What is a Clinical Investigation?
Clinical investigation or ‘clinical research’ or ‘clinical study’ or ‘clinical trial’: research that either directly involves human participants or uses materials of human origin (for example, blood) to test the safety and/or effectiveness of drugs, medical devices, procedures, or preventions.
What is a medical research study?
A medical research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. They are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people.
What is a clinical trial?
Describes a clinical trial or other experiment in which the researchers know what treatments are being given to each study subject or experimental group. If human subjects are involved, they know what treatments they are receiving. (NCI)
What is a patient informed clinical trial?
A type of clinical trial in which only the doctor knows whether a patient is taking the standard treatment or the new treatment being tested. This helps prevent bias in treatment studies. (NCI)
What is the purpose of a pharmacologic investigation?
What is clinical trial?
What is a placebo controlled study?
What is clinical research?
What is an open label clinical trial?
What is the plan that outlines how individuals will be recruited for the study and how the study will reach the recruitment goal
What is a single blinding study?
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What is the purpose of randomization quizlet?
The purpose of randomization is to reduce error that results from assignment to study conditions.
Which type of validity is threatened by repeated testing?
In time series designed studies, there is often a threat to the validity of repeated testing because one cannot conclude that changes or differences are not a result of sensitization or learning. Increasing sample size is a good means of reducing systematic error.
Which of the following is an example of the beneficence principle?
Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects? Ensuring that risks are reasonable in relationship to anticipated benefits.
What is an important goal of any intervention study?
What is an important goal of any intervention study? To provide a definitive positive or null effect. ,To result in the proper distribution of resources.
What is validity experiment?
Validity refers to how accurately a method measures what it is intended to measure. If research has high validity, that means it produces results that correspond to real properties, characteristics, and variations in the physical or social world. High reliability is one indicator that a measurement is valid.
What is internal validity in qualitative research?
Internal validity is the extent to which a study establishes a trustworthy cause-and-effect relationship between a treatment and an outcome. 1 Internal validity also reflects that a given study makes it possible to eliminate alternative explanations for a finding.
What is beneficence and Nonmaleficence?
The “Beneficence” principle refers to actions that promote the well-being of others. The duty of professionals should be to benefit a party, as well as to take positive steps to prevent and to remove harm from the party. Non-maleficence reminds you that the primary concern when carrying out a task is to do no harm.
What is beneficence in research?
Beneficence. The definition of beneficence is action that is done for the benefit of others. This principle states that research should: Do no harm. The purpose of health research is to discover new information that would be helpful to society.
What is beneficence and Nonmaleficence in psychology?
Principle A (Beneficence and Nonmaleficence) indicates that psychologists should do their best to protect the welfare and rights of those with whom they have a professional relationship, but also be aware that others might take advantage of their professional status.
What is an interventional study?
Interventional Studies An interventional study tests (or tries out) an intervention -- a potential drug, medical device, activity, or procedure -- in people. It is also commonly referred to as a clinical trial.
What is an experiment study?
Experimental studies are ones where researchers introduce an intervention and study the effects. Experimental studies are usually randomized, meaning the subjects are grouped by chance. Randomized controlled trial (RCT): Eligible people are randomly assigned to one of two or more groups.
What are observational studies in clinical trials?
Observational studies aim to find out what happens to people in different situations. The research team observe the people taking part, but they don't influence what treatments people have. The people taking part aren't put into treatment groups.
Glossary of Common Terms | National Institutes of Health (NIH)
Clinical Research. Clinical research is medical research that involves people to test new treatments and therapies. Clinical Trial. A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
Short List of Commonly Used Acronyms in Clinical Research
ICD-9 International Classification of Disease Codes, 9th revision ICD-9-CM International Classification of Disease Codes, 9th revision-Clinical Modification
Glossary of Clinical Research Terms
Adverse event: any unexpected change in health or any side effect that occurs in a person while they are still under the effect of a treatment in a clinical trial. All adverse events must be reported to an institutional review board, whether they are serious or minor. Assent: a child’s consent to participate in a clinical trial. Blinded study: a study done in such a way that the study ...
