Document background
The Confidentiality Agreement Clinical Trials is essential for protecting sensitive information exchanged during clinical trials in the Netherlands. It is used when parties need to share confidential information related to clinical trials, including trial protocols, patient data, research methodologies, and proprietary information. The agreement ensures compliance with Dutch legal requirements, including the Medical Research Involving Human Subjects Act (WMO), as well as EU regulations such as the Clinical Trials Regulation and GDPR. This document is particularly crucial in the early stages of trial planning and throughout the trial's duration, establishing clear guidelines for information handling, permitted disclosures, and data protection measures. It serves as a foundational document for maintaining confidentiality in clinical research while facilitating necessary information sharing between sponsors, research institutions, and other involved parties.
