CSRs are detailed study reports that provide additional details on design and results of clinical trials that form the basis for submissions to regulatory authorities. We consider requests for CSRs from investigators and physicians for scientific research and medical purposes, and are currently evaluating our processes and procedures for handling these requests.
Dedicated to protecting patient privacy and other partner commitments
We appreciate and acknowledge that study participants (patients, investigators and sites) who agree to participate in our clinical trials are critical partners in advancing medical knowledge. We are dedicated to protecting the commitments we have made with them, including patient privacy.
We also abide by the agreements we have made with our co-development partners, which may set out different procedures, contractual agreements, and expectations. We also have an obligation to protect intellectual property rights and confidential company information.
Engaged with experts and stakeholders for governance framework
We are fully engaged with experts and stakeholders, both internally and externally, across academia, government and industry, on a unified approach, including common processes and procedures, for handling CSR requests, and on a governance framework to protect patient privacy, intellectual property, and scientific integrity, while creating greater transparency to advance medical knowledge and science.
For more information about our clinical trials please visit: