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Selecting and Implementing Electronic Data Capture (EDC1) - 2022



Selecting and Implementing Electronic Data Capture (EDC1)

July 4 - July 31

  • Orientation Session: June 28
  • Pre-Course Activities: July 1 - 3

Overview
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.

Who should attend
This course is relevant to 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 .

Meet the Instructor 
Farida Dabouz, PhD. CCRP
President, FB2D Clinical Research Consulting Inc.

Over the course of her multi-faceted 23 year career, Farida has worked in international pharmaceutical companies, CROs as well as academic international oncology group, in Europe and Canada. She has experience in the field of biostatistics, data management and medical writing as well as process improvement (quality assurance), applied in a vast array of therapeutics areas from Phase II to Phase IV, and observational studies.
Dr. Dabouz has a strong experience in training investigators, study coordinators, nurses, project managers, CRAs, administrative assistants, QA and data managers, IT, as well as statisticians covering all data aspects, mainly demystifying statistics in clinical trials. Dr Dabouz has a PhD in statistics and certified SOCRA. This certification allows being closer to clinical sites and working with investigators’ teams in improving data quality/integrity at the source.

Course Tuition
$1020 for Members / $1140 for 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.

Earn CEUs
Participants are eligible to receive CEUs upon successful completion of the course.
SCDM is authorized by IACET to offer 4.0 CEUs for this program.

Need Support?
Technical support:
Click on the help button on the bottom right, select contact support and email the Bluesky team with any technical issues.
Otherwise e-mail directly to support@blueskyelearn.com or call +1-888-705-6002 for immediate help.
General support:
The SCDM Learning team is here to help. Contact us at learning@scdm.org or call +32 232 024 87