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Last Updated: Jun 19, 2026
No. of Questions: 127 Questions & Answers with Testing Engine
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1. A PI is reviewing the CRF for a recent subject visit and notices the participant's heart rate and temperature are not recorded. Which of the following study documentation practices was neglected?
A) Original
B) Complete
C) Attributable
D) Contemporaneous
2. Source data/documentation should be:
A) Attributable, legible, contemporaneous, original, accurate, and complete.
B) Attributable, legible, contemporaneous, original, accurate, and clear.
C) Attributable, legible, correct, original, accurate, and complete.
D) Attributable, legible, correct, original, accurate, and clear.
3. What would a sponsor use to implement and maintain quality in a study?
A) Statistical analysis plan
B) Protocol signature pages
C) Standard operating procedures
D) Clinical trial agreement
4. After enrolling and treating a few subjects on an investigator-initiated trial, the PI would like to include a subject diary for each trial subject to capture their activities and experiences on the trial regimen. After the PI has generated a diary, what should the PI do next?
A) Submit the diary to the sponsor for approval.
B) Submit the diary to the IRB/IEC for approval.
C) No approval is necessary: give the diary to each subject.
D) Submit the diary to the regulatory authority for approval.
5. The inclusion and exclusion criteria are in place so all subjects are:
A) Healthy and willing to complete the clinical trial.
B) Ethically vulnerable and patients with the disease under study.
C) Medically appropriate and protected from ethical vulnerability.
D) Patients with the disease under study and will not have any adverse events.
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: A | Question # 3 Answer: C | Question # 4 Answer: B | Question # 5 Answer: C |
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