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Protocol No.

This number should be updated with a study HUM# when assigned. Upon receiving the trial’s HUM number, DO NOT include the HUM prefix in this field. All leading zeros should be included. If not assigned during the feasibility process, enter it into the PC Console.

Protocol Staff

Study Team members who will be engaged in the conduct of the trial as Protocol Staff

Protocol Target Accrual

Overall accrual goal for the protocol, including all affiliated institutions if a multisite trial.

Protocol Type

There are three different options for entering the Protocol Type into OnCore. When determining the Protocol Type, select from the drop-down list using the following definitions: 1. Treatment: Clinical trials with therapeutic intent using drugs, radiation, surgery, other biological agents, or behavioral or other interventions. 2. Diagnostic: Clinical trials directly testing the efficacy of devices, techniques, procedures; or tests for earlier or more accurate detection or diagnosis of disease. 3. Other

Protocol Violation

Accidental or unintentional changes to or non-compliance with the IRB approved protocol without prior sponsor and IRB approval. Violations generally increase risk or decrease benefit, affects the subject's rights, safety, or welfare, and/or the integrity of the data.

Protocol-related Costs

The Protocol Related tab identifies all the events that relate to the operation of the protocol as a whole (IRB fees, IRB Amendment fees, Advertising fees, and Quarterly Pharmacy fees). These are fees that you would incur even without a single subject accrued.

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