Draft qualification opinion on Proactive in chronic obstructive pulmonary disease (COPD)

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Download document Draft qualification opinion on Proactive in chronic obstructive pulmonary disease (COPD)
Reference number EMA/810227/2017
Status draft: consultation open
First published 2017-12-20
Last updated 2017-12-20
Consultation start date 2017-12-20
Consultation end date 2018-01-29
Email address for submissions qualification@ema.europa.eu

Summary

Under the Innovative Medicines Initiative Joint-Undertaking (IMI-JU) framework, the public-private PROactive Consortium developed two Patient Reported Outcome (PRO) instruments to capture physical activity (PA) data in patients with Chronic Obstructive Pulmonary Disease (COPD) in clinical trial settings. One of those tools is the D-PPAC which is supposed to enable daily data collection (recall period of 1 day).