CRA EXAM WITH ALL CORRECT & 100% VERIFIED
ANSWERS|ACTUAL COMPLETE EXAM|ALREADY
GRADED A+
ALCOA ✔Correct Answer-Attributable Legible Contemporaneous Original Accurate
Essential documents ✔Correct Answer-1572, Staff CV, Delegation Log, Medical Licenses, Lab
Certificates, IRB approvals, Lab normal ranges, Lab director CV, Blank ICF, Blank SAE, Protocol
Signature Page (PSP), Investigator Brochure (List sides effects of drug, Investigator Brochure Signature
Page, past visit confirmation letters, and follow up letters.
What is the role of a IRB? ✔Correct Answer-To Protect the subjects
Types of IRB ✔Correct Answer-Central: Private (everywhere)
Local: large hospitals
-minimum of 5 members
Lab Certificates ✔Correct Answer-CAP (College of American Pathologist)
CLIA (Clinical Laboratory Improvement Act)
FDA 1572 ✔Correct Answer-FDA legally binding document the PI signs stating all research will be
conducted according to regulatory guidelines.
Who are the players in clinical research? ✔Correct Answer--Regulatory Authority (FDA NAFDAC)
-Sponsor (Who, Pharma, NIH)
-Clinical Research Organization (CRO)
(Project Physician, Project Manager, CRA, Regulatory Personal, data manager, statistician
-Investigator Sub-Investigator, IRB/IEC
-CRC
Study Subjects (patients)
Single blind Study ✔Correct Answer-The subjects do not know what they are getting.
Double-blind Study ✔Correct Answer-The subjects and the observer does not know.
Selecting a PI
(Principal Investigator) Medical Doctor ✔Correct Answer-Experience, Education, Reputation,
Facility/Equipment, Staff, Location (access to subjects), Time to complete study, ensure they did not
vote on the study, Local or Central IRB?
Site Selection ✔Correct Answer-Site Selection Visit, Pre-evalution Visit
What document can you look to see the education and experience of someone ✔Correct Answer-
Curriculum Vitae
(CV)
, Nuremberg War Tribunal (1947) ✔Correct Answer-Criminal proceeding against 23 leading German
physicians and administrators for their war crimes against concentration camp subjects research
without their consent.
Syphilis Study in Tuskegee (1932-1972) ✔Correct Answer-Study of 600 low income African-
American males, 400 of whom infected with Syphilis monitored for 40 years. Cure in 1950, penicillin,
continued to study until 1972.
Thalidomide use ✔Correct Answer-Cause birth defects in over 12,000 babies, was not disclosed as
an investigational drug
U. S. Regulation Code and Guidelines ✔Correct Answer--Pure Food and Drug Act (1906)
-Food Drug and Cosmetic Act (1938) Replaced
-Nuremberg Code (1947)
-Kefaver Harris Amendments (1942)
-Declaration of Helsinki (1964-2000)
-The Belmont Report (1979)
-ICH/GCP-International Conference on Harmonization Good Clinical Practice (1996)
-FDA Moderation Act (1997)
What Are the 3 Basic Principles of the Belmont Report 1979? ✔Correct Answer--Respect for
Persons
-Beneficence
-Justice
CFR ✔Correct Answer-Code of Federal Regulations
Where do you store all the essential documents at the site? ✔Correct Answer-Site Master File or
Regulatory binder
What is a financial disclosure form? ✔Correct Answer-A form the PI has to sign to disclose any
financial interest in a company.
What is a placebo? ✔Correct Answer-The control in a study, given inactive.
What are 5 good qualities of essential documents? ✔Correct Answer-ALCOA
What process is used to eliminate bias when assigning subjects to a group. ✔Correct Answer-
Randomization
How do you know if the PI has signed received / signed the protocol? ✔Correct Answer-Protocol
Signature Page
Where do all the Investigator Site Files/Site Master Files go to be viewed by the Sponsor? ✔Correct
Answer-Trial Master File
TMF, sponsor electronic share drive system of scanned documents. CRA job to upload SMF to TMF.
