Study Coordinator Exam 2016
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Questions and Answers
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Please make sure you have also completed the Clinical Research Staff Orientation: Evaluation in Survey Monkey.This exam is 30 questions in multiple choice, matching, and true/false formats. You may navigate back and forth through the questions. Please click your selected answer and submit at the end. You will receive your score and certification soon after completion. Good luck!
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Name:
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Date (MM/DD/YYYY):
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1) The National Research Act of 1974 was a direct result of:
- A.
The Declaration of Helsinki
- B.
The Tuskegee Syphilis Study
- C.
The International Conference on Harmonization
- D.
None of the above
Correct Answer
B. The Tuskegee Syphilis StudyExplanation
The National Research Act of 1974 was a direct result of the Tuskegee Syphilis Study. The Tuskegee Syphilis Study was an unethical research study conducted by the U.S. Public Health Service from 1932 to 1972. It involved withholding treatment from African American men who were infected with syphilis, without their informed consent. The study violated ethical principles and led to the development of regulations and guidelines to protect human subjects in research. The National Research Act was passed in response to the public outrage and aimed to ensure the ethical conduct of research involving human subjects.Rate this question:
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- 5.
3) Which of the following is true of an Institutional Review Board?
- A.
Made up of at least 5 individuals: one scientist, one non scientist, one individual who is not affiliated with the institution
- B.
Established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.
- C.
Has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy.
- D.
All of the above.
- E.
None of the above.
Correct Answer
D. All of the above.Explanation
An Institutional Review Board (IRB) is made up of at least 5 individuals, including a scientist, a non-scientist, and an individual who is not affiliated with the institution. The purpose of an IRB is to protect the rights and welfare of human research subjects who are recruited to participate in research activities conducted under the institution's auspices. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction, as specified by federal regulations and local institutional policy. Therefore, the correct answer is "All of the above."Rate this question:
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- 6.
4) Which document in the IRB application should be written in non-technical language for the lay people and non-scientists on the review panel?
- A.
Consent form
- B.
Detailed protocol
- C.
Protocol summary
- D.
Additional protection for children form
Correct Answer
C. Protocol summaryExplanation
The protocol summary should be written in non-technical language for the lay people and non-scientists on the review panel. This document provides a concise overview of the research study, including the objectives, methods, and anticipated outcomes. It is important for the summary to be easily understandable by individuals who may not have a scientific background, allowing them to make informed decisions about the research. The consent form, detailed protocol, and additional protection for children form may contain more technical language and details that are not suitable for a general audience.Rate this question:
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- 7.
5) Which of the following are criteria used by the IRB to approve a study?
- A.
Risks to subject are minimized
- B.
Risks are reasonable in relation to anticipated benefits
- C.
Selection of subjects is equitable
- D.
Informed consent will be obtained from each subject
- E.
Informed consent will be properly documented
- F.
All of the above
- G.
None of the above
Correct Answer
F. All of the aboveExplanation
The IRB (Institutional Review Board) is responsible for reviewing and approving research studies involving human subjects. They ensure that certain criteria are met before approving a study. These criteria include minimizing risks to the subjects, ensuring that the risks are reasonable in relation to the anticipated benefits, ensuring equitable selection of subjects, and obtaining informed consent from each subject. Additionally, the IRB also requires that the informed consent is properly documented. Therefore, the correct answer is "All of the above" as all of these criteria are considered by the IRB when approving a study.Rate this question:
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6) Which department can help investigators by auditing study files and assisting in correction of errors?
- A.
Center for Clinical Investigation (CCI)
- B.
Office of Research Compliance
- C.
Quality Improvement Program (QI)
- D.
Partners Human Research Committee (PHRC)
Correct Answer
C. Quality Improvement Program (QI)Explanation
The Quality Improvement Program (QI) can help investigators by auditing study files and assisting in the correction of errors. QI is a department that focuses on identifying areas for improvement and implementing strategies to enhance the quality of research and healthcare practices. By auditing study files, they can ensure that all necessary documentation is present and accurate, and by assisting in the correction of errors, they can help investigators rectify any mistakes or discrepancies in their research. This ensures that the research is conducted in compliance with regulations and standards, ultimately enhancing the integrity and reliability of the study.Rate this question:
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7) Which department can help investigators by providing space, supplies and nursing or study coordinators?
- A.
Center for Clinical Investigation (CCI)
- B.
Office of Research Compliance
- C.
Quality Improvement Program (QI)
- D.
Partners Human Research Committee (PHRC)
Correct Answer
A. Center for Clinical Investigation (CCI)Explanation
The Center for Clinical Investigation (CCI) can provide assistance to investigators by offering space, supplies, and nursing or study coordinators. This department is specifically dedicated to supporting and facilitating clinical research activities. They have the resources and expertise to help investigators carry out their studies effectively and efficiently.Rate this question:
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8) Which department must approve all human research prior to implementation of any study activities?
- A.
Center for Clinical Investigation (CCI)
- B.
Office of Research Compliance
- C.
Quality Improvement Program (QI)
- D.
Partners Human Research Committee (PHRC)
Correct Answer
D. Partners Human Research Committee (PHRC)Explanation
The Partners Human Research Committee (PHRC) must approve all human research prior to implementation of any study activities. This committee is responsible for ensuring that research involving human subjects is conducted ethically and in compliance with regulations and guidelines. They review research protocols, assess the risks and benefits to participants, and ensure that informed consent is obtained. The PHRC plays a crucial role in protecting the rights and welfare of human subjects involved in research conducted within the Partners Healthcare system.Rate this question:
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- 11.
9) You have just received an amendment approval letter and the approved amended version of the consent form. Which of the following is true?
- A.
The previous version of the consent form may still be used since it has not expired.
- B.
The newly approved version will expire one year from its approval date.
- C.
Only the newly approved version may be used; all other versions should be archived.
Correct Answer
C. Only the newly approved version may be used; all other versions should be archived.Explanation
The correct answer is that only the newly approved version may be used; all other versions should be archived. This means that the previous version of the consent form cannot be used, even if it has not expired. The newly approved version is the only valid version that should be used going forward.Rate this question:
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- 12.
10) You assist an investigator with consenting a subject and you are present when the subject and the investigator sign the consent form. Three days later you notice that the investigator failed to fill in the date of consent. You should:
- A.
Bring the form to the investigator and request that he or she fill in the date when the form was signed.
- B.
Leave the date blank and write a note to file explaining the oversight and report as a minor violation.
- C.
Fill in the date yourself as you were present and witnessed the signing.
Correct Answer
B. Leave the date blank and write a note to file explaining the oversight and report as a minor violation.Explanation
In this situation, the correct answer is to leave the date blank and write a note to file explaining the oversight and report it as a minor violation. This is because the investigator is responsible for filling in the date of consent, and it is not appropriate for the assistant to fill it in themselves. By leaving it blank and documenting the oversight, it ensures that the proper procedures are followed and any potential issues are addressed.Rate this question:
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- 13.
11) Major protocol violations should:
- A.
Be tracked on a log sheet and reported to the IRB at continuing review.
- B.
Be reported individually immediately to the IRB.
- C.
Be reported to the IRB only if the PI feels it is necessary.
Correct Answer
B. Be reported individually immediately to the IRB.Explanation
Major protocol violations should be reported individually immediately to the IRB. This is the correct answer because major protocol violations can have serious ethical and safety implications for research participants. Reporting them immediately to the IRB allows for timely investigation and corrective actions to be taken to protect the welfare of the participants and maintain the integrity of the research study. Tracking violations on a log sheet and reporting them at continuing review may not be sufficient if immediate action is required. Reporting to the IRB only if the PI feels it is necessary may lead to underreporting and potential harm to participants.Rate this question:
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- 14.
12) You are working on a low-risk non-interventional study enrolling men ages 35-50. A potential subject is interested and willing to participate. He is eligible in every way except he turned 51 three days ago. The PI decides she would be able to use the data from this subject anyway. She contacts the IRB and receives permission to enroll this subject in spite of his recent birthday. This is an example of:
- A.
A protocol amendment
- B.
A minor protocol violation
- C.
A major protocol violation
- D.
A protocol exception
Correct Answer
D. A protocol exceptionExplanation
The PI's decision to enroll the subject despite his recent birthday, after obtaining permission from the IRB, is considered a protocol exception. This means that an exception was made to the study protocol in order to include this subject. The subject's age is slightly outside the specified range, but the PI determined that the data from this subject would still be valuable for the study. By obtaining permission from the IRB, the PI ensured that the decision to enroll the subject was in line with ethical and regulatory guidelines.Rate this question:
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13) You are working on a low-risk non-interventional study enrolling men ages 35-50. The subjects must keep a diary to be reviewed by study staff at each visit. Mr. Jones comes in for his visit, but he has forgotten to bring in his diary. This is an example of:
- A.
A protocol amendment
- B.
A minor protocol violation
- C.
A major protocol violation
- D.
A protocol exception
Correct Answer
B. A minor protocol violationExplanation
Forgetting to bring in the diary is considered a minor protocol violation. It is a deviation from the study protocol, but it does not significantly impact the study results or pose any risk to the subject's safety or well-being. It can be addressed by reminding the subject to bring the diary for future visits and ensuring compliance moving forward.Rate this question:
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14) You are working on a low-risk non-interventional study enrolling men ages 35-50. A potential subject is interested and willing to participate. He is eligible in every way except he turned 51 three days ago. In the process of discussing this particular potential subject, the PI realizes she could really include data from men up to the age of 53. She changes the protocol, protocol summary and consent form to reflect this, and the IRB approves these changes. This is an example of:
- A.
A protocol amendment
- B.
A minor protocol violation
- C.
A major protocol violation
- D.
A protocol exception
Correct Answer
A. A protocol amendmentExplanation
In this scenario, the PI realizes that the study protocol needs to be changed to include data from men up to the age of 53 instead of just 50. The PI updates the protocol, protocol summary, and consent form to reflect this change and obtains approval from the IRB. This is considered a protocol amendment because it involves modifying the study protocol to accommodate the inclusion of a broader age range for participants.Rate this question:
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15) You are working on a low-risk non-interventional study enrolling men ages 35-50. You are working within a tight deadline to get all of the subject data, including demographics, entered into the database. You decide to bring home the study laptop so you can get some work done over the weekend. Returning to your car after dinner Friday evening, you realize the laptop has been stolen. This is an example of:
- A.
A protocol amendment
- B.
A minor protocol violation
- C.
A major protocol violation
- D.
A protocol exception
Correct Answer
C. A major protocol violationExplanation
Bringing home the study laptop without proper authorization and security measures is a major protocol violation. It goes against the study protocol which likely specifies that all study-related materials should be kept secure and not taken offsite without permission. The theft of the laptop puts the confidentiality and integrity of the subject data at risk, which is a serious breach of protocol.Rate this question:
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16) You are working on a low-risk non-interventional study enrolling men ages 35-50. The continuing review for the study was submitted one month before the study expiration date. The IRB had multiple questions which took some time for your PI to answer. You submitted the response to review 4 days ago and are waiting to hear back from the IRB. The study expiration date is tomorrow. In this situation:
- A.
If approval is not received by the expiration date, the study may continue since the original continuing review was submitted one month before expiration
- B.
If approval is not received by the expiration date, the study will be granted an extension by the IRB
- C.
If approval is not received by the expiration date, the study cannot enroll new subjects but may continue work on data collection
- D.
If approval is not received by the expiration date, the study must cease all study activities
- E.
None of the above
Correct Answer
D. If approval is not received by the expiration date, the study must cease all study activitiesExplanation
If approval is not received by the expiration date, the study must cease all study activities because the study expiration date has passed and continuing the study without approval would be a violation of research regulations. The fact that the continuing review was submitted one month before the expiration date does not change the requirement for approval to continue the study.Rate this question:
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- 19.
17) Source documents are:
- A.
Where data are first recorded
- B.
Optional study documents
- C.
Lists of all members of a study team
- D.
Adverse event tracking tools
Correct Answer
A. Where data are first recordedExplanation
Source documents are the original documents or records where data is first recorded. These documents serve as evidence of the data collected during a study or research. They are important for ensuring the accuracy and reliability of the data and are often used as a reference for data entry and analysis. Source documents can include medical records, questionnaires, consent forms, laboratory reports, and other relevant documents that contain the initial data collected for a study.Rate this question:
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18) What is the Partners IRB standard for retaining study records?
- A.
3 years
- B.
5 years
- C.
7 years
- D.
10 years
Correct Answer
C. 7 yearsExplanation
The Partners IRB standard for retaining study records is 7 years. This means that according to the Partners IRB, study records should be kept for a period of 7 years. This duration is likely determined based on regulatory requirements and best practices in research. By retaining study records for 7 years, researchers and organizations can ensure that the data and information collected during the study are available for future reference, analysis, and potential audits.Rate this question:
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19) If you see something or are asked to do something that doesn’t seem quite right, ask for guidance from:
- A.
Your supervisor
- B.
BWH Research Compliance Office
- C.
Dr. Barbara Bierer (BWH Research Integrity Officer)
- D.
IRB
- E.
Partners QI/QA Office
- F.
Partners Compliance Helpline 1-800-856-1983
- G.
Any of the above
Correct Answer
G. Any of the aboveExplanation
The correct answer is "Any of the above." This means that if you see something or are asked to do something that doesn't seem right, you can ask for guidance from any of the listed options, including your supervisor, the BWH Research Compliance Office, Dr. Barbara Bierer, the IRB, the Partners QI/QA Office, and the Partners Compliance Helpline.Rate this question:
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20) Clinical trial billing process is important because:
- A.
Double billing has been a focus of Medicare and the subject of numerous OID/DOJ investigations and settlements.
- B.
OIG work plans have recently included clinical trial billing in its top compliance initiatives.
- C.
Not managing clinical research billing risks may lead to fraudulent billing.
- D.
All of the above
- E.
None of the above
Correct Answer
D. All of the aboveExplanation
The correct answer is "All of the above." The explanation for this answer is that the clinical trial billing process is important because double billing has been a focus of Medicare and has been investigated and settled by the OID/DOJ. Additionally, the OIG includes clinical trial billing in its top compliance initiatives, indicating its importance. Lastly, not managing clinical research billing risks may lead to fraudulent billing, further emphasizing the significance of the process.Rate this question:
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21) True or False: On drug and device studies, consent can be obtained only by a physician investigator.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
In drug and device studies, consent can be obtained only by a physician investigator. This is because physicians are trained and qualified to properly explain the risks and benefits of participating in the study to the participants. They have the medical knowledge and expertise to ensure that the participants fully understand the implications of their decision to participate. Additionally, physicians can address any concerns or questions that the participants may have, and provide appropriate medical advice and guidance throughout the study.Rate this question:
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22) True or False: Minor changes to an approved protocol do not have to be approved by the IRB.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
False. Minor changes to an approved protocol still need to be approved by the IRB. The IRB is responsible for ensuring the protection of human subjects in research, and any changes to the protocol, regardless of their magnitude, need to be reviewed to assess their potential impact on the subjects' safety and welfare. This ensures that the research continues to comply with ethical and regulatory standards.Rate this question:
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23) True or False: An adverse event must be reported to the IRB when the event is unexpected and related or possibly related to participation in the research.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
An adverse event must be reported to the IRB when the event is unexpected and related or possibly related to participation in the research. This means that if an event occurs during the research study that was not anticipated and is connected to the participant's involvement in the study, it must be reported to the Institutional Review Board (IRB). The IRB is responsible for ensuring the safety and ethical conduct of research studies, so reporting adverse events helps to ensure that any potential risks or issues are addressed appropriately.Rate this question:
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24) True or False: Even though a study received initial approval, there may be significant questions or concerns to be answered at continuing review.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
It is possible for a study to receive initial approval but still have significant questions or concerns that need to be addressed during the continuing review process. This means that even though the study was initially deemed acceptable, there may be new information or issues that arise during the course of the study that require further evaluation or clarification. Therefore, it is true that even with initial approval, there may still be questions or concerns to be addressed during continuing review.Rate this question:
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25) True or False: For very senior and well-funded investigators, the President of the hospital has the authority to approve a protocol that the IRB has not approved.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
The explanation for the correct answer, False, is that the President of the hospital does not have the authority to approve a protocol that the IRB (Institutional Review Board) has not approved. The IRB is responsible for reviewing and approving research protocols to ensure the protection of human subjects involved in the study. The President of the hospital may have a high position, but they still need to follow the established procedures and guidelines set by the IRB.Rate this question:
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26) True or False: Patient care charges are defined in the institution’s rate book or chargemaster.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
Patient care charges are defined in the institution's rate book or chargemaster. This means that the charges for various services provided to patients, such as medical procedures, tests, and medications, are listed and defined in the institution's rate book or chargemaster. This allows healthcare providers to have a standardized and transparent system for determining the costs associated with patient care.Rate this question:
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27) True or False: An MCA (Medicare coverage analysis) includes a reimbursement analysis.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
An MCA (Medicare coverage analysis) is a process that determines whether a clinical trial or research study is eligible for Medicare coverage. It involves evaluating the study protocol, patient population, and other factors to determine if the study meets Medicare's coverage criteria. While a reimbursement analysis may be conducted separately to assess the financial implications of the study, it is not inherently included in an MCA. Therefore, the statement that an MCA includes a reimbursement analysis is false.Rate this question:
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28) True or False: A Partners investigator doing research using identifiable medical information on her own patients from her private practice records does not need Partners IRB review.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
False. A Partners investigator who is using identifiable medical information on her own patients from her private practice records still needs Partners IRB review. The IRB review is necessary to ensure that the research is conducted ethically and that the privacy and confidentiality of the patients' information are protected.Rate this question:
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29) True or False: On a non-drug or device trial, the PI may assign any member of the study staff to obtain consent without involving the IRB.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
On a non-drug or device trial, the PI cannot assign any member of the study staff to obtain consent without involving the IRB. The IRB is responsible for ensuring the protection of human subjects in research studies, and obtaining informed consent is a critical part of that protection. The IRB must review and approve the consent process, including who will obtain consent, to ensure that it is conducted ethically and in accordance with regulatory requirements. Therefore, it is not true that the PI can assign any study staff member to obtain consent without involving the IRB.Rate this question:
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30) True or False: A copy of the signed consent form must be given to the study subject.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
A copy of the signed consent form must be given to the study subject to ensure that they have a record of what they have agreed to and can refer to it if needed. This also helps to maintain transparency and accountability in the research process.Rate this question:
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