Good Clinic Practice Certification Exam Answers

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During registration, new users will have the option to select 100% for a passing score on quizzes. This is an enhancement for IRBs that require 100%. Existing users will need to contact an administrator to activate this option. If the 100% option is not activated, all quizzes will need a score of 80% or better to pass. In order to recertify or to improve quiz scores, users will no longer be able to re-attempt the quizzes after receiving a passing score. Users will need to either activate the 100% option or choose to Recertify. After completion of the course, the most recent certificate is displayed in the Certification tab and is available for download. This Certificate will be replaced by the renewal certificate upon recertifying. It is recommended that each user maintains a local copy of all certificates.

Module	Score
Introduction	N/A
Institutional Review Boards	Take the Quiz
Informed Consent	Take the Quiz
Confidentiality & Privacy	Take the Quiz
Participant Safety & Adverse Events	Take the Quiz
Quality Assurance	Take the Quiz
The Research Protocol	Take the Quiz
Documentation & Record-Keeping	Take the Quiz
Research Misconduct	Take the Quiz
Roles & Responsibilities	Take the Quiz
Recruitment & Retention	Take the Quiz
Investigational New Drugs	Take the Quiz

Institutional Review Boards Quiz Exam Answers:

Question 1: An IRB may suspend or terminate an ongoing clinical study if:

• Subjects are not being enrolled quickly enough.
• A drug being used in the trial is approved by FDA.
• Instructions from the IRB are not being followed.
• The clinical trial sponsor conducts an audit at the site.

Question 2: The three key principles that serve as the criteria for IRB approval of research can be found in which of the following documents:

• Belmont Report
• Code of Federal Regulations (CFR)
• ICH Good Clinical Practice guidelines (ICH GCPs)
• Declaration of Helsinki

Question 3: The site staff has prepared a postcard to be sent to past study participants telling them about a new study that they may have an interested in. This postcard does not have to be reviewed by the IRB.

• TRUE
• FALSE

Question 4: An IRB may perform an expedited review of a protocol or informed consent form change if the change involves no more than minimal risk to study participants.

• TRUE
• FALSE

Question 5: A protocol that has been previously reviewed by the full IRB is always eligible for expedited review.

• TRUE
• FALSE

Informed Consent Quiz Exam Answers:

Question 1: Of the following factors, which one does not influence the capacity to consent?

• Age
• Cognitive (mental) impairment
• Illness
• Financial factors

Question 2: When an original consent form has been lost, the only steps that must be taken are that study staff report the loss immediately to the IRB, the sponsor, and get another signed as soon as possible.

• TRUE
• FALSE

Question 3: Which of the following safeguards are included as protections for prisoners involved in research?

• The IRB must approve the study as prisoner research.
• The study must present no more than minimal risk to the participants.
• The IRB that reviews and approves the study must not include prisoners or prisoner advocates in its membership.
• The research must involve practices intended to improve the health or well-being of the participants.
• All of the above.
• A, B, and D

Question 4: Informed consent is:

• The process by which a person voluntarily agrees to participate in a research study after being fully informed about the study.
• The legal document that explains the study.
• A document stating that the study information was presented orally to the person.
• All of the above.

Question 5: According to 45 CFR 46 Subpart B, when research involves pregnant women as participants, both mother and father must always be informed about any potential impact of the research on the fetus.

• TRUE
• FALSE

Question 6: As part of the consent, each participant must be informed that she/he has a right to withdraw only at the beginning of a study.

• TRUE
• FALSE

Question 7: Which of the following statements is false regarding errors in the informed consent process?

• Errors are considered protocol violations and must be reported to the relevant IRB.
• Errors are very uncommon and always result in suspension of the study.
• Errors must be dealt with openly and honestly.
• Once errors are identified, a description must be provided of the action taken to correct the error and prevent it from occurring again.

Question 8: If the research participant is a minor (under the age of 18), which of the following must occur before the individual can participate in the research study?

• The parent/legal guardian must give permission for the minor to participate.
• The minor must agree to participate in the research.
• A judge gives permission for the minor to participate in the research.
• A and B
• A, B, and C

Question 9: Which of the following applies when new information is available to researchers regarding the study medication?

• Study participants will be advised promptly if the researchers find any new information that might affect them.
• Participants are never informed of the new information on study medication.
• Participants do not have to continue taking part in the study.
• Participants will not incur penalties or loss of benefits if they withdraw from the study.
• A, C, and D

Question 10: According to GCP and CFR regulations, documentation of informed consent include which of the follow?

• The IRB must approve the consent form.
• The participant or the participant’s legally authorized representative must sign the current version of the IRB approved consent form.
• A copy must be given to the person that signs it.
• All of the above.

Question 11: Jan W. is a former Marine who is on parole. He has been invited to participate in a study on the effects of an investigational medication on post-traumatic shock in Gulf War veterans. He is told a certain amount of blood and several urine samples will be taken sometime during the study. He is not told when these tests will occur and it has not been explained to him that any positive test results for other drugs must be reported to his parole officer. Has Jan W. been properly informed and consented for the study?

• YES
• NO

Question 12: Failure to comply with general requirements for informed consent and documentation of informed consent may result in suspension of a study.

• TRUE
• FALSE

Confidentiality & Privacy Quiz Exam Answers:

Question 1: Certificates of Confidentiality may contribute to increased enrollment in trials due to assurance of participant privacy.

• TRUE
• FALSE

Question 2: The HIPAA Privacy Rule applies to which of the following identifiable health information for individuals:

• Fingerprints and voice prints
• License and license plate numbers
• Names
• Dates
• All of the above.

Question 3: According to the Code of Federal Regulations, there are certain exceptions to confidentiality requirements for alcohol and drug abuse patient records.

• TRUE
• FALSE

Question 4: In research, once a covered entity obtains a participant’s authorization for disclosure of PHI, there is no need to keep track of disclosures made.

• TRUE
• FALSE

Question 5: Which of the following is not protected health information (PHI) subject to the HIPAA Privacy Rule?

• E-mail address.
• Telephone and Fax numbers.
• Zodiac signs.
• Name.
• Social Security Number (SSN).

Question 6: In research, once a covered entity obtains a participant’s authorization for disclosure of PHI, there is no need to keep track of disclosures made.

• TRUE
• FALSE

Question 7: When a study participant no longer wants to disclose PHI, what can be done?

• It is too late to make changes after consent has been given.
• The participant must petition removal through court order.
• The participant may revoke authorization for future disclosures of PHI.

Question 8: Medical records, paper based and electronic, are subject to disclosure and confidentiality requirements.

• TRUE
• FALSE

Question 9: The document that provides protection for the privacy of study participants in alcohol and drug abuse research studies is called:

• Affidavit
• Certificate of Confidentiality
• Disclosure Certificate
• Confidentiality Agreement Form

Question 10: Researchers are not required to account for disclosures of protected health information (PHI) when:

• The participant authorizes disclosure.
• The information is provided as a complete data set.
• The information contains participant identifiers.

Question 11: Researchers use various practices to ensure participant confidentiality, such as:

• Disposing properly of all documentation with PHI identifiers.
• Maintaining a notebook of all participant addresses and names in the researcher’s personal papers.
• Storing participant paper records in a locked cabinet.
• Assigning security codes to electronic records.
• A, C, and D.

Question 12: Each research site taking part in a study is always responsible for obtaining its own Certificate of Confidentiality.

• TRUE
• FALSE

Question 13: Disclosure of protected information is only a breach of confidentiality when disclosed in writing.

• TRUE
• FALSE

Participant Safety & Adverse Events Quiz Exam Answers:

Question 1: A participant missed several study visits and the research site staff becomes aware of a participant’s death searching through public records. What is the most appropriate next course of action?

• Report this as a serious adverse event (SAE).
• Report this as an adverse event (AE).
• No action is required.
• Contact the Study Physician for instructions on next steps.

Question 2: Mandatory elements in the definition of an adverse event (AE) include which of the following?

• Untoward medical occurrence.
• Use of pharmaceutical product or a study intervention.
• Patient or clinical investigation subject involvement.
• Causal relationship with the pharmaceutical product.
• A, B, and C only
• All of the above.

Question 3: The site investigator receives a copy of an expedited safety report that represents an increased risk to the study participants.

• File it in regulatory binder.
• Report to local IRB.
• Inform all participants.
• All of the above.

Question 4: All serious adverse events (SAEs) must be reported to the research site’s Institutional Review Board (IRB).

• TRUE
• FALSE

Question 5: A participant missed a study visit as he was hospitalized for pneumonia, and then he reported to the study clinic a week later. What is the most appropriate course of action?

• No action is required.
• Report it as an adverse event (AE).
• Remind the participant of the importance of attending study visit as scheduled without exception
• Report it as a serious adverse event (SAE).

Question 6: Which source document may NOT be used to determine whether an adverse event is expected or not in clinical studies in which an investigational new drug is used?

• Investigator Brochure
• Protocol
• Informed Consent Form
• Annual Safety Report
• All of the above may be used.

Question 7: The severity of an adverse event (AE) is the same as its seriousness.

• TRUE
• FALSE

Question 8: The person(s) responsible for assuring the safety and rights of study participants include:

• Principal Investigator.
• Sub-Investigator.
• Data and Safety Monitoring Board.
• Research Assistant.
• Study Physician.
• Phlebotomist.
• All of the above.

Question 9: This is not one of the serious advent event (SAE) criteria.

• Death
• Life threatening
• Pregnancy
• Hospitalization

Question 10: Which adverse event feature is NOT used to determine whether expedited reporting to the FDA by the Sponsor is required?

• Seriousness (threatening life or function)
• Expectedness
• Causal relationship with study product
• Severity
• All of the above.

Quality Assurance Quiz Exam Answers:

Question 1: Quality Assurance is the responsibility of all research team members.

• TRUE
• FALSE

Question 2: The main reason site monitoring visits are conducted is to:

• Socialize with the research team members.
• Ensure compliance with quality standards.
• Punish the research staff for making mistakes.
• All of the above.

Question 3: Protocol Monitors perform which of the following duties during the conduct of a trial:

• Verify the accuracy of reported trial data.
• Verify the financial statements of the research site.
• Verify that the site has the adequate resources to continue the trial.
• Verify that all research site staff has documentation of driver’s licensure.
• Verify that participant rights and well-being is being protected.
• A, C, and E
• B, D, and E

Question 4: Protocol Monitor responsibilities are outlined in GCP guidelines, and include which one of the following responsibilities?

• Verifying investigator and research staff qualifications.
• Consenting research participants.
• Performing physical examinations.
• Administering investigational drug to research participants.

Question 5: The sponsor has the ultimate responsibility for implementing and maintaining Quality Assurance systems.

• TRUE
• FALSE

The Research Protocol Quiz Exam Answers:

Question 1: The research protocol describes:

• Why the study is being conducted.
• What will be done in the study.
• Who will be involved in the research study
• All of the above

Question 2: Which section of the research protocol should contain a description of the type and duration of follow-up of participants who experience adverse events?

• Assessment of Efficacy
• Assessment of Safety
• Background Information
• Study Objectives and Purposes

Question 3: Which of the following documents are essential for ensuring that a research study is conducted in a standardized manner?

• Research Protocol, Operations Manual, and SOPs.
• Contract.
• Calendar of Events
• All of the above.

Question 4: What can be done to try to reduce the number of protocol violations?

• Provide thorough protocol trainings and refreshers.
• Notify all staff members of protocol amendments.
• Update the Operations Manual to reflect the changes to the protocol.
• All of the above.

Question 5: Unless there is an immediate safety concern, implementation of an amendment to a protocol (that does not involve a product regulated by the FDA) must be approved by:

• Food and Drug Administration (FDA).
• Institutional Review Board (IRB).
• Sponsor.
• All of the above.

Documentation & Record-Keeping Quiz Exam Answers:

Question 1: The Case Report Form (CRF) is treated as a source document if data is directly entered onto the document.

• TRUE
• FALSE

Question 2: Choose the statement that is true of Case Report Forms (CRFs).

• Similar to progress notes, CRFs are never considered source documents.
• According to GCP guidelines, CRFs may be printed, optical, or electronic documents, used for the collection of protocol-required information.
• All research studies use electronic CRFs.
• Investigators are never required to maintain CRFs according to the records retention schedule as defined in the Code of Federal Regulations.

Question 3: Essential documents defined in GCP guidelines fulfill all of the following purposes, including:

• Assist in the documentation management for a research trial.
• Provide quality assurance auditors and regulatory inspectors with an audit trail for assessing the validity in the conduct of a study.
• Verify compliance to GCP, sponsor, and regulatory requirements.
• All of the above.

Question 4: Which is the correct order of shortest record storage requirement to longest storage requirement?

• HIPAA, NIH, FDA
• NIH, HIPAA, FDA
• FDA, HIPAA, NIH
• FDA, NIH, HIPAA
• NIH, FDA, HIPAA

Question 5: The Investigator should only record observations and other data he/she feels is important to the study.

• TRUE
• FALSE

Question 6: Source documents are records created during a trial for data collection and can be related to participants medical treatment and history.

• TRUE
• FALSE

Question 7: Choose the correct example(s) of source documents in a research project.

• Study participant’s state issued driver’s license.
• Participant diagnostic test results.
• Participant’s AARP card.
• A and C.

Question 8: Study drug accountability is not as important in research projects and investigators do not need to maintain accurate records of study drug disposition.

• TRUE
• FALSE

Question 9: Federal regulations outline the records requirements and retention schedule for all federally funded research projects.

• TRUE
• FALSE

Question 10: According to regulations, every aspect of a research study must be documented in compliance with GCP guidelines in order to obtain useful data.

• TRUE
• FALSE

Question 11: GCP guidelines define essential documents for which phase(s) of a clinical trial?

• Before the trial starts
• During the clinical trial
• After the clinical trial closes
• All of the above.

Question 12: How long does the FDA require storage of trial-related records?

• 2 years
• 5 years
• 3 years
• 18 months

Question 13: One (1) bottle of study medication containing 100 tablets was supplied to the research center. 55 tablets were ingested and 3 tablets were lost. How much study medication is on hand?

• 42 tablets.
• 45 tablets.
• 97 tablets.
• Amount unknown.

Question 14: Source documents may include which of the following:

• Participant appointment diaries.
• Informed consent forms signed by participants.
• Study medication logs.
• All of the above.

Question 15: Select the types of progress notes used in research trials.

• Clinical notes.
• Research notes.
• Practitioner-to-Nurse conversation transcripts.
• Protocol change history notes.
• A and B.

Research Misconduct Quiz Exam Answers:

Question 1: Which agency or agencies oversee investigations of alleged research misconduct?

• Food and Drug Administration
• National Institutes of Health
• Office of Research Integrity
• Center for Drug Evaluation and Research
• All of the above.

Question 2: Choose the definition for Plagiarism:

• Making up data or results and recording or reporting them.
• Changing the research record so that it does not accurately reflect the research findings.
• Using another person’s ideas, processes, results, or words without giving credit.

Question 3: Which of the following improper activities is viewed as research misconduct:

• Financial conflicts of interest.
• Misuse of grant funds.
• Destruction of the integrity of the research record.
• Discrimination.
• All of the above.

Question 4: An informant is considered:

• a whistleblower.
• one who alleges research misconduct.
• A and B.
• one who does not disclose research misconduct.
• None of the above.

Question 5: Which of the following constitutes research misconduct according to federal regulations?

• Financial conflict of interest.
• Misuse of grant funds.
• Violation of human subject protections.
• Using falsified data.
• All of the above.

