Electronic data capture (EDC) is being utilized as a preferred method for “real time” data capture for sponsors of clinical trials. This webinar will review the considerations for selecting an EDC system; evaluation of systems, user requirements, process change and implementation of systems, so that the needs and requirements are identified to ensure a comprehensive study application. Multiple roles on study teams use the EDC system and should be involved in software selection.
- Determine business needs regarding an EDC system
- Identify the method of delivery required and ensure that internal/external skills are present to support the system and application (study)
- Identify any industry or company standards that must be followed
- Determine data flow and identify which data can be collected electronically (eSource).
- Prepare a thorough Scope of Work (SOW) to ensure that Sponsor/EDC Vendor have a full understanding of expectations/deliverables
- Ensure that complete Software Development Life Cycle (SDLC) principles are performed/documented for the system
This webinar is aimed at all clinical data managaers that are investigating the identification, availability and attributes of selecting an EDC system for their company.
Maxine Pestronk, MS, RD, LDN, CCDM - Founder & CEO Passion for Clinical Data Management
Maxine 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 Education Committee since 2009, has authored 6 online courses and 5 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®)!
Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assesment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.