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EMA (EU) 536 - Clinical Document Redaction in the Spotlight

The Clinical Trial Disclosure and Transparency regulatory landscape has undergone a substantial transition in recent years. Regulatory bodies around the globe are reshaping expectations around public disclosure of clinical trial information and results which in turn is placing additional pressure on medical writing, regulatory, disclosure and transparency teams. These disclosure expectations focus primarily on protecting patient privacy and commercial sensitive information.  

Regulators such as Health Canada and EMA have changed their expectations of sponsors from a qualitative approach with emphasis on redaction to a quantitative evaluation of patient characteristics within the trial(s) resulting in data transformations and anonymization techniques. This quantitative approach requires a more empirical evaluation of the data which is then applied to the public facing documents which are a primary aspect of the disclosure submission. With the recent implementation of EMA’s Regulation 536/2014, public facing trial documents such as the Protocol, Investigator Brochures and more will be publicly disclosed via CTIS.  This requirement adds additional workload and pressure for Disclosure, Transparency, Medical Writing and Publishing teams to comply as public and regulator-facing versions of these documents must be submitted simultaneously.  

Per the EMA, “As defined in Article 81(4), both personal data and commercial confidential information are exempted from publication. In order to address this requirement CTIS provides the functionality to upload, via the CTIS secure domain for sponsors and authorities, a version of the document ''for publication'' and one ''not for publication'. It is expected that sponsors will provide at the same time redacted (for publication) and unredacted (not for publication) versions of documents, and only the redacted version will be published, with timing depending on the deferral rules - as applicable. CTIS will not allow the uploading of a ‘not for publication’ version of a document without having already uploaded a ‘for publication’ version of a document.”

Key Considerations

Real Life Sciences supports dozens of study sponsors with their public disclosure projects with its RLS Protect software as a service application and managed services delivery team. Consistently, study sponsors have shared their priority considerations for selecting a partner to support the scalability and processing of documents for anonymization and/or redaction in support of these regulatory requirements. The most common evaluation criteria mentioned is regulatory experience. Sponsors seek a trusted partner with the practical and hands-on regulatory experience for Health Canada PRCI, EMA Policy 70 and EMA Regulation 536 / CTIS projects. For many sponsors, the engagement starts with an immediate need such as a redaction only project and then expands to include quantitative risk analysis of trial datasets and document anonymization. RLS’ managed services delivery team processes trial datasets and documents on a daily basis in support of these regulatory requirements. Further, this team assists study sponsors with strategy planning for disclosure projects, direct discussions with regulators and identification of commercial confidential information.  

Sponsors have also highlighted the need for sophisticated anonymization and redaction tools to achieve regulator deadlines.  RLS’ fit-for-purpose risk assessment, document anonymization and document redaction solution, RLS Protect, includes functionality designed specifically for the Life Sciences industry to fulfill these regulatory requirements in an efficient and scalable manner.  

CTIS Process Considerations for Preparing EU 536 / CTIS Public Documents

Summary

The EU Clinical Trial Regulation (EU 536/2014 and the Clinical Trials Information System (CTIS) system have been live since January 31, 2022.  From a clinical disclosure perspective, EU CTR aims to provide transparency of all aspects of the clinical trial including outcomes and adverse events.  Pharmaceutical sponsor disclosure and transparency teams need to ensure they are prepared to fulfill the requirements of the CTIS with a clear understanding of how their processes will vary from other regulations such as Health Canada Public Release of Clinical Information (PRCI).   

EU 536 shares similarities with other regulatory requirements but also includes some unique characteristics which will require modified or new processes for clinical disclosure teams. 

Regulation 536 / CTISHealth Canada PRCI &
EMA Policy 70
IntentPublic disclosure of trial information - and protection of Personal Information and Commercial Confidential InformationPublic disclosure of trial information - and protection of Personal Information and Commercial Confidential Information
ScopeAll submitted documents starting with CTAClinical summaries, CSRs, Anonymization Report
TimingThroughout the trial process - public and non-public documents are submitted simultaneously Submission after Marketing Authorization
HA / Regulator EngagementQueries / RFI’s as neededDirect involvement with scope definition and approval of disclosure submission

With implementation of CTIS, Disclosure teams need to balance the volume of documents to be processed, the time frame within which it needs to be submitted in and the concurrence of clinical trial document creation and anonymization. This will require organizations to implement a process that spans across medical writing, disclosure and transparency, legal and regulatory.  It is also critical that organizations align with a preferred partner that provides regulatory knowledge, document anonymization and redaction expertise using a quantitative methodology to align with Health Authority expectations.

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