T

Tabled

An IRB “action” that indicates that review was not initiated or was not completed, resulting in postponement of convened IRB review, usually due to loss of quorum or other administrative issue. Research tabled at a convened meeting will be reviewed at a future convened meeting.

Technology Transfer (Tech Transfer)

Tech Transfer is a process involving assessing an invention disclosure (technology), patenting the technology, marketing and finally licensing the technology or forming start-up companies based on technology.

Teratogenicity

The study of abnormalities of physiological development. It is often thought of as the study of human birth defects, but it is much broader than that, taking in other non-birth developmental stages, including puberty; and other non-human life forms, including plants. A newer term developmental toxicity includes all manifestations of abnormal development. These may include growth retardation or delayed mental development without any structural malformations.

Terminally Ill

Terminally ill patients are those who are deteriorating from a life-threatening disease or condition for which no effective standard treatment exists.

Terminated

A study may be Terminated for many reasons. Different parts of the study can be terminated, i.e., recruitment or all study activities.  The termination can be required by the Sponsor or the IRB, or the PI can voluntarily suspend the study.

Termination

An action taken by the convened IRBs to permanently withdraw approval for all research activities (except for those follow-up procedures that may be necessary to protect the health and/or welfare of participants). This may occur on a particular study or on all studies where an investigator is named PI.

Terms of Award

All legal requirements imposed on an agreement by the sponsor, whether by statute, regulation(s), or terms in the award document. The terms of an agreement may include both standard and special provisions that are considered necessary to protect the sponsor's interests.

Test Article

Any drug, biological product, medical device, human food additive, color additive, electronic product, or any other article under investigation in a research study (included approved and unapproved drugs, biologics and devices).

Test Procedure

Any investigational method (other than test articles) being developed, tested and evaluated, designed to develop or contribute to generalizable knowledge. Examples include surgical techniques and psychological therapy.

Therapeutic Intent

The research physician’s intent to provide some benefit to improving a subject’s condition (e.g., prolongation of life, shrinking of tumor, or improved quality of life, even though cure or dramatic improvement cannot necessarily be effected). This term is sometimes associated with Phase I drug studies in which potentially toxic drugs are given to an individual with the hope of inducing some improvement in the patient’s condition, as well as assessing the safety and pharmacology of a drug.

Therapeutic Misconception

Research participant's belief that enrolling in a research study will provide therapeutic benefit. Participants confuse the goal of clinical therapy which is to provide benefit to the individual patient and where any new knowledge gained is incidental and the goal of research which is to gain knowledge to help future patients (generalizable) and where therapeutic benefit to individual maybe secondary.

Therapeutic Research

Research involving an intervention that has the likelihood of providing a therapeutic, diagnostic or preventive benefit to the subjects.

Therapy

Treatment intended and expected to alleviate a disease or disorder.

Total Direct Costs

The total of all allowable direct costs of a project.

Total Project Costs

The total allowable direct and indirect costs incurred by the institution to carry out an approved project or activity.

Toxicity

An adverse effect produced by a drug that is detrimental to the participant's health. The level of toxicity associated with a drug will vary depending on the condition which the drug is used to treat.

Trade Secret

Information that companies keep secret to give them an advantage over their competitors. The formula for Coca-Cola is the most famous Trade Secret. No registration is required and the Trade Secret is valid as long as long as it is kept a secret from the public.

Trademark
(TM/®)

Trademark is a symbol, design, picture, word, phrase, or a combination of words, phrases, symbols or designs, that identifies and distinguishes the source of the goods of one party from those of others. The owner of a trademark has exclusive right to use it on the product it was intended to identify and often on related products and may use the symbol TM to let the public know that the mark is a trademark. The symbol ® can only be used in the US if the trademark is registered.

Treatment and Parallel Track INDs

Investigational new drugs may be made available outside of a clinical trial, through a treatment protocol, to multiple patients with life-threatening or other serious diseases for which no satisfactory alternative drug or other therapy exists.

Treatment IND

IND stands for Investigational New Drug application, which is part of the process to get approval from the FDA for marketing a new prescription drug in the US. It makes promising new drugs available to desperately ill participants as early in the drug development process as possible. Treatment INDs are made available to participants before general marketing begins, typically during Phase III studies. To be considered for a treatment IND a participant cannot be eligible to be in the definitive clinical trial.

Treatment or Professional Practice

Interventions designed solely to enhance the well-being of a particular individual.

Treatment trials

Refers to trials which test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Trial design

Some Phase II trials are designed as case series, demonstrating a drug's safety and activity in a selected group of patients. Other Phase II trials are designed as randomized clinical trials, where some patients receive the drug/device and others receive placebo/standard treatment. Randomized Phase II trials have far fewer patients than randomized Phase III trials.