Clinical test managing method and system

Abstract

The invention discloses a clinical test managing method and system. The clinical test managing method includes the steps that information of a tested drug is obtained, according to preset drug information, the information of the tested drug is checked, and according to checking results, test items are established; according to the test items, a test scheme is established; the test scheme includes research content information and research stage information; according to the test scheme, testees' information is collected and recorded into the test scheme; according to testees' information and research stage information, clinical tests related to the research content information are conducted to obtain corresponding clinical test data and to record the corresponding clinical test data into the test scheme, and clinical test management is completed. According to the clinical test managing method and system, through the test scheme, the testees are centrally managed, related data is recorded, so that it is convenient for drug users and supervision departments to conduct checking, researchers synchronize real-time data at any time, diversified and integrated management on the clinical tests is achieved, the phenomenon of disordered clinical test data is reduced, and the reliability of clinical pharmacological test results is improved.

Description

technical field [0001] The invention relates to the technical field of information management, in particular to a clinical trial management method and system. Background technique [0002] Clinical trials are a complex experimental system involving many aspects such as pathology, pharmacology, ethics, and statistics. According to the definition of clinical trials in the "Quality Management Practices for Drug Clinical Trials" promulgated by the State Food and Drug Administration, clinical trials refer to any systematic research on drugs in humans (patients or healthy volunteers) to confirm or reveal the experimental drugs. The effect, adverse reactions and / or absorption, distribution, metabolism and excretion of the test drug, the purpose is to determine the efficacy and safety of the test drug. In foreign countries, people who participate in clinical trials are called volunteers, and in China they are generally called "subjects". Volunteers include healthy people and patien...

AI Technical Summary

Problems solved by technology

[0003] At present, almost all hospitals still rely on some existing systems that have been used clinically in the hospital for the management of subjects, such as the outpatient clinic system, inpatient doctor order system, etc., so that the management of subjects is the same as that of ordinary patients. Due to the relative isolation of data between different systems, it is easy to cause many problems such as incomplete data records, lagging data transmission, random data design, unprofessional data statistical analysis, and non-standard management of subjects, resulting in many problems such as pharmaceutical prescriptions, drug use, etc. It is difficult for parties and regulatory authorities to verify, researchers cannot synchronize real-time data, data confusion and other phenomena affect the reliability of clinical pharmacological test results

Images