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Submit all materials required for IRB review (e.g., intervention materials, investigator brochures for device or drugs, instruments, protocol, informed consent, information sheet, recruitment). Use the appropriate informed consent template (expedited and full board studies only).
How to fill IRB form?
In order to establish an individual research project as exempt, an investigator must complete an IRB application. On the IRB application the investigator should indicate the number of the category under which an exemption is claimed. Final determination as to whether a project is exempt rests with the IRB.
What are IRB reporting requirements?
What Events Must Be Reported to the IRB within 10 Working Days? Non-Compliance. Failure to follow the protocol due to the action or inaction of anyone conducting protocol procedures that results in harm to the integrity of the research data. Subject complaint that cannot be resolved by the research team.
What needs to be submitted to IRB?
Before completing the IRB application form, you must know: The identity of all of the investigators who will be working on the project; Who will be recruited to participate and how they will be recruited; Where the research will be conducted; What data will be collected and what will happen to that data; How
What is the IRB checklist?
Checklists are used by the IRB staff and reviewers to document required IRB determinations. Investigators may consult the checklists to understand the regulatory requirements related to research, however, Investigators are not required to complete the checklists: HRP-410 - Waiver or Alteration of the Consent Process.
IRB APPLICATION NUMBER: DATE OIC RECEIVED: UMD IRB APPLICATION. Instructions: Questions are in bold. Required items are specified with an asterisk. Question
University of California, Los Angles Application (PDF)
IRB Review is pending. We anticipate this research to be Exempt for the following reasons: The evaluation and research study connected with the ExcEL Peer
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