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IRB Protocol # PI Reviewer Date WIRB INITIAL APPLICATION

IRB Protocol # PI Reviewer Date WIRB INITIAL APPLICATION 2025

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The document outlines the requirements and checklist for the initial submission of a clinical research study protocol to the UCSD Institutional Review Board (IRB). It details necessary documentation, including application forms, consent templates, training certifications for principal investigators and co-investigators, and specific approvals needed for studies involving drugs or devices. The checklist ensures compliance with human research protections and regulatory standards.

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What is the IRB approval date?

The IRB calculates the date of initial IRB approval in the following manner: When a research study is approved at a convened meeting, the date of the convened meeting is the date of IRB approval.

Does investigator brochure need IRB approval?

For studies conducted under an investigational new drug application, an investigators brochure is usually required by FDA. Even though 21 CFR part 56 does not mention the investigators brochure by name, much of the information contained in such brochures is clearly required to be reviewed by the IRB.

What is the initial review of the IRB?

Initial Review of Research The IRB Chair and the Board are charged at the initial review of a study with determining the type of review category under which a research proposal falls. It is the responsibility of the investigator to obtain approval from the IRB Chair prior to conducting a research study.

What is an IRB continuing review and when should it occur?

Continuing review provides the IRB with an opportunity to determine whether there is any new information that should be considered to represent such a docHub new finding and therefore be communicated to subjects who have already enrolled in the research (e.g., important new toxicity information or new adverse

What is the IRB review of protocol?

A project requires Institutional Review Board (IRB) review if it includes both research and human subjects. An IRB protocol is a group of documents that conveys all the necessary information about your research with human subjects to IRB reviewers (e.g., consent form, IRB application).

When must IRB review occur?

When should study subjects be informed of changes in the study? Protocol amendments must receive IRB review and approval before they are implemented, unless an immediate change is necessary to eliminate an apparent hazard to the subjects (21 CFR 56.108(a)(4)).

What does an IRB look for in the initial review of a protocol?

The IRB will evaluate the information to be presented to subjects in light of the risks and benefits of the proposed research procedures. Privacy and Confidentiality.

Which 3 main areas does the IRB verify?

IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major types of review: Exempt, Expedited, and Full.

IRB Protocol # PI Reviewer Date WIRB INITIAL APPLICATION 2025

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