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.
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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/
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]
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]
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]
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/
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/]
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]
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]
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]
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]
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/
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]
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]
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]
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/
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/]
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]
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]
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]
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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