The determination of inspection in clinical trials should be carried out by professional doctors or personnel with corresponding qualifications. These personnel need to have relevant medical knowledge and skills, and be able to accurately interpret and judge the examination results.
In clinical trials, the specific determination steps are as follows:
1. When conducting clinical trials, medical personnel with corresponding qualifications or other relevant personnel are responsible for the specific implementation and judgment of the tests.
2, medical personnel or other relevant personnel should according to the requirements of the test plan and relevant laws and regulations, to participate in the test of the subjects to carry out the corresponding inspection and inspection.
3. During the inspection and inspection, medical personnel or other relevant personnel shall make detailed records of the physical condition, illness and medical history of the subject, and make a review and signature confirmation according to the prescribed procedures.
4, for the test results and test data, medical personnel or other relevant personnel should conduct a comprehensive analysis and evaluation, to determine whether the physical condition of the subject meets the test requirements, and whether it is necessary to take corresponding treatment measures.
5, in the process of judgment, medical personnel or other relevant personnel should according to the requirements of the inspection plan and relevant laws and regulations, the inspection results and inspection data for strict review and comparison, to ensure the accuracy and reliability of the data.
6. In case of serious adverse events or abnormal conditions in clinical trials, medical personnel or other relevant personnel shall report to the applicant in time and take corresponding measures to ensure the safety and health of the subjects.
7. After the clinical trial, medical personnel or other relevant personnel should sort out and analyze all the test results and data, and summarize and write a report according to the prescribed procedures.
In a word, the determination of tests in clinical trials is a very important work, which needs to be carried out by professional doctors or personnel with corresponding qualifications. These personnel need to have relevant medical knowledge and skills, and can accurately interpret and judge the test results to ensure the accuracy and reliability of clinical trials.