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ACRP Certified Professional Sample Questions:
1. Who is responsible for outlining written procedures in a study to assure that changes or corrections in CRFs are documented, are necessary, and are endorsed by the investigator?
A) Data Manager
B) Sponsor
C) CRO
D) CRA
2. All site financial matters pertaining to a trial are listed in what document?
A) Protocol
B) Informed consent form
C) Financial disclosure
D) Signed contract
3. Which of the following reports should be retained in participant charts?
A) Safety reports
B) IRB/IEC progress reports
C) DSMB/IDMC reports
D) Lab reports
4. A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?
A) Standard Operating Procedure
B) Data & Safety Monitoring Plan
C) Investigator's Brochure
D) Clinical Monitoring Plan
5. 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) Comparing source document data to other data recorded in the same study time period.
C) Recording data on source documents at the time the data are collected during the conduct of the study.
D) Allowing real-time access for data review in the eCRF.
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: D | Question # 3 Answer: D | Question # 4 Answer: A | Question # 5 Answer: C |



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