ACRP-CP 試験問題を無料オンラインアクセス

During a monitoring visit, a CRA notices that a piece of equipment required for the study needs to be serviced. Who is responsible for addressing this problem?

• A.Sponsor
• B.CRC
• C.PI
• D.CRA

Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?

• A.Sponsor
• B.Investigator
• C.CRO
• D.CRC

A root cause analysis should be:

• A.Validated before use in a CAPA.
• B.Specific to a clinical trial.
• C.Written by the investigator.
• D.Focused on issues of non-compliance.

The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

• A.Regulatory Agency
• B.Sponsor
• C.CRC
• D.PI

Who takes responsibility for initiating a clinical trial?

• A.Sponsor
• B.Investigator
• C.CRO
• D.IRB/IEC