LIBRARY CONTENT SERIES: Starter Questions

Date: February 2021 Created by: Qstream

Use Case Topic: Good Clinical Practice (GCP)

LIBRARY CONTENT SERIES: Starter Questions The purpose of these questions is to show examples of potential Qstream content and is created from publicly available information. The questions are available for Qstream clients to use as a “starter” and should be reviewed thoroughly to ensure the information is accurate and applicable prior to use.

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Qstream Library Content: Good Clinical Practices (GCP)

That following content was developed based on information from: https://gcp.nidatraining.org/

QUESTION 1 Topic: Introduction

Question Type: Knowledge

Question Label for Reports: (35 character limit)

GCP Definition

Question stem: The standard definition of Good Clinical Practice (GCP) is a/n ______ ethical and scientific standard for conducting biomedical and behavioral research involving _______ participants.

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Answer Choice (A) international; human

Answer Choice (B) international; human and non-human

Answer Choice (C) US-based; human

Answer Choice (D) US-based; human and non-human participants

Answer Choice (E)

Correct Answer: A

Explanation: Good Clinical Practice (GCP) is an international ethical and scientific standard for conducting biomedical and behavioral research involving human participants. The GCP guidelines provide a unified standard for data from clinical trials by Regulatory Authorities across many countries (European Union [EU], Japan, the United States, Canada, and Switzerland). The development of the GCP regulations and ethical guidelines to protect human research participants were developed in response to situations in which research participants were grossly abused. GCP is currently widely accepted and expected in all research involving human participants. Questions written for this Qstream are based on content from: https://gcp.nidatraining.org/

Images/Media:

https://gcp.nidatraining.org/


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QUESTION 2 Topic: Institutional Review Board

Question Type: Scenario


What is an Institutional Review Board

Question stem: Jessica is a manager at the Institutional Review Board (IRB), an independent body whose purpose is to protect the rights and welfare of human research participants. Today, she’s reviewing the work of her team, who is working on a variety of projects. Which of the following activities are appropriate for the IRB to do?

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Answer Choice (A) Reviewing the plans for each research study to ensure it meets the IRB’s criteria Answer Choice (B) Confirming that the research plans do not expose participants to unreasonable risks

Answer Choice (C) Assessing suspected/alleged protocol violations

Answer Choice (D) Paying monitors to view all interactions with each research participant throughout the study

Answer Choice (E)

Correct Answer: A, B, C

Explanation: The Institutional Review Board (IRB) protects the rights and welfare of human research participants by:

• Reviewing the plans for each research study to ensure it meets the IRB’s criteria

• Confirming that the research plans do not expose participants to unreasonable risks

• Reviewing and approving all payments and other compensation to study participants

• Assessing suspected/alleged protocol violations, complaints submitted by research participants, or

violations of institutional policies

• Considering interim findings and recent literature that may be relevant to the research

In addition, the IRB may suspend or terminate ongoing research that:

• Is not being conducted in accordance with the IRB requirements

• Results in unexpected or serious harm to participants

• Increases the study's likely risks or benefits

LEARN MORE: How IRBs Protect Human Research Participants (7-minute video) [https://www.youtube.com/watch?v=U8fme1boEbE] In this animated video by the US Department of Health and Human Services, review what IRB are and how they serve to protect people who participate. Questions written for this Qstream are based on content from: https://gcp.nidatraining.org/

Images/Media:

https://www.youtube.com/watch?v=U8fme1boEbE


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QUESTION 3 Topic: Institutional Review Board



Investigators' Responsibilities

Question stem: Adam is an IRB investigator who’s reviewing a research study sponsored by USAMed on the effects of their new medication for psoriasis. As Adam conducts his review, he must:

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Answer Choice (A) Ensure that the IRB receives all of the documents needed to review the proposed research

Answer Choice (B) Validate that no participant is admitted before the IRB has approved the study in writing

Answer Choice (C) Not change the study protocol without prior written approval from the IRB under any conditions

Answer Choice (D) Promptly report to the IRB any changes to the protocol that eliminate immediate hazards to study participants

Answer Choice (E)

