Title 15. DATA MANAGEMENT _ ITS COMPONENTS.pdf ✅

PHARMD GURU Page 1 1) Clinical data management is the collection, integration, and validation of clinical trial data. 2) During the clinical trial, the investigators collect the data of patient’s health for a definite time period. 3) The collected data is sent to the sponsor, who then analyzes the pooled data using statistical analysis. 4) This data gathered at the investigator site in the Case Report Form (CRF) and stored in Clinical data management system. 5) CRF is a paper or electronic questionnaire, used as a tool in the clinical trial to collect and record the data on each patient from each participating site. CRF’S ALLOW US TO:  Record the data in a manner that is both efficient and accurate.  Recording the data in a manner is suitable for processing, analysis, and reporting. STEPS IN DATA MANAGEMENT PROCESS: PUBLICATION DATA REPORTING DATA ANALYSIS DATA CLEANUP DATA VALIDATION DATA ENTRY DATA COLLECTION DATA DESIGN DATA MANAGEMENT & ITS COMPONENTS