One primary objective of the CTR is to increase transparency and availability of information of clinical trials and their results. Regulation EMA (EU) 536/2014 (the 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.
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'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
The FDA, as outlined in 42 CFR Part 11, indicates that the Study Protocol and Statistical Analysis Plan must be shared via clinicaltrials.gov. 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 clinicaltrials.gov.
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