Ethics
By US law, this board must review and approve all research conducted at an institution, including the informed consent form.
What is an Institutional Review Board?
This section of a protocol provides a summary of what is known to date about the investigational drug or intervention.
What is the Background & Rationale?
This phase of clinical trial enrolls the smallest number of participants and is focused on safety and determining the appropriate dose of the drug.
What is Phase 1?
This group of people has historically been OVER represented in research.
Who are white men?
By US Law, all clinical trials must be posted on this government-run website.
What is Clinicaltrials.gov?
A description of foreseeable risks and who to contact for questions about a study are examples of this.
What are required elements of a consent form?
The rules that define who can enter a study and who cannot.
What are the Inclusion/Exclusion Criteria?
This phase of clinical trial enrolls the largest number of participants and continues to evaluate safety and effectiveness of an investigational medication.
What is Phase 3?
A clinical trial intended to improve outcomes is also known as this type of study.
What is an interventional trial?
True or False: Overly restrictive inclusion/exclusion criteria may result in a study which has failed to recruit a population representative of patients with the disease being studied.
What is true?
The name for an independent board charged with reviewing study data and safety throughout the conduct of a particular clinical trial.
What is a Data Safety and Monitoring Committee?
In this type of study, neither the investigator nor the study participants know which treatment they have been assigned to.
What is a double blind study?
The title of the individual at a research site who is responsible for the conduct of the study at that site.
What is a Principal Investigator?
Clinical trials are often randomized in order to prevent this.
What is bias?
True or False: When you participate on a clinical trial, you should expect all of the care for your illness paid for by the study.
What is false?
A state of genuine uncertainty on the part of the clinical investigator regarding the comparative therapeutic merits of each arm in a trial.
What is Equipoise?
This section of a protocol tells you what procedures will be done and at what time points.
What is the schedule of events?
The first FDA application completed by the sponsor that gives permission to test a new drug in humans.
What is an Investigational New Drug (IND) Application?
A reason to participate in clinical research, which means "for the benefit of others."
What is altruism?
True or False: Healthy volunteer studies often involve staying overnight in a specialized facility.
What is true?
This report, which came out in 1978, established Respect for Persons, Beneficence, and Justice as the 3 basic ethical principles guiding the conduct of clinical research.
What is The Belmont Report?
The scientific term for what we predict might be true.
What is a hypothesis?
The sponsor completes this FDA application in order to market a drug to the public.
What is a New Drug Application (NDA)?
Government agencies, foundations, pharmaceutical companies and device manufacturers are all examples of this.
What is a sponsor?
When the study population represents the population of patients with the disease, we can say that the study results will be this.
What is generalizable?