Get the free Exempt Protocol ExtensionChange Request ERAU - research erau

Exempt Protocol Extension/Change Request ERA Institutional Review Board (IRB) Protocol Number: Research Title: Principal Investigator: (Must be Faculty Advisor if undergraduate.) 1. Extend Protocol:

How to fill out exempt protocol extensionchange request

How to fill out exempt protocol extension change request:

1. Follow the guidelines provided by your institution or regulatory body for submitting a protocol extension change request.
2. Ensure that you have all the necessary information and documents related to your exempt protocol, such as the protocol number, title, and principal investigator's name.
3. Specify the reason for the extension change request clearly and concisely. This could be due to unforeseen circumstances, delays, or the need for additional data collection.
4. Provide a detailed explanation of how the extension will impact the study, including any modifications to the original protocol or study objectives.
5. Include any supporting documentation, such as updated consent forms, data collection tools, or participant information sheets.
6. If applicable, outline any potential risks or challenges associated with the extension and how they will be mitigated.
7. Ensure that all required signatures are obtained, including the principal investigator, relevant co-investigators, and any necessary institutional or ethics committee signatures.
8. Review the completed form for accuracy and completeness before submission.

Who needs exempt protocol extension change request:

1. Researchers conducting a study under an exempt protocol and require additional time to complete their research.
2. Principal investigators and co-investigators responsible for overseeing exempt protocols that require an extension due to unforeseen circumstances or delays.
3. Institutional review boards or ethics committees that oversee exempt protocols and need to evaluate extension change requests to ensure compliance with regulations.

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What is exempt protocol extensionchange request?

Exempt protocol extension/change request is a formal request to extend or make changes to a protocol that has been deemed exempt from full review by the Institutional Review Board (IRB).

Who is required to file exempt protocol extensionchange request?

Researchers who are conducting studies under an exempt status are required to file an exempt protocol extension/change request if they need to extend the duration of the study or make changes to the protocol.

How to fill out exempt protocol extensionchange request?

To fill out an exempt protocol extension/change request, researchers must provide detailed information about the study, the reason for the extension or changes, and any potential impact on participants.

What is the purpose of exempt protocol extensionchange request?

The purpose of an exempt protocol extension/change request is to ensure that any changes to the study do not compromise the rights and safety of the research participants.

What information must be reported on exempt protocol extensionchange request?

Researchers must report the original protocol number, the reason for the extension or changes, a detailed description of the proposed changes, and any potential risks or benefits to participants.