Milly Nakatabira

Clinical Research Fastrack Trainee @Clinical Research Fastrack

Baltimore, MD, US

ICH-GCP E6 (R2)-FDA Regulations 21 CFR11, 50, 54 and the Common Rule 45CFR46-Data Management-Informed Consent Process-Clinical Trial Operations from feasibility through close-out-GDP following ALCOA-C principles-Identification and reporting of AEs and SAEs-Quality Assurance, Monitoring and Query Resolution-Comprehension and Execution of Clinical Trial Protocols-Maintaining a regulatory binder, housing essential documents including but not limited to 1572, DOA, Training Logs, and other Investigator Site File (ISF) documents

Makerere University

Bachelor's degree

Johns Hopkins Bloomberg School of Public Health

Certificate

Makerere Univeristy school of Statistics

Certificate

Lund University

Master of Science - MS

Clinical Research Fastrack

Certificate

CITI

Certificate