Security and Compliance FAQs

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How does CTMS handle unblinded data? Does it offer a way to restrict certain roles from accessing unblinded subject data?

CTMS does not capture any data that could lead to the unblinding of a blinded individual. Blinded data, such as drug dosing and treatment assignments, is not collected within the system and cannot be included in visit reports. The CTMS strictly records basic subject-related metadata for identification purposes (e.g., subject ID, enrollment ID) along with details of the ICF signed by the subject and their visit dates—nothing beyond this.