Which of the following is an adequate definition of quality assurance for the conduct of a clinical trial?

• A.The systematic plan to review, approve, and monitor biomedical and behavioral research involving human subjects
• B.The planned and systematic actions established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with GCP and the applicable regulatory requirements
• C.An official review by a regulatory authority of documents, facilities, records, and any other resources that are deemed to be related to the trial
• D.The act of reviewing and approving the investigational protocol and informed consent document

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The sponsor withdrew an IND due to safety. Who must be notified promptly, in addition to FDA?

• A.Investigational pharmacies
• B.Site coordinator
• C.Reviewing IRBs/IECs
• D.OHRP

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In accordance with ICH, which of the following is an acceptable protocol review frequency for an IRB?

• A.6 months
• B.12 months
• C.24 months
• D.36 months

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A Phase I clinical trial is initiating. Who is responsible for ensuring that site staff are adequately informed about trial duties?

• A.Sponsor
• B.Program manager
• C.IRB/IEC
• D.Clinical investigator

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A monitor is conducting a site closeout visit. The study site kept electronic medical records and source documents in a system verified to be 21 CFR Part 11 compliant. The monitor reviewed all electronic documents by logging into the system with a unique login ID and password. In addition to the essential document file, which of the following sets of documents should be provided to the monitor during the study closeout visit?

• A.A copy of the final report for the IRB and investigational product shipment records
• B.Informed consent documents and printouts of electronic source documents
• C.Printouts of electronic source documents and the remaining investigational product
• D.Informed consent documents and investigational product documentation

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