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What is a naive study?

What is a naive study?

In research methodology, a participant or subject who has no previous experience of the procedure, or one who is unaware of the purpose of the research or the hypothesis being tested. In research involving confederates, the term is used to denote a participant who is not one of the confederates.

What are the ethical requirements for clinical trials?

To preserve human dignity and the rights of subjects, clinical trials must follow a framework of seven ethical principles:

  • Social and clinical value.
  • Scientific validity.
  • Fair subject selection.
  • Favorable risk-benefit ratio.
  • Independent review.
  • Informed consent.
  • Respect for subjects.

Why are clinical trials required?

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Clinical trials are important for discovering new treatments for diseases, as well as new ways to detect, diagnose, and reduce the chance of developing the disease. Clinical trials can show researchers what does and doesn’t work in humans that cannot be learned in the laboratory or in animals.

What is the study site in research?

A facility in which study activities are conducted. EXAMPLE(S): The site where the study subject encounter occurs, or the site of the Investigator. (

What is clinical trial subject?

An individual who participates in a clinical trial either as a recipient of the investigational product(s) or as a control. The term “subject” is part of the federal regulation and may be used interchangeably with participant.

What is vulnerable subjects in clinical trials?

Vulnerable population includes people who are institutionalized such as prisoners, pregnant women and women of child bearing potential because of the risks involved to their fetuses, children as they have underdeveloped skills when it comes to decision making, people with psychiatric disorders as may not conceive the …

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Why are clinical trials important for testing new treatment interventions?

They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.

Why is location important in research?

Location plays a fundamental role in information flows and the development of knowledge networks in R&D and this paper seeks to present that a locational per- spective is important to our understanding of the structure and functioning of research activity.

Why is research site important?

Why Research Is Necessary and Valuable in Our Daily Lives It’s a tool for building knowledge and facilitating learning. It’s a means to understand issues and increase public awareness. It helps us succeed in business. It allows us to disprove lies and support truths.

What is a clinical trial and why are they conducted?

Clinical trials are conducted for many reasons: to determine whether a new drug or device is safe and effective for people to use. to study different ways to use standard treatments or current, approved treatments so that they will be more effective, easier to use, or decrease certain side effects.

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What are the eligibility criteria for clinical trials?

All clinical trials have guidelines, called eligibility criteria, about who can participate. The criteria are based on such factors as age, sex, type and stage of disease, previous treatment history, and other medical conditions.

What should not be in an advertisement for a clinical trial?

The advertisement should not promise providing free treatment or claim the safety or effectiveness of the investigational or experimental drug, device, or biologic [5]. The Institutional review board (IRB) is responsible to identify the degree of risk in a clinical trial.

How can I find out if there are any clinical trials?

One good way to find out if there are any clinical trials that might help you is to ask your doctor. Other sources of information include: FDA Clinical Trials Search.

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