In clinical trial transparency, the terminology used in processes and reports is critical and can have significant downstream regulatory effects. The language used in an anonymization report influences how reviewers understand the strategy, how consistently teams apply it, and how easily a disclosure package can be adapted for another market.
Protected personal data, or PPD, is well established in European transparency work. The term is useful, but it can become too broad when used as shorthand for every privacy-related edit. Health Canada’s Public Release of Clinical Information (PRCI) framework, for example, refers to personal information and direct and indirect identifiers. The GDPR defines its own terms for personal data, pseudonymization, and anonymous information.1,2,3
For sponsors working across jurisdictions, it can be challenging to know which terms and language to use in regulatory submissions. What can be helpful for these groups is building a vocabulary that remains clear and defensible wherever the submission is made. In this blog, we discuss PPD, what different agencies actually care about, and how to navigate CTT language in an ever-changing regulatory landscape.
Why Consider Higher-Level Terminology for PPD?
Moving from routine PPD labeling to higher-level descriptors can help teams explain the logic behind an anonymization decision. Terms such as “participant-identifying information,” “direct identifier,” and “indirect identifier” provide the reader with more insight into the nature of the risk than PPD alone. 1,2 This supports a principles-based approach. Rather than asking whether a value fits under a particular label, the transparency team can ask: What information is present? Could it identify a participant on its own or with other details? What transformation is appropriate? How will that transformation affect data utility?
The shift also helps global teams develop a common internal framework. PPD can still be used where it matches EMA terminology, while PRCI submissions can follow Health Canada’s wording. The underlying classification and decision-making model remain consistent.1,2 That does not mean sponsors should remove PPD from their documentation. It means the term should be defined and used deliberately, rather than treated as a catch-all explanation.
What Clearer Wording Looks Like in Practice
Consider a typical statement in an anonymization report:
“All PPD was identified and redacted.”
The sentence is simple, but it leaves several questions unanswered. What information was identified? Was everything suppressed? Were some values generalized or replaced? How was re-identification risk assessed?
A stronger version might read:
“Direct identifiers were suppressed or replaced. Indirect identifiers were assessed individually and in combination, then transformed where they materially increased the risk of participant re-identification.”
The revised wording gives the reviewer a clearer picture without turning the summary into a technical manual.
Instead of writing, “Dates containing PPD were anonymized,” the report could state:
“Exact participant-level dates were classified as indirect identifiers. Dates were shifted consistently within each participant record to preserve clinical intervals while reducing identifiability.”
For demographic information, “Demographic PPD was generalized” could become:
“Age and geographic variables were generalized where combinations created small or unique groups within the selected reference population.”
PRCI annotations benefit from the same discipline. “Redacted: PPD” may be accurate, but “Direct identifier: investigator contact details” is more informative. The anonymization report can then explain the applicable rules and treatment.2
Higher-level terminology only works when anchored to concrete techniques. These may include suppression, redaction, masking, pseudonymization, date shifting, randomization, or generalization. The documentation should connect the information type, technique, rationale, and effect on risk and utility.1,2
What Agencies Care About Most
Regulators may question unclear or inconsistent wording, but terminology is not the main test of a submission. EMA’s Policy 0070 guidance addresses the anonymization of clinical reports and supporting documentation. Health Canada’s PRCI guidance likewise requires manufacturers to prepare clinical information for release while protecting personal information. Its approach includes direct and indirect identifiers, risk assessment, and documentation of the anonymization method.1,2
Across these frameworks, the central concerns are familiar: has the sponsor reduced re-identification risk, preserved useful clinical information, and provided a rationale that another reviewer can follow?1,2
The GDPR reinforces the importance of identifiability rather than labels alone. Its treatment of anonymous information turns on whether a person is no longer identifiable, taking into account the means reasonably likely to be used.3 A defensible submission should therefore show that the sponsor has identified relevant information, considered combinations of variables, applied proportionate transformations, and checked the result. It should also maintain consistency across the anonymization report, annotated documents, transformation logs, and final publication files.1,2
Recommendations for Sponsors on PPD
Sponsors that want to reduce reliance on PPD as a blanket term should not word-smith, but start with governance.
First, define the terminology in the anonymization report. Explain how higher-level categories relate to the language used by the relevant regulator. A short definitions section can prevent confusion later.1,2
Second, retain jurisdiction-specific wording where it adds value. An EMA submission may appropriately refer to PPD, whereas a Health Canada submission should use PRCI terminology. The aim here is to align reasoning, not necessarily identical wording, across markets. 1,2
Third, document the link between each category and the available anonymization techniques. A reviewer should understand why a date was shifted, an age was generalized, or a name was suppressed.
Fourth, make consistency part of quality control. Terminology should match reports, annotations, trackers, and final documents. Small differences can create unnecessary questions, especially when several teams contribute to the same submission.
Fifth, involve privacy, regulatory, disclosure, and clinical stakeholders early. These decisions influence SOPs, risk-assessment methods, annotation conventions, templates, and training.
Finally, keep pace with regulatory guidance. EMA’s current external guidance for Policy 0070 is Version 1.5, published in May 2025, while Health Canada continues to maintain its PRCI guidance and process information. Sponsors should periodically review their terminology and procedures against current expectations.1,2
How Instem Can Help
Instem helps life sciences organizations translate regulatory expectations into repeatable CTT processes. Our teams support document and data de-identification, re-identification risk assessment, anonymization strategy, operating-model development, and training. Support can be delivered as an outsourced service or alongside an internal transparency team.4
Instem’s Blur™ platform supports scalable de-identification and quantitative risk assessment for clinical trial documents and data. Within a defined governance model, it can help teams apply transformations consistently, preserve an audit trail, and manage PPD and other participant-related information with greater control.
結論
PPD remains a useful and regulator-recognized term. The problem arises when it replaces explanation. Strong transparency submissions identify the information at issue, describe the risk, name the transformation, and show why the result is appropriate. Broader terminology can make that reasoning easier to understand, particularly for sponsors operating across the EU and Canada.1
The goal is not to trade one label for another. It is to make the anonymization strategy clear enough to defend, consistent enough to scale, and practical enough to use across submissions. Reach out today if you have any questions about PPD, clinical trial transparency, or want to speak to an expert. And don’t forget to follow us and d-wise on LinkedIn!
Sources
- European Medicines Agency, Clinical Data Publication and External Guidance on the Implementation of Policy 0070, Version 1.5.
- Health Canada, Public Release of Clinical Information: Guidance Document.
- European Union, Regulation (EU) 2016/679, General Data Protection Regulation.
