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Guide for CCRP: SOCRA Certified Clinical Research Professional

Quiz CCRP: SOCRA Certified Clinical Research Professional

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/ 10

Quiz

1/10
Which of the following is an example of an additional protection required when conducting research
on children?
Select the answer
1 correct answer
A.
There must be an impartial advocate present during the consent process
B.
The investigator must obtain age-appropriate assent as determined by the IRB/IEC
C.
Parents must be present during all procedures
D.
The study must be approved by a central pediatric IRB

Quiz

2/10
A subject currently on a clinical trial was hospitalized for 2 days due to a SAE. The subject reported
the hospitalization to the investigator at the next study visit. According to the ICH GCP Guideline,
when should the investigator report the SAE to the sponsor?
Select the answer
1 correct answer
A.
Immediately
B.
Within 7 working days
C.
Within 10 working days
D.
Within 15 working days

Quiz

3/10
In accordance with the ICH GCP Guideline, when a sponsor transfers trial-related duties and
functions to a contract research organization (CRO), who is ultimately responsible for the quality and
integrity of the trial data?
Select the answer
1 correct answer
A.
The investigator
B.
The IRB/IEC
C.
The CRO
D.
The sponsor

Quiz

4/10
During an internal compliance review, the site study team identified that a protocol-required blood
sample collection was not obtained for a majority of the subjects enrolled. In accordance with the
ICH GCP Guideline, the clinical investigator should:
Select the answer
1 correct answer
A.
Suspend all trial-related activities until the events of the deviation have been mitigated
B.
Document and explain the deviation from the protocol
C.
Assign another investigator to perform sample collections until an internal investigation is completed
D.
Immediately report the observation to the regulatory authority

Quiz

5/10
A coordinator for an ongoing industry-sponsored, multi-site Phase II clinical trial is taking an
unexpected, long-term medical absence. The trial site retains coordinator services from an external
source to support clinical trial activities. According to the ICH GCP Guideline, which of the following
is responsible for implementing procedures to ensure the integrity of the clinical trial-related duties?
Select the answer
1 correct answer
A.
The sponsor
B.
The investigator/institution
C.
The IRB/IEC
D.
The external source

Quiz

6/10
In accordance with the CFR, a sponsor must submit a protocol amendment to the FDA for which of
the following?
Select the answer
1 correct answer
A.
The addition of a new test that is intended to improve monitoring the subject for an adverse effect
B.
A significant change in an investigator's financial interest in the investigational product
C.
The addition of a sub-investigator with the scientific training and expertise to conduct the investigation
D.
A change in the manufacturing site for the investigational product

Quiz

7/10
In an IND study, the specified dosage of an investigational product is 2 mg twice a day for 10 days.
The product is available in 1 mg tablets. The subject was given 45 tablets and was instructed to take 2
mg of the product twice a day for 10 days. How many tablets should the subject have after the 10
days?
Select the answer
1 correct answer
A.
0
B.
1
C.
5
D.
20

Quiz

8/10
According to the CFR and the ICH GCP Guideline, which of the following must be submitted to the
IRB after completion of the trial at the site?
Select the answer
1 correct answer
A.
The final report
B.
The monitoring close-out visit report
C.
The data safety monitoring summary
D.
The final subject enrollment log

Quiz

9/10
In determining the classification of risk for a study involving a medical device, it is necessary to
consider the:
Select the answer
1 correct answer
A.
Number of patients to be treated with the device
B.
Cost of device
C.
Investigators’ prior training and experience
D.
Use of the device in the particular study

Quiz

10/10
A research assistant on a study was recently promoted to a clinical research coordinator (CRC) role
after one year on the study. In order to fulfill the significant new responsibilities, the CRC completed
additional institutional training. According to ICH GCP Guidelines and 21 CFR, which of the following
must be filed in the regulatory binder?
Select the answer
1 correct answer
A.
The letter documenting the promotion to a CRC
B.
A brochure from the training course
C.
An updated performance review summary
D.
An updated curriculum vitae
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Info quiz:

  • Quiz name:CCRP: SOCRA Certified Clinical Research Professional
  • Total number of questions:130
  • Number of questions for the test:50
  • Pass score:80%

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