An unwanted or undesirable effect associated with the administration of a medication.
Certified Clinical Research Coordinator:
(CCRC) A research professional who has worked at least 2 years full time as a research coordinator and passed an examination to earn this certification.
Standard against which clinical observations may be evaluated. In research studies one group of patients are given the medication under study while the control group are given the standard treatment or a placebo.
Declaration of Helsinki:
Developed by the World Medical Association as a set of ethical principles for the medical community regarding human clinical studies.
Dose Ranging Study:
A study in which one or more doses are compared against each other to find the most effective and least harmful dose.
Double Blind Study:
A study in which neither the investigator nor the patient knows which arm of treatment the patient is receiving.
A medication’s maximum ability to produce a beneficial result regardless of dosage on the course or duration of a disease or condition.
A patient’s ability to meet the criteria set forth by the sponsor’s protocol defined inclusion/exclusion criteria.
The standards set forth by the sponsor of the study to allow or reject entry into the study. Factors can include: age, severity of disease, co-morbidities and medications, for example.
Food and Drug Administration:
(FDA) The regulatory governing agency over pharmaceutical research in the United States. It is responsible for the safety and effectiveness of all drugs, medical devices, biologics and vaccinations.
Good Clinical Practices:
An international code of ethics that ensures the rights and confidentiality of participants are protected. It also ensures the scientific integrity and accuracy of the study data.
A required document that is completed prior to any study event that details every procedure that will occur during the study. This document is signed and dated by the patient and at least one member of the research staff. This document must be approved by an ethics committee. This is a voluntary decision that is made only after a complete discussion of the study design has been covered and a potential patient has clear understanding of all aspects of the proposed study.
Institutional Review Board:
An ethics committee that is independent of the research site, and the sponsor, that oversees the conduct of the research study. It is in place to ensure that the rights of research subjects are protected. This group is composed of physicians, pharmacists, clergy, attorney and patient advocates.
Investigational New Drug:
A new drug that is used in an investigational study.
A representative hired by the sponsor to review the work performed by the research site prior to submission to the sponsor. This person ensures that the study is being conducted according to the protocol, GCPs, SOPs and regulatory requirements.
In this study none of the patients are given a placebo.
The study of the effects of a medication on the body and the relationship between medication absorption and effect.
The process of absorption, distribution, metabolism, and excretion of a medication or vaccine.
A substance that contains no active ingredient. In a research study it is used test the treatment’s effectiveness.
Oversees the conduct of the research study at a clinical research site. This is a person who is trained in the conduct of clinical research and ultimately responsible for the study, usually a physician.
A study plan set forth by the sponsor and designed to answer specific scientific questions. It details all study specific procedures and is meant to protect research patients. It must be IRB approved before it is put into use.
A method by which patients are randomly assigned to treatment arms. This is to assure that patients are evenly assigned to each arm and no bias is given to a specific arm or patient.
Serious Adverse Event:
An adverse event that is serious, life threatening, fatal, permanently disabling, or results in hospitalization.
A study in which one party, either the investigator or patient, does not know what medication the patient is taking.
Individual, company, institution or group taking responsibility for initiation, managing and/or financing a clinical study.
An individual who assists in the conduct of the research study, usually a physician, physician-assistant or nurse practitioner.
Wash Out Period:
A period in which the patient is removed from their current treatment prior to initiation of the trial medication. This is done to distinguish the effects of the medication under study and the patient’s current medication.