CCRP SOCRA Exam Practice Exam #1 Latest Update 2026 |
Exam Prep
1. Which of the following best describes a significant risk device in clinical
research?
C) For a use of substantial importance in diagnosing, curing,
mitigating, or treating disease, or otherwise preventing impairment of
human health and presents a potential for serious risk to the health,
safety, or welfare of a subject.
D) All the above
A) Intended as an implant and presents a potential for serious risk to
the health, safety, or welfare of a subject
B) Purported or represented to be for a use in supporting or sustaining
human life and presents a potential risk to the health, safety, or welfare
of a subject
2. Discuss the role of the principal investigator in relation to data transcription in
clinical trials.
The principal investigator does not have any role in data transcription.
The principal investigator oversees the data transcription process
and ensures that authorized personnel are trained to accurately
transcribe data.
The principal investigator is solely responsible for all data transcription
without any assistance.
The principal investigator only reviews the data after it has been
transcribed.
3. In a clinical trial involving pediatric subjects, which regulation must be
adhered to for ensuring ethical treatment?
, 45 CFR 46 Subpart A
45 CFR 46 Subpart B
45 CFR 160
21 CFR 50
4. What is one requirement for IRB/IEC membership according to the FDA and
ICH?
A majority of the members are from or have ties to the institution of
record
At least one member holds a Ph.D. degree or equivalent
At least one member's primary area of interest is in a nonscientific
area
A majority of the members' primary area of interest is in a scientific
area
5. Discuss the significance of having a member with a nonscientific background
on an IRB/IEC.
It is necessary for all members to have scientific expertise to evaluate
research proposals.
Having a member with a nonscientific background ensures diverse
perspectives and ethical considerations in the review process.
The presence of nonscientific members is irrelevant to the IRB/IEC's
function.
Nonscientific members are only included for regulatory compliance,
not for their input.
,6. Who is primarily responsible for transcribing data from the source document
to the Case Report Form (CRF)?
Any member of the research team
The clinical research coordinator only
Only the principal investigator
The principal investigator and authorized personnel
7. By regulation, investigators are required to make a final study report to:
The Sponsor, the IRB, and the FDA
The institution
The Sponsor and the IRB
The FDA and the Sponsor
The Sponsor
8. Which entity is responsible for approving the informed consent document
before a clinical trial begins?
Investigator
Sponsor
IRB or IEC
A, B & C
9. According to 21 CFR Part 312, how many calendar days does a sponsor have
to notify the FDA and participating investigators after determining that
information qualifies for reporting?
30 calendar days
, 15 calendar days
7 calendar days
10 calendar days
10. What right is guaranteed to subjects participating in a clinical trial according
to regulations?
Participate in all phases of the trial
Receive medical treatment
Withdraw at any time
Access trial results
11. If a clinical trial is being conducted and the investigator fails to sign the 1572
Statement of Investigator form, what potential consequences could arise
according to regulatory guidelines?
The study results will still be valid.
The coordinator will be held responsible for the oversight.
The trial may face regulatory scrutiny and could be deemed non-
compliant.
The trial will proceed without any issues.
12. The Investigator must obtain IRB approval of the study and the consent form
Before the study has been completed
Before the first patient has completed the study
Before receiving any grant money for the study
Before enrolling any patients
Exam Prep
1. Which of the following best describes a significant risk device in clinical
research?
C) For a use of substantial importance in diagnosing, curing,
mitigating, or treating disease, or otherwise preventing impairment of
human health and presents a potential for serious risk to the health,
safety, or welfare of a subject.
D) All the above
A) Intended as an implant and presents a potential for serious risk to
the health, safety, or welfare of a subject
B) Purported or represented to be for a use in supporting or sustaining
human life and presents a potential risk to the health, safety, or welfare
of a subject
2. Discuss the role of the principal investigator in relation to data transcription in
clinical trials.
The principal investigator does not have any role in data transcription.
The principal investigator oversees the data transcription process
and ensures that authorized personnel are trained to accurately
transcribe data.
The principal investigator is solely responsible for all data transcription
without any assistance.
The principal investigator only reviews the data after it has been
transcribed.
3. In a clinical trial involving pediatric subjects, which regulation must be
adhered to for ensuring ethical treatment?
, 45 CFR 46 Subpart A
45 CFR 46 Subpart B
45 CFR 160
21 CFR 50
4. What is one requirement for IRB/IEC membership according to the FDA and
ICH?
A majority of the members are from or have ties to the institution of
record
At least one member holds a Ph.D. degree or equivalent
At least one member's primary area of interest is in a nonscientific
area
A majority of the members' primary area of interest is in a scientific
area
5. Discuss the significance of having a member with a nonscientific background
on an IRB/IEC.
It is necessary for all members to have scientific expertise to evaluate
research proposals.
Having a member with a nonscientific background ensures diverse
perspectives and ethical considerations in the review process.
The presence of nonscientific members is irrelevant to the IRB/IEC's
function.
Nonscientific members are only included for regulatory compliance,
not for their input.
,6. Who is primarily responsible for transcribing data from the source document
to the Case Report Form (CRF)?
Any member of the research team
The clinical research coordinator only
Only the principal investigator
The principal investigator and authorized personnel
7. By regulation, investigators are required to make a final study report to:
The Sponsor, the IRB, and the FDA
The institution
The Sponsor and the IRB
The FDA and the Sponsor
The Sponsor
8. Which entity is responsible for approving the informed consent document
before a clinical trial begins?
Investigator
Sponsor
IRB or IEC
A, B & C
9. According to 21 CFR Part 312, how many calendar days does a sponsor have
to notify the FDA and participating investigators after determining that
information qualifies for reporting?
30 calendar days
, 15 calendar days
7 calendar days
10 calendar days
10. What right is guaranteed to subjects participating in a clinical trial according
to regulations?
Participate in all phases of the trial
Receive medical treatment
Withdraw at any time
Access trial results
11. If a clinical trial is being conducted and the investigator fails to sign the 1572
Statement of Investigator form, what potential consequences could arise
according to regulatory guidelines?
The study results will still be valid.
The coordinator will be held responsible for the oversight.
The trial may face regulatory scrutiny and could be deemed non-
compliant.
The trial will proceed without any issues.
12. The Investigator must obtain IRB approval of the study and the consent form
Before the study has been completed
Before the first patient has completed the study
Before receiving any grant money for the study
Before enrolling any patients
