Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.Clinical data management (CDM) is paramount for a successful research. After all, Garbage In, Garbage Out (GIGO).
CDM involves all aspects of collecting, processing, and interpreting information. There are many types of computer applications and database systems to support data collection and management. However, there are elements of
CDM that apply across the board.
Review and approval of drugs or devices by regulatory agencies requires the assumption that the data presented are valid and reliable. Integrity of the data is paramount to ensure confidence in the results and conclusions you will make.
This seminar is based on FDA E6 GCP Guidelines which are the basis of effective data quality management. Even if your research is not FDA regulated, the information you learn in this course will help to ensure a robust data collection and management plan.
The information conveyed in this course will also assist investigators in setting up processes for smoother data monitoring and auditing.
Examples of CRF's and required documentation will be presented. Data collection and preparation techniques will also be demonstrated. Additionally, this workshop will provide you with the knowledge and tools needed to assure a
CDM plan that holds up when the inevitable deviations from protocol occur.
Disclaimer: This seminar is not endorsed by, directly affiliated with, maintained, authorized, or sponsored by the Society for
Clinical Data Management or any other clinical research society. All products, processes, and company names are the registered trademarks of their original owners. The use of any trade name or trademark is for identification and reference purposes only and does not imply any association with the trademark holder of their brand.
Learning Objectives:
- Regulatory guidelines for Clinical Data Management
- Best practices for data collection
- CDISC/CDASH/STDM standards
- Responsibilities of personnel
- Case report form criteria
- Maintaining confidentiality of data
- Data storage and transferability
- Data preparation and quality assurance for accuracy
- Data monitoring plan criteria
- Data systems validation
- Adverse event reporting and coding criteria
- What to expect on a monitoring visit
- Troubleshooting and resolution of deviations from plan
Who will Benefit:
- Study Investigators
- Data managers
- Data processors
- Statisticians
- Site Personnel
- Clinical Research Associates
- Clinical Project Managers/Leaders
- Study Sponsors
- Professionals in pharmaceutical, medical device, clinical and biotechnology research who oversee or work with data collection and management
- Staff in the above fields who work with data collection/management and require training in CDM.
- Compliance auditors and regulatory professionals who require a knowledge of CDM in assessment of study protocols and reports
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:
Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation - the same as you would get in an in-person seminar
- Opportunities to connect with your peers to share knowledge at a different time and have group discussions
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- As usual more content, activities and case studies and now adding homework for a comprehensive understanding
- Certification
Elaine Eisenbeisz, Owner, Omega Statistics
Elaine Eisenbeisz is a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California. Elaine has over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations, to start-up companies and individual researchers.
Elaine’s love of numbers began in elementary school where she placed in regional and statewide mathematics competitions. She attended University of California, Riverside, as a National Science Foundation scholar, where she earned a B.S. in Statistics with a minor in Quantitative Management, Accounting. Elaine received her Master’s Certification in Applied Statistcs from Texas A&M, and is currently finishing her graduate studies at Rochester Institute of Technology. Elaine is a member in good standing with the American Statistical Association as well as many other professional organizations. She is also a member of the Mensa High IQ Society. Omega Statistics holds an A+ rating with the Better Business Bureau.
Elaine has designed the methodology for numerous studies in the clinical, biotech, and health care fields. She currently is an investigator on approximately 10 proton therapy clinical trials for Proton Collaborative Group, based in Illinois. She also designs and analyzes studies as a contract statistician for nutriceutical and fitness studies with QPS, a CRO based in Delaware. Elaine has also worked as a contract statistician with numerous private researchers and biotech start-ups as well as with larger companies such as Allergan and Rio Tinto Minerals. Not only is Elaine well versed in statistical methodology and analysis, she works well with project teams. Throughout her tenure as a private practice statistician, she has published work with researchers and colleagues in peer-reviewed journals. Please visit the Omega Statistics website at www.OmegaStatistics.com to learn more about Elaine and Omega Statistics.
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