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.
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.