Podcast
Questions and Answers
Which of the following are the three principles included in the Belmont Report?
Which of the following are the three principles included in the Belmont Report?
- Justice (correct)
- Respect for Persons (correct)
- Beneficence (correct)
- Confidentiality
What is an example of how the Principle of Beneficence can be applied to a study employing human subjects?
What is an example of how the Principle of Beneficence can be applied to a study employing human subjects?
Determining that the study has maximized benefits and minimized risks.
What best describes the principle of Respect for Persons as described in the Belmont Report?
What best describes the principle of Respect for Persons as described in the Belmont Report?
Information, comprehension, voluntariness.
How long does the development of most new drugs from discovery to marketing approval usually take?
How long does the development of most new drugs from discovery to marketing approval usually take?
Which phase best describes the clinical phase of a study where adults with a history of migraines were treated with experimental drug X or placebo?
Which phase best describes the clinical phase of a study where adults with a history of migraines were treated with experimental drug X or placebo?
Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development?
Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development?
Which clinical phase of a study in humans refers to pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug?
Which clinical phase of a study in humans refers to pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug?
In a phase I new drug study in humans, what is the primary source of data included in the initial Investigator's Brochure?
In a phase I new drug study in humans, what is the primary source of data included in the initial Investigator's Brochure?
What is a primary purpose of the ICH?
What is a primary purpose of the ICH?
What do the ICH GCP Guidelines set standards for?
What do the ICH GCP Guidelines set standards for?
To whom do the ICH E6 GCP describe standards that apply?
To whom do the ICH E6 GCP describe standards that apply?
Is following the ICH E6 GCP voluntary in the United States for FDA-regulated drug studies?
Is following the ICH E6 GCP voluntary in the United States for FDA-regulated drug studies?
Regarding explaining the probability of assignment to trial arms in consent forms, what does the ICH note?
Regarding explaining the probability of assignment to trial arms in consent forms, what does the ICH note?
What do FDA regulations state about the subject's receipt of consent forms?
What do FDA regulations state about the subject's receipt of consent forms?
What is required by the new ICH E6 integrated addendum (R2) regarding the management of quality in trials?
What is required by the new ICH E6 integrated addendum (R2) regarding the management of quality in trials?
What must investigators disclose in the informed consent form when complying with ICH E6 guidelines?
What must investigators disclose in the informed consent form when complying with ICH E6 guidelines?
What is the legal status of ICH in the U.S.?
What is the legal status of ICH in the U.S.?
What is an acceptable criterion for determining that a study of an approved drug does not require an IND?
What is an acceptable criterion for determining that a study of an approved drug does not require an IND?
What must a sponsor-investigator holding an IND be responsible for annually reporting to the FDA?
What must a sponsor-investigator holding an IND be responsible for annually reporting to the FDA?
Who is responsible for making the initial risk determination for a device being used in a study?
Who is responsible for making the initial risk determination for a device being used in a study?
When must the investigator update the IRB about the progress of a trial?
When must the investigator update the IRB about the progress of a trial?
Who is responsible for reporting directly to the FDA the investigator's financial interests with the sponsor?
Who is responsible for reporting directly to the FDA the investigator's financial interests with the sponsor?
What is an investigator's commitment to the sponsor?
What is an investigator's commitment to the sponsor?
To whom must the investigator report adverse events?
To whom must the investigator report adverse events?
What is Form FDA 1572, Statement of Investigator?
What is Form FDA 1572, Statement of Investigator?
What is an important component of drug accountability?
What is an important component of drug accountability?
Who has ultimate responsibility for an investigational product?
Who has ultimate responsibility for an investigational product?
Where is investigational product dispensing or administration information recorded for the sponsor?
Where is investigational product dispensing or administration information recorded for the sponsor?
What should the packaging of investigational drugs ideally do?
What should the packaging of investigational drugs ideally do?
Where is information on storage requirements for the investigational product usually found?
Where is information on storage requirements for the investigational product usually found?
What must an investigator conducting a study of a medical device under an IDE complete and sign?
What must an investigator conducting a study of a medical device under an IDE complete and sign?
When is a 510(k) Premarket Notification submitted?
When is a 510(k) Premarket Notification submitted?
Who must report Evaluation of Unanticipated Adverse Device Effects (UADEs) to the FDA?
Who must report Evaluation of Unanticipated Adverse Device Effects (UADEs) to the FDA?
What should an investigator do if a subject enrolled in a phase III study has access to a new beneficial drug?
What should an investigator do if a subject enrolled in a phase III study has access to a new beneficial drug?
What describes the best course of action for an investigator using a test article in a life-threatening situation without consent?
What describes the best course of action for an investigator using a test article in a life-threatening situation without consent?
Which statement in a consent form is an example of exculpatory language?
Which statement in a consent form is an example of exculpatory language?
Under which circumstance does the FDA allow verbal consent prior to participation in a research study?
