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Good Clinical Practice (GCP)

Good Clinical Practice (GCP) is the ethical, scientific, and practical standard by which all clinical research is conducted. It is important that everyone involved in research is trained or appropriately experienced to perform the specific tasks they are being asked to undertake. Learn about good clinical practice with this starter Qstream microlearning course.

Category: Compliance

Industry: Pharmaceutical

Questions: 10

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Good Clinical Practice (GCP)

Navigate through the Qstream questions below to preview. Each challenge is designed following Qstream’s best practices for maximum knowledge reinforcement and engagement. This Qstream is free for clients to use as a starting point.

1. GCP Definition >
2. What is an Institutional Review Board >
3. Investigators' Responsibilities >
4. What is informed consent? >
5. Special Requirements Concerning Consent >
6. Quality Control in the Informed Consent Process >
7. Types of Confidential Information >
8. Maintaining the Security of Written Records >
9. Definition of Adverse Event >
10. Adverse Event Reporting >

Follow the interactions on each screen to answer Qstream questions as a Participant.

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

Answer 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 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/

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 her team's work across a variety of projects.

Which of the following activities are appropriate for the IRB to do?

Answer 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]

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:

Answer 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]

Chloe is considering participating in a clinical study from GenMed for 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?

Answer 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]

A standard informed consent document used in research studies must cover specific items, including which of the following?

Answer 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/

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?

Answer 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/]

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?

Answer 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]

Isabella’s clinical trial is scheduled to end in a week. As the Principal Investigator during the trial, she 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?

Answer 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]

“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?

Answer 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]

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?

Answer 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 with 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 describes 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]

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

Answer 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 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/

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 her team's work across a variety of projects.

Which of the following activities are appropriate for the IRB to do?

Answer 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]

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:

Answer 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]

Chloe is considering participating in a clinical study from GenMed for 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?

Answer 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]

A standard informed consent document used in research studies must cover specific items, including which of the following?

Answer 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/

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?

Answer 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/]

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?

Answer 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]

Isabella’s clinical trial is scheduled to end in a week. As the Principal Investigator during the trial, she 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?

Answer 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]

“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?

Answer 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]

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?

Answer 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 with 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 describes 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]

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