Data management in clinical researchJuly 24, 2013 2013-07-24 15:06
Data management in clinical research
Clinical Data management in clinical research involves the process of data compilation & clean-up, to organize clinical data in compliance with good clinical data management practices and applicable regulatory requirements. The fundamental objective of clinical data management (CDM) process is to provide superior-quality data by reducing data entry errors and avoid negligible data as far as possible and gather maximum relevant data for analysis. To achieve this objective, best clinical data management practices in clinical research are adopted to make sure that the data is comprehensive, consistent, and thoroughly checked. This can be achieved by using 21 CFR 11 compliance software tools that keep up an audit trial and offer easy detection and resolution of discrepancies if any.
As a clinical study is deliberated to produce data for a research attempt, the data management in clinical research is destined to produce an error-free, convincing and statistically relevant database. To accomplish this goal, the Clinical Data Management process starts little early even before the finalization of the clinical trial protocol.
There are several tools available for clinical data management in clinical research and these are popularly called Clinical Data Management Systems (CDMS). In multi-location trials, CDMS are of essentiality & of great purpose to handle vast amount of data generated simultaneously from different sites distributed across several continents.