Free SOCRA CCRP Exam Dumps Questions & Answers

According to ICH GCP, sponsor-specific essential documents must be retained until:

• A.25 years after last approval
• B.5 years after last approval
• C.2 years after last approval and no pending applications
• D.3 years after last approval

A subject was instructed to do a glucose check 4 times a day for 10 days using an investigational glucose meter. The meter requires one new glucose test strip for each test. The subject received the meter along with
45 glucose test strips. How many unused test strips should the subject have after the 10 days?

• A.5
• B.31
• C.0
• D.35

In accordance with ICH/GCP Guidance, how long should an IRB/IEC retain all relevant study-related records pertaining to the IRB/IEC's review after a trial has been completed?

• A.At least 15 years
• B.Indefinitely
• C.Until the regulatory authority has approved the investigational product for use
• D.At least 3 years

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?

• A.A statement confirming that the subject has received a copy of the signed consent document
• B.A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
• C.A note that the qualified investigator could be financially compensated by the sponsor to conduct the clinical trial
• D.An explanation of the person to contact at the sponsor for further information regarding research subjects' rights

Which of the following identifies content that should be included in a clinical research protocol?

• A.A summary of findings of nonclinical studies that potentially have clinical significance
• B.IRB/IEC approval and meeting minutes
• C.Criteria for the selection of an investigator
• D.Standard operating procedures for data collection