Trusted Resource for Clinical Trials, Protocols & Progress
This SOP describes the procedures for aligning sponsor and investigator activities with the China GCP (2020) requirements and securing necessary approvals from the National Medical Products Administration (NMPA). It ensures compliance with regulatory and ethical obligations for clinical trials conducted in China.
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This SOP establishes the procedures for securing approvals for the collection, use, storage, and export of Human Genetic Resources (HGR) in clinical trials conducted in China. It defines sponsor, investigator, and institutional responsibilities to ensure compliance with Chinese HGR regulations under the National Medical Products Administration (NMPA) and the Ministry of Science and Technology (MOST).
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The purpose of this SOP is to establish requirements for the localization of clinical trial data in China and define governance measures for cross-border transfer of trial data. It ensures compliance with Chinese laws, NMPA regulations, and data protection standards to safeguard participant information and trial integrity.
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This SOP defines the process for preparing, translating, and quality-assuring Chinese language informed consent forms (ICFs) and other essential trial documents. It ensures participants fully understand trial information in their native language and that sponsors comply with NMPA and ICH GCP requirements for subject comprehension and regulatory submissions.
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