This Webinar will address the importance of understanding the Statistical Analysis Plan (SAP). We will explore how the SAP affects data collection, data validation and data processing. Familiarity with the SAP helps data managers better attend to data management activities. From study design though Database Lock (and Unlock), understanding the importance of the proper data collection and processing is vital to the study analysis.
The randomization mystery will be solved by providing an overview of what randomization schemes are all about, and how they affect the work of the Data Manager. Merely deciding on a method of randomization in a study is insufficient. It is also important for the study team to follow SOPs guiding the process to ensure its appropriate implementation.
- Interpret both the Protocol and Statistical Analysis Plan content, as they are related to study design and data collection
- Describe randomization schemes and their importance to trial design
- Understand Data Management involvement in study design for effective randomization
Who Should Attend:
Beginners and Intermediate; and those eager to learn more about the mystery of Randomization and Statistical Analysis Plans.
Participants will benefit from attending this webinar, by learning how to work with their Statisticians, to ensure that the data collected is the data needed to prove Safety and/or Efficacy
Meet the Instructors
Maxine Pestronk, MS,RD,LDN,CCDM - Founder & CEO Passion for Clinical Data Management
Maxine has been in the Clinical Trial industry since 1993. Having worked for Contract Research Organizations, EDC Software, Pharmaceutical and Biotechnology companies, Ms. Pestronk has an array of experiences in the field of Clinical Data Management. Many of Maxine's years in the industry were in roles related to training of data managers; reengineering process for conducting studies using EDC systems; and demonstrating the usefulness of quality metric programs. Maxine has been a member of the SCDM Education Committee since 2009, has authored 5 online courses and 4 Webinars.
Ms. Pestronk has a Master of Science in Computer Information Systems, is a Licensed and Registered Dietitian (RD / LDN) and is proud to be a Certified Clinical Data Manager (CCDM®).
Farida Dabouz, PhD. CCRP, is the president of FB2D Clinical Research Consulting Inc., a consulting company.
Over the course of her multi-faceted 23 year career, she has worked in international pharmaceutical companies, CROs as well as academic international oncology group, in Europe and Canada. She has experience in the field of biostatistics, data management and medical writing as well as process improvement (quality assurance), applied in a vast array of therapeutics areas from Phase II to Phase IV, and observational studies.
Dr. Dabouz has a strong experience in training investigators, study coordinators, nurses, project managers, CRAs, administrative assistants, QA and data managers, IT, as well as statisticians covering all data aspects, mainly demystifying statistics in clinical trials.
Dr Dabouz has a PhD in statistics and certified SOCRA. This certification allows being closer to clinical sites and working with investigators’ teams in improving data quality/integrity at the source.
Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.
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