Clinical Trial Regulations

Health Canada and EMA regulations are evolving and adding new pressure points to Transparency and Disclosure teams (and those who take on these responsibilities) around the world. New regulations such as EMA's Clinical Trial Regulation and systems like the CTIS are changing how clinical teams manage trials. Power your transparency projects with experience, specialty knowledge and cutting edge tools.
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Clinical Trial Transparency and Disclosure Regulations

Not Sure How to Best Navigate the Clinical Transparency Puzzle?
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RLS has been supporting its Sponsor and CRO customers with our transparency software and services for years. We understand the ins and outs, the gotchas and how to stay clear of unexpected regulatory hurdles. The team members at RLS pride themselves on partnering closely with our customers of all types and sizes and helping them through the end-to-end anonymization process.

EMA Regulation (EU) No 536/2014

Europe’s Clinical Trial Regulation (CTR) and the CTIS (Clinical Trial Information System)

One primary objective of the Clinical Trial Regulation (CTR) is to increase transparency and availability of information of clinical trials and their results.  Regulation EMA (EU) 536/2014, known as CTR, implemented in early 2022, includes strict expectations for the simultaneous publishing of “public” and “non-public” documents within the CTIS portal.  Further, for “public” version documents, the CTR also requires protection of personal data and Commercially Confidential Information (CCI) through adherence to GDPR and the regulation’s own guidance. This has resulted in new expectations for Transparency teams to consistently anonymize all pertinent documents throughout the study lifecycle prior to posting in the CTIS.

For more Information about the CTR and CTIS: 

European Medicines Agency (EMA) Clinical Trial Regulation (CTR) Overview

European Medicines Agency (EMA) Clinical Trials Information System (CTIS) Overview

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European Medicines Agency (EMA)

Policy 0070

First implemented in 2016, EMA Policy 0070 seeks to enable the wider scientific community to make use of detailed clinical data to develop new knowledge in the interest of public health. The scope of the policy relates to clinical data, composed of clinical reports and individual patient data (IPD), submitted under the centralized marketing authorization. This Policy’s guidance includes detailed expectations for anonymization and protection of personal data and Commercially Confidential Information (CCI).  With the anticipated restart of EMA Policy 0070, study sponsors should implement a quantitative data analysis methodology.

Health Canada

Health Canada Public Release of Clinical Information (PRCI)

Health Canada's objective with PRCI, as introduced in 2019, is to make anonymized clinical information in drug submission applications publicly available for non-commercial purposes following the completion of Health Canada's regulatory review process.

Example critical components in preparing your organization for PRCI submissions include

  1. Planning for and maximizing the value of the Process Initiation Meeting (PIM)
  2. Anonymization of Personal Information (PI) using quantitative analysis
  3. Special considerations for rare disease trials
  4. Protection of Confidential Business Information (CBI)

View our Webinar - Practical Strategies for Successfully Navigating Your Health Canada PRCI Regulatory Disclosure Projects

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FDA Required Disclosures

The FDA, as outlined in 42 CFR Part 11, indicates that the Study Protocol and Statistical Analysis Plan must be shared via The aim of the rule is to help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research. The rule goes on to state that the responsible party (study sponsor) may redact names, addresses, and other personally identifiable information, as well as any trade secret and/or confidential commercial information prior to disclosure on  

Tackling Global Transparency Regulations

Experience Matters:
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Through close partnerships with our customers, over forty (40) regulatory disclosure submissions, anonymization of over 1 million clinical document pages and thousands of datasets, RLS can help your organization maintain pace with the ever changing regulatory landscape. 

Whether you are a growing biotech about to embark on your first transparency initiative, or a mid-sized or large Pharma transitioning from qualitative to quantitative  anonymization processes or simply seeking confirmation of your processes and approach, RLS can help.

Through sharing our regulatory experiences, implementation of RLS Protect and acting as an extension of our customer’s own teams, RLS will help you achieve your transparency needs. 

Anonymization of study documents for CTIS
On-demand anonymization business process outsourcing
Full service delivery of regulatory disclosure submissions for EMA and Health Canada
Voluntary data sharing dataset anonymization  
Quantitative risk assessment methodology training and awareness
Preparation for regulatory justification meetings (e.g.; Health Canada Process Initiation Meeting (PIM))
Implementation of RLS Protect anonymization solution
…and more!

Let us show you how RLS can help.

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Our team is made up of passionate leaders in the fields of machine learning, natural language processing, clinical trials, data analysis and regulatory submissions. We help Pharmaceutical Sponsors and CROs focus on their primary business goals while protecting patient identity and company confidential information while maximizing data utility and adhering to regulatory requirements.
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