Glossary of Clinical Trial Terms | Novartis
Find definitions for common clinical trial terms you may want to know, including double-blind, informed consent, placebo, protocol, eligibility criteria, and more.
Glossary of Terms Used in Clinical Trials
HYPOTHESIS: An assumption put forward as a basis for reasoning or argument, or as a guide to experimental investigation. INCLUSION/EXCLUSION CRITERIA: The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such factors as age,
Clinical Trials Glossary of Commonly Used Terms
Administration In medicine, the act of giving a treatment, such as a drug, to a patient. It can also refer to the way it is given, the dose, or how often it is given.
What is the purpose of a pharmacologic investigation?
Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care . The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy.
What is clinical trial?
Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Behavioral clinical trials involving an intervention to modify behavior (diet, physical activity, cognitive therapy, etc.) fit this definition of a clinical trial.
What is a placebo controlled study?
Placebo Controlled Study – A method of investigation in which an inactive substance/treatment (the placebo) is given to one group of participants, while the test article is given to another group.
What is clinical research?
Clinical Research – NIH defines clinical research as: Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator directly interacts with human subjects.
What is an open label clinical trial?
Open-Label Trial – A clinical trial in which investigators and participants know which intervention is being administered. Pharmacokinetics – The process (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine.
What is the plan that outlines how individuals will be recruited for the study and how the study will reach the recruitment goal
Recruitment Plan – The plan that outlines how individuals will be recruited for the study and how the study will reach the recruitment goal. Retention Plan – The plan that details the methods in which the study will use in order to retain study participation in the clinical trial.
What is a single blinding study?
Single blinding usually refers to the study participant (s) being unaware, and double blinding usually refers to the study participant (s) and any of the following being unaware of the treatment assignment (s): investigator (s), monitor, and data analyst (s). Manual of Procedures (MOP) – A set of procedures describing study conduct.
What is the term for a group of patients that are given the new treatment that is under evaluation?
A person participating in a clinical trial. Treatment arm or Experimental arm: The group of patients that are given the new treatment that is under evaluation. Wash-out: A required period of time when a patient is not undergoing any treatment (chemotherapy or cancer drug) before a patient enters a clinical trial.
What are the characteristics of a clinical trial?
Characteristics required for entry into a clinical trial may include ‘men and women between the ages of 18 and 75’, and ‘metastatic triple negative breast cancer’. A process in which patients are given important information, including possible risks and benefits, of a treatment, genetic testing or a clinical trial.
What is RP2D study?
A type of study where enrolled patients receive different doses of the drug or investigational agent to determine the recommended phase 2 dose ( RP2D ). Dose limiting toxicities: Describes side effects of a treatment that are serious enough to prevent an increase in dose of that treatment. Drug holiday:
What is a Phase 1 study?
The dose of a drug or drug combination that was identified in a Phase 1 study (dose finding study) that was identified for continued study in future clinical trials. A standard way to measure how well a patient responds to treatment.
What is blinded study?
Blinded study: A type of study in which the patients (single-blinded) or both the patients and their doctors (double-blinded) do not know which drug or treatment is being given. Cancer recurrence: Cancer that has come back, usually after a period of time during which the cancer could not be detected. Compassionate use:
What is the FDA oncology center?
The FDA Oncology Center of Excellence Patient-Friendly Language Project began with the need to update the definitions of common terms used in cancer clinical trials for better understanding and use by healthcare providers and patients.
What is a protocol in medicine?
Protocol: Detailed plan of how a new drug will be studied. In clinical trials, it states what the study will do, how it will be done, and why it is being done. Randomization:
What is clinical investigation?
Clinical investigation or ‘clinical research’ or ‘clinical study’ or ‘clinical trial’: research that either directly involves human participants or uses materials of human origin (for example, blood) to test the safety and/or effectiveness of drugs, medical devices, procedures, or preventions.
