Once subject enrollment begins, the data manager ensures that data is collected, validated, complete, and consistent. 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. 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 plays a key role in the setup and conduct of a clinical trial. Job profile acceptable in CDM: clinical researcher, clinical research associate, clinical research coordinator etc. Role of the clinical data manager in a clinical trial
6 Professional organizations for clinical data management.3.6 Serious adverse event reconciliation.1 Role of the clinical data manager in a clinical trial.
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