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Study documents

 

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 electronic CRF system, 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 (D:A:D-events), and causes of death (CoDe) are collected. In addition, a plasma sample is requested from all patients every 6 months. This plasma sample is stored locally at minus 80 degrees centigrade, and intermittently shipped to the central repository at the coordinating centre in Copenhagen.

Staff from the coordinating office visit all centres regularly to ensure correct patient selection and that accurate data was provided. 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: eurosida.rigshospitalet@regionh.dk

EuroSIDA study documents

Instructions for EuroSIDA data collection ds44 (Autumn 2016)

SOP for electronic data collection ds44 (Autumn 2016)

Case definitions INSTI Hypersensitivity Reaction/Liver Toxicity

Coauthorships

Criteria for participation in the EuroSIDA study

REDCap instructions (Video) (2014)

Information o­n plasma collection

Payment Instruction form (2016)

The most recent HICDEP protocol may be found here

Sample HCV Treatment Form This is only a sample version of the form. Please do not use.

Sample HCV Adverse Event form This is only a sample version of the form. Please do not use.

Sample HSR form. This is only a sample version of the form. Please do not use.

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