The course will address evaluation of systems, user requirements, and process change and implementation of systems, as well as training. A sample protocol will provide application of learning to real world situations.
Over four weeks, this course will address general principles, best practice and issues to consider for choosing and implementing an EDC platform. The focus will be on the choices required to meet the business needs of an organization, whether using EDC as a sponsor directly with an EDC vendor or a sponsor partnered with a CRO.
Topics will include designing the application to interface with other data components such as ePRO, IVRS and Central Labs. Participants will gain insightful examples of how to perform and document UAT; set up EDC users, roles and permissions; and to comply with regulations that affect data collection in an electronic format. Collaboration and communication with appropriate team members during all phases of clinical trials will be highlighted.
What You’ll Learn
Participants completing the training should be able to accomplish the following objectives:
- Identify business needs related to implementing an EDC system for a study and/or program
- Create (or give guidance for implementing) necessary features of an EDC system
- Understand data specifications unique to EDC
- Discuss the impact of EDC on existing DM processes and data collection tools
- Associate the information for full system implementation and documentation
- This course addresses competencies tested in the CCDM® exam under the EDC domain.
All CDMs that are investigating the identification, availability and attributes of selecting an EDC system for their company.
Participants should be experienced data managers who have in-depth knowledge of the majority of data management and related processes. The course will focus on the foundational components of evaluating and developing the requirements, vendor selection and implementation of EDC systems for clinical trials databases. 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
Denise Redkar-Brown is the Principal at Sunburst Clinical Solutions dedicated to consultation in the area of Clinical Data Management training and auditing capabilities. Her last assignment in the corporate area was as Director of Scientific Affairs, Data Management at Cetero Research in Fargo, North Dakota. She is also a frequent contributor to the GCDMP and chairs SCDM's sub-taskforce on Electronic Learning. Denise began her career as a Medical Technologist working in a hospital laboratory environment. She made the transition to the pharmaceutical industry, and after more than 20 years, she has held positions in basic and clinical research. She is published in the European Journal of Pharmacology for her work in Pharmacology while at AstraZeneca and contributed to the successful submission for Accolate®, the first leukotriene antagonist for asthma therapy as well as other drugs and vaccines. Her latest publication was in the Good Clinical Practices journal (GCPj) in 2008 describing the evolving role of Clinical Data Managers.
$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.