The ultimate goal of CDM is to assure that data support conclusions drawn from research.
The data collected during a clinical trial forms the basis of subsequent safety and efficacy analysis which in turn drive decision making on product development in the pharmaceutical industry.
The clinical data manager is involved in early discussions about data collection options and then oversees development of data collection tools based on the clinical trial protocol.
This paper focuses on the top e Clinical trends in 20.
During the past year, the clinical trial industry has made considerable progress in adopting technology as a way to streamline data collection, transmission, and monitoring.
From an ethical perspective, clinical data affect treatment decisions, which affect patient health, and the patient population in question is virtually all of the United States and a significant fraction of the rest of the world.
For both of these reasons, clinical data quality and integrity are critical.
In an industry that seems to be focused on cutting the cost of clinical trials, it’s no surprise that reducing the amount of source data verification (SDV) performed in studies—the process of cross-referencing data recorded in a case-report form to the original source information—is an integral part of risk-based monitoring (RBM) strategies.
Eliminating source data checks that do not add value to the study is certainly a breakthrough for trials where we have historically performed 100 percent data verification.
Trends are also being driven by FDA embracing technology, and willingness to dialogue with experts on how to best channel this revolution in order to advance clinical research.
The move from conducting clinical trials on paper to Electronic Data Capture (EDC) has accelerated over the past 10 years in an overall effort to increase data quality and regulatory compliance and reduce costs.
Job profile acceptable in CDM: clinical researcher, clinical research associate, clinical research coordinator etc.