GOOD CLINICAL PRACTICE COMPREHENSIVE EXAM
UPDATED QUESTIONS AND ANSWERS GRADED A+
✔✔Any study of a drug or device in humans submitted in a marketing application that the applicant or
FDA relies on to establish that the product is effective or any study in which a single investigator makes a
significant contribution to the demonstration of safety.
a. Phase 2 Clinical Study
b. Clinical Pharmacology Study
c. Covered Clinical Study
d. Phase 1 Clinical Study - ✔✔c. Covered Clinical Study
✔✔Payments that have a cumulative monetary value of $25,000 or more and are made
by any sponsor of a study to the investigator or the investigator's institution during the
time the clinical investigator is carrying out the study and for one year following
completion of the study.
a. Equity Interest
b. Financial Interest
c. Significant Payments of Other Sorts
d. Proprietary Interest - ✔✔c. Significant Payments of Other Sorts
✔✔A copy of the original record that has been verified to have the same information,
including data that describe the context, content, and structure, as the original.
a. Certified Copy
b. Clinical Study Report
c. Essential Study Document
d. Source Document - ✔✔a. Certified Copy
✔✔An adverse reaction, the nature or severity of which is not consistent with the
applicable product information.
a. Unexpected Adverse Drug Reaction
b. Adverse Event
c. Serious Adverse Drug Reaction
d. Serious Adverse Drug Event - ✔✔a. Unexpected Adverse Drug Reaction
✔✔A document that describes the strategy, methods, responsibilities, and requirements
for monitoring the trial.
a. Audit Report
b. Monitoring Report
c. Clinical Development Plan
, d. Monitoring Plan - ✔✔d. Monitoring Plan
✔✔A person responsible for the conduct of the clinical trial at a trial site.
a. Investigator
b. Study Coordinator
c. Site Monitor
d. Medical Monitor - ✔✔a. Investigator
✔✔The process of assigning trial subjects to treatment or control groups using an
element of chance to determine the assignments in order to reduce bias.
a. Stratification
b. Masking
c. Randomization
d. Blinding - ✔✔c. Randomization
✔✔Original documents, data, and records (e.g., hospital records, clinical and office
charts, laboratory notes, subjects' diaries or evaluation checklists, etc. kept at the
pharmacy, at the laboratories and at medical or technical departments involved in the
clinical trial).
a. Source Documents
b. Clinical Study Reports
c. Certified Copies
d. Clinical Trial Records - ✔✔a. Source Documents
✔✔A written description of a study of any therapeutic, prophylactic, or diagnostic agent
conducted in human subjects, in which the clinical and statistical description,
presentations, and analyses are fully integrated into a single report.
a. Compliance Report
b. Monitoring Report
c. Audit Report
d. Clinical Study Report - ✔✔d. Clinical Study Report
✔✔Permission to examine, analyze, verify, and reproduce any records and reports that
are important to evaluation of a clinical trial.
a. Waiver
b. Informed Consent
c. Direct Access
d. Audit - ✔✔c. Direct Access
UPDATED QUESTIONS AND ANSWERS GRADED A+
✔✔Any study of a drug or device in humans submitted in a marketing application that the applicant or
FDA relies on to establish that the product is effective or any study in which a single investigator makes a
significant contribution to the demonstration of safety.
a. Phase 2 Clinical Study
b. Clinical Pharmacology Study
c. Covered Clinical Study
d. Phase 1 Clinical Study - ✔✔c. Covered Clinical Study
✔✔Payments that have a cumulative monetary value of $25,000 or more and are made
by any sponsor of a study to the investigator or the investigator's institution during the
time the clinical investigator is carrying out the study and for one year following
completion of the study.
a. Equity Interest
b. Financial Interest
c. Significant Payments of Other Sorts
d. Proprietary Interest - ✔✔c. Significant Payments of Other Sorts
✔✔A copy of the original record that has been verified to have the same information,
including data that describe the context, content, and structure, as the original.
a. Certified Copy
b. Clinical Study Report
c. Essential Study Document
d. Source Document - ✔✔a. Certified Copy
✔✔An adverse reaction, the nature or severity of which is not consistent with the
applicable product information.
a. Unexpected Adverse Drug Reaction
b. Adverse Event
c. Serious Adverse Drug Reaction
d. Serious Adverse Drug Event - ✔✔a. Unexpected Adverse Drug Reaction
✔✔A document that describes the strategy, methods, responsibilities, and requirements
for monitoring the trial.
a. Audit Report
b. Monitoring Report
c. Clinical Development Plan
, d. Monitoring Plan - ✔✔d. Monitoring Plan
✔✔A person responsible for the conduct of the clinical trial at a trial site.
a. Investigator
b. Study Coordinator
c. Site Monitor
d. Medical Monitor - ✔✔a. Investigator
✔✔The process of assigning trial subjects to treatment or control groups using an
element of chance to determine the assignments in order to reduce bias.
a. Stratification
b. Masking
c. Randomization
d. Blinding - ✔✔c. Randomization
✔✔Original documents, data, and records (e.g., hospital records, clinical and office
charts, laboratory notes, subjects' diaries or evaluation checklists, etc. kept at the
pharmacy, at the laboratories and at medical or technical departments involved in the
clinical trial).
a. Source Documents
b. Clinical Study Reports
c. Certified Copies
d. Clinical Trial Records - ✔✔a. Source Documents
✔✔A written description of a study of any therapeutic, prophylactic, or diagnostic agent
conducted in human subjects, in which the clinical and statistical description,
presentations, and analyses are fully integrated into a single report.
a. Compliance Report
b. Monitoring Report
c. Audit Report
d. Clinical Study Report - ✔✔d. Clinical Study Report
✔✔Permission to examine, analyze, verify, and reproduce any records and reports that
are important to evaluation of a clinical trial.
a. Waiver
b. Informed Consent
c. Direct Access
d. Audit - ✔✔c. Direct Access
