The EMA Policy 0070 and Health Canada Public Release of Clinical Information (PRCI) Anonymization Report

How the New Anonymization Report Template Impacts Study Sponsors

Collaboration between Health Canada & EMA

While Health Canada PRCI and EMA Policy 0070 are distinct policies, Health Canada and EMA collaborate on harmonizing approaches to clinical trial transparency. In most circumstances, both recommend a 9% re-identification risk threshold for disclosure submissions and provide a unified Anonymization Report Template. Further, both share a similar scope for submission with focus on ICH CTD/eCTD M2.5, M2.7 and M5.3.

What is the Anonymization Report Template?

The Anonymization Report Template is a crucial document used in these disclosure submissions. . The report captures the methods you applied to anonymize the clinical data and assessment of risk of re-identification applicable for your submission.

Thoroughly completing and thoughtfully justifying your anonymization methods in the report is crucial for a smooth and successful EMA Policy 0070 submission. If you have any specific questions about the template or the anonymization process, consider contacting Real Life Sciences for more information.

Here's a breakdown of the key aspects of the anonymization template (key terms defined below):

Structure and Content:

  • The template follows a structured format with specific sections to address. Note the descriptions of the requested information for these sections are not exhaustive. Further, this template is now offered for both EMA Policy 0070 and Health Canada’s PRCI project submissions.
  • Methodology: Describes the specific anonymization methodology or strategy employed for the data within the submission package.
  • Identification of Data Variables: Indicate the direct and indirect identifiers found within the package.  For each, indicate what anonymization technique was used such as generalization, redaction, recoding, offset, retained, other.
  • Risk Assessment: Indicate initial risk of reidentification value, the risk threshold you have applied and the residual risk value. The risk of reidentification evaluates the likelihood of individuals being re-identified based on the applied anonymization methods. This will involve a risk-based assessment of your data, as can be performed by Real Life Sciences.
  • Data Utility: List variables with the highest data utility and describe how their utility was maintained
  • Deviations: Indicate if there are any deviations in your approach for the CDP package as compared to the stated guidance provided by EMA.
  • Attestation: Confirm the accuracy of the information provided and that the anonymization techniques were applied consistently across all documents in the final package submission.

Importance and Benefits:

  • The Anonymization Report plays a critical role in demonstrating compliance with EMA Policy 0070's data protection requirements.
  • It allows the EMA to assess the effectiveness of your anonymization efforts and ensure appropriate protection of participant privacy.
  • A well-prepared report can expedite the data publication process by addressing potential concerns upfront and minimizing the risk of delays or rejection.

Key terms

Risk of Reidentification

In the context of clinical trial transparency, the risk of re-identification refers to the probability of an adversary successfully identifying  a specific individual who participated in  the trial, even when their data has been anonymized or de-identified. This re-identification could potentially happen through a combination of factors, such as:

  • Unique data points: An individual's medical history, demographic information (e.g., age, race, gender), genetic markers, or even geographic location could be sufficiently unique to allow them to be singled out even in a large dataset.
  • External data linkage: Anonymized data from the clinical trial could be linked with other datasets, such as public records or social media, which contain additional information about individuals that could lead to their re-identification.
  • Statistical techniques: Advanced statistical techniques, such as machine learning algorithms, could be used to analyze the anonymized data and identify patterns that allow for the identification of specific individuals

Risk Threshold

Risk Threshold is the maximum acceptable probability of an individual being correctly re-identified from anonymized clinical trial data. It's a crucial measure for balancing data privacy and transparency.

Residual Risk 

Residual risk is the remaining risk that individuals could be re-identified from a dataset, even after anonymization techniques have been applied. It's the risk that lingers even after safeguards are in place.

Data Utility 

Data utility is the usefulness and accuracy of the anonymized data for its intended purpose. It essentially describes how well the anonymized dataset retains its value for analysis and insights, while still protecting the privacy of individuals.

Why a New Template?

In designing the new Anonymization Report Template (launched in 2023), EMA and Health Canada aimed to achieve the following benefits:

  • Improved predictability for Sponsors through use of a structured form
  • Improved writing efficiency for Sponsors
  • Structured drop down options provide improved quality and consistency
  • One consistent template applicable for EMA Policy 0070 and Health Canada PRCI submission projects
  • For regulators, the new template will provide additional efficiency through use of a standard and structured template
  • For readers, portal users and consumers of the anonymized information, the new template is more concise and will be easier to understand; it helps to clearly identify the most pertinent an useful information

Contact Real Life Sciences:

If you have questions or would like some consultation prior to starting your EMA Policy 0070 or Health Canada PRCI project, please contact us directly at


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