FREE Introduction to Certified Clinical Research Associate Questions and Answers

Question 1

Statistical evaluation of subject data according to the group they were placed in despite not adhering to the study protocol

Accepted Answer

Intention to treat analysis

Answer

Random assignment

Answer

Blinding of subjects

Answer

A-b-a or withdrawal design

Question 2

The initial recording of data for a clinical study is called __________ and comprises notes from observations, lab results, and other relevant documents.

Accepted Answer

Source Document

Answer

Storage Fees

Answer

Sales Invoice

Answer

Source Data

Question 3

When an investigator is taking part in a fresh protocol that has been added to the IND
When a fresh researcher is brought into the research

Accepted Answer

In the guidance, the FDA noted that there are two instances when it is necessary for an investigator to complete and sign a new Form FDA 1572:

Answer

Once an IND application becomes effective, a sponsor-investigator is required to submit the following reports/updates to the FDA.

Answer

If a research pharmacy is not available, investigational products can be stored in other areas as long as the following requirements are met

Answer

Blister packages (where each drug is placed in an individual plastic dome on a card) enhance compliance in three ways:

Question 4

Analysis of all trial participants who followed procedure and finished the experiment

Accepted Answer

per protocol analysis

Answer

repeated measures

Answer

blinding of the researchers

Answer

bayesian approaches

Question 5

Dosage and safety (Find out how the medicine affects human metabolism and pharmacology).

Accepted Answer

Primary purpose of a phase 1 study?

Answer

Non-refundable start-up fees:

Answer

ICH HARMONISED TRIPARTITE GUIDELINE E11

Answer

Type of Trial Comparisons?

Question 6

Any type of legal body, such as a business, a nonprofit group, or an individual, may serve as _______

Accepted Answer

Sponsor

Answer

Principal

Answer

Lis Pendens

Answer

Institution

Question 7

The IRB is not required under the FDA standards to make sure that children's consent is secured.

Accepted Answer

Investigational Drug

Answer

Phase I Clinical Trials

Answer

Formulary Drug

Answer

Established Drug