Under which circumstance does the FDA allow verbal consent prior to participation in a research study?
When evaluating the causality of an adverse event, what should be considered?
When evaluating the causality of an adverse event, what should be considered?
Why is accurate reporting of adverse events most important?
Why is accurate reporting of adverse events most important?
What should an investigator do when learning of a subject involved in a car crash sustaining injuries?
What should an investigator do when learning of a subject involved in a car crash sustaining injuries?
Who should determine causality of a serious adverse event in a subject enrolled in a phase I study?
Who should determine causality of a serious adverse event in a subject enrolled in a phase I study?
Under what conditions must a sponsor submit an IND safety report to the FDA?
Under what conditions must a sponsor submit an IND safety report to the FDA?
In a double-blinded trial, what should the investigator submit an SAE report for?
In a double-blinded trial, what should the investigator submit an SAE report for?
For which observations is an IND Safety Report most likely to be filed with the FDA?
For which observations is an IND Safety Report most likely to be filed with the FDA?
What should an investigator do if a subject has elevated WBC counts without clinical signs?
What should an investigator do if a subject has elevated WBC counts without clinical signs?
How is an 'Audit' defined according to ICH E6 GCP?
How is an 'Audit' defined according to ICH E6 GCP?
How is an inspection defined according to ICH E6 GCP?
How is an inspection defined according to ICH E6 GCP?
What will FDA inspectors do during an inspection?
What will FDA inspectors do during an inspection?
What is the overall goal of monitoring, audits, and inspection activities?
What is the overall goal of monitoring, audits, and inspection activities?
What is OHRP primarily concerned with?
What is OHRP primarily concerned with?
When should the sponsor-monitor conduct the most detailed review of the study protocol with the site's study staff?
When should the sponsor-monitor conduct the most detailed review of the study protocol with the site's study staff?
When is the majority of case report form (CRF) data verified against source record information?
When is the majority of case report form (CRF) data verified against source record information?
At which study visits can the sponsor expect to review subjects' signed informed consent forms?
At which study visits can the sponsor expect to review subjects' signed informed consent forms?
Which is required at a prestudy site visit?
Which is required at a prestudy site visit?
Which monitoring visit would NOT include an inventory of investigational agents?
Which monitoring visit would NOT include an inventory of investigational agents?
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Study Notes
Principles of the Belmont Report
- Key principles: Respect for Persons, Beneficence, Justice.
- Respect for Persons entails information, comprehension, and voluntariness in informed consent.
Application of Beneficence
- Beneficence in studies involves maximizing benefits while minimizing risks to participants.
Drug Development Timeline
- Development of new drugs typically requires 9 years or more from discovery to market approval.
Clinical Study Phases
- Randomized studies of interventions like drug X on migraine patients classify as Phase III trials.
- Phase I studies focus on pharmacokinetics and pharmacodynamics of new formulations.
- Preclinical studies evaluate long-term drug toxicity in animals.
ICH and GCP Guidelines
- The ICH aims to minimize redundant research and establish standards for clinical trials.
- ICH GCP guidelines specify responsibilities for investigators, sponsors, and IRBs.
Compliance and Regulatory Aspects
- Following ICH E6 GCP in the U.S. is voluntary for FDA-regulated drug studies.
- Consent forms must clarify probability of assignment to trial arms, without mandated formats.
- Subjects can receive either signed or unsigned copies of consent forms.
Risk Management and Quality Systems
- ICH E6 requires sponsors to implement risk-based quality management throughout trial stages, identifying study risks appropriately.
- ICH E6 has stringent requirements for confidentiality regarding medical records and subject access.
Investigator Responsibilities
- The sponsor-investigator is responsible for making initial risk determinations for devices in studies and reporting annually to the FDA.
- Investigators must update IRBs about trial progress and submit Form FDA 1572 when necessary.
Adverse Event Reporting
- Adverse events must be reported to the sponsor, and accurate reporting is critical for subject safety.
- Causality evaluations of adverse events consider the timing of the event relative to drug administration.
- Serious unexpected adverse events must prompt IND safety reports to the FDA if reasonably believed to be caused by the drug.
Monitoring and Auditing
- Audits are independent examinations of trial-related activities, while inspections involve official reviews by regulators.
- The primary goal of monitoring and audits is to protect human research subjects and ensure data integrity.
Special Situations
- In life-threatening situations necessitating rapid action, the investigator can use a test article without prior consent but must notify the IRB later.
- Discussing alternative treatment options with subjects enrolled in ongoing trials is essential when new beneficial therapies arise.
Study Logistics
- Investigator must report elevated lab values, even if not listed as adverse events, to the sponsor.
- Inventory checks for investigational products occur during periodic site visits but not during pre-study visits.
Oversight and Ethical Standards
- OHRP focuses on the protection of human research subjects ensuring ethical standards in clinical trials.
- The site initiation visit is critical for thorough reviews of the protocol and site staff capabilities.
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