April 2022: Guidance on Protection of Personal Data and Commercially Confidential Information in CTIS

European Medicines Agency uploaded the  Draft guidance document on how to approach the protection of personal data and commercially confidential information in documents uploaded and published in the Clinical Trial Information System (CTIS) over the What’s New Section on April 08, 2022:

The document briefly explains the clinical trial module in CTIS consisting of the EU Portal and Database (EU PD) that includes both the secure and public domains. It also exhibits the interface of CTIS with other EMA data sources along with the legal framework.

It describes the CTIS structure and components including the functionalities and exerts publication rules for clinical trials information enlisting all types of documents that are required for submission in CTIS. It further categorizes these documents into ‘for publication’ and ‘not for publication’. A deferral mechanism is introduced for sponsors and the Member States providing them a prospect to delay the publication of clinical trial information to protect CCI. It summarizes the data and documents that could be considered for deferrals along with the timeline for each document.

It provides the general principles for anonymization and pseudonymization along with the guidelines for anonymization of personal data, personal data of trial participants, and personal data other than trial participants. It also provides a guideline for pseudonymization of the personal data of trial participants.

It includes the 3-step approach proposed by EMA and points to consider for the identification of CCI. It provides guidelines for redacting the CCI of ‘for publication’ documents submitted to CTIS. It also provides minimization approaches that could reduce the efforts of sponsors while redacting the documents and enlists the information that is not considered CCI. It also covers the guidelines for redaction of PPD and CCI in inspection reports.