Natural History of Andes Virus Infection (NAVIS) Study Documents

The protocol and consent documents were developed by the NAVIS investigators (listed within the protocol) under the coordination of the World Health Organization. These documents are designed as templates for adaptation to local requirements and research capabilities.

• NAVIS Study Protocol(v1.1) & Participant Information Sheets and Consent Forms

The CRF is tailored to the NAVIS study schedule and is designed on the ISARIC data structure to support international interoperability.

• NAVIS CRF

The daily self-reported symptoms and wellbeing survey is tailored to longitudinal participant monitoring and is designed to align with the symptom sections of the CRF.

• NAVIS Self-Reported Symptoms and Wellbeing daily Survey

The fortnightly self-reported wellbeing questionnaire is tailored to longitudinal follow-up and is designed to capture changes in participant wellbeing over time using the Generalized Anxiety Disorder 2-item (GAD-2) and Patient Health Questionnaire-2 (PHQ-2) instruments.

• NAVIS Self-Reported Wellbeing fortnightly Survey

The Terms of Submission is the data sharing agreement to be executed between each site and ISARIC who will host the central data for collaborative analysis. All data collected on the platform remain the property of the individuals and institutions that collect them and can be withdrawn at any time. ISARIC acts as a Data Processor to execute the instructions of those who deposit data. Queries and signed agreements can be sent to data@isaric.org.

• Terms of Submission

These documents support understanding of the NAVIS case report form and database to support consistent, high quality data collection. They can serve as training tools for the study team.

• NAVIS Database Structure Guide
• Data Entry Guide

Sites participating in the NAVIS protocol may use the central database hosted by ISARIC or host their own database using the database files below. In either case, sites are required to execute the Terms of Submission in the CORE DOCUMENTS above.

USING THE ISARIC DATABASE: By collecting data directly to the ISARIC platform, NAVIS investigators will benefit from access to real-time analytics on clinical risk factors, treatments and outcomes. Following execution of the Terms of Submission, sites may request database access at data@isaric.org by sending the first and last name of study team members using an institutional email address.

SITE BASED DATABASE: Sites can use the database files below to launch a REDCap database identical to the centrally hosted database. Use of this standardised structure will ensure accuracy and efficiency in collaborative data analysis. If you are hosting your own database, please contact ISARIC at data@isaric.org to receive a site ID which will enable data aggregation in the future.

Available Resources

• NAVIS REDCap XML File
• NAVIS Data Dictionary
• Symptoms and Wellbeing-daily Survey REDCap XML File
• Wellbeing-fortnightly Survey REDCap XML File
• Data Management Plan
• Local REDCap Setup Guidance