An electronic data capture (EDC) system is software that’s used to electronically collect, manage, store, and export data for the clinical investigations which are critical to support safety and effectiveness claims for drugs, devices, and diagnostic tests. Most EDC systems can be customized to ensure data collection matches the product performance criteria, population characteristics, and statistical analysis plan for a product regulatory submission. This session will describe best practices and pitfalls to avoid when ensuring an EDC system is fit for each unique clinical investigation purpose. Let’s talk about the dos and don'ts and the collaborative sponsor/site/contract research organization approach to EDC validation to make sure we have a clean dataset with the most automated efficiencies and data mapping to scientific endpoints to achieve EDC that's fit for purpose every time.

CEU: 1.00 ACRP

Speaker:

• Patricia Smith, Senior Clinical Data Manager, NAMSA

Related Resource:

The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.