Data Collection in EuroSIDA
A data collection form is completed by the sites at the time of enrolment and annually hereafter on to a standardized data collection form. From follow-up Winter 2014/2015 (DS41), all data collection is in the browser-based electronic CRF data collection platform, REDCap at https://chip-crf.info/redcap/. Access of a test version of this form is available upon request.
For each patient, the date of HIV diagnosis and way of transmission is recorded. The date of diagnosis of all AIDS defining diseases are recorded, using the 1993 Centers for Disease Control and Prevention definitions. Further, the date of starting and stopping each antiretroviral drug is recorded, as is the use of drugs for prophylaxis against opportunistic infections. All CD4 lymphocyte counts and viral load measurements are requested at every follow-up, as well as a range of other laboratory values. Further, data about non-AIDS defining diseases, adverse events of anti-HIV drugs, and causes of death (CoDe) are collected. In addition, a plasma sample is requested from all patients once a year. This plasma sample is stored locally at minus 80 degrees centigrade, and intermittently shipped to the central repository at the coordinating centre in Copenhagen.
All sites complete the follow-up forms within a two month period, after which the forms are sent to the coordinating centre for data entry. An updated version of the database is usually available 3 months later, allowing the study to provide almost real-time data on the patients followed.
For more information about the EuroSIDA study, please contact the Coordinating Centre at: firstname.lastname@example.org
EuroSIDA study documents
Instructions for EuroSIDA data collection 47 (Autumn 2019)
SOP for electronic data collection ds47 (Autumn 2019)
EuroSIDA-RESPOND Electronic Submission Tool (REST) - Guide v3 (2019)
List of Definitions: Severe Opportunistic Infections
RESPOND Manual of Operations for clinical events (MOOP) v.1.6 2019
EuroSIDA study Protocol v.4.0 2019
Patient personal data information pursuant to GDPR Article 13
EuroSIDA Sample informed consent form v.4.0 2019
Sample Informed Consent form, RESPOND data repository
Criteria for participation in the EuroSIDA study
Information on plasma collection
The most recent HICDEP protocol may be found here