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Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. [1] Clinical data management ensures collection, integration and availability of data at appropriate quality and cost.
This analysis can be restricted to only the participants who fulfill the protocol in terms of the eligibility, adherence to the intervention, and outcome assessment. This analysis is known as an "on-treatment" or "per protocol" analysis. A per-protocol analysis represents a "best-case scenario" to reveal the effect of the drug being studied.
A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data.
Health care analytics is the health care analysis activities that can be undertaken as a result of data collected from four areas within healthcare: (1) claims and cost data, (2) pharmaceutical and research and development (R&D) data, (3) clinical data (such as collected from electronic medical records (EHRs)), and (4) patient behaviors and preferences data (e.g. patient satisfaction or retail ...
No matter how much time and effort go into conducting the clinical trial, if the correct data points were not collected, a meaningful analysis may not be possible. It follows, therefore, that the design, development and quality assurance of such an instrument must be given the utmost attention. The ICH guidelines on good clinical practice (GCP ...
Medical investigators often have difficulties in completing ITT analysis because of clinical trial issues like missing data or poor treatment protocol adherence. [ 3 ] To address some of these issues, many clinical trials have excluded participants after the random assignment in their analysis, which is often referred to as modified intention ...
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