Common Research Terminology
Principal Investigator
The person qualified, by training and experience, as an appropriate expert to study the drug/device in human biological systems. Coastal Clinical Research’s principal investigators are listed with credentials.
Clinical Research Coordinator / CRC
A person who handles most of the administrative responsibilities of clinical trials; acts as a liaison between investigative site and sponsor; reviews all data and records before monitor’s visit.
IRB / Institutional Review Board
“Ethics Committee” - An independent body, constituted by medical professionals and non-medical members, whose responsibility is to verify that the safety, integrity and human rights of the subjects participating in a particular trial are protected, thereby providing public reassurance.
Wash-Out Period
A period during a clinical trial when the trial subjects receive no active medication. The wash-out period is typically used to generate patient baseline data.
Study Sponsor
Pharmaceutical company responsible for creating the specific study designed protocol and elements.
Informed Consent
The informed consent is the process of learning key facts about a clinical research trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information to participants. The attending principal investigator and study coordinator are involved in the consent process to assist in explain or making clear any elements involved in the specific study design. If the participant’s native language is not English, translation assistance can be provided. All study related risks and potential benefits are outlined in the informed consent. All participants are reimbursed for time and travel, and reimbursement stipends are discussed within the informed consent. It is important for each participant to understand that the informed consent is not a contract and therefore the study participant may withdraw from the study at any given time.
Patient Stipend
Each patient is reimbursed a specific amount for every completed office visit. The stipend is predetermined by the study sponsor and research site prior to enrollment of patients. Patient stipend amounts vary with each study.
Placebo
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebo’s to assess the treatment’s effectiveness.
Double Blind Procedure / Study
An investigational study design feature which shields study participants 9subjects, patients, medical personnel administering treatment and/or medical personnel evaluating patients) from knowledge about which patients are being treated with experimental drug, standard drug or placebo. A trial that has been blinded stands the best chance of producing data that are relatively free of investigational assessment bias (this is what the FDA likes to see- objective data as opposed to subjective data). Therefore, double blind studies are when the patients, the investigators, nor the study coordinator know which patients are receiving the investigational drug.
GCP / Good Clinical Practice
A standard by which clinical trials are designed, implemented and reported so that there is public assurance that the data are credible, and that the rights, integrity and confidentiality of subjects are protected.
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