Overview
The COVID-19 Immunity Task Force’s (CITF) mandate, from April 23, 2020 to March 31, 2024, included harmonizing research about COVID-19 immunity to inform Canadian policymakers and support evidence-based decisions. The CITF therefore asked our funded researchers to share three types of research products with the CITF: 1) metadata, 2) results, and 3) where ethically and legally possible, individual-level data. Details are available in our Brief Guide to Sharing Metadata, Data, and Results with the CITF.
The CITF used the results from studies to inform policymaking throughout the pandemic. Additional value has been realized by making the data from these studies available to researchers around the world for further research via the CITF Databank. Our databank allows mathematical, statistical, and machine learning analyses to explore novel research questions and extract new insights.
HARMONIZATION OF DATA AND CORE DATA ELEMENTS
Data collected in a standard manner are easier to harmonize, which is a necessary step before analyzing and directly comparing data across multiple studies. To assist researchers with the design of data collection and facilitate harmonization of data from CITF-supported studies, researchers were asked to use Core Data Elements (CDE): a set of standard questions and immunology measures developed by the CITF Secretariat. The CDE were updated periodically over the course of the pandemic.
Questionnaires for participants
The CDE include questions related to demographics and housing, COVID-19 status, symptoms, risk factors and health behaviours, and vaccination. Questions were based on those asked by Statistics Canada and other national organizations. Our goal was to encourage groups to acquire and record data in a manner consistent with health and social surveys.
- COVID-19 history and vaccination questionnaire
- Background questionnaire (demographics and general health)
- Vaccine safety questionnaire
Laboratory data reporting
The CDE also include standard reporting formats for serological and cell-mediated immunity assays. Formats were based on international standard coding schemes as much as possible. The CDE are available on request.
- Serologic Assay Results: Guide to Using the Lab Results Data Schema – 1.1
- Cell-Mediated Immunity Assay Results: Guide to Using Lab Results Data Schema – 0.9
Data preparation
This document provides guidance on the creation of shared datasets such how to create participant ID codes and how to format the datasets. It also outlines the procedure the CITF staff used to map a study’s collected variables to the CITF Core Data Elements.
- Data Preparation Guide – 1.1
DOCUMENTS REQUIRED FOR DATA SHARING
These documents describe the legal and ethical conditions and procedures for sharing individual-level data.
Data sharing agreement
CITF-supported researchers who could legally and ethically share individual-level data completed a Data Sharing Agreement. Sharing individual-level data required Institutional Review Board approval and that certain clauses were included in the informed consent obtained from study participants.
Informed consent guidance
These documents outline the minimum required consent elements for a participant’s individual-level de-identified data to be contributed to the CITF Databank.