Module 2

Question 1

What is a Research
Protocol?

Answer 1

A detailed written plan of the study. The contents provide the background, specify the objectives, and describe the
design and organization of the trial. It is prepared before the acquisition of data,
and involves the collaboration of medical specialists with expertise in the therapeutic
area, clinical investigators, monitors, and a biostatistician

Question 2

PICO(S)

Answer 2

Population Intervention Comparator Outcome Setting

Question 3

Baseline
Characteristics

Answer 3

different data types:
* Continuous: measure of central
tendency (e.g., mean) and
measure of dispersion (e.g.,
standard deviation)
* Categorical: for each category –
(1) a count or (2) measure of
central tendency and measure of dispersion

Question 4

Primary
Question

Answer 4

It will be in the form of testing a
hypothesis

Question 5

Secondary
Question

Answer 5

Usually related to primary question. Data collected for the purpose of answering the primary question may also elucidate the secondary questions

Question 6

Subgroup hypotheses

Answer 6

Hierarchy in terms of credibility

Question 7

Intervention

Answer 7

potential benefit of the intervention must be maximized while possible toxicity is kept to a minimum

Question 8

Study Population

Answer 8

Subset of the population with the condition or characteristic of interest defined by the eligibility criteria

Question 9

Eligibility Criteria
Inclusion/Exclusion
Criteria

Answer 9

Conditions used to determine if
a person qualifies to participate
in a clinical trial

Question 10

Quality check

Answer 10

Review record to ensure:
Categories do not overlap and all categories are presented.
Range and direction of scores in baseline characteristics description are explained. Terms are understandable to the general public.

Question 11

Response variables/endpoints

Answer 11

Outcomes measured during the course of the trial, and they define and answer the question

Question 12

Event times

Answer 12

time to recurrence of cancer, survival time

Question 13

Counts

Answer 13

frequency of occurrence of migraine headaches, number of
uses of rescue meds for asthma

Question 14

Binary endpoints

Answer 14

no recurrence/recurrence, major cardiac event yes or no

Question 15

Ordered categories

Answer 15

absent, mild moderate, severe pain, NYHA status

Question 16

Unordered categories

Answer 16

categories of adverse experiences: GI, cardiac, etc.

Question 17

Adverse Event

Answer 17

Any untoward medical
occurrence associated with the use of a drug, whether or not considered drug related

Question 18

Serious Adverse Event

Answer 18

Death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or
substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect