Role of clinical data managerJuly 7, 2013 2013-07-07 16:34
Role of clinical data manager
Role of clinical data manager :- Clinical trial is conducted to find out answers to the research queries by means of producing data to prove or disprove an assumption. Proper data management process will radically reduce time from drug development to commercialization. The clinical data management team ought to have sufficient process understanding that help in safeguarding the quality principles of CDM process.
The clinical data manager is accountable for managing the complete CDM practice. The data manager puts in place the Data Management Plan, endorse the CDM events and all in-house documents pertaining to CDM following Good clinical data management practices laid by the industry. Controlling and assigning the database access to team affiliates is also the duty of the data manager.
Through involvement with the study team during the plan of the study, the data manager gains the required understanding of the essential data based on the protocol specifications and the standards anticipated with respect to data integrity and quality. The data manager must have to sit with other team players during eCRF design as it is a vital quality step in generating the authentic data expected by the sponsors, regulatory compliance for safety and efficacy calculations.
The data manager must have to properly plan for when and how the data cleaning should be done. He ensures that the data entry is complete and quality checks are done before the medical coding. It he should take a call along with other stakeholders as when to proceed with database lock or freeze.