Anatomy And Physiology Of Clinical Research Flashcards
Protocol
The written plan of the study
Research Question
Is the objective of the study; the uncertainty the investigator wants to solve
Define: FINER
Feasible, interesting, novel, ethical, relevant
Background and significance
The section of a protocol that sets the proposed study in context and gives its rationale
Observational Study
Observing the events taking place in the study subjects
Clinical trial
Apply an intervention and examine its effects on these events
Cohort Studies
A type of observational study in which observations are made in a group of subjects that is followed over time
Cross-sectional Study
Observations are made on a single occasion
Prospective Study
A cohort study that begins in the present and follow subjects into the future
Retrospective Study
Cohort study that examines information and specimens that have been collected in the past
Case-control Design
Cohort study that compares a group of people who have a condition with another group who do not
Randomized Blinded Trial
Clinical trial where subjects are chosen at random and both investigator and subjects do not know who receives the treatment
Descriptive Study
Observational study that explores the lay of the land; might describe distributions
Analytic Studies
Evaluate associations to permit inferences about cause-and-effect relationships
Inclusion/exclusion Criteria
Define the target population in a study
Predictor Variable
The treatment in a study
Outcome Variable
The outcome of a study
Confounding Variables
Other predictors of the outcome that could be related to the effects of the intervention and confuse the interpretation of the findings
Statistical Power
Reasonable probability in a study
Internal Validity
The degree to which the investigator draws the correct conclusions about what actually happened in the study.
External Validity
The degree to which these conclusions can be appropriately applied to people and events outside the study.
Random Error
Is a wrong result due to chance.
Systematic Error
Is a wrong result due to bias.
Descriptive Statistics
Has to do with collecting, organizing, summarizing, and presenting data.
Inferential Statistics
Has to do with drawing inferences or conclusions (making conjectures) about populations based on information from samples.
Parametric Test
Assume that the data approximates a certain distribution.
Non-parametric test
Assumes the data does not approximate a normal distribution.
Central Tendency
A representative value from the data
Dispersion
How much the data deviates from the central tendency
What measure of central tendency is appropriate at the nominal level?
Mode
What level of measurement of central tendency is appropriate at the ordinal level?
Mode
Median
What level of measurement is appropriate at the interval/ratio level?
Mode
Median
Mean
What is the appropriate measure of dispersion at the nominal level?
None as all measures of dispersion require quantitative data
What is the appropriate measure of dispersion at the ordinal level?
Range
Interquartile (preferred since it’s more informative)
What is the appropriate measure of dispersion at the interval/ratio level?
Range Interquartile range Standard deviation (if there is skewness or outliers use interquartile range)
