Objective of this platform: is to set up a user-friendly database infrastructure which amalgamates the clinical research needs of the individual / groups of investigator initiated research / study. By utilizing Web-based technology, open source system and the mid-range level of data security will be leveraged to support the research team with access to data that can support current and future clinical research endeavours.
Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. The vehicle to support CDM process is a reliable eCRF platform.
Various procedures in CDM including Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality at regular intervals during a trial. In the present scenario, there is an increased demand to improve the CDM standards to meet the standard good practices. Many software tools are available for data management, and these are called Clinical Data Management Systems (CDMS). In multicentric trials, a CDMS has become essential to handle the huge amount of data. Most of the CDMS used in pharmaceutical companies are commercial, but a few open source tools are available as well. These CDM software are available free of cost and are as good as their commercial counterparts in terms of functionality.
Sample size and power are key elements of any study. It is advisable to take the help of a statistician at this stage of the study as well. Authors must provide detailed information regarding the sample size calculation used when publishing their papers. Many null studies may be underpowered to detect the desired difference due to a smaller sample size.
Randomization as a method of experimental control has been extensively used in human clinical trials and other clinical research. It prevents the selection bias (to write more)