COVID-19 clinical trials IO and clinical trials records retention: Consultation report

Learn about the outcomes of the public consultations on the COVID-19 clinical trials Interim Order and clinical trials records retention.

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COVID-19 clinical trials interim order and consultation

On May 23, 2020, the Minister of Health approved the Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19. This Interim Order (IO) responds to the need for urgent COVID-19 diagnosis, treatment, mitigation or prevention options. An IO is one of the fastest ways the federal government can make health products available during larger-scale public health emergencies. An IO is temporary in nature.

We intend to:

On Monday, December 14, 2020, we hosted 2 virtual consultation sessions. A total of 98 external stakeholders attended. The purpose of the consultation sessions was to:

We accepted written comments until January 25, 2021. Stakeholders provided feedback and comments on the:

We evaluated stakeholder questions and comments received during the virtual consultations. The results are summarized in this report.

Topics addressed during the consultation

We addressed 3 main areas during the consultation.

Medical devices

Overall, stakeholders sought:

Records retention for clinical trials

During the consultation, we proposed changes to how long clinical trial records need to be retained. We proposed that sponsors retain clinical trial records for a period of 15 years for:

We also presented possible exceptions to the proposed requirements. In response to the proposal, stakeholders requested greater clarity in the requirements for retaining records of trials that are closed and the definition of the end of the trial.

Informed consent for clinical trials

Extending the IO provisions enables alternate means of obtaining the informed consent of trial participants. We are looking at different ways to obtain informed consent in the future through the Clinical Trial Modernization initiative. One stakeholder raised the issue of differences in legislation between provinces in terms of providing informed consent.

Other comments and questions

The IO introduced key flexibilities while upholding strong patient safety and data reliability requirements. One stakeholder requested clarity about the notification requirements of the Food and Drug Regulations for applications authorized under the IO and the submission of updated Investigator Brochures.

Conclusion of consultation

Stakeholders asked questions about 3 distinct areas including:

We will continue to communicate with stakeholders to keep them informed about extending the IO and transitioning it into regulations. The feedback from these consultations will also help us understand the potential challenges when moving forward with the Clinical Trials Modernization framework.

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