CCRP問題集、SOCRA実際の試験問題

質問 1

A clinical investigator is developing the assent procedure for the enrollment of children into a new pediatric clinical trial. The ages of the children are described in the IRB/IEC submission. A description of which of the following must also be included in the submission?

A. The physiological status of the children

B. The pediatrician (primary care provider notification process)

C. The psychological status of the children

D. The economic status of the children

正解: C

解説: (PassTest メンバーにのみ表示されます)

質問 2

An IND application must contain all EXCEPT:

A. Chemistry, manufacturing, and control information

B. Financial disclosure information

C. A cover sheet

D. Investigator's brochure

正解: B

解説: (PassTest メンバーにのみ表示されます)

質問 3

Which of the following entities, if any, must provide an approval before an investigator may enroll subjects in a quality-of-life research questionnaire study?

A. The Department of Health and Human Services

B. The IRB/IEC

C. The FDA or another regulatory authority

D. No approvals are necessary if no pharmaceutical drugs are involved

正解: B

解説: (PassTest メンバーにのみ表示されます)

質問 4

Sponsor must maintain drug disposition records for how long after marketing approval?

A. 1 year

B. 5 years

C. 2 years

D. 3 years

正解: C

解説: (PassTest メンバーにのみ表示されます)

質問 5

Which of the following should a clinical investigator include in a submission to an IRB/IEC for a Phase IV drug study?

A. The investigator's clinical trial agreement with the sponsor

B. The drug development and marketing plan

C. The amount of payments and compensation to subjects

D. The itemized study budget

正解: C

解説: (PassTest メンバーにのみ表示されます)

質問 6

The study coordinator for a new Phase III vaccine study is preparing documents for IRB/IEC submission.
According to the ICH GCP Guidelines, which of the following documents should be included in the submission?

A. Recruitment materials

B. Local lab normal ranges

C. Case report forms

D. The investigators' CVs

正解: A

解説: (PassTest メンバーにのみ表示されます)

質問 7

A revised protocol added genomic testing to banked tissue samples. Before shipping samples, what must the site do?

A. Execute material transfer agreement

B. Obtain IRB/IEC approval for revised protocol and ICF

C. Notify enrolled subjects

D. Ship under dangerous goods requirements

正解: B

解説: (PassTest メンバーにのみ表示されます)

SOCRA Certified Clinical Research Professional (CCRP) - CCRP 模擬練習