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      Clinical Data Management (CDM): 2-Day In-Person Seminar in Houston

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      January 17, 2019

      Thursday   8:30 AM

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      Clinical Data Management (CDM): 2-Day In-Person Seminar

      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. Learning Objectives: Regulatory guidelines for Clinical Data Management Best practices for data collection 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 Speaker: Elaine EisenbeiszOwner, 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. For More Info:

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