Health Canada released guidance on 2019年3月12日 pertaining to its Public Release of Clinical Information (PRCI) initiative. Health Canada’s objective with this initiative is to make anonymized clinical information in drug submissions and medical device applications publicly available for non-commercial purposes to enable re-analyses of data, foster new research questions, and help Canadians to make more informed decisions regarding their health.
Click here to read our summary of the PRCI guidance, including which past drug submissions and medical device applications for which clinical information may be requested; procedures to prepare information for release; and the implementation schedule for proactive disclosure.
Health Canada Public Release of Clinical Information Guiding Principles
- All transformation of data should be conducted for the sole purpose of preventing the disclosure of personal information.
- All data transformations should be accompanied by robust justification, and be applied to limited variables that risk re‐identification, not to broad sections of clinical information.
- Data transformation should favor methods that retain analytical value, e.g. generalization, randomization and offsetting, as opposed to redaction.
- Must be non-readable text and NOT machine readable or searchable.
- Ability to submit final redacted documents previously accepted by the EMA through certification
- Confidential Business Information (CBI) may be rejected if there is inadequate explaining of:
- how the information was not used to support the conditions of use or purpose for the drug or device, as set out in the submission or application
- how the proposed information describes a test, method, or assay that is used exclusively by the manufacturer
Observations in the First Submissions Requested by Health Canada
- Process Initiation Meeting (PIM) within 20 days scope of the request and to address any questions by the sponsor
- PRCI email from Health Canada will differ if the request is a retrospective request
- Members of the public may request clinical information from past submissions through Health Canada’s clinical information portal with an electronic request form identifying the product name and the information requested (e.g. clinical study report, clinical overview, clinical summary)
- Retrospective requests have no limit on how far back they can go but Health Canada will scan old submission documents for sponsors to anonymize
- EMA formatting and overlay is accepted by Health Canada but terminology differences must be specified in the anonymization report
- Redaction as an anonymization technique is accepted but requires a justification in the anonymization report
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