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We are committed to helping advance COVID-19 studies quickly and effectively.COVID-19 RESOURCES & UPDATES

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Clinical Trial Restart Resource Toolkit

 

This toolkit provides a collection of best practices, considerations, and resources for clinical trial conduct in the face of the COVID-19 pandemic. The aim of this toolkit is to provide guidance for sites and sponsors that are looking to restart clinical trials during a pandemic. Many of the strategies and tools provided have been implemented in sites across Ontario.

 

About this resource:

Clinical trial activity in Ontario, and worldwide, has been impacted by the COVID-19 pandemic. Since the onset of the pandemic, clinical trial sites and sponsors have been tasked with the challenge of conducting clinical trials safely in our new reality. CTO took on the role of supporting our community through this challenging time by facilitating a cross-stakeholder working group to establish best practices and harmonized solutions for Ontario’s clinical trials community. CTO thanks the key stakeholders from sites, sponsors and CROs who contributed to this resource. In working with the community, five topic areas were recognized as essential for clinical trial restart: pandemic management, on-site visits, remote data monitoring, eConsent, and remote consent. To explore each topic area, click on the icons below.

This is a live resource. We recognize that additional resources and best practices may exist. If you would like to contribute to the toolkit please email Linnea Aasen-Johnston or Andrew Haller.

Pandemic Management

Pandemic Management

Operational oversight in re-opening and “ramp down”.

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On-Site Visits

On-Site Visits

If a representative from a sponsor must come on site, procedures should be put in place to protect all stakeholders.

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Remote Data Monitoring

Remote Data Monitoring

Considerations and resources to support the secure viewing of data and documents.

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eConsent

eConsent

Innovative consenting methods that use multimedia components.

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Remote Consent

Remote Consent

Considerations and resources for the implementation of remote consent.

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