What is an investigational drug?
Investigational drug/device: a new medical drug and/or device that has been tested in a laboratory but has not yet been approved by the Food and Drug Administration (FDA) to be legally sold and used by health care providers and/or patients. Investigators: These are researchers.
What is blinded study?
Blinded study: a study done in such a way that the study participants do not know whether they are getting a placebo (an inactive substance) or a drug, but the study team does know. If the study is comparing two different doses or two different medications, then the human participants do not know which they are getting.
What is a protocol in clinical research?
Protocol: a written plan for carrying out a clinical study. A protocol includes what will be done, when, and how. Randomization: Mixing up the types of participants in enrolled into an experimental group or a control group, so that it will be fair to compare the two groups.
What is the FDA?
FDA (Food and Drug Administration): an agency of the United States federal government that approves or disapproves new drugs and devices. Human subject: a participant who volunteers to be in a clinical study.
What is an adverse event in clinical research?
Adverse event: any unexpected change in health or any side effect that occurs in a person while they are still under the effect of a treatment in a clinical trial. All adverse events must be reported to an institutional review board, whether they are serious or minor.
What is an effective drug?
An effective drug or prevention will improve health or successfully prevent a disease. Experimental drug or device: see Investigational drug or device. Experimental group: the group of subjects exposed to the new, researched treatment. This group is often compared to a ‘control group’, the subjects who are are not exposed to that treatment.
What is a case series in which the patients receive treatment in a clinic or other medical facility?
A case series in which the patients receive treatment in a clinic or other medical facility. (NCI) Clinical study or Clinical trial. A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease.
What is a clinical trial?
(NCI) A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments.
What is NCI in animal studies?
(NCI) Any law (s) and regulation (s) addressing the conduct of clinical trials of investigational products of the jurisdiction where trial is conducted.
What is the NCI in medical?
Also called ADL. (NCI) In the preapproval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose (s) may not be established, all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions.
What is a randomized trial?
Also called biometry and biometrics. (NCI) Blind. A randomized trial is "Blind" if the participant is not told which arm of the trial he is on. A clinical trial is "Blind" if participants are unaware on whether they are in the experimental or control arm of the study; also called masked.
What is cohort in medicine?
In medicine, a cohort is a group that is part of a clinical trial or study and is observed over a period of time. (NCI) In epidemiology, a group of individuals with some characteristics in common.
What is a clinical researcher?
Clinical researcher. A health professional who works directly with patients, or uses data from patients, to do research on health and disease and to develop new treatments. Clinical researchers may also do research on how health care practices affect health and disease. (NCI) Clinical series.
What is the purpose of a pharmacologic investigation?
Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care . The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy.
What is clinical trial?
Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Behavioral clinical trials involving an intervention to modify behavior (diet, physical activity, cognitive therapy, etc.) fit this definition of a clinical trial.
What is a placebo controlled study?
Placebo Controlled Study – A method of investigation in which an inactive substance/treatment (the placebo) is given to one group of participants, while the test article is given to another group.
What is clinical research?
Clinical Research – NIH defines clinical research as: Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator directly interacts with human subjects.
What is an open label clinical trial?
Open-Label Trial – A clinical trial in which investigators and participants know which intervention is being administered. Pharmacokinetics – The process (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine.
What is the plan that outlines how individuals will be recruited for the study and how the study will reach the recruitment goal
Recruitment Plan – The plan that outlines how individuals will be recruited for the study and how the study will reach the recruitment goal. Retention Plan – The plan that details the methods in which the study will use in order to retain study participation in the clinical trial.
What is a single blinding study?
Single blinding usually refers to the study participant (s) being unaware, and double blinding usually refers to the study participant (s) and any of the following being unaware of the treatment assignment (s): investigator (s), monitor, and data analyst (s). Manual of Procedures (MOP) – A set of procedures describing study conduct.