Correct Answer: A, B, D

Explanation: IRB investigators must first ensure that the IRB receives all of the documents needed to review the proposed research. Investigators must also ensure that no participant is admitted before the IRB has approved the study in writing. Once that is completed, the study protocol must not change without prior written approval from the IRB with the exception of when it is necessary to eliminate immediate hazards to participants. It is also the investigator's responsibility to know and follow the individual reporting requirements of each IRB involved with the research study, since reporting requirements may vary across time, region, and agency. LEARN MORE: Why Do Researchers Do Different Kinds of Research Studies? (5-minute Infographic) [https://www.nih.gov/sites/default/files/health-info/clinical-trials/infographic-why-researchers-different-kinds-clinical-studies.pdf] Explore the different types of clinical studies and why scientists use them. Questions written for this Qstream are based on content from: https://gcp.nidatraining.org/

Images/Media:

https://www.nih.gov/sites/default/files/health-info/clinical-trials/infographic-why-researchers-different-kinds-clinical-studies.pdf


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QUESTION 4 Topic: Informed Consent



What is informed consent?

Question stem: Chloe is considering participating in a clinical study from GenMed for a new hypertension medication. Today, she received an email with some documents attached, including an informed consent PDF. Although she’s not a lawyer, her understanding is that informed consent is a legal document that explains the study and will contain signatures and dates. Before Chloe signs the document, she’ll find out that informed consent also includes which of the following?

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Answer Choice (A) All of the information that she needs to make an informed decision about taking part in the study

Answer Choice (B) Language that she may withdraw consent and decline to participate in the study at any time before or after signing the consent document

Answer Choice (C) Voluntarily agreeing to participate in a study after being fully informed about it via verbal discussion with the study staff

Answer Choice (D) Her consent will be only be sought prior to the beginning of the study

Answer Choice (E)


Explanation: Although informed consent is a legal document that explains the study, it also includes other aspects. Fundamentally, informed consent is a continuing process that includes all of the information that participants need to make an informed decision about taking part in the study. It begins with people voluntarily agreeing to participate in a study after being fully informed about it via a verbal discussion with the study staff. It then continues with documentation in a written, signed, and dated informed consent form. Participants’ consent will be continually validated throughout the study and the participants will be notified of any changes to the study. Further, participants have the right to withdraw consent and decline to participate in the study at any time before or after signing the consent document. LEARN MORE: Informed Consent with Research on Medical Practice (ROMP) (21-minute podcast) [https://soundcloud.com/publicresponsibility/benjamin-wilfond-informed-consent-with-romp] Dr. Benjamin Wilfond discusses his study on the ethical and informed consent considerations of research on the types of care that work best in clinical practice. Questions written for this Qstream are based on content from: https://gcp.nidatraining.org/

Images/Media:

https://soundcloud.com/publicresponsibility/benjamin-wilfond-informed-consent-with-romp


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Special Requirements Concerning Consent

Question stem: The informed consent document covers many items, including which of the following?

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Answer Choice (A) The purpose of the research and a description of the procedures and interventions to be used

Answer Choice (B) Who is funding the research study and how much is sponsored by a government agency

Answer Choice (C) Who the participants can contact with questions about the research and their rights

Answer Choice (D) A guarantee that participants will receive health benefits in the research study

Answer Choice (E)

Correct Answer: A, C

Explanation: Standard informed consent documents used in research studies must at least include these items:

• The purpose of the research

• A description of the procedures and interventions to be used

• Any foreseeable risks or discomforts participants may experience

• Who the participants can contact with questions about the research and their rights

• The extent to which records will be kept confidential

Questions written for this Qstream are based on content from: https://gcp.nidatraining.org/

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Quality Control in the Informed Consent Process

Question stem: Emma is reviewing the informed consent forms of 14 participants in her clinical trial for a new breast cancer treatment. She becomes alarmed when she realizes that they all completed an outdated draft version of the forms—not the correct updated version. She knows errors in the informed consent process are considered protocol violations and may suspend or halt her research study. Emma knows she must report this violation to which of the following parties?

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Answer Choice (A) Relevant IRBs

Answer Choice (B) Local or regional police

Answer Choice (C) Local or national media outlets

Answer Choice (D) Participants’ immediate family

Answer Choice (E)

Correct Answer: A

Explanation: The protection of research participants is the primary goal of the informed consent process and the IRB. When there are errors in the informed consent process, they are considered protocol violations. These errors must be reported to the relevant IRBs, along with a description of the action taken to correct the error and prevent it from occurring again. If informed consent process violations are severe or ongoing, the IRB may impose penalties as well as report the problem to the regulatory authorities. LEARN MORE Human Research Violations By UCSD Eye Doctor Showcase A National Problem (7-minute news article) [https://www.kpbs.org/news/2019/apr/18/human-research-violations-ucsd-eye-doctor-showcase/] Read how a well intentioned framework designed to protect research participants from harm can collapse. Questions written for this Qstream are based on content from: https://gcp.nidatraining.org/

