최신 ACRP Certified Professional ACRP-CP 무료샘플문제:

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

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

2. A protocol requires participants to take IP for 6 months. The protocol allows for any participants who are noncompliant to be replaced by enrolling additional participants, except if it is due to an AE. The investigator has enrolled 12 participants.
The status of the enrolled participants is as follows:
* 3 participants were withdrawn due to noncompliance
* 1 participant withdrew consent after experiencing severe nausea
* 1 participant had to discontinue IP for an unscheduled hospitalization
* 1 participant who is not returning for visits
* 2 participants completed the 6 months of treatment
* 4 participants currently on IP
How many participants should be replaced?

A) 5 participants
B) 4 participants
C) 6 participants
D) 3 participants

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

A) CRO
B) PI
C) Sponsor
D) Subject

4. A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?

A) The IRB/IEC must approve the transfer of duties to a CRO.
B) Any trial-related duties can be documented as transferred by verbal agreement.
C) All duties transferred to a CRO should be specified in writing.
D) Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.

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

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