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Clinical Research Overview: 


There is so much more to research than most people could imagine... 


Research involves a systematic investigation designed to develop or contribute to generalizable knowledge, including research development, testing, and evaluation.


Research with - Human subjects - involves a living individual about whom an investigator (whether professional or student) conducting research obtains: 


Data is collected through intervention or interaction with the individual or identifiable private information.


U.S. Department of Health & Human Services: Governs Human Research Regulations (45 CFR 46)-- Current information via link below...



What is clinical research? 


Research that either directly involves a particular person or group of people or uses materials from humans, such as their behavior or samples of their tissue, which can be linked to a specific living person (National Institutes of Health).


Clinical research involves two main components: anatomy and physiology.


In simple terms, the anatomy of research is the study's structure. It consists of the tangible elements of the study plan, including the background, significance, research question (PICO method or FINER method), design (observational- cohort, cross-sectional or case-control; clinical trial), subjects (inclusion and exclusion criteria), measurements, etc. The objective of preparing the blueprint for the anatomy of the study is to create these elements to make the project feasible, efficient, and cost-effective (Hully et al., 2013).


The physiology of research is how the study works. A helpful study yields valid inferences about (1) what happened in the study and (2) how the findings can be generalized to people outside the study. The goal is to minimize systematic and random errors that threaten conclusions based on the inferences (Hulley et al., 2013). 


More to come... 


Reference:


Hulley, S.B., Cummings S.R., Browner, W.S., Grade, D.G., & Newman, T.B. (2013 ). Designing clinical research ( 4th ed.). Pennsylvania: Lippincott Williams and Wilkins.


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