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1. All of the following are examples of what monitors review EXCEPT:
A) Potential patient medical records for eligibility prior to the informed consent process.
B) The signed ICF retained in the participant's study file.
C) Documentation in the participant's medical record of study drug administration.
D) Regulatory binder which includes copies of current certifications for all laboratories.
2. Which document confirms the PI's agreement to permit auditing at the study site?
A) ICF
B) Protocol
C) Delegation Log
D) IB
3. Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:
A) Applicable regulatory authorities
B) Applicable site SOPs
C) PI
D) Sponsor
4. One key attribute for good study documentation is that the data are contemporaneous, which refers to the practice of:
A) Comparing source document data to other data recorded in the same study time period.
B) Recording the date and time each data element is entered onto the source document.
C) Allowing real-time access for data review in the eCRF.
D) Recording data on source documents at the time the data are collected during the conduct of the study.
5. A new device trial is being considered. Before committing to participate in the trial, what is the MOST important item the PI needs to evaluate?
A) Location of stored trial records
B) Length of time to receive the approved trial device
C) Information to be included in the advertising flyer
D) Availability of qualified staff to conduct the trial
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: A | Question # 3 Answer: A | Question # 4 Answer: D | Question # 5 Answer: D |
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