Managing Clinical Trials Utilizing Electronic Data Capture (EDC)
Course Dates: April 01 – 28
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The course will address study conduct utilizing Electronic Data Captures (EDC) systems, whether managed directly by a sponsor, with an EDC vendor, or through a Contract Research Organization (CRO). Concepts related to the EDC system, the EDC study application, user roles, responsibilities and training as well as regulatory requirements for change management will be addressed. A sample protocol will provide application of learning to real world situations.
Over four weeks, the course will address general principles, best practice and issues that will allow a Data Manager to work collaboratively and communicate effectively with appropriate team members during study conduct. Topics will include user management, training compliance and regulatory considerations for working in an electronic environment. Participants will gain an understanding of necessary Software Development Life Cycle (SDLC) documentation for EDC system updates, as well as mid-study updates for the EDC study application. Considerations for 'faster to lock" will be introduced to take advantage of EDC process.
What You'll Learn
Participants completing the training should be able to accomplish the following objectives:
- Define EDC workflow, change management, and documentation unique to EDC
- Describe best practice for proactively validating data to achieve faster DB Lock
- Author test scripts needed for Validation and change control
- Compare criteria for EDC system management verses EDC study management
This course addresses competencies tested in the CCDM® exam under the EDC domain.
CDMs and others involved in study conduct that will be or are currently responsible for conducting clinical trials utilizing EDC.
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 managing clinical trials utilizing EDC,
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
Maxine Pestronk has been in the Clinical Trial industry since 1993. Having worked for Contract Research Organizations, EDC Software, Pharmaceutical and Biotechnology companies, Ms. Pestronk has an array of experiences in the field of Clinical Data Management. Many of Maxine's years in the industry were in roles related to training of data managers; reengineering process for conducting studies using EDC systems; and demonstrating the usefulness of quality metric programs. Maxine has been a member of the SCDM Online Courses Committee since 2009, has authored 5 online courses and 2 Webinars.
Ms. Pestronk has a Master of Science in Computer Information Systems, is a Licensed and Registered Dietitian (RD / LDN) and is proud to be a Certified Clinical Data Manager (CCDM®).
$850 members/$950 non-members
Group rates available. Please contact firstname.lastname@example.org for more information.
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.