Study documents

 

Data Collection in EuroSIDA

A data collection form is completed by the sites at the time of enrolment and hereafter a standardized data collection form is completed once annually. All data collection is in the browser-based electronic CRF data collection platform in REDCap. Access to a test version of this form is available upon request. 
 
For each patient, the date of HIV diagnosis and way of transmission is captured. The date of diagnosis of all AIDS-defining diseases is 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 and a range of other laboratory values. Further, data on 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. 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.
 

EuroSIDA study documents

 

Procedural Documents

Instructions for EuroSIDA Data Collection 51 (Autumn 2023)
Инструкция по наблюдению пациентов в исследовании EuroSIDA сбор данных 49 (осень 2021)
SOP for Electronic Data Collection Version 7.0 (Autumn 2023)
EuroSIDA-RESPOND-MISTRAL Electronic Submission Tool (REST) - Guide 6 (2022)
RESPOND Cancer Histology 
RESPOND tblMED Lookup Tool 
 

Regulatory Documents

EuroSIDA Study Protocol Version 4.0 2019
Patient Personal Data Information Pursuant to GDPR Article 13
EuroSIDA Sample Informed Consent Form Version 4.0 2019
Sample Informed Consent form, RESPOND Data Repository
Criteria for Participation in the EuroSIDA Study
Coauthorships
Information o­n Plasma Collection
 

Manuals and Work Instructions

Work Instruction R11: RESPOND Query Form 
RESPOND Manual of Operations for Clinical Events (MOOP) Version 1.8 2023
EuroSIDA Cover Letter for Cabotegravir 2021
Manual of operations for the EuroSIDA Longacting Cabotegravir/Rilpivirine Case Report Form (eCRF) (2021)
Manual of operations for the EuroSIDA Hepatotoxicity Event Case Report Form (eCRF) (2022)
Most recent HICDEP Protocol 
List of Definitions: Severe Opportunistic Infections 

For more information about EuroSIDA Study Documents, please contact the Coordinating Centre at: eurosida.rigshospitalet@regionh.dk