.
CDISC Public Courses Content
CDISC holds Public Courses in several topical areas, including:
CDASH - Clinical Data Acquisitions Standards Harmonization training focuses on building the skills for specifications and design of data collection forms and domains. Participants learn:
- What data to collect on each form
- What to call back-end variables
- How to define the variables for CRF data with standard question text, implementation guidelines, and best practices
ADaM - Analysis Data Model training teaches the fundamental principles and standards for representing analysis datasets and metadata. This training shows:
- How analysis datasets should be structured
- What variable names should be used for derived analysis variables
SDTM - Study Data Tabulation Model – In this training, participants learn the model for representing study tabulation data in clinical research, which is the standard the FDA is requiring for all future submissions. In this training, participants will learn:
- How to format data submitted to the FDA and the structure
- Define-XML Schema specification based on ODM to describe metadata for SDTM, SEND and ADaM submission datasets
- How the details around the type of data being submitted to the agency needs to be defined
Controlled Terminology – This training focuses on understanding the options to address clinical data questions such as:
- How is 'Severity' defined?
- How is 'Outcome' defined?
- How do I know which choices to present on the collection forms
- And more
Top three take-a-ways
As a data professional and big proponent of the standards, here are my top three training take-a-ways:
- How to use the CDISC fundamentals to apply the standard to your clinical data using real-world examples.
- Best practice implementation strategies from the Implementation guideline on using the standards in new programs and legacy studies.
- Meeting other industry professionals whom you can reach out to later and bounce off questions, ideas, and successes!
Learn CDISC from CDISC!
CDISC Education is globally recognized as the only authorized provider of training on the CDISC standards. Adding a CDISC Education certificate to your resume will help with career advancement. CDISC standards are in especially high demand in 2016 as both the FDA and PMDA are requiring the use of SDTM, ADaM, Controlled Terminology and Define-XML in submissions. After taking training, many people get involved with CDISC as volunteers. Some even become sought-after industry experts. Will you be the next to join the ranks?
CDISC offers Public Courses in Audubon, Pennsylvania from March 2-12 at Bioclinica's eHealth Solutions global headquarters, located at 800 Adams Avenue.
To learn more about available CDISC education, the training schedule, or to register for the Public Courses in Audubon or other locations, please visit http://cdisc.org/public-courses.
I hope to see you at the CDISC training being hosted at Bioclinica in Audubon!