Health Canada’s Public Release of Clinical Information (PRCI) initiative was launched in March 2019 in response to the growing demand for transparency with the public regarding clinical documents as well as allowing the scientific community to benefit from this research. Health Canada has taken the lead in the requirements for publication of clinical documents. So how do sponsors set themselves up for a successful Health Canada PRCI compliant submission? Here are five things you need to know.
Health Canada’s timeline for publishing clinical submission documents is 120 days from the regulatory decision. While this may appear an ample timeframe, there are factors that can affect meeting this deadline. These may include the number of documents to anonymize, the method of anonymization, and whether the study is an unexpected retrospective request. It is important to have a plan in place as 120 days can pass quickly.
Health Canada strongly encourages a quantitative approach to the anonymization methodology. Their guidance is to establish a risk threshold of 0.09 by anonymizing variables that could lead to re-identification of participants. This approach requires both expertise and technology that is not readily available for all sponsors. Therefore, a qualitative approach to the de-identification of clinical documents with redaction of personal information (PI) has been a long-standing industry practice. Although Health Canada is currently accepting a qualitative approach with redaction, the future is strongly in favor of anonymization rather than redaction due to the amount of data utility that is lost.
3. Key Data Elements
Feedback from Health Canada has translated into lessons learned by sponsors. Health Canada has consistently rejected fully redacted sections (including case narratives, patient-level tables, listings, and figures). Some sponsors have received a notice included with their published submission on the Health Canada PRCI portal that states their non-conformance to the guidance when sections are fully redacted. It is worthwhile to consider an approach that provides the maximum data utility while protecting patient privacy and conforming to Health Canada guidance.
4. Confidential Business Information
An important consideration when preparing clinical documents for publication is what company information should remain confidential. Health Canada has very specific guidance on what is accepted as confidential business information (CBI) that can be redacted. The information must not be in the public domain, and revealing the CBI must create economic hardship for the sponsor. Health Canada accepts minimal Confidential Business Information.
5. Infrastructure and Partnership
Thoughtful evaluation of your company’s ability to meet the transparency requirements and proactive preparation of the clinical submission documents are the foundation to a successful Health Canada PRCI compliant submission. Here are a few important questions to ask:
- What is our transparency strategy? Having a well-thought out transparency strategy in place before a regulatory decision will ultimately save time and money and help to avoid the stress of meeting timelines.
- Who should be part of our transparency team? Team members representing clinical, regulatory, and legal departments to review, redact and/or anonymize PI and CBI, and submit edited documents constitute a solid transparency team.
- How will our company meet the transparency requirements for a successful Health Canada PRCI submission? A key question to ask is whether your company has the infrastructure to successfully complete the transparency requirements in-house or whether a partnership with a vendor is the best solution.
With careful consideration of these five key factors, the goal of having a successful Health Canada PRCI compliant submission can be achieved. As the leading technology and services provider in clinical trial disclosure and transparency, Synchrogenix can help sponsors meet these goals. Click below to learn more and to contact us.