Question 6: When imposing penalties for research misconduct, the Office of Research Integrity (ORI) may consider which of the following:

• Was research misconduct committed in a knowing, intentional, or reckless manner?
• Was this an isolated event or part of a pattern?
• Did this have a significant impact on the research record, research subjects, other researchers, institutions, or the public welfare?
• A, B, and C.
• None of the above.

Question 7: Choose the definition for Falsification:

• Making up data or results and recording or reporting them.
• Changing the research record so that it does not accurately reflect the research findings.
• Using another person’s ideas, processes, results or words without giving credit.

Question 8: Which one is NOT a goal of the regulations for dealing with research misconduct (42 CFR 50 subpart A)

• To define research misconduct.
• To define penalties for research misconduct.
• To establish procedures for reporting and investigating research misconduct.
• To protect both those who report alleged research misconduct.
• To protect those accused of research misconduct.

Question 9: Regarding penalties for research misconduct which of the following is CORRECT:

• Research institutions may penalize researchers found to have committed research misconduct.
• The Office of Research Integrity (ORI) may impose penalties of its own on researchers or institutions.
• Researcher’s employment termination is one possible penalty.
• Supervision of future research activities may be imposed to the researcher as a penalty.
• All of the above.

Question 10: Researchers and research institutions have the primary responsibility for reporting and investigating allegations of research misconduct.

• TRUE
• FALSE

Question 11: Choose the definition for Fabrication:

• Making up data or results and recording or reporting them.
• Changing the research record so that it does not accurately reflect the research findings.
• Using another person’s ideas, processes, results, or words without giving credit.

Question 12: The term fraud describes:

• Illegal and deceptive practices.
• Fabrication.
• Falsification.
• Plagiarism.
• None of the above.

Question 13: Penalties for research misconduct imposed by the Office of Research Integrity (ORI) may include which of the following:

• Correction of the research records.
• Letter of reprimand.
• Researcher’s employment termination.
• Suspension or termination of the research grant.
• A, B, and D.

Question 14: Which element or elements are required for a finding of research misconduct?

• The misconduct must have resulted in harm to human research subjects.
• Research misconduct must be committed “intentionally, or knowingly, or recklessly.
• An allegation of research misconduct must be proven by “a preponderance of the evidence” (that is, by most of the evidence).
• Significant departure from accepted practices of the relevant research community.
• B, C, and D.

Question 15: Which of the following events is considered research misconduct?

• Unintentional errors in data entry.
• Differences of opinion.
• Failure to protect human research subjects.
• Authorship dispute not involving plagiarism.
• None of the above.

Question 16: Regarding response to allegations of research misconduct, which of the following is CORRECT:

• The accused researcher is entitled to know who the informant is.
• The informant privacy must be protected to the extent possible and may remain anonymous.
• The informant may be penalized if the allegations are not sustained even if made in good faith.
• Anyone with appropriate expertise may be selected to investigate an allegation of research misconduct.
• All cases of alleged misconduct in a clinical trial must be immediately reported to the trial principal investigator, the federal agency sponsoring the trial and the Office of Research Integrity (ORI).

Roles & Responsibilities Quiz Exam Answers:

Question 1: Principal Investigators are encouraged, but not required, to conduct research in compliance with the study protocol. Occasionally, they may deviate from the protocol as needed for certain participants.

• TRUE
• FALSE

Question 2: According to GCP, who is responsible for all study-related medical decisions?

• Study Coordinator
• Pharmacist
• Qualified physician
• Phlebotomist

Question 3: The Sponsor is responsible for:

• Implementing and maintaining quality assurance and quality control systems.
• Ensuring that the study is conducted and documented in compliance with the protocol and GCP.
• Ensuring that the study is conducted and documented in compliance with regulatory requirements.
• All of the above.

Question 4: Of the following study roles, which one would be responsible for receiving and dispensing medications?

• Supervisor
• Pharmacist
• Quality Assurance Monitor
• Regulatory Specialist

Question 5: The Sponsor may NOT do which of the following actions:

• Transfer to or share with a CRO most or all regulatory activities, providing core training, and on site data monitoring.
• Transfer to a CRO the responsibility for data storage, quality and analysis.
• Transfer the ultimate responsibility for quality and integrity of the trial data to a Lead Investigator.
• Designate appropriately qualified medical personnel to advise on trial-related medical questions or problems.

