Clinical Data Management (CDMS) Course

Service Description

This Training Program will Include Module 1.Clinical Trail Process and Design Module 2.ICH-GCP and GCDMP Module 3.Clinical Data Management Systems CRF Design Data Entry & Data Collection Data Load/Transfer Data Storage Data Validation Data Export (SDTM) Query Management Data Archiving Quality Systems,SOPs and Audits Safety Management and Pharmacovigilance Data Management Systems and Tools Medical Codings and Medical Dictionaries CDMS, AERS,EDC,OCTMS Documentation and Document Management System Module 4.Statistical Analysis (analytical Tools) and Reporting Module 5.Project Management Module 6.Security Systems Practical Training will be also provided on Oracle Argus Safety Database on the following topics: Case processing MeDRA coding & WHO DD coding Duplicate Check and case initiation SAE Narrative writing

Contact Details