ACRP-CP 試験問題を無料オンラインアクセス

After the site qualification visit report has been finalized, it must be:

• A.Included in the PI's regulatory file.
• B.Sent to the IRB/IEC for review and approval.
• C.Kept in the CRO/sponsor's trial master file.
• D.Stored in the sponsor's budgets and contracts file.

At a close-out visit, which document should be retained only at the site?

• A.Final trial close-out monitoring report
• B.IP accountability
• C.Subject identification code list
• D.Treatment allocation

Which of the following activities would be undertaken by the sponsor to BEST ensure overall quality of the study data?

• A.Conduct annual reviews of the protocol and accompanying study documents.
• B.Ensure submission of a data management plan to the regulatory authorities.
• C.Ensure there is an accompanying written record that describes the consent process.
• D.Develop a plan that describes the monitoring approach for a clinical study.

Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:

• A.Sponsor
• B.Applicable regulatory authorities
• C.PI
• D.Applicable site SOPs

Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?

• A.Sponsor
• B.CRO
• C.PI
• D.Subject