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Clinical data management (CDM) is a wide field of study that encompasses everything from entering data obtained during a clinical trial to validating and quality checking it. A vital part of clinical analysis, data management helps ensures that all the information obtained during the clinical trial is accurate. Collecting and validating data obtained during clinical trials are of great importance as it not only determines the fate of the manufactured drug, but also of the company that produces it. The results also have a great significance in the lives of the patients. Therefore, there are many rules and standard operating procedures that have to be followed while collecting and managing clinical data. Clinical data management ensures that all the procedures have been correctly followed during the data collection process. This procedure also checks if the collected data is complete and consistent. Clinical development management also ensures that the right kind of information is provided to the right person in the chain. The researchers developing the drug and the company manufacturing the medicine; each requires data in a different format. CDM helps classify all the data and label them into different formats, so the right people get the right format of the clinical trial results. A Case Report Form should be prepared and submitted to the concerned authorities. This report has various attributes such as data entry, data validation and data query. The data entry person helps create a digital copy of all the collected data. Even if the data is collected in different formats, everything is converted to a single format and entered, which makes validation easy. After all the data is entered, a quality person checks the entries to ensure no errors are made during the transfer. Once the data entry stage is completed, any queries regarding the collected data are raised and verified by the researchers. Another similar report, called the Patient Recorded Data Form is created if the clinical trial involves collecting personal and medical details of the patient. Some clinical data management service providers make use of technology and software to ensure precise results each time. The software used varies from one service provider to another. These software programs allow researchers to collate, consolidate and analyze large amounts of data in short spans of time. Such software also helps create various reports quickly and easily. They also create a backup of all the data, which can be used in future, if required.

What is clinical data management  

ICBio Clinical Research, Clinical Data Management Training Institute in Bangalore, India offers Pharmacovigilance Training, MSc Clinical Res...