Study documents

Data Collection in EuroSIDA

A data collection form is completed by the participating sites at the time of enrolment. Thereafter, a standardized data collection form is completed annually. All data are collected using a browser-based electronic CRF data collection platform in REDCap. Access to a test version of the form is available upon request.

For each enrolled person, the date of HIV diagnosis and way of transmission are recorded. The dates of all AIDS-defining diseases are collected according to the 1993 Centers for Disease Control and Prevention (CDC) definitions. In addition, the start and discontinuation dates of each antiretroviral drug are recorded, together with the use of medications for prophylaxis against opportunistic infections.

CD4 lymphocyte counts, HIV viral load measurements, and a range of other laboratory values are collected at each annual follow-up. Information on non-AIDS defining diseases, adverse events associated with antiretroviral therapy, and causes of death (CoDe) is also recorded. In addition, one plasma sample is requested from each patients annually. Plasma samples are stored locally at -80°C, and intermittently shipped to the central repository at the EuroSIDA coordinating centre in Copenhagen.

Please note that plasma sample collection was discontinued from 1 August 2025. Plasma samples are no longer collected as part of the EuroSIDA study. All samples collected before 1 August will continue to be reimbursed in accordance with the study reimbursement policy.

All sites complete the annual follow-up forms within a two-month data collection period. An updated version of the database is typically available 3 months later, allowing the study to provide almost real-time data on the patients followed.

EuroSIDA study documents

Study documents

Data Collection in EuroSIDA

EuroSIDA study documents

Procedural Documents

Regulatory Documents

Manuals and Work Instructions