Transparency Requirements and the Requirement for Document Redaction

In an era of increasing scrutiny and demand for transparency in clinical research, the European Union (EU) has taken significant strides to enhance public access to clinical trial data and ensure the integrity of the research process. The EU Clinical Trial Regulation (CTR) (No. 536/2014) is central to these efforts, establishing rigorous transparency requirements that aim to foster public trust, safeguard patient safety, and improve the overall efficiency of clinical trials.

In June 2024, new provisions under the EU CTR came into effect, marking a significant shift in the extent to which Sponsors are required to redact sensitive information. Among the updated regulations were new transparency requirements which have impacted Sponsors in various ways, including redaction requirements.

Understanding the Requirements

The CTR mandates that Sponsors of clinical trials disclose detailed information about their trials. This is part of a broader effort to ensure that clinical trials are conducted transparently and that the data generated is made publicly available.

The initial transparency and deferral requirements foreseen by the CTR faced many difficulties with complexity regarding information management and data security for both EU Member States and Sponsors. Therefore, in June 2024, the EMA adopted revised transparency rules, but what does this really mean for Sponsors and what can you do to ensure you’re prepared to face the challenge?

What Documents Should I Redact?

The number of documents that require redaction has been reduced since June 2024, thus decreasing the burden on Sponsors. However, it can still be overwhelming to understand what information and in which document(s) requires attention. The documents required for redaction are as follows:

Types of Data Redaction Needed

Sensitive or commercially confidential information must be redacted before documents are made publicly available.

There are two types of data to consider:

1. Personal Data Protection: Information that could lead to the identification of participants, such as personal data or other private information, will need to be redacted in compliance with the EU General Data Protection Regulation (GDPR).
2. Commercially Confidential Information: Any information that could undermine the commercial interests of the sponsor, such as trade secrets, proprietary methodologies, and pricing information, may also require redaction. This ensures that transparency is balanced with the protection of intellectual property.

Sponsors should develop clear procedures for preparing documents and identifying sensitive information that may require redaction. Implementing robust processes to review trial documents and determine which parts must be redacted is crucial. Ensuring staff are well-versed in the new transparency and redaction requirements will avoid costly mistakes and delays.

ProPharma: Your Partner in European Transparency Compliance

ProPharma's dedicated team can help you identify both types of data in all documents, keeping your people and commercial assets safe. Our specialists will work directly with your project manager, legal, or data protection departments to ensure the correct data is protected We have already helped numerous clients achieve this, with one client recently commented 'The work is excellent and high quality. We greatly appreciate the meticulousness, and care and attention on this document.'

The EU Clinical Trial Regulation represents a significant step forward in ensuring transparency and public access to clinical trial data. While the changes from June 2024 reduce the redaction burden on Sponsors, the exact requirements can still be difficult to understand and navigate. ProPharma’s team of expert regulatory consultants can help you navigate these requirements. In addition, our expert document team can work with you to ensure complex document redactions are completed to a high standard to drive your submission forwards.