In clinical trials, why is AE bad or unexpected?

In the medical field, AE refers to the adverse events that occur after patients or clinical trial subjects receive drugs, but it does not necessarily have a causal relationship with treatment.

There are many kinds of adverse events, which can be divided into: drug adverse events, medical device adverse events and nursing adverse events. Unpreparable adverse events refer to the unpreparable damage caused by correct medical behavior; Preventable adverse events refer to injuries caused by errors or equipment failures that cannot be prevented during medical treatment.

The correlation is as follows

According to Article 47 of the Quality Management Standard for Drug Clinical Trials, inspectors shall supervise clinical trials in accordance with standard operating procedures to ensure that clinical trials are carried out as planned. The specific contents include:

(a) Before the test, confirm that the test taker has appropriate conditions, including staffing and training, and the laboratory is well equipped and running, and has various inspection conditions related to the test. It is estimated that there are enough subjects and the participating researchers are familiar with the requirements in the test plan. ?

(2) Monitor the researcher's implementation of the test plan during the test, confirm the informed consent of all subjects before the test, understand the selection rate of subjects and the progress of the test, and confirm that the selected subjects are qualified. ?

(three) to confirm that all data records and reports are correct and complete, and all case report forms are filled in correctly, which is consistent with the original data. All errors or omissions have been corrected or marked, signed and dated by the researcher. Dose changes, treatment changes, combined medication, intermittent diseases, lost visits and inspection omissions of each subject should be confirmed and recorded. Verify that the withdrawal and loss of follow-up of the selected subjects have been explained in the case report form.

(4) Confirm that all adverse events are recorded, and serious adverse events will report and record them within the specified time.

(5) Verifying the supply, storage, distribution and withdrawal of experimental drugs according to relevant laws and regulations, and making corresponding records.

(six) to assist the researchers to make the necessary notification and application, and report the test data and results to the applicant.