Expert Answers to SOCRA Exam CCRP Questions

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Clinical Research Professional Certified Clinical Research Professional (CCRP)

Certified Clinical Research Professional (CCRP)

Last Update Nov 3, 2025
Total Questions : 130

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Questions 2

An investigator received an updated investigator's brochure from the sponsor; the update did not include changes related to subject safety. Which of the following parties, if any, is the investigator required to notify?

Options:

The IRB/IEC

The Data Safety Monitoring Board (DSMB)

The regulatory authority

No notification is required

Discussion 0

Questions 3

A pharmaceutical company is developing a biologic study. In accordance with ICH, which of the following items should be included in an investigator's brochure (IB)?

Options:

Lab draw requirements

Results of recent nude mouse study

Dispensing instructions

Schedule of events

Discussion 0

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Questions 4

According to the CFR, which of the following is a complete and accurate list of the signatures required on the short form consent document?

Options:

The subject or else the subject's legally authorized representative; the witness

The subject or else the subject's legally authorized representative

The subject or else the subject's legally authorized representative; the investigator or else the investigator's designee

The subject or else the subject's legally authorized representative; the investigator or else the investigator's designee; the witness

Discussion 0

Questions 5

A study coordinator is developing an informed consent form for the first time. As per the CFR and ICH GCP Guideline, which of the following elements must be included?

Options:

An explanation of the person to contact at the sponsor for further information regarding research subjects’ rights

A note that the qualified investigator could be financially compensated by the sponsor to conduct the clinical trial

A statement confirming that the subject has received a copy of the signed consent document

A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject

Discussion 0

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