Document background
The Clinical Study Agreement serves as the primary contractual document for establishing and governing clinical trials in Hong Kong. It is essential when any organization wishes to conduct clinical research involving human subjects, typically used by pharmaceutical companies, biotechnology firms, or medical device manufacturers collaborating with healthcare institutions. The agreement must comply with Hong Kong's regulatory framework, including the Pharmacy and Poisons Ordinance, Hospital Authority guidelines, and data privacy laws, while also adhering to international clinical practice standards. It comprehensively addresses crucial aspects such as trial protocol, participant safety, data management, financial terms, and intellectual property rights, ensuring all parties understand their roles, responsibilities, and obligations throughout the clinical trial process.
