Study identification

PURI

https://redirect.ema.europa.eu/resource/37195

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

Contact details

Valerie Strassmann

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

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

English (139.01 KB - PDF)View document
Updated protocol

Survey Protocol on collection and management of safety information in registries

English (136.84 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable