Terms
Here are some common terms you will here when participating in a research study.
Adverse Event (Side effect) → A secondary and usually undesirable effect from a drug or treatment. Nausea is a common example.
Blind or Double Blind Study → A study design in which patients do not know whether they are receiving the medication being tested, a control medication or a placebo. A study in which neither patients nor research team knows is referred to as double blind. Performed to eliminate the possibility of bias in reporting results. Of course, in an emergency, a treatment can be easily and quickly identified.
Case Report Form → A form developed by sponsor or investigator on which all data are transmitted to the sponsor and subsequently to the FDA.
Clinical Research Associate (CRA) → Term used to designate the person who administratively supervises clinical investigators, always performing some of this supervision in the field.
Clinical Trial → Systematic investigation of the effect of materials or methods, completed according to a formal study plan. Done in a human population with a particular disease. Treatment methods, prevention, detection, or diagnosis are possible subjects for study.
Control Group → Refers to the group of patients that receive the “standard” treatment: the prevailing and considered effective treatment. Results from the control group are then compared to the test group. In the event that no standard treatment exists, the control group receives no treatment, provided this is not harmful.
Enrollment → The final process of entering the subject into a protocol, signifying that the subject and the Principal Investigator are fully satisfied that this is an appropriate action. Both have agreed to become collaborators in the conduct of the research.
Inclusion Criteria → Essential features the patient must possess to be included in a study.
Informed Consent → The process by which a patient learns about the purpose and specifics of a clinical trial, and then agrees to participate. A patient is not bound by this agreement; he or she is free to leave a trial at any time.
Institutional Review Board (IRB) → A supervisory board composed of physicians, scientists, laypersons and ethics experts. This board oversees safety, and makes risk- benefit judgments of research that utilizes human subjects.
Investigator or Principal Investigator (PI) → An experienced clinical researcher who prepares and implements a study protocol.
Investigational New Drug → A drug that the FDA has approved for use in clinical trials only.
Medical Monitor → The physician or the sponsoring pharmaceutical firm who has the medical authority for a given drug investigation.
Monitor → Appropriate research representative of the sponsoring pharmaceutical firm who verifies that the information in the case report form is complete and accurate and has been appropriately documented in the patient’s medical record.
Placebo → Anything resembling the medication being tested, but is actually a harmless, inactive substance.
Protocol → A plan of treatment designed by the sponsor of the research. Like a recipe, a study protocol specifies the medications, dosages, length of treatment, as well as the frequency and number of visits, and lab or other tests required to monitor the progress.
Randomization → Participants are placed by chance (randomly) into separate groups, which either receive the test treatment, the control treatment or the placebo. Random placement creates groups that are roughly equal, and allows for result comparison from one group to another without interference from other factors that might affect study results.
Risk/Benefit Analysis → An examination of the perceived risks and potential benefits of a particular clinical trial. It is the responsibility of the IRB to assure that risks and benefits are presented. It is the responsibility of the patient to assure that the risks and benefits are understood.
Sponsor → Pharmaceutical company or device manufacturer conducting testing of drugs/devices in humans.
Study Coordinator → Nurse or other medical professional who oversees details of a clinical trial.