CTN COVID-19 studies data support portal

Welcome to the CTN COVID-19 studies data support portal. The CTN is pleased to make available the COVID-19 Vaccine Implementation in Canada (CVIC) standardized study document templates that include a consent form, protocol and case report form. These have been developed for clinicians to use to facilitate collection of necessary data for the successful evaluation of Canada’s COVID-19 vaccination programs.

We welcome your feedback on refinements and changes to any of these documents via email to covid19@ctnplus.ca.

Disclaimer

These documents have been prepared by the CIHR Canadian HIV Trials Network (CTN) for studies related to the COVID-19 pandemic. All of the documents are public, available without charge or additional permissions. Participant identifying data will not be captured or shared. Stewardship of the data resulting from these tools is the responsibility of the parties collecting the data. The use and interpretation of these documents is the responsibility of the user. Under no circumstances shall the CTN be liable for damages arising from their use. The intention of these documents is to facilitate data sharing between researchers and clinicians across Canada and we request that those who use them participate in or remain amenable to data sharing. As the CTN is funded by CIHR, we may track anonymized usage and download numbers for annual reporting purposes.

Case Report Form

The case report form includes a Registration Page (1 question) and two self-completed questionnaires, Baseline Information (up to 45 questions) and a daily Symptoms Diary (28 questions). They are designed to be filled out electronically by participants on their phones, tablets, or computers. After completion of the Registration Page, the Baseline Information questionnaire, and Symptoms Diary will be automatically emailed to the respondent. Permission is granted for these questionnaires to be utilized freely for clinical or research purposes.

The registration page and case report questionnaires have been developed in REDCap. The data dictionary is available for uploads, and includes basic questionnaire distribution configuration. Additional configuration guidance will be available soon, check this space for updates. For investigators who use a different data collection platform, the codebook is also available. To facilitate future data sharing, please do not alter field/variable labels, names, code lists, or other attributes. Investigators can add assessments and instruments to their particular studies according to the protocols, but these core datapoints are intended to be common across COVID-19 case report forms in Canada.

No reference ranges or other edit checks have currently been programmed on these instruments, and, as participants will enter the data directly, there is no opportunity to query and validate responses. Rules, limits, and ranges may be added by sites as per their requirements and lab reference ranges. The CTN may also program such checks in a future version of the instruments. For small sites with limited infrastructure and capacity, the CTN may be able to host your data on our secure REDCap servers in Vancouver, including the facilitation of paper-based questionnaires and data entry if necessary. Please contact covid19@ctnplus.ca to arrange a consultation.
We welcome all feedback in the interest of improving these data collection instruments. Periodic revisions will adhere to change and version control procedures and release notes will be provided as appropriate. To suggest changes, or to register for updates, please contact covid19@ctnplus.ca.

Case Report Form and Related Files

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Protocol and Informed Consent Templates

The below documents are intended as templates and must be revised as per local REB requirements and vaccine rollout specifics.

Study Protocol
Template

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Informed Consent Form Template

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About the CTN

The CTN is a collaborative network committed to generating knowledge on the prevention, treatment, and management of HIV, hepatitis C, and other sexually transmitted and blood-borne infections (STBBIs) through the conduct of scientifically sound clinical trials, research, and other interventions.

Led by National Director Dr. Aslam Anis, with National Co-Directors Drs. Sharon Walmsley and Marina Klein, the CTN is dedicated to engaging with the community, maximizing the impact of research, and ultimately improving the health of Canadians.

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Drs. Marina Klein, Aslam Anis, and Sharon Walmsley

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