Get the free Irb Addendum/modification Request Form

This form is used by Internal and External Investigators to request modifications or addendums to currently approved research protocols. It includes sections for the Principal Investigator\'s information,

How to fill out irb addendummodification request form

How to fill out irb addendummodification request form

1. Obtain the IRB Addendum/Modification Request Form from the institutional website or IRB office.
2. Review the instructions provided with the form to understand the required sections.
3. Fill in the project title and IRB number in the designated fields at the top of the form.
4. Clearly identify the modifications being requested, specifying what is being changed and why.
5. Provide a detailed description of the new procedures or changes to the study.
6. Upload any revised documents that are relevant to the changes, such as consent forms or study protocols.
7. Ensure that all investigators and key personnel involved in the study have reviewed and agreed to the changes.
8. Sign and date the form as required by the institution.
9. Submit the form through the designated submission method (online portal, email, etc.) as instructed.

Who needs irb addendummodification request form?

1. Researchers conducting studies that have previously received IRB approval.
2. Investigators who need to amend their study protocol, consent documents, or any other part of their research.
3. Institutions requiring documentation for compliance and regulatory purposes.

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What is irb addendummodification request form?

The IRB addendum/modification request form is a document used to seek approvals from an Institutional Review Board (IRB) for changes or modifications to an existing research protocol.

Who is required to file irb addendummodification request form?

Researchers or institutions that have already received IRB approval for a study and wish to make changes to the original protocol are required to file the IRB addendum/modification request form.

How to fill out irb addendummodification request form?

To fill out the IRB addendum/modification request form, carefully complete the required sections, including details about the proposed changes, justification for the modifications, and any potential impacts on the study's participants and outcomes.

What is the purpose of irb addendummodification request form?

The purpose of the IRB addendum/modification request form is to ensure that any changes made to a research study are reviewed and approved for compliance with ethical standards and regulatory requirements to protect the rights and welfare of study participants.

What information must be reported on irb addendummodification request form?

The information that must be reported on the IRB addendum/modification request form typically includes a description of the proposed changes, rationale for the changes, how the changes affect the study's methodology, participant consent processes, and any potential risks to participants.