DF/HCC Research Personnel - Policy & Requirements Comprehension Quiz

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 are subject registration requirements under DF/HCC policies and operations? (Select all that apply.)

Research subjects must not be associated with a study in DF/HCC’s OnCore system until they are confirmed to be eligible for the study.

Registration in DF/HCC’s OnCore system must occur after obtaining informed consent and prior to the start of any protocol treatment/intervention.

Accruals must be captured in DF/HCC’s OnCore system for all cancer-related, hypothesis-driven clinical research studies conducted within the DF/HCC, including interventional, observational, ancillary and correlative research.

Research subjects are not required to be registered in DF/HCC’s OnCore system if the same subjects will be registered with the external sponsor.

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* 2. 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?

Dr. Jameson is considered the sponsor-investigator and has additional responsibilities for the initiation, management, and oversight of the research under DF/HCC policies.

Dr. Jameson is considered a sponsor-investigator but does not have any additional responsibilities under DF/HCC policies since the study is non-clinical and minimal risk.

NHLBI is considered the sponsor of the study and is responsible for the initiation, management, and oversight of the research. Dr. Jameson only has the responsibilities of a site PI.

DF/HCC is considered the sponsor of the study and is responsible for the initiation, management, and oversight of the research. Dr. Jameson only has the responsibilities of a site PI.

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

True

False

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

a. A subject with a history of frequent migraine headaches reports an increase in the frequency of migraines while participating in a trial involving a non-drug intervention.

b. During the screening visit, a subject reports having heart failure that was first diagnosed 5 years earlier.

c. A subject’s lab results indicate lower than normal hemoglobin levels for the first time and received a transfusion after having been randomized to the control arm and receiving a placebo.

d. A subject that has consented to a clinical trial and undergone research screening procedures reports a new skin rash that first appeared prior to receiving a dose of any investigational agent.

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

a. Studies involving benign hematological conditions and/or infectious diseases that do not target cancer-relevant populations for recruitment or ask cancer-related scientific questions.

b. Observational studies with scientific objectives evaluating cancer screening, risks and/or prevention.

c. NCI funded studies involving healthy populations that are hypothesis-driven and statistically powered to answer a scientific question.

d. Interventional studies evaluating a potential new cancer treatment in research subjects diagnosed with cancer.

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* 6. 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?

a. Core Site

b. Subsite

c. Clinical Trials Office

d. IRB

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* 7. 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.)

a. That the subject was given a copy of the signed and dated consent form.

b. Whether the subject will be paid for their participation in the research.

c. That the subject had an opportunity to ask questions.

d. The date the informed consent discussion(s) occurred.

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* 8. 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.)

a. Presenting the subject with a fully translated written consent form in a language understandable to the subject, while providing an oral explanation of the research to the subject with the assistance of an interpreter.

b. Presenting the subject with a fully translated written consent form in a language understandable to the subject, while providing an oral explanation of the research in English in the presence of a witness.

c. Presenting the subject with an English version of the study’s written consent form and a translated, pre-approved short form in a language understandable to the subject, while providing an oral explanation of the research to the subject with the assistance of an interpreter who is also acting as a witness.

d. Presenting the subject with an English version of the study’s written consent form and a translated, pre-approved short form in a language understandable to the subject, while a member of the study team fluent in the subject’s language provides an oral explanation of the research to the subject in the presence of a separate witness unaffiliated with the research team.

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* 9. 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?

Any research involving human subjects

Research that is determined to be exempt from IRB review

Research that is determined to be no greater than minimal risk by the IRB

An interventional or observational study that is determined to be greater than minimal risk by the IRB

None of the above

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* 10. 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?

To confirm that the screening staff are trained and qualified to determine the subject is eligible.

To verify that the screening staff completed the eligibility checklist completely and accurately based on the available source data or source documentation.

To apply independent clinical judgement to confirm the investigator's interpretation of the subject's results and medical condition.

To make the initial determination of the subject's eligiblity.

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* 11. 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.

True

False

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

a. Correction for a mistake made on a paper questionnaire.

b. An explanation of why study procedure was not performed per protocol.

c. To resolve a finding from the study monitor regarding a subject that did not receive a copy of the consent form.

d. To explain local site practices for how or where research information is documented and stored.

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

a. Planned changes to the protocol require prospective approval by the IRB of record.

b. Deviation from the protocol can occur prior to IRB approval if necessary to eliminate an immediate hazard to research subjects.

c. Exceptions to the eligibility criteria can occur prior to IRB approval in order to enroll subjects that have a life-threatening condition with no remaining treatment options.

d. For studies under an IND, changes that significantly affect safety of subjects, scope of the investigation, or scientific quality of the study can be implemented once submitted to the FDA and do not require waiting for FDA approval.

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* 14. 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.)

a. The appropriate cancer clinical trials office (CTO/CCPO/CCTO) at the PI’s home institution.

b. Applicable individuals listed on the DF/HCC External Regulatory Inspection Contact List.

c. The IRB of record for the research being inspected.

d. The sponsor of the research being inspected.

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

a. All research staff listed on the FDA 1572.

b. All research staff listed on the delegation of authority log.

c. All research staff for whom the changes are relevant based on an individual’s role and responsibilities.

d. All research staff who will perform any research procedures for the protocol.

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* 16. 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?

a. Study team member who discovered the error

b. Research Manager/Study Manager

c. IRB

d. PI

e. N/A – Since it was an administrative error, no reporting or additional action is required.

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

a. By all investigators, sub-investigators, and study personnel who are responsible for the design, conduct, or reporting of the research and will make a direct and significant contribution to the research.

b. Prior to being added to a new research study.

c. Within 30 days of acquiring a new outside interest.

d. Only when the individual has an outside interest greater than $0 to report.

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* 18. 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?

a. All DF/HCC research protocols

b. Any protocol with eligibility criteria where participants are to be registered in the DF/HCC OnCore system

c. Only clinical research studies

d. Only research determined to be greater than minimal risk by the IRB

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* 19. 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?

a. DF/HCC Office of Data Quality

b. Protocol statistician

c. Research staff delegated this responsibility on the delegation of authority log

d. PI listed as the responsible party

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* 20. 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?

Core Site PI

PI at the site where the SAE occured

Clinical Trials Office

Patient Quality and Safety