Question: ArrayBefore updating the researchers' manual, researchers should be informed first and communicate with the ethics committee and drug regulatory department if necessary. Why emphasize informing researchers before updating? How to execute notification? (GCP No. 57 of 2020, Article 75) @ @ GCP Article 47 "The applicant is responsible for the safety evaluation of the trial drug during the drug trial. The applicant shall promptly notify the researcher, clinical trial institution, and drug regulatory department of any issues found in the clinical trial that may affect the safety of the subject, affect the implementation of the clinical trial, or change the consent of the ethics committee. Article 48 of the GCP states that applicants shall report adverse drug reactions (SUSAR DSURs) in accordance with the requirements and time limits. The above information may be recorded in the researcher's manual, which is regularly updated, so it is necessary to communicate with the researcher/ethics committee/drug regulatory department before updating.