Why India?   Clinical Research Industry      Europe      Asia      Latin America      United States   Clinical Trials   Clinical Data Management   Central Reference Lab     CLINICAL DATA MANAGEMENT   01.What is Clinical Data Management?   Clinical Data Management is the technology and processes that manage clinical data to produce a high quality, clean and analyzable database.   02. Elements of Data management?   Elements of Data management consists of Data Management Plan, CRF Processing/Filing, Data Entry, Validation (Query Generation), Query Management, Coding, Quality Checks, Audits   03. What are the sources from which Clinical Data col-   Clinical data are collected from CRFs, Patient Diary Card, Lab Reports and Questionnaries   04. What is cleaning of CRF page ?   Cleaning of CRF means the collected data is made analyzable by statistics.   05. What are the Data Entry Methods?   Data Entry menu of Oracle Clinical 4.5.1 will be used to carry out data entry operations. Data is entered using double data entry method to make sure that the quality of the data is high.   06. What are Data Metric Reports?   Common metrics reported by data management are "number of queries generated per patient", or "number of data entry errors found in 10,000 fields", This metric will assess if data managers are producing quality data in the timeframe given for the study.   07. What is Medical Coding?   If textual or free text data are collected and reported, they usually must be coded before they can be aggregated and used in summary analyses. Medical history, adverse events, procedures, and medications are usually coded with standard dictionaries. The coding process consists of matching text collected on the CRF to terms in a standard dictionary. There are often items that cannot be matched, or coded without clarification from the site. WHODD and MedDRA are the dictionaries used for medical coding.   > next

Privacy Policy     Disclaimer