Role of the clinical research data manager in a clinical trial
The clinical research data manager plays a key role in the setup and conduct of a clinical trial. 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 research 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. Once subject enrollment begins, the data manager ensures that data is collected, validated, complete and consistent. The data manager liaise with other data providers (e.g. a central laboratory processing blood samples collected) and ensures that such data is transmitted securely and is consistent with other data collected in the clinical trial. At the completion of the clinical trial, the clinical research data manager ensures that all data expected to be captured has been accounted for and that all data management activities are complete. At this stage, the data is declared final (terminology varies but common descriptions are Database Lock and Database Freeze) and the clinical research data manager transfers data for statistical analysis.
This should be of interest to all. l think it fairly safe to assume that the 350th event has occurred if the results are to be announced within 6 weeks. What would be interesting to know is the timeframe to complete data management activities in order to declare the lock in.
ACL Price at posting:
56.5¢ Sentiment: Hold Disclosure: Held
(20min delay)