Survey to Measure the effectiveness of the Mycamine Prescriber Checklist in the European Union

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/19727
• EU PAS number:
  EUPAS13634
• Study ID:
  19727
• Official title and acronym:
  Survey to Measure the effectiveness of the Mycamine Prescriber Checklist in the European Union
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  France

  Germany

  Greece

  Italy

  Poland

  Spain

  United Kingdom
• Study description:
  This online survey aims to check the effectiveness of the Mycamine prescriber checklist on the prescribing of the product, and is a repeat of the study conducted in 2013. The first survey was conducted in 2013, and its protocol was agreed upon with the EMA in January 2013 (EMA/47969/2013). Astellas and EMA agreed on 23 July 2015 (EMEA/H/C/000734/II/0026) to repeat the survey using the same protocol.
• Study status:
  Finalised

Research institutions and networks

Institutions

GfK Health

Study timelines

Date when funding contract was signed

Planned: 25/01/2016

Actual: 25/01/2016

Study start date

Planned: 29/02/2016

Actual: 14/03/2016

Date of final study report

Planned: 29/07/2016

Actual: 08/06/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)