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ACRP Certified Professional Sample Questions:

1. One key attribute for good study documentation is that the data are contemporaneous, which refers to the practice of:

A) Recording the date and time each data element is entered onto the source document.
B) Allowing real-time access for data review in the eCRF.
C) Recording data on source documents at the time the data are collected during the conduct of the study.
D) Comparing source document data to other data recorded in the same study time period.

2. The PI should ensure that source data is:

A) Kept on site for a minimum of 2 years.
B) On worksheets that are provided by the sponsor.
C) Accurately reflected in the eCRFs.
D) Printed directly from the EMR.

3. When assessing the monitoring needs for a study, sponsors should:

A) Use central monitoring instead of conducting physical monitoring visits at sites.
B) Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.
C) Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.
D) Permit PIs to select a monitor for their site as long as they are independent of the PI.

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

A) Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
B) Training records of site personnel on study protocol, and their study-related duties and functions.
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.

5. In addition to members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial, it is recommended that the IRB/IEC should include:

A) One member who is independent of the institution/trial site.
B) One member whose primary area of interest is in the same scientific area.
C) A total of five members.
D) One member of the site's QA group.

Solutions: