Who is responsible for safety evaluation during drug trials?

The sponsor is responsible for the safety evaluation during the drug trial.

(a) the applicant is responsible for providing experimental drugs to researchers and clinical trial institutions.

(2) The applicant shall not provide experimental drugs to researchers and clinical trial institutions before the clinical trial has been reviewed by the Ethics Committee and approved or put on record by the drug supervision and administration department.

(3) The applicant shall provide the researchers and clinical trial institutions with written descriptions of the experimental drugs, which shall clearly specify the use, storage and relevant records of the experimental drugs.

(four) the applicant shall ensure that the experimental drugs are delivered to the researchers and clinical trial institutions in time, and ensure that the subjects use them in time; Keep records of transportation, receipt, distribution, recovery and destruction of experimental drugs; Establish a management system for the recovery of experimental drugs to ensure the recall of defective products, recovery after testing and recovery after failure; Establish the system of destroying unused experimental drugs.

(5) The applicant shall take measures to ensure the stability of the test drug during the trial. The retention period of test drug samples should be kept until the end of clinical trial data analysis or the period required by relevant laws and regulations, whichever is longer.