Investigação Clínica: Contexto Histórico e Diretrizes Atuais

Code	16706
Year	1
Semester	L0
ECTS Credits	3
Workload	OT(60H)/T(20H)/TP(5H)
Scientific area	Health Sciences
Entry requirements	not applicable
Learning outcomes	Framing the historical context of clinical research in current legislation and study design. Identify the historical events and evolution of clinical research; Identify the different phases of drug development; Recognize the importance of study design and protocol preparation.
Syllabus	- Historical introduction to clinical trials and relation to current legislation; - Clinical and translational research (bench-to-bedside); - Study design and protocol preparation.
Main Bibliography	Zgheib, N. K., Tomasic, S. L., & Branch, R. A. (2017, January 1). Chapter 15 - Good Clinical Practice and Good Laboratory Practice (D. Robertson & G. H. Williams, Eds.). ScienceDirect; Academic Press Kandi, V., & Vadakedath, S. (2023). Clinical Trials and Clinical Research: A Comprehensive Review. Cureus, 15(2), 1–15.
Language	Portuguese. Tutorial support is available in English.