Processing Lab Data

Online course runs April 30 - May 26

 

 

 

 


View the 30-minute course information session where course instructor Petrolene Le Roux, course designer Carrianne Hayslett, Sharon Kayne Chaplock and Amanda Knack discuss course objectives, expectations and structure.

 

 

Overview

This 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.

This course is intended for intermediate/advanced CDMs.

 

What You'll Learn

Module 1

  • Identify reference ranges/LNRs for labs relevant to study
  • List commonly measured lab parameters
  • Describe attributes that may affect normal ranges (age, exercise, etc.)
  • Compare central and local labs

Module 2

  • Examine the fundamentals of management of local laboratory data including the specification and checking of normal ranges and units and QC of ranges and units against listings from the patient database
  • Develop data base specifications, collecting, processing and reporting for lab data
  • Generate standard reports of missing local laboratory data from the patient database
  • Define the types of edit checks against the data

Module 3

  • Identify when normal range should be updated
  • Identify different types of lab tests and units appropriate to those tests
  • Manage lab unit conversions
  • Identify and follow appropriate process to obtain missing lab range data

Module 4

  • Review your understanding of managing lab data to determine leaps and gaps in learning
  • Examine organization-specifc finalization processes and compare industry-wide finalization practices to develop a lab data finalization checklist
  • Apply the lab data finalization checklist to a study status scenario to access the viability of the checklist as a lab data finalization tool

 

Meet the Instructor

Based in Bloemfontein, South Africa, Petrolene le Roux joined Quintiles 9 years ago with over 12 years of experience in the clinical field.  She graduated from the University of the Free State with a Nursing Degree and started her career as a Registered Nurse in a Trauma Unit with significant experience in advance trauma life support and cardiac life support.  During this time, she completed the ACLS from the American Heart Association, Post-Basic Certificate Course in Pharmacology and MBA with electives in Risk Management, Project Management, New Venture, Research Methodology at the University of the Free State.  She is a Certified Clinical Data Manager and currently has operational project management responsibilities for projects ranging from mega trials to FSPs (functional outsourcing projects) for Quintiles.

 

Course Tuition
$850 members/$950 nonmember
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.