Page 1 of 82
CCRP SOCRA STUDY GUIDE| SOCRA CCRP
EXAM WITH PRACTICE QUESTIONS AND
CORRECT ANSWERS TESTED AND
APPROVED!!!
Unexpected serious suspected adverse reactions and observations from animal studies
suggesting significant risk to human subjects must be reported to FDA as soon as possible but
no later than within __ calendar days following the sponsor's initial receipt of the
information. -- ANSWER--15 days
the sponsor must notify FDA of any UNEXPECTED FATAL LIFE THREATENING
SUSPECTED adverse reactions ASAP but no later than __calendar days following the
sponsor's initial receipt of the information -- ANSWER--7 days
Follow-up IND Safety Report. Such report should be submitted without delay, as soon as the
information is available but no later than __calendar days after the sponsor receives the
information. -- ANSWER--15 days
What date should an investigator write when he failed to sign the consent form on the date of
consent? -- ANSWER--date of investigators signature
A____________ can be any unfavorable and unintended sign) including an abnormal
laboratory finding), symptom, or disease temporally associated with the use of a medicinal
, Page 2 of 82
(investigational) product, whether or not related to the medicinal (investigational) product. --
ANSWER--adverse event
The FDA form 483 is used for _______ -- ANSWER--Inspectional oberservation
The international ethical and scientific quality standard for designing, conducting, recording
and reporting trials that involve the participation of human subjects is known as -- ANSWER-
GCP
A(n) _________ is an investigational or marketed product, or placebo, used as a reference in
a clinical trial. -- ANSWER--comparator
What is 21 CFR 50.23 Subpart B? -- ANSWER--the exception to the general requirements
This form is used for the voluntary reporting of adverse events and product problems --
ANSWER--3500
is permission to examine, analyze, verify, and reproduce any records and reports that are
important to evaluation of a clinical trial -- ANSWER--direct access
21 cfr part b -- ANSWER--ICF
Belmont Report (1979) -- ANSWER--respect for persons, beneficence, justice
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significant risk device -- ANSWER--s a study of a device that presents a potential for serious
risk to the health, safety, or welfare of a subject and (1) is intended as an implant; or (2) is
used in supporting or sustaining human life; or (3) is of substantial importance in diagnosing,
curing, mitigating
Contract Research Organization -- ANSWER--A person or an organization (commercial,
academic, or other) contracted by the sponsor to perform one or more of a sponsor's
trial-related duties and functions.
When a short form is used for informed consent the witness must sign the short form or the
summary? -- ANSWER--False-they must sign both
What is FDA form 3454 -- ANSWER--Certification Financial Interests and Arrangements of
Clinical Investigators
What are the three main basic ethical principles of the Belmont Report? -- ANSWER-Respect
for persons.
Beneficence.
Justice.
Phase III -- ANSWER--Study Participants: 300 to 3,000 volunteers who have the disease or
condition
Length of Study: 1 to 4 years
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Purpose: Efficacy and monitoring of adverse reactions
Phase I -- ANSWER--20 to 100 healthy volunteers or people with the disease/condition.
Length of Study: Several months
Purpose: Safety and dosage
Phase II -- ANSWER--Study Participants: Up to several hundred people with the
disease/condition.
Length of Study: Several months to 2 years
Purpose: Efficacy and side effects
The main concept of 21 CFR 50 is -- ANSWER--protection of human subjects
21 CFR 50 part D -- ANSWER--protection of childern
A ________is a printed, optical or electronic document designed to record all of the protocol
required information to be reported to the sponsor on each trial subject -- ANSWER--crf
CCRP SOCRA STUDY GUIDE| SOCRA CCRP
EXAM WITH PRACTICE QUESTIONS AND
CORRECT ANSWERS TESTED AND
APPROVED!!!
Unexpected serious suspected adverse reactions and observations from animal studies
suggesting significant risk to human subjects must be reported to FDA as soon as possible but
no later than within __ calendar days following the sponsor's initial receipt of the
information. -- ANSWER--15 days
the sponsor must notify FDA of any UNEXPECTED FATAL LIFE THREATENING
SUSPECTED adverse reactions ASAP but no later than __calendar days following the
sponsor's initial receipt of the information -- ANSWER--7 days
Follow-up IND Safety Report. Such report should be submitted without delay, as soon as the
information is available but no later than __calendar days after the sponsor receives the
information. -- ANSWER--15 days
What date should an investigator write when he failed to sign the consent form on the date of
consent? -- ANSWER--date of investigators signature
A____________ can be any unfavorable and unintended sign) including an abnormal
laboratory finding), symptom, or disease temporally associated with the use of a medicinal
, Page 2 of 82
(investigational) product, whether or not related to the medicinal (investigational) product. --
ANSWER--adverse event
The FDA form 483 is used for _______ -- ANSWER--Inspectional oberservation
The international ethical and scientific quality standard for designing, conducting, recording
and reporting trials that involve the participation of human subjects is known as -- ANSWER-
GCP
A(n) _________ is an investigational or marketed product, or placebo, used as a reference in
a clinical trial. -- ANSWER--comparator
What is 21 CFR 50.23 Subpart B? -- ANSWER--the exception to the general requirements
This form is used for the voluntary reporting of adverse events and product problems --
ANSWER--3500
is permission to examine, analyze, verify, and reproduce any records and reports that are
important to evaluation of a clinical trial -- ANSWER--direct access
21 cfr part b -- ANSWER--ICF
Belmont Report (1979) -- ANSWER--respect for persons, beneficence, justice
, Page 3 of 82
significant risk device -- ANSWER--s a study of a device that presents a potential for serious
risk to the health, safety, or welfare of a subject and (1) is intended as an implant; or (2) is
used in supporting or sustaining human life; or (3) is of substantial importance in diagnosing,
curing, mitigating
Contract Research Organization -- ANSWER--A person or an organization (commercial,
academic, or other) contracted by the sponsor to perform one or more of a sponsor's
trial-related duties and functions.
When a short form is used for informed consent the witness must sign the short form or the
summary? -- ANSWER--False-they must sign both
What is FDA form 3454 -- ANSWER--Certification Financial Interests and Arrangements of
Clinical Investigators
What are the three main basic ethical principles of the Belmont Report? -- ANSWER-Respect
for persons.
Beneficence.
Justice.
Phase III -- ANSWER--Study Participants: 300 to 3,000 volunteers who have the disease or
condition
Length of Study: 1 to 4 years
, Page 4 of 82
Purpose: Efficacy and monitoring of adverse reactions
Phase I -- ANSWER--20 to 100 healthy volunteers or people with the disease/condition.
Length of Study: Several months
Purpose: Safety and dosage
Phase II -- ANSWER--Study Participants: Up to several hundred people with the
disease/condition.
Length of Study: Several months to 2 years
Purpose: Efficacy and side effects
The main concept of 21 CFR 50 is -- ANSWER--protection of human subjects
21 CFR 50 part D -- ANSWER--protection of childern
A ________is a printed, optical or electronic document designed to record all of the protocol
required information to be reported to the sponsor on each trial subject -- ANSWER--crf
