Database Lock and Randomization

Course runs October 1 - 26

Overview
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.  

The randomization mystery will also be solved with the understanding of what randomization schemes are all about.

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-  Understanding Randomization and Blinding

Meet the Instructor
Maxine Pestronk has been in the Pharmaceutical/Biotech industry since 1993. Having worked for CROs, software, pharmaceutical and biotech companies, Ms. Pestronk has an array of experiences in the implementation and use of metrics via old and new technologies; as well as some eclectic experiences closing out studies. Several of Maxine's years in the industry were in roles related to training of data managers. Most recently, she has been working with data management groups in small to mid-size biotechs to review and reengineer their process for conducting studies using EDC systems. Ms. Pestronk has a Master of Science in Computer Information Systems and is proud to be a Certified Clinical Data Manager (CCDM®).

Course Tuition
SCDM members: $850/ Non-members: $950
Group rates available.  Please contact info@scdm.org for more information.

Earn CEUs
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.