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ACRP Certified Professional Sample Questions:

1. Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

A) Training records of site personnel on study protocol, and their study-related duties and functions.
B) Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
C) A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
D) A monitoring report that identifies deviation from the approved protocol.

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

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

3. While consenting a potential subject, a coordinator discovered the subject could not read. Under what conditions can this potential subject be enrolled?

A) There are no circumstances under which this person can be enrolled.
B) Have the Principal Investigator consent the person.
C) Get an impartial witness involved in consenting this person.
D) Locate a translator and have them work with the person.

4. A protocol amendment is needed to collect additional data from a participant's medical record. When can the research team begin collecting the additional data?

A) When the need for the additional data is discovered
B) After the protocol amendment is approved by the IRB/IEC
C) As soon as the protocol amendment is submitted to the IRB/IEC
D) After the original planned data collection is completed

5. A PI on a study is a regular member of the IRB/IEC. Which of the following statements is TRUE regarding their participation in the IRB/IEC discussion and deliberation?

A) They cannot be the PI on the clinical study due to conflict of interest.
B) They can attend the meeting, but should not vote/provide opinion on whether to approve the study.
C) They can attend the meeting and can vote/provide opinion on whether to approve the study.
D) They must recuse themselves from the meeting given their dual roles as IRB/IEC member and PI.

Solutions: