Course runs May 22 - June 18, 2017
This intermediate-level, four week online course is targeted at those directly involved in the oversight or hands-on management of EDC or paper CRF trials. The ability to identify value-added key performance indicators (KPIs) against goals and objectives provides a quantitative measurement when escalating issues or areas for process improvement. In many cases, existing primary data (e.g., audit trails, tracking systems) can be used to support metrics and identify trends that drive follow-up action. This course provides perspective to make the most of available data and best leverage this information for overall study management and issue escalation.
What You'll Learn
By the end of the Course, participants should be able to:
- Evaluate the company’s need to implement a metrics program for measuring the deliverables and performance of processes that are the primary responsibility of CDM
- Discuss appropriate CRF metrics for quantity, quality, time, and cost
- Recognize users and determine requirements for CRF traceability and reporting
- Explain relationships across data process flow and data status reporting
- Identify trends that may impact timelines or deliverables and initiate steps to resolve
- Determine how to watch data for safety or efficacy at aggregate and site levels
- Identify trends or outline values during the data validation process
This Course is aimed at project managers, program managers, and project team leaders.
Participants will need a computer with access to the Internet and the ability to print out course handouts. You will need an application to read PDFs. There are no course pre-requisites. Recommended time commitment is 9 hours per week to complete each module.
Meet the Instructor
Sonia M. Yanes, MAS, BAIS
Program Clinical Data Manager, Oncology Data Management, at Novartis Pharmaceuticals Corporation
Sonya has been working in the pharmaceutical industry for the last 18 years in the Data Management department. She has a Bachelor’s degree in business and a MAS Degree from Fairleigh Dickinson University.
Members $1020/ Non-members $1140
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.