This course is part of the EDC Course Series. Benefit from a 20% discount on course fees by booking 2 out of 3 EDC courses.
July 31 - August 27, 2017
This four-week asynchronous course combines self-study and instructor-led lessons. Participants complete one module per week, moving through the course as a group, including contribution to asynchronous discussions. Projects have deadlines according to a predetermined schedule. An orientation will be held via webcast in advance to discuss technology needs and course expectations.
What You'll Learn
The objective of this program is to reinforce those data management tasks that are required for the final preparation of the database release for analysis. What are the steps necessary to ensure a documented process for locking? Who are the key stakeholders and their responsibilities? We will discuss the answers to these questions and explore the logical progression of those steps to arrive at database lock and ensure proper documentation.
This four-week program will cover some of the most important data management processes that culminate in the final deliverables for the discipline.
Module 1 - Laying the Foundation for the Process of Database Lock
Module 2 - Locking the Database
Module 3 - Unlocking and Relocking the Database
Module 4- Assuring Regulatory Compliance for Quality Data and the Lock Process
Who should attend
Experienced data managers with in-depth knowledge of the majority of data management and related processes. The course will focus on the foundational components of managing clinical trials utilizing EDC. Once enrolled, participants will need a computer with access to the Internet and the ability to print out course materials. Recommended time commitment is 8-10 hours per week to complete each module. Four modules will be offered; one module per week with discussions, activities and assignments required for each module.
Meet the Instructor
Joseph Fitzgerald works as a Manager, Oncology Data Management Operations at Novartis Pharmaceuticals Corporation. He started in the pharma industry in 1999 and is the instructor of the following SCDM Online Courses: Metrics and Identifying Data Trends; and Managing Clinical Trials Utilizing EDC (EDC2 and EDC3).
Joe is Chair of the SCDM Online Course Committee.
$1020 members/$1140 non-members
Refund Policy: 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 1.6 CEUs for this program.