The role of the CRO is to conduct research in terms of:
Data quality assurance
Monitoring the study
Verifying the correctness of the data against the source documentation
Help investigatos and research teams
Support for clinical trial documentation including:
Study protocol
Investigator's Brochures
The Informed Consent Form (ICF)
and Information form for the patient
Administrative support:
perform comprehensive site management and monitoring activities to include the following types of monitoring visits:
Complete the necessary documents
Application submission to EC and CA
Keeping correspondence with EC (KB) and CA (URPL)
Trainings
Good Clinical Practice (GCP)
Study specific trainings - procedures
Principles of keeping source documentation
Data entry to the database (CRF)
Cooperating Universities
