An Overview of Drug Development:
Preclinical research
Regulating drug development
Phases of clinical research
Developing informed consent materials
Site selection
Following up a study
Marketing a drug
The role of the CRA in drug development
Conducting the Study Initiation Visit:
Preparing for the visit
Group meeting study overview
Group meeting Protocol/CRF
Individual contacts
Preparing documentation and following up
Appendices and exhibits
Identifying & Screening Investigators:
Significance of investigator selection
Identifying potential investigators
Contacting potential investigators
Selection criteria
Investigators access to subjects
Time and cost factors
Conducting Routine Monitoring Visits:
Types of monitoring visits
Preparing for the visit
Making the first visit
Conducting routine monitoring visits
Closing out a study
Regulatory and certification requirements
Adverse events
Query verification
Monitoring reports
The CRAs Reference for Adverse Events:
What is an adverse event?
Why are AEs so important?
CRF recording procedures
AE reporting procedures
AE reporting for marketed drugs
Adverse event management
Reporting adverse events under ICH Guidelines and FDA regulations
Conducting the Prestudy Visit:
Preparing for the prestudy visit
Conducting the prestudy visit
Assessing the site
Documenting the prestudy visit
Exhibits sample agendas, budget worksheets and forms
Appendix covering ICH Guideline for Good Clinical Practice
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