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This document is used for submitting amendments or revisions to existing protocols to the Institutional Review Board (IRB) at Saint Luke's Hospital of Kansas City.
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How to fill out amendmentrevision submission form
How to fill out Amendment/Revision Submission Form
01
Begin by downloading the Amendment/Revision Submission Form from the official website.
02
Fill in the project title at the top of the form.
03
Provide the name and contact information of the principal investigator.
04
Indicate the type of amendment or revision you are submitting.
05
Clearly describe the changes being proposed, including any new procedures or modifications to existing ones.
06
Justify the need for the amendment or revision, detailing its significance.
07
Attach any supporting documents, if required, such as updated protocols or consent forms.
08
Review the completed form for accuracy and completeness.
09
Submit the form to the appropriate regulatory body or ethics committee, following the specified submission guidelines.
Who needs Amendment/Revision Submission Form?
01
Researchers conducting studies that require changes to approved protocols.
02
Institutional Review Boards (IRBs) or Ethics Committees needing to review proposed modifications.
03
Principal investigators and study sponsors who are managing ongoing research projects.
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What is Amendment/Revision Submission Form?
The Amendment/Revision Submission Form is a document used to request changes or updates to previously submitted information, such as registration details, product specifications, or regulatory submissions.
Who is required to file Amendment/Revision Submission Form?
Individuals or organizations that have submitted an original application, registration, or other documentation to a regulatory authority and wish to modify or update that information are required to file an Amendment/Revision Submission Form.
How to fill out Amendment/Revision Submission Form?
To fill out the Amendment/Revision Submission Form, provide the required information accurately, including the original submission details, the specific changes being made, and any supporting documents or rationale for the amendments.
What is the purpose of Amendment/Revision Submission Form?
The purpose of the Amendment/Revision Submission Form is to ensure that regulatory bodies are informed of any modifications to previously submitted information, allowing them to maintain accurate and up-to-date records for compliance and safety assessments.
What information must be reported on Amendment/Revision Submission Form?
The Amendment/Revision Submission Form must report the original submission reference number, details of the proposed amendments, reasons for the changes, and any relevant documentation that supports the request.
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