Clinical research is a branch of science in health care that deals with the safety and effectiveness of drugs, devices, and diagnostic products intended for human use. These can be used for the prevention, treatment, diagnosis of a disease. Clinical research enables researchers to find better ways to understand, detect, control, and treat human diseases. Clinical research is a way to find answers to difficult scientific or health questions. A clinical study will be carried to identify what causes people to get a disease (observational study), surgical procedure, or lifestyle change can cure or prevent a disease from occurring (interventional study). Clinical research is a type of study for the use of human subjects. It can include observational studies, in which subjects are followed over a period of time to determine health output. Clinical research may also be used to determine the usefulness and safety of a new diagnostic procedure or drug treatment. Clinical research studies are planned in prior and follow a defined protocol and epidemiologic studies examine the specific populations to clarify how frequently a disease occurs, the individual factors that can cause or worsen disease progression.
Clinical Trial Data quality is evaluated on the basis of clinical trial results to ensure accurate and reliable results of clinical trials, scientific credibility of the international community and countries in the world have issued a series of rules, regulations, and guidelines to regulate the management of clinical trial data of the entire process. clinical trials and data management standardization provide new technical support, also contributed to the international community to actively explore the clinical test data management and standardization of new models. Conference on Harmonization of clinical study drug quality management practices, ICH E6 GCP for clinical trial data management has a principled requirement. To carry out clinical trials, research and maintenance of source data, verification, and all types of data obtained in clinical trials true, accurate, complete, and reliable.
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