Recruitment & Retention Quiz Exam Answers:

Question 1: It is a best practice in clinical research to establish highly stringent inclusion and exclusion criteria.

• TRUE
• FALSE

Question 2: Study participant recruitment cannot begin until the IRB has approved the:

• Informed Consent form.
• Protocol.
• Advertisements.
• All of the above.

Question 3: It is important that findings from a clinical study be relevant to people who were not in the study but have the same characteristics as the study participants.

• TRUE
• FALSE

Question 4: Which group must approve recruitment and retention materials for any federally funded research prior to utilization in a clinical study?

• Administrative Research Board
• Institutional Review Board
• International Conference on Harmonisation
• Ethical Advisory Committee

Question 5: In order for a clinical investigation of a research question to occur, research sites must fulfill which of the following goals?

• Improve an investigator’s prominence in a field of study.
• Increase the popularity of a research site.
• Recruit an adequate number of appropriate participants.
• Retain study participation numbers for the time period specified in the research protocol.
• A and C
• C and D

Question 6: The National Institutes of Health has issued policies to include women and minorities in clinical research.

• TRUE
• FALSE

Question 7: Which of the following are elements of a successful recruitment plan?

• Avoiding unnecessarily restrictive inclusion and exclusion criteria in the protocol.
• Identifying a recruiting strategy during protocol development.
• Adequately reimbursing participants for their time and expenses without being coercively generous.
• All of the above.

Question 8: The FDA has strict guidelines on the exact dollar amount of money to offer study participants enrolled in a clinical investigation; therefore, this amount is not required for inclusion in the study’s Informed Consent document.

• TRUE
• FALSE

Question 9: Which agency has issued guidelines for clinical studies involving alcohol-abusing participants?

• National Advisory Council on Alcohol Abuse and Alcoholism
• Research Board for Substance Abuse
• Scientific Advisory Board for Alcohol and Substance Use Dependence
• Research Council for Substance Use and Alcohol Addiction

Question 10: There are two major elements involved in recruitment: Defining the right study population; and Recruiting participants appropriately and ethically.

• TRUE
• FALSE

Investigational New Drugs Quiz Exam Answers:

Question 1: A study conducted in a small number of participants, with a specific disease and investigating a number of doses of a drug to assess safety, is usually considered a _______ study.

1. Phase 1
2. Phase 2
3. Phase 3
4. Phase 4

Question 2: If a drug has never been tested in humans before and the goal of the initial study is to establish the safety and pharmacokinetics of a single ascending dose in healthy subjects, this study is considered a _____ study.

• Phase 1
• Phase 2
• Phase 3
• Phase 4

Question 3: In the U.S. Food and Drug Administration (FDA) regulations, an investigational new drug is:

• No substance seeking FDA approval.
• Any substance (such as, a drug, vaccine or biological product) for which FDA approval is being sought.
• Generic of a �branded� drug.
• All of the above.

Question 4: An investigational drug cannot be a controlled substance as it is not yet approved for sale.

• TRUE
• FALSE

Question 5: A drug has been on the market for a long time as a treatment for migraine, but has been used by some doctors to treat depression in children. An IND, therefore, is not needed to conduct a clinical trial using this drug, which is supplied by the manufacturer free of charge for use in the treatment of childhood depression.

• TRUE
• FALSE

Question 6: If a study is exempt from IND requirements, then monitoring of the safety of participants on the study is not required.

• TRUE
• FALSE

Question 7: A clinical trial powered to show the efficacy of a drug in a specific disease population, with the goal of using these data as part of a marketing application, is usually considered a _____ study

• Phase 1
• Phase 2
• Phase 3
• Phase 4

Question 8: If a study is exempt from IND requirements, then an IRB does not have to be involved at any point during study conduct.

• TRUE
• FALSE