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ACRP Certified Professional Sample Questions:

1. Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

A) Protocol, informed consent, and clinical trial agreement
B) Protocol, IB, and information about payments and compensation available to subjects
C) Protocol, site coordinator CVs, and clinical trial agreement
D) IB, site coordinator CVs, and information about payments and compensation available to subjects

2. A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?

A) Consult with the IRB/IEC first.
B) Deny the request until the sponsor approves.
C) Redact subject identification for privacy protection.
D) Allow access to the entire records.

3. A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?

A) The number of users with access was not defined.
B) The list of comparable technology solutions was not included.
C) The number of unique eCRF templates was not specified.
D) The frequency of data backup was not defined.

4. The investigator/institution should permit:

A) Monitoring and inspection by the appropriate regulatory authority(ies), and auditing by the sponsor.
B) Monitoring and inspection by the sponsor, and auditing by the appropriate regulatory authority(ies).
C) Monitoring and auditing by the appropriate regulatory authority(ies), and inspection by the sponsor.
D) Monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).

5. A deferred consent can take place in which of the following situations?

A) Only when the PI approves such a consent process immediately prior to patient enrollment, regardless of the situation being classed as emergency.
B) In an emergency situation only, when this process is described in the protocol and has received permission from the ethics committee.
C) Only when the PI approves such a consent process, regardless of the emergency situation described in the protocol.
D) In an emergency situation only, even when this process is not described in the protocol, but the sponsor approves the consent process.

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