What we heard report: Records retention consultations related to the clinical trials interim order transition regulations

On this page

• About the clinical trials interim order
• About the transition approach
• About the consultations
• What stakeholders said
• Next steps

About the clinical trials interim order

On May 23, 2020, Canada's Minister of Health made the Interim Order respecting clinical trials for medical devices and drugs relating to COVID-19. This interim order (IO) was replaced with a second, similar interim order on May 3, 2021. IO No. 2 created a new pathway to facilitate clinical trials to meet the urgent need to diagnose, treat, mitigate or prevent COVID-19.

Health Canada proposes to transition IO No. 2 into regulations, to carry over the flexibilities and provisions from the IO.

Alongside these regulations, we will be introducing permanent amendments to the Food and Drug Regulations (FDR) and Natural Health Products Regulations(NHPR). The amendments will reduce the period for keeping clinical trial records of all drugs, including COVID-19 drugs, and natural health products. They will also promote competitiveness and innovation, as promised in the Health and Biosciences Sector Regulatory Review Roadmap.

About the transition approach

The proposed amendments to the FDR and NHPR will be delivered through the transition regulations. These regulations will:

• reduce the period for keeping records of clinical trials of drugs and natural health products from 25 years to 15 years
• apply to all drug and natural health product clinical trials authorized before and after the regulation takes effect in the winter of 2022
• coordinate the approach for records retention between drugs and natural health products
• not affect Health Canada's own recordkeeping requirements

About the consultations

Health Canada published a notice of intent in Canada Gazette, Part I and held consultations in December 2020. Based on responses, we proposed to explore the need for certain exceptions to the 15-year records retention period (for example, for pediatric and oncology clinical trials).

We held 4 virtual engagement sessions from March 8 to 12, 2021. Forty-four individuals representing patient safety organizations, academic researchers, medical professional groups and industry took part. By late March 2021, we had also received 11 cost-benefit surveys and 13 written submissions.

The stakeholder comments received during these virtual consultations are summarized below.

What stakeholders said

Overall comments

Stakeholders supported the proposed 15-year requirement. They said the proposal would reduce the administrative burden for investigators of keeping paper records on-site.

They also said that including exceptions for clinical trials would add administrative complexity and burden. Different retention periods would mean requirements based on the type of trial or participant rather than a single retention period for all trials.

Reducing burden

Many stakeholders supported the proposed 15-year records retention period requirement. They said this would:

• reduce the financial and administrative burden of maintaining records
• decrease training costs
• benefit investigator sites greatly

Exceptions and participant safety

Stakeholders expressed concerns that exceptions to the proposal may:

• add adminstrative complexity and burden due to having to keep track of different retention periods based on the type of trial or participants in the same trial
• differ from other international jurisdictions that do not have regulatory exceptions for different types of clinical trials
• prevent future re-analysis of raw trial data beyond the 15-year retention period

Next steps

Health Canada appreciates all the feedback received on the regulatory proposal to transition IO No. 2. Feedback will be included in the Clinical Trials Interim Order Transition Regulations, which will come into force in the winter of 2022.

We will continue to communicate with stakeholders on concerns raised during the initial consultations. These include:

• addressing when the "clock starts" on records retention for all health products and foods for a special dietary purpose and
• clarifying medical devices records retention timelines as part of our regulatory initiative to modernize the regulation of clinical trials