Anatomy And Physiology Of Clinical Research

Question 1

Protocol

Answer 1

The written plan of the study

Question 2

Research Question

Answer 2

Is the objective of the study; the uncertainty the investigator wants to solve

Question 3

Define: FINER

Answer 3

Feasible, interesting, novel, ethical, relevant

Question 4

Background and significance

Answer 4

The section of a protocol that sets the proposed study in context and gives its rationale

Question 5

Observational Study

Answer 5

Observing the events taking place in the study subjects

Question 6

Clinical trial

Answer 6

Apply an intervention and examine its effects on these events

Question 7

Cohort Studies

Answer 7

A type of observational study in which observations are made in a group of subjects that is followed over time

Question 8

Cross-sectional Study

Answer 8

Observations are made on a single occasion

Question 9

Prospective Study

Answer 9

A cohort study that begins in the present and follow subjects into the future

Question 10

Retrospective Study

Answer 10

Cohort study that examines information and specimens that have been collected in the past

Question 11

Case-control Design

Answer 11

Cohort study that compares a group of people who have a condition with another group who do not

Question 12

Randomized Blinded Trial

Answer 12

Clinical trial where subjects are chosen at random and both investigator and subjects do not know who receives the treatment

Question 13

Descriptive Study

Answer 13

Observational study that explores the lay of the land; might describe distributions

Question 14

Analytic Studies

Answer 14

Evaluate associations to permit inferences about cause-and-effect relationships

Question 15

Inclusion/exclusion Criteria

Answer 15

Define the target population in a study

Question 16

Predictor Variable

Answer 16

The treatment in a study

Question 17

Outcome Variable

Answer 17

The outcome of a study

Question 18

Confounding Variables

Answer 18

Other predictors of the outcome that could be related to the effects of the intervention and confuse the interpretation of the findings

Question 19

Statistical Power

Answer 19

Reasonable probability in a study

Question 20

Internal Validity

Answer 20

The degree to which the investigator draws the correct conclusions about what actually happened in the study.

Question 21

External Validity

Answer 21

The degree to which these conclusions can be appropriately applied to people and events outside the study.

Question 22

Random Error

Answer 22

Is a wrong result due to chance.

Question 23

Systematic Error

Answer 23

Is a wrong result due to bias.

Question 24

Descriptive Statistics

Answer 24

Has to do with collecting, organizing, summarizing, and presenting data.

Question 25

Inferential Statistics

Answer 25

Has to do with drawing inferences or conclusions (making conjectures) about populations based on information from samples.

Question 26

Parametric Test

Answer 26

Assume that the data approximates a certain distribution.

Question 27

Non-parametric test

Answer 27

Assumes the data does not approximate a normal distribution.

Question 28

Central Tendency

Answer 28

A representative value from the data

Question 29

Dispersion

Answer 29

How much the data deviates from the central tendency

Question 30

What measure of central tendency is appropriate at the nominal level?

Answer 30

Mode

Question 31

What level of measurement of central tendency is appropriate at the ordinal level?

Answer 31

Mode | Median

Question 32

What level of measurement is appropriate at the interval/ratio level?

Answer 32

Mode Median Mean

Question 33

What is the appropriate measure of dispersion at the nominal level?

Answer 33

None as all measures of dispersion require quantitative data

Question 34

What is the appropriate measure of dispersion at the ordinal level?

Answer 34

Range | Interquartile (preferred since it's more informative)

Question 35

What is the appropriate measure of dispersion at the interval/ratio level?

Answer 35

``` Range Interquartile range Standard deviation (if there is skewness or outliers use interquartile range) ```