Clinical Trial Management | MARS (Medical Agency for Research and Statistics)

Site evaluation and selection
Review of inclusion exclusion criteria
Subjects consent forms
Subject recruitment
Review of quality systems at the site
Ensure all sites are audit ready
Initiate interim monitoring
Essential document collection, review and processing
Good Clinical Practice training for the research site staff
CAPA plan development and implementation
Source documentation review
CRF review and query resolution
Review of accountability for all study documents
Review of Investigational Product storage
Review of safety information of all subjects
Logging and correcting of protocol deviations
Monitoring study progress
Communication with sites
Database lock and study close out