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https://www.kpbs.org/news/2019/apr/18/human-research-violations-ucsd-eye-doctor-showcase/


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QUESTION 7 Topic: Confidentiality and Privacy



Types of Confidential Information

Question stem: Emma is having lunch with several of her colleagues at CMI Pediatric Services and the discussion turns to work. One of them, Ben, asks Emma, “So Emma, I hear you’re working with one of my patients, Samantha, in your research. Which study is she in?” Which of the following is an appropriate way for Emma to reply?

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Answer Choice (A) Samantha is in my HIV study.

Answer Choice (B) Samantha is in my research study, but I can’t tell you which one it is.

Answer Choice (C) I work with Samantha, but I can’t tell you how I work with her.

Answer Choice (D) I can’t tell you if I work with her or not.

Answer Choice (E)

Correct Answer: D

Explanation: Emma should not tell Ben or her other colleagues anything about her research participants. They are having a social discussion- not a professional discussion about a patient. Research participants have confidentiality protections afforded them by the Code of Federal Regulations, Part 46, (45 CFR 46). These regulations are divided into four sections:

• Subpart A: Basic protections of human research participants

• Subpart B: Additional protections for pregnant women, fetuses, and neonates

• Subpart C: Additional protections for prisoners in biomedical and behavioral research

• Subpart D: Additional protections for children

LEARN MORE Electronic Code of Federal Regulations (e-CFR) (10-minute reference) [https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML] Browse the many sections of Part 46- Protection of Human Subjects, in this online reference. Questions written for this Qstream are based on content from: https://gcp.nidatraining.org/

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https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML


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QUESTION 8 Topic: Confidentiality and Privacy



Maintaining the Security of Written Records

Question stem: Isabella’s clinical trial is scheduled to end in a week. As the Principal Investigator during the trial, she has safely stored the written records that are covered by confidentiality regulations in a locked file cabinet in a secure room. Next week, when her trial is completed, she will need to manage the clinical records of her participants. Isabella will need to do which of the following with the clinical records when her clinical trial is over?

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Answer Choice (A) Follow the procedures outlined by the clinical trial sponsor

Answer Choice (B) Make a backup copy of all of the written records covered by the confidentiality regulations

Answer Choice (C) Identify the retention period requirements for each type of document

Answer Choice (D) Remove all participant-identifying information from all records, in all cases

Answer Choice (E)

Correct Answer: A, C

Explanation: When a clinical trial ends, there are medical record responsibilities that must be followed. The sponsor and regulatory entities with oversight authority will have already created procedures and retention period requirements for medical and study related records. Additionally, the sponsor will also identify where these documents must be kept and for what period of time. The clinical trial must also remove all participant-identifying information from its records or destroy the records unless:

• The subject of the records gives written consent to transfer the records

• The law requires that the records be kept for a specified period

LEARN MORE Your Rights Under HIPPA (2-minute video) [https://www.youtube.com/watch?list=PLACD9536723837201&v=FKTHncn-5Vs&feature=youtu.be] In this short video from the Department of Health & Human Services, find out about patient rights regarding written records. Questions written for this Qstream are based on content from: https://gcp.nidatraining.org/

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https://youtu.be/FKTHncn-5Vs?list=PLACD9536723837201


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QUESTION 9 Topic: Participant Safety and Adverse Events



Definition of Adverse Event

Question stem:

“Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical

product and which does not necessarily have to have a causal relationship with this treatment” is a definition of

which of the following terms?

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Answer Choice (A) Adverse Event

Answer Choice (B) Adverse Drug Reaction Answer Choice (C) Unexpected Adverse Drug Reaction Answer Choice (D) Serious Adverse Event Answer Choice (E)

Correct Answer: A

Explanation:

An adverse event (AE) can be more readily understood as any unfavorable and unintended sign, symptom, or

disease temporally associated with the use of a medicinal product, whether or not it is considered related to the

medicinal product.

LEARN MORE Guideline for Industry Clinical Safety Data Management: Definitions and Standards (10-minute read)

[https://www.fda.gov/media/71188/download]

Read the definitions for all of the terms in this question.


