Survey on the collection of data on adverse events related to medicinal products through registries

Study identification

• EU PAS number:
  EUPAS35474
• Study ID:
  37195
• Official title and acronym:
  Survey on the collection of data on adverse events related to medicinal products through registries
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Bulgaria

  Croatia

  Cyprus

  Denmark

  Estonia

  Finland

  France

  Germany

  Greece

  Hungary

  Iceland

  Ireland

  Italy

  Liechtenstein

  Lithuania

  Luxembourg

  Netherlands

  Norway

  Poland

  Portugal

  Romania

  Slovakia

  Slovenia

  Spain

  Sweden

  United Kingdom

  United States
• Study description:
  Registries can be used as data sources for conducting post authorisation safety studies (PASS) that aim to identify, characterise or quantify a safety hazard, aim to confirm the safety profile of a medicine or measure the effectiveness of risk-management measures. In order to better understand the approach of registries towards the collection and reporting of adverse events related to medicines, the EMA will conduct a survey among registries registered within the ENCePP Resources database.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 16/03/2020

Actual: 16/03/2020

Study start date

Planned: 01/04/2020

Actual: 17/04/2020

Data analysis start date

Planned: 29/06/2020

Date of final study report

Planned: 31/07/2020

Actual: 31/07/2020

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable