MedDRA dictionary in eCRF.
Using the license, we have equipped eCRF.bizTM system with the MedDRA medical dictionary containing international medical terminology used in clinical trials, clinical trial reports, data presentation and medical coding.
The use of the MedDRA dictionary in the eCRF system provides global standardization of terminology in a regulatory-compliant study and allows to properly classify diseases, diagnoses, symptoms, therapeutic indications, tests, procedures, and medical history of patients.
After typing few letters into adverse event or medical history input fields a physicians can choose suitable low level term from the list of matching proposals, which make the process of medical coding, necessary in the preparation of a clinical study report, substantially easier. Data Managers use the dictionary in the Autocoder application, which allows partial automation of the medical coding process and verification of coding by Medical Monitors or other persons. The process of medical coding, like other aspects of work in the system, is documented using the audit trail module.