What is scientific misconduct and what are the consequences? ✔Correct Answer-Falsification,
Fabrication, and Plagiarism. Jeopardize the study and legal action (fines, imprisonment, loss of
Medical Licenses)
ANSWERS|ACTUAL COMPLETE EXAM|ALREADY
GRADED A+
ALCOA ✔Correct Answer-Attributable Legible Contemporaneous Original Accurate
Essential documents ✔Correct Answer-1572, Staff CV, Delegation Log, Medical Licenses, Lab
Certificates, IRB approvals, Lab normal ranges, Lab director CV, Blank ICF, Blank SAE, Protocol
Signature Page (PSP), Investigator Brochure (List sides effects of drug, Investigator Brochure Signature
Page, past visit confirmation letters, and follow up letters.
What is the role of a IRB? ✔Correct Answer-To Protect the subjects
Types of IRB ✔Correct Answer-Central: Private (everywhere)
Local: large hospitals
-minimum of 5 members
Lab Certificates ✔Correct Answer-CAP (College of American Pathologist)
CLIA (Clinical Laboratory Improvement Act)
FDA 1572 ✔Correct Answer-FDA legally binding document the PI signs stating all research will be
conducted according to regulatory guidelines.
Who are the players in clinical research? ✔Correct Answer--Regulatory Authority (FDA NAFDAC)
-Sponsor (Who, Pharma, NIH)
-Clinical Research Organization (CRO)
(Project Physician, Project Manager, CRA, Regulatory Personal, data manager, statistician
-Investigator Sub-Investigator, IRB/IEC
-CRC
Study Subjects (patients)
Single blind Study ✔Correct Answer-The subjects do not know what they are getting.
Double-blind Study ✔Correct Answer-The subjects and the observer does not know.
Selecting a PI
(Principal Investigator) Medical Doctor ✔Correct Answer-Experience, Education, Reputation,
Facility/Equipment, Staff, Location (access to subjects), Time to complete study, ensure they did not
vote on the study, Local or Central IRB?
Site Selection ✔Correct Answer-Site Selection Visit, Pre-evalution Visit
What document can you look to see the education and experience of someone ✔Correct Answer-
Curriculum Vitae
(CV)
, Nuremberg War Tribunal (1947) ✔Correct Answer-Criminal proceeding against 23 leading German
physicians and administrators for their war crimes against concentration camp subjects research
without their consent.
Syphilis Study in Tuskegee (1932-1972) ✔Correct Answer-Study of 600 low income African-
American males, 400 of whom infected with Syphilis monitored for 40 years. Cure in 1950, penicillin,
continued to study until 1972.
Thalidomide use ✔Correct Answer-Cause birth defects in over 12,000 babies, was not disclosed as
an investigational drug
U. S. Regulation Code and Guidelines ✔Correct Answer--Pure Food and Drug Act (1906)
-Food Drug and Cosmetic Act (1938) Replaced
-Nuremberg Code (1947)
-Kefaver Harris Amendments (1942)
-Declaration of Helsinki (1964-2000)
-The Belmont Report (1979)
-ICH/GCP-International Conference on Harmonization Good Clinical Practice (1996)
-FDA Moderation Act (1997)
What Are the 3 Basic Principles of the Belmont Report 1979? ✔Correct Answer--Respect for
Persons
-Beneficence
-Justice
CFR ✔Correct Answer-Code of Federal Regulations
Where do you store all the essential documents at the site? ✔Correct Answer-Site Master File or
Regulatory binder
What is a financial disclosure form? ✔Correct Answer-A form the PI has to sign to disclose any
financial interest in a company.
What is a placebo? ✔Correct Answer-The control in a study, given inactive.
What are 5 good qualities of essential documents? ✔Correct Answer-ALCOA
What process is used to eliminate bias when assigning subjects to a group. ✔Correct Answer-
Randomization
How do you know if the PI has signed received / signed the protocol? ✔Correct Answer-Protocol
Signature Page
Where do all the Investigator Site Files/Site Master Files go to be viewed by the Sponsor? ✔Correct
Answer-Trial Master File
TMF, sponsor electronic share drive system of scanned documents. CRA job to upload SMF to TMF.
What is scientific misconduct and what are the consequences? ✔Correct Answer-Falsification,
Fabrication, and Plagiarism. Jeopardize the study and legal action (fines, imprisonment, loss of
Medical Licenses)