Images/Media:

https://www.fda.gov/media/71188/download


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QUESTION 10 Topic: Participant Safety and Adverse Events



Adverse Event Reporting

Question stem: James is part of a research team for a new heart valve and works directly with the participants in the study. He just met with Kim, one of the participants, who complained about worsening, yet mild, symptoms consistent with seasonal allergies including coughing and sneezing. James knows he needs to report any Adverse Events (AE) that occur and refers to his research documentation and protocols for guidance. Based on this case study, James should do which of the following?

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Answer Choice (A) Immediately submit a Severe Adverse Event to the IRB

Answer Choice (B) Immediately submit an Adverse Event to the IRB

Answer Choice (C) Document it in the patient’s Progress Notes

Answer Choice (D) Document it in the patient’s Progress Notes and then submit an Adverse Event to the IRB within 24 hours

Answer Choice (E)

Correct Answer: C

Explanation:

Determining whether a patient incident is a reportable Adverse Event (AE) and what should be reported, to

whom, and by when depends on many factors such as:

• Previous experience of the drug/intervention

• The Disease being treated

• Regulatory requirements

However, not all AEs require reporting the IRB. The protocol and operations manual of the clinical study describe

the details of adverse event reporting for that specific trial. The research team and sponsor may decide that

minor complaints like the one in this case study are not considered AEs at all- but they would be captured in the

patients’ Progress Notes or a Case Report Form.

LEARN MORE Unanticipated Problems Involving Risks & Adverse Events Guidance (12-minute reference) [https://www.hhs.gov/ohrp/regulations-and-policy/guidance/reviewing-unanticipated-problems/index.html] Explore OHRP’s recommendations on Unanticipated Problems and Adverse Events.


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https://www.hhs.gov/ohrp/regulations-and-policy/guidance/reviewing-unanticipated-problems/index.html


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QUESTION 11 Topic: Quality Assurance



When Monitoring Occurs

Question stem: Isaiah has been selected to be a Quality Assurance (QA) monitor for GlobalMeds’ research trial on a new psoriasis treatment. As a QA monitor, he needs to check the quality before, during, and after the study. One part of his duties includes monitoring the reported trial data (including source documents). To assure quality, he verifies that the data is attributable, legible, accurate, and complete. Monitoring the reported trial data happens ________ the trial.

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Answer Choice (A) before

Answer Choice (B) during

Answer Choice (C) after

Answer Choice (D) before, during, and after

Answer Choice (E)

Correct Answer: B

Explanation: Monitoring reported trial data happens as the trial is being conducted. This is one of many activities that a monitor does during a clinical trial. While a clinical trial is in progress, monitors also:

• Assess the progress

• Verify that the participants’ rights and well-being are protected

• Verify that the conduct of the trial is in compliance with IRB guidelines

Monitoring also happens before to ensure the trial documents are complete and in order. After the trial, monitors ensure all trial documents are complete and ready for storage and that drug accountability records have been finalized. LEARN MORE Good Clinical Practice Network- Section 5 (4-minute resource) [https://ichgcp.net/5-sponsor] Explore all of a QA monitor’s responsibilities in section 5.18.4. Questions written for this Qstream are based on content from: https://gcp.nidatraining.org/

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https://ichgcp.net/5-sponsor


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QUESTION 12 Topic: Research Protocol



Research Protocol

Question stem: Manuel is writing the protocol for his research trial on a new treatment for opioid addiction so he can submit it for approval. To make sure he’s addressing all of the components that are required, he’s using a template developed by the CTN research network. There are over a dozen sub-topics that are needed, so it’s essential that he references a good resource. Which of the following topics is included in the protocol?

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Answer Choice (A) Study Objectives and Purposes

Answer Choice (B) Assessment of Safety

Answer Choice (C) Ethics

Answer Choice (D) Findings/Conclusions

Answer Choice (E)


Explanation: A research protocol describes main aspects of a research trial including:

• Why it’s being done • What will be done

• Where it will be conducted

• Who is involved

• When it will occur

Detailed descriptions of the topics can be viewed at ICH GCP E6 6 [https://ichgcp.net/6-clinical-trial-protocol-and-

protocol-amendments].

Because this document is completed before the research trial begins, the findings and conclusions can’t be

included.


Images/Media:

https://ichgcp.net/6-clinical-trial-protocol-and-protocol-amendments




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LIBRARY CONTENT SERIES: Starter Questions