This three-week course will focus on understanding the Randomization process and the Statistical Analysis Plan (SAP), as well as how they affect data management activities, such as collection/validation and data quality/integrity. Participants will explore how the SAP affects data collection and data validation. Together with the instructor, they will solve the randomization mystery through an overview of what randomization schemes are all about and how they effect the work of the Data Manager. Lastly, the course will review how EDC/CTMS databases can be integrated with Randomization systems. Throughout the course, the emphasis will be put on ensuring regulatory compliance, particularly by working with example situations that were not planned for.
What you will learn
By attending this SCDM Online Course, you will learn to:
• Understand the data related contents of a SAP, and the TFLs
• Identify the ways in which E9 Statistical Principles for Clinical Trials relate to clinical data management.
• Understand the Randomization process and the impact on data management activities
• Understand the regulatory requirements in terms of unblinding data.
Beginners to intermediate and/or advanced:
• Data managers and associate data managers
• And clinical research professionals who want to learn more about data processing from collection to analysis, to ensure data quality/integrity and compliance with study protocol as well as regulatory requirements.
Participants will get a better understanding of the randomization process as well as SAP. Demystifying SAP (and TFLs) will improve communications within study team and improve data quality/integrity.
Meet the Instructor
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.
$1020 members/$1140 non-member
Participants will receive a full refund if notice is provided in writing via post or email one week prior to the course start date. If cancellation occurs by the end of week one of the course, students will be allowed to apply 50% of the course fee to the next offering of the same course. No refunds will be offered after that time.
Participants are eligible to receive CEUs upon successful completion of the course.
SCDM is authorized by IACET to offer 1.2 CEUs for this program.