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SOCRA CCRP Dumps

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SOCRA CCRP Sample Questions

Question # 1

According to the ICH GCP Guidelines, what is the purpose of source documents? 

A. To establish diverse subject enrollment 
B. To validate insurance reimbursement 
C. To provide a record of subjects’ investigational medical treatment 
D. To validate reports submitted to the IRB/IEC 



Question # 2

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? 

A. Immediately 
B. Within 7 working days 
C. Within 10 working days 
D. Within 15 working days 



Question # 3

Which of the following is considered a source document? 

A. The subject instruction sheet 
B. Standard operating procedures (SOPs) 
C. The protocol 
D. Pharmacy dispensing records



Question # 4

What is included in the Statement of Investigator (Form FDA 1572)? 

A. A statement disclosing investigator financial interests 
B. A statement responding to FDA inspection observations 
C. A statement describing preclinical and human safety data 
D. A statement agreeing to comply with FDA regulations 



Question # 5

After randomization, investigational drug is shipped to site. Who is responsible for accountability? 

A. Investigator 
B. Research coordinator
 C. Investigational pharmacist 
D. Sponsor 



Question # 6

A sponsor's monitor is conducting a site selection visit for an interventional drug trial. In accordance with ICH GCP, which pharmacy drug storage facility information should be collected in order to determine whether the site could be selected for the trial? 

A. Number of staff members 
B. Available storage square footage 
C. Storage facility temperature range 
D. Storage cost 



Question # 7

The sponsor of a multi-institutional clinical trial provided a site with information regarding a newly identified unanticipated adverse event attributed to study drug administration. The site’s investigator has a subject actively receiving this study drug. Which of the following is the site investigator’s responsibility to the subject? 

A. To discontinue the subject’s study drug 
B. To submit this safety update to the regulatory authority
C. To provide the subject with information regarding the significant new findings 
D. To give the subject’s contact information to the sponsor in order to allow the sponsor to contact the subject 



Question # 8

In accordance with the ICH GCP Guideline and the CFR, who is directly responsible for ensuring that an IRB/IEC will conduct the initial and continuing review of a study? 

A. The sponsor 
B. The monitor
C. The investigator 
D. The study coordinator 



Question # 9

In accordance with the CFR, the IRB/IEC membership must have: 

A. At least seven individuals 
B. A majority of individuals whose primary area of expertise is nonscientific 
C. At least one cleric 
D. At least one individual who is not affiliated with the institution 



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