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The questions that follow test one’s comprehension of regulatory requirements and DF/HCC policies governing the conduct of clinical and non-clinical research. Investigators and research staff should take this assessment once they have completed DF/HCC mandated trainings in Human Subjects Protection, Good Clinical Practice, and DF/HCC Policies.

For reference, please see the Policy and Operation Library, the Training and Education page, and the Policy-Related Resources page. For questions, please contact ODQEducation@dfci.harvard.edu.

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* 1. Which of the following statements are true regarding DF/HCC requirements for reporting outside interests? (Select all that apply.)

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* 2. Clinicaltrials.gov registration and results reporting is required for applicable protocols as defined in FDAAA 801. Results reporting may also be required under the HHS final rule and/or the NIH policy. When results reporting is required, who is ultimately responsible for the timely reporting of research results in Clinicaltrials.gov?

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* 3. According to DF/HCC policy, which of the following would be appropriate for the PI to document in a Note to File (NTF)?

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* 4. Which of the following are subject registration requirements under DF/HCC policies and operations? (Select all that apply.)

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* 5. When a research subject provides written informed consent, which of the following must be documented separately by the person obtaining informed consent? (Select all that apply.)

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* 6. Which of the following statements are true regarding changes to or deviations from the approved research protocol? (Select all that apply.)

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* 7. When multiple DF/HCC institutions are participating on the same trial, who is responsible for submitting an amendment in iRIS to propose revisions to the written informed consent document?

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* 8. An investigator is conducting a greater than minimal risk research study that requires screening staff and enrollment monitor signature on the eligibility checklist, per DF/HCC policy. What is the role of the enrollment monitor in this process?

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* 9. When obtaining written informed consent from a non-English speaking research subject, which of the below are appropriate methods under DF/HCC policy? (Select all that apply.)

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* 10. Dr. Judy J. Jameson, a DF/HCC investigator, has received a federal grant from the National Heart, Lung, and Blood Institute (NHLBI) to design and conduct a non-clinical, minimal risk research study. Which of the following statements regarding responsibility for the research is correct?

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* 11. Once a PI receives notification from the FDA of an upcoming regulatory authority inspection of their research, who must be notified of the upcoming inspection according to DF/HCC policy? (Select all that apply.)

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* 12. According to DF/HCC policy, when a protocol amendment occurs the PI must ensure that which of the following are trained on the modifications?

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* 13. When an eligibility checklist is required and posted to OncPro, the checklist must be completed to confirm eligibility of each research subject prior to enrollment. Which research studies require the use of an eligibility checklist?

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* 14. Which types of new studies must be submitted through the DF/HCC for scientific review and approval? (Select all that apply.)

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* 15. Due to an administrative error, an outdated version of the consent form was accidentally used to obtain consent from multiple research subjects. In this situation, who is ultimately responsible for reporting this event and implementing an appropriate corrective and preventative action plan?

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* 16. When multiple DF/HCC institutions are participating on the same trial, who is responsible for submitting an SAE report to the IRB for an event that occurred at a DF/HCC institution?

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* 17. Which of the following must be captured and documented as an adverse event? (Select all that apply.)

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* 18. The Principal Investigator will determine whether research data collected under a protocol at DF/HCC can be shared with external collaborators.

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* 19. When a Principal Investigator has research data collected under a  previous protocol, that PI can decide whether it's appropriate to share these data with an external collaborator, or with another DF/HCC researcher for a separate project.

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* 20. According to DF/HCC policy, in which situation is the PI required to maintain a delegation of authority log to document all individuals to whom significant trial-related duties have been delegated?

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