Many biotechnology and pharmaceutical companies are working on the development of new devices, drugs and compounds and device for betterment of human health and increase the life quality globally. This process of drug development and discovery when attains the stage of testing in human volunteers includes people from different specialty and varies background. The last aim of any human trial is to be able to inquire the safety and efficacy of the investigative device or compound in human subjects with the regulatory guidelines and accepted standards of patient care, safety and data interpretation.
The clinical study
The initial stage of any clinical study includes the collection of data such as observational and laboratory of the trail subjects and is the most essential part in the study life cycle. Its this collected data, which will be used in analyzes of final end points of any study. The data quality and accuracy then become most essential thing. The greater the ambiguity of collected data the quicker will be the analyzes of the study objectives. This becomes critical in this aspect in the role of clinical data management.
Coming to the modern time the paper CRFs became the de- facto mode of collecting the observation data for any clinical data. This data which is collected then reaches the CDMD (Clinical Data Management Department). The main role of CDM is to confirm the data accuracy and correct any quality in it. This process will involve many backs and forth communication with the related investigative sites until hundred percent data is reported clean.
There are many CDMS which collects the source data from these paper CRFs. But in spite of having these systems there is still a space in global standardization in data naming conventions and an extensive range of forms and formats are being used to gather clinical trail information into these CDMS systems. Various companies have developed their own methods and processes. This has resulted in data being gathered and submitted to regulatory bodies in different formats and which in turn made the complete process of clinical study life cycle less streamlines and resulted in delays in various components of drug discovery and clinical trial process.
In order to create a global standard in how the data must be gathered and submitted to the regulatory bodies, the CDISC then tool the initiative to bring consensus on the standardization of not just in the data of submission but also, in the very source of data collection into CDMS. Initially, this was to come up with the format and standards in which the final data to be submitted to regulatory authorities. SDTM and ODM where the initially step from CDSIC in this direction. CDISC have worked with the FDA to help in the development of a complete electronic medical research process.
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