Glossary

510(K): A regulatory submission made to the FDA in the United States for diagnostics.

Adverse Event (AE): An Adverse Event is any unfavorable event that occurs in a patient who is participating in a clinical trial, whether or not related to the medicinal (investigational) product. Pre-existing conditions that worsen during a study are to be reported as Adverse Events.

Audit: A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements.

Autoimmune disease: A disease in which the body’s immune system attacks the body producing a disease state. Examples include psoriasis, rheumatoid arthritis, diabetes, Systemic Lupus Erythematosus (Lupus), Crohn’s disease and others.

Blinding: A procedure in which one or more parties to the trial is kept unaware of the treatment assignment(s). Single-blinding usually refers to the subjects being unaware, and double-blinding usually refers to the subjects, investigators, monitor, and, in some case, data analysts being unaware of the treatment assignment(s).

Calcineurin: A specific enzyme (phosphatase enzyme) that can have its activity inhibited by immunosuppressive (anti rejection) drugs called calcineurin inhibitors. This includes cyclosporine (Neoral) and tacrolimus (ProGraf). Isotechnika uses this enzyme as a surrogate marker to assess the amount of immunosuppression achieved using drugs in this category.

Case Report Form: A printed, optical or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject.

Clinical Trials/Study: Any investigation in human subjects intended to discover or verify the clinical, pharmacological and /or other pharmacodynamic effects of an investigational product(s). A Clinical Trial can also be used to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.

Conformance: An affirmative indication or judgment that a product or service has met the requirements of a relevant specification, contract, or regulation.

CTA: Clinical trial application is filed in Canada to get approval prior to doing a clinical trial.

Cyclosporine (Neoral): A drug that suppresses the immune system and is used to prevent rejection following organ transplantation.

DiatestTM: A diagnostic breath-based test used to diagnose diabetes and insulin resistance.

emesis: Vomiting.

FDA: The Food and Drug Administration of the United States government which is responsible for the regulation and approval of the sale of drugs and diagnostics in the United States.

Good Clinical Practice (GCP): A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected.

H. pylori: Helicobacter pylori, a bacteria known to cause stomach and intestinal ulcers.

HelikitTM: A diagnostic breath-based test used for the detection of the bacterium, H. pylori which is known to cause ulcers.

IND: Investigational new drug. An IND application must be submitted and approved by a regulatory agency prior to clinical trials of an investigational (novel) drug in humans in the United States.

Immunosuppressive: Drugs that down regulate (suppress) the immune system. These drugs are used in transplantation and auto-immune diseases.

Informed Consent: A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.

in vitro: Experimental procedure conducted artificially (in a test tube).

in vivo: Experimental procedure conducted in a living organism.

Monitoring: The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

NDA: New Drug Application made to a regulatory agency.

NDS: New Drug Submission made to a regulatory agency.

nephrotoxicity: Kidney damage.

neurotoxicity: Brain or nerve damage.

PMA: Pre-marketing approval. The FDA and Health Canada may require this approval prior to the sale of a diagnostic test.

Protocol: A document that describes the objectives, design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents.

Protocol Amendment: A written description of a change(s) to or formal clarification of a protocol.

Psoriasis: Psoriasis is a common skin disease that comes in different forms and varying levels of severity. It affects up to 3 percent of populations worldwide. Most researchers agree that it is an auto-immune disease. It is not contagious, and is generally found on the knees, elbows, scalp, hands, feet or lower back. Most cases are not severe enough to affect general health and are treated in the outpatient setting.

pharmacokinetics: The processes of drug absorption, distribution, metabolism and excretion in a living system (e.g., in humans).Rapamycin (Rapamune, Certican): A drug that suppresses the immune system and is used to prevent rejection following organ transplantation.

Principal Investigator: A responsible leader of a team of individuals at a trial site for the conduct of the clinical trial at that trial site.

Quality Assurance: All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).

Quality Control: The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.

Randomization: The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. This is like flipping a coin.

Renal Transplant: Kidney transplant

Sensitivity: The ability of a diagnostic test to distinguish between truly diseased and truly healthy individuals.

Serious Adverse Events: Any untoward medical occurrence that at any dose:

  • results in death,
  • is life-threatening,
  • requires in subject hospitalization or prolongation of existing hospitalization,
  • results in persistent or significant disability/incapacity,
  • is a congenital anomaly/birth defect, or
  • is medically significant or requires intervention to prevent one or other of the outcomes listed above.
  • SAEs are required to be reported to federal health authorities in a rapid timeframe to ensure patient safety.
    Confidentiality: Prevention of disclosure of a subject’s identity or of a sponsor’s proprietary information to non-authorized individuals.

serum creatinine: A muscle breakdown product in blood that is removed by the kidneys.

specificity: The capability of a test to not detect a disorder in healthy individuals. The capability of a test to be restricted in application or effect to a particular function or structure.

Sponsor: An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.

Standard Operating Procedures (SOPs): Detailed, written instructions to achieve uniformity of the performance of a specific function.

Tacrolimus (ProGraf): A drug that suppresses the immune system and is used to prevent rejection following organ transplantation.

TPD: Therapeutic Products Directorate, a Canadian Government Agency that is responsible for the regulation and approval of the sale of drugs and diagnostics in Canada.

Last updated April 24,