ACRP 2017 Meeting & Expo

15-5 - A Quick Guide to Managing and Monitoring IVD Studies

May 1, 2017 3:45pm ‐ May 1, 2017 4:45pm

Expiration Date: May 2, 2020


Credits: None available.

Standard: $75.00
Members: $25.00

Description

How well a study is conducted determines whether the application for market approval of the new device is successful. Thus, it is crucial to know the appropriate processes to utilize while conducting in vitro diagnostic product, or IVD, clinical trials to ensure compliance with regulatory requirements. This session explores the technical and logistical considerations critical to conducting IVD studies and helps you assess the factors that impact the generation of quality data.

Learning Objectives:

  1. Outline the technical and logistical considerations that are critical to conducting IVD studies
  2. Discuss the sponsor perspective from investigational device production to study execution
  3. Discuss the site perspective from execution to study close-out

Speaker(s):

  • Romiya Barry, M.Sc., Translational Health Scientist, Angiodynamics, Inc
  • Ann Hou, Clinical Research Associate II Clinical Operations, Alere San Diego

Credits Available


A Quick Guide to Managing and Monitoring IVD Studies Exam

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