A subject enrolled in a drug clinical trial has withdrawn from the study. In accordance with ICH GCP, which of the following documents should be consulted to determine whether the participant should be replaced?

• A.The data safety monitoring plan
• B.The protocol
• C.The Investigator's Brochure
• D.The informed consent document

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According to the CFR, which of the following is a complete and accurate list of the signatures required on the short form consent document?

• A.The subject or else the subject's legally authorized representative; the witness
• B.The subject or else the subject's legally authorized representative
• C.The subject or else the subject's legally authorized representative; the investigator or else the investigator's designee
• D.The subject or else the subject's legally authorized representative; the investigator or else the investigator's designee; the witness

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A research protocol requires patients to complete a patient reported outcome questionnaire in the sponsor's electronic data capture (EDC) system. What is the source data?

• A.The EDC record
• B.The electronic medical record
• C.A printout of the electronic medical record
• D.A printout of the EDC record

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Which of the following elements should NOT influence the investigator's ability to obtain endpoint data?

• A.Participant compliance
• B.Complexity of study
• C.Length of study follow-up
• D.Complexity of CRFs

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After completion of a Phase III trial, which document should IRB/IEC retain?

• A.Occupations and affiliations of IRB members
• B.Sponsor/investigator contracts
• C.Subject enrollment logs
• D.Investigational product labels

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