Data Source

Registry

Type of Study

Longitudinal survey. Data colleceted from different sources (health staff, marketing authorisation holders, patients, side effects in clinical trials, etc.)

Data gathering method

Registries

Conditions of access

Formal agreements (e.g. fees, research contracts, institutional agreements, etc.)

Free access

Time elapsed between application and reception of data

Up to one year

Type of available data (e.g. anonymised microdata, aggregated tables, etc.)

Aggregated tables

Formats available

Excel

Language issues

Data is available in English and Croatian.

Years of collection, reference years, and sample sizes

Data has been collected from 2004 until 2012.

First year of collection

2005

Stratification if applicable

Stratification by county, adverse drug reactions, side effects

Base used for sampling

Official Statistics

Geographical coverage and breakdowns

NUTS-1, NUTS-3

Age range

All ages

Statistical representativeness

Patients with side effects

Coverage of main and cross-cutting topics

The data cover all spontaneous reporting of adverse drug reactions. The data source allows for a detailed study.

Further Reading

• Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2012 - Croatian Document

Standardisation

The European Medicines Agency (EMA) and The Heads of Medicines Agencies

Possibility of linkage among databases

A common variable is patient ID.

Entry errors if applicable

NA

Breaks

NA

Consistency of terminology or coding used during collection

NA

Stable and harmonized data source.