Which strategy is used to safeguard subject privacy?

• A.Store source documentation in the CRC's office.
• B.Email updated enrollment logs to the CRA.
• C.Utilize subject initials on correspondence.
• D.Conduct subject-related conversations in controlled environments.

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In addition to members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial, it is recommended that the IRB/IEC should include:

• A.A total of five members.
• B.One member whose primary area of interest is in the same scientific area.
• C.One member of the site's QA group.
• D.One member who is independent of the institution/trial site.

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The CRC is prepared to consent a cognitively impaired participant to an Alzheimer's clinical trial. The CRC is required to utilize which of the following in the consent process?

• A.A witness
• B.A family member
• C.A member of the research team
• D.A legally acceptable representative

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Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?

• A.Pre-qualification assessment of CRO
• B.Co-monitoring of CRO site visits
• C.Central monitoring of data fields by sponsor
• D.Risk-based audits of CRO activities as delegated

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A sponsor writes a protocol comparing an IP XYZ to a marketed drug ABC to determine if XYZ is more efficacious in the target population than ABC. Both drugs are prepared in identically masked IV bags and distributed according to the randomization scheme outlined in the protocol such that the study team is unaware of the treatment assignment.
Which of the following is an appropriate title for this study?

• A.A randomized, single-blind, placebo-controlled study comparing the efficacy of XYZ to ABC in the target population
• B.A randomized, double-blind, superiority study comparing the efficacy of XYZ to ABC in the target population
• C.A randomized, open-label, comparator study comparing the efficacy of XYZ to ABC in the target population
• D.A randomized, double-blind, double-dummy, superiority study comparing the efficacy of XYZ to ABC in the target population

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