Socra udemy selected Ccrp Clinical Research Professional Questions Answers by Madiha q117 vce pdf

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Exam Name:	Certified Clinical Research Professional (CCRP)
Exam Code:	CCRP Dumps
Vendor:	SOCRA	Certification:	Clinical Research Professional
Questions:	130 Q&A's	Shared By:	madiha

Question 24

During an audit for a Phase II IND study, the auditor identified unreported serious protocol deviations. Which party must take prompt action to ensure compliance?

Options:

The investigator

The IRB/IEC chair

The sponsor

The CRO

Discussion

Question 25

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:

Options:

Suspend all trial-related activities until the events of the deviation have been mitigated

Document and explain the deviation from the protocol

Assign another investigator to perform sample collections until an internal investigation is completed

Immediately report the observation to the regulatory authority

Discussion

Question 26

A study team is preparing to initiate a Phase II trial for a novel colon cancer therapy. By signing the Form FDA 1572, the investigator is certifying that the investigator has:

Options:

Read and understood the investigator's brochure

Completed other relevant research projects

Confirmed that the site's SOPs are in place

Obtained malpractice insurance

Discussion

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