Glossary
Adverse reaction – an undesirable side effect or reaction to
a medication or treatment.
Blinding - Research also often uses a technique called
"blinding." Blinding means that the subjects and often the
investigator do not know what drug or medical procedure they are
receiving. There is both single blinding and double blinding. In
double blinding, neither the subject nor the investigator knows
which drug or procedure the subject will receive. In single
blinding, only one person does not know, either the subject or
the investigator. Blinding is done to help eliminate the
possibility of bias by the investigator and or the subject, and
to help the research results be accurate. There are several ways
that a study can be blinded. One common way to blind a study is
to use a placebo.
Clinical Investigator / Principal Investigator – the
researcher, or study doctor, monitors the clinical research
study, the health of participants, and the safety and
effectiveness of the investigational treatment; the principal
investigator is the person ultimately responsible for ensuring
that the research is being done according to the protocol (study
plan). The Principal Investigator ensures the adherence to Good
Clinical Practice guidelines as well as ensuring that clinical
studies are conducted in accordance with guidelines of the FDA
and other regulatory agencies.
Clinical Research Coordinator - Clinical Research
Coordinators (CRCs) work in a team environment under the
direction of the Principal Investigator. The primary objective
of the CRC is to ensure the adherence to Good Clinical Practice
guidelines as well as ensuring that clinical studies are
conducted in accordance with guidelines of the FDA and other
regulatory agencies. The responsibilities of a CRC include
arranging for a research study site; recruiting, screening and
enrolling clinical study participants; arranging follow-up
visits; maintaining and dispensing drug and other study
supplies; completing and ensuring the accuracy of case report
forms and regulatory documents.
Contraindication – any disease, allergy, or known drug
interaction that makes a specific treatment, such as an
investigational drug, inappropriate for a participant’s use.
Data safety and monitoring board (DSMB) – independent
committee that reviews information in a clinical research study
to make sure that participants are not exposed to too much risk;
the DSMB may recommend a study be stopped or adjusted due to
safety concerns or if study goals are achieved.
Diabetes – disease where the body provides too little
insulin or develops insulin resistance; may be type 1 (generally
starts abruptly when a person is in their early teens and needs
to be treated with insulin), type 2 (symptoms begin gradually
and may be controlled by diet or oral hypoglycemics) or
gestational (developed by a woman during pregnancy)
Electrocardiogram (ECG) – a test that measures how often
and how regularly the heart beats.
Eligibility Criteria – inclusion and exclusion
requirements that show who can participate in a clinical
research study; these requirements for or against participation
may include age, gender, type of disease, previous treatment
history, and other medical conditions.
Food and Drug Administration (FDA) – The FDA is
responsible for protecting the public health by assuring the
safety, efficacy, and security of human and veterinary drugs,
biological products, medical devices, our nation’s food supply,
cosmetics, and products that emit radiation. The FDA is also
responsible for advancing the public health by helping to speed
innovations that make medicines and foods more effective, safer,
and more affordable; and helping the public get the accurate,
science-based information they need to use medicines and foods
to improve their health. (Website:
http://www.fda.gov/).
Inclusion/exclusion Criteria – see "Eligibility
criteria".
Informed consent – a participant agrees to be part of a
clinical research study after talking with the study nurse or
doctor about the study's procedures, benefits, and risks; study
participants may withdraw from (leave) a clinical research study
at any time.
Institutional Review Board (IRB) – group that reviews
clinical research studies to make sure they are ethical and to
protect the rights of participants.
Placebo - A placebo looks like a drug but contains no
active medicine. In studies that use placebo, all the
participants in the research receive drugs that look exactly the
same, but do not all have the same ingredients. Researchers
compare the information about subjects receiving the active drug
to the information about subjects who receive the placebo.
Placebos help ensure that research results are accurate.
Placebos are not just pills. Sometimes placebos are used in
device studies or studies of medical procedures. In these cases,
the placebo may be a device that doesn't work, or a fake surgery
where a cut is made, but no surgery is done.
If a study involves a placebo, this will be explained in the
consent form, so you will know if there is a chance that you
will get a placebo.
Protocol - The protocol is the "blueprint" for how the
study will be conducted. All the details of the study are
described in the protocol. The principal investigator and other
research staff must follow the protocol. If the protocol is not
followed, the results of the research study may not be useful
enough to answer the questions the research is trying to answer.
Randomization - In many research studies subjects are assigned
to different groups. The subjects in the different groups may
receive different doses of drugs, or different drugs, or
different devices or other medical procedures. Many times the
assignment to a group is made randomly (like drawing a number
from a hat). This means that neither the subject nor the
investigator chooses which group the subject is placed in.
Randomly assigning subjects to groups helps ensure that the
results from the study are more accurate.
Study drug -- an active drug or a placebo (sugar pill)
that is being tested in a clinical research study.