$999 – $1,499

Good Clinical Data Management Practices (GCDMP): 2-Day In-Person Seminar

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Sydney

Sydney, NSW 2000

Australia

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Description

Good clinical data management (CDM) is paramount for a successful research. After all, Garbage In, Garbage Out (GIGO).

CDM is involved in 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 Good Clinical Practice 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 cleaning techniques will also be demonstrated. Additionally, this workshop will provide you with the knowledge and tools needed to assure GCDMP’s that hold up when the inevitable deviations from protocol occur.

Learning Objectives:

  • Brief detail about Good Clinical Data Management Practices (GCDMP)
  • 21 CFR Parts 11, 312.62, 812.140
  • NIH Policy (SOP 15, 17, 19)
  • Data Management Plan
  • Data privacy, Data Collection, Data Quality and Data Review

Who will Benefit:

Professionals in pharmaceutical, nutraceutical, medical device, clinical and biotechnology research who oversee or work with data collection and management will be benefited by this seminar.

  • Study Investigators
  • Data managers
  • Data processors
  • Statisticians
  • Site Personnel
  • Clinical Research Associates
  • Clinical Project Managers/Leaders
  • Study Sponsors
  • Clinical Research Organizations
  • Clinical and Biotech Start-ups
  • Individual researchers in health and biotech fields.
  • Study Investigators
  • Medical and Health Sciences
  • Clinical Trials
  • Clinical Research
  • Physicians
  • Medical Students
  • Graduate Students in the Biological Sciences
  • Researchers
  • Staff in the above fields who work with data collection/management and require training in GCDMP
  • Compliance auditors and regulatory professionals who require a knowledge of GCDMP in assessment of study protocols and reports

Speaker:

Elaine Eisenbeisz

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.


For More Info:

https://www.complianceonline.com/good-clinical-data-management-practices-gcdmp-sydney-seminar-training-80551SEM-prdsm?channel=eventbrite


Note: Use coupon code < REFERRAL10 > and get 10% off on registration.

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Sydney

Sydney, NSW 2000

Australia

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