Course runs June 12 - July 9, 2017
This 4-week course will focus on the local labs that may be captured via CRF that will involve the maintenance of laboratory normal ranges as well as the concept of conversion to Standard SI Units for data display. The QC/QA of these data and associated edit checks to ensure data integrity will also be addressed. The process of management of electronic data transfers from a Central Lab environment, reconciliation process and the technical aspects to prepare a Data Definition Document and Data Transfer Agreement will be included.
What you will learn
By the end of the course, participants should be able to:
- Identify different types of lab tests and units appropriate to those tests
- Identify reference ranges relevant to study, Describe attributes that may affect ranges and when they should be updated, Manage lab unit conversions
- Develop data base specifications (including edit checks), collecting, processing and reporting for lab data
- Identify and follow appropriate process to obtain missing lab range data, Generate standard reports of missing local laboratory data from the patient database, Compare central and local labs
Who Should Attend
Intermediate/advanced CDMs and others involved in study conduct that will be or are currently responsible for working with lab data. Participants should be experienced data managers who have in-depth knowledge of data management and related processes. The course will focus on the foundational components of managing lab data within a study.
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.
Meet the Instructor
Valerie Aybar is a Director of Data Management at INC Research. She has 13 years in pharmaceutical data management. In her work, Valerie manages teams of specialized lab data groups. She has hands on experience with lab data loading, normal ranges, lab slip entry, reconciling lab data. In addition, she is a subject matter expert in Oracle Clinical lab subsystem.
$1020 SCDM 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.