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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.
The date the document was actually received and attached to the protocol in OnCore, or the date the activity was actually completed. It is important to track these dates so that tasks
are marked as completed and do not show up in the Active or Upcoming Task widgets in the OnCore dashboard.
The person (or role) responsible for completing the task. This may be a particular person (user) in OnCore or a role (such as CTSU Coordinator), which allows any user in that role (with access to the protocol) to be notified about Active or Upcoming Tasks.
The expected date the document will be received and attached, or the activity will be completed. It is recommended these dates are completed when the task list is first applied to the protocol.
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.
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.
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.
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).
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.
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.
Research involving an intervention that has the likelihood of providing a therapeutic, diagnostic or preventive benefit to the subjects.
Equivalent to the U-M Full Title in the eResearch Proposal Management system; ultimately, this should be the title as found exactly on the contract. Entries must be 4000 characters or less.
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.
Tissue Procurement Core
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.
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.
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.
