Question: How can both parties reach a consensus when the applicant uses the SOP of the central laboratory, such as how can the applicant be informed of the SOP content of the central laboratory? Is it necessary to transfer the SOP of the central laboratory to the applicant for internal controlled documents
Answer: The development of the SOP for the central laboratory is to standardize the responsibilities of internal personnel in the laboratory, as well as the standards and processes related to laboratory activities, to ensure compliance with relevant regulations, certification standards, guiding principles, etc. The responsibilities of both the sponsor and the laboratory are generally clearly defined in the contract, laboratory project work instructions, or other project related documents that need to be signed and followed by both parties. If the applicant needs to refer to the content of the SOP of the central laboratory, it is recommended to reach a consensus with the central laboratory on how to obtain the content of the SOP, and develop operational procedures related to the activities of the central laboratory according to the internal document management process.