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Updated: Jun 24, 2026
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1. 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 original planned data collection is completed
C) As soon as the protocol amendment is submitted to the IRB/IEC
D) After the protocol amendment is approved by the IRB/IEC
2. A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?
A) No, the PI is taking part in too many ongoing studies to participate in this study.
B) Yes, the PI can perform other imaging scans instead of the PET scans.
C) Yes, the PI has a sufficient patient population to take part in this study.
D) No, the PI does not have the resources to perform all protocol-required procedures.
3. The inclusion and exclusion criteria are in place so all subjects are:
A) Medically appropriate and protected from ethical vulnerability.
B) Patients with the disease under study and will not have any adverse events.
C) Ethically vulnerable and patients with the disease under study.
D) Healthy and willing to complete the clinical trial.
4. The composition of an IDMC/DSMB should include which one of the following?
A) A clinical scientist who is knowledgeable in the appropriate discipline
B) A sponsor representative who is knowledgeable about the study's unblinded information
C) A lead PI for the study
D) A member from the IRB/IEC
5. Which of the following elements of the Informed Consent are NOT required?
A) Statement that study involves research
B) A description of any reasonably foreseeable risks or discomforts
C) A description of potential benefits
D) Subject legal rights can be waived
Solutions:
| Question # 1 Answer: D | Question # 2 Answer: D | Question # 3 Answer: A | Question # 4 Answer: A | Question # 5 Answer: D |
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