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This document is used by the University of Rhode Island's Institutional Animal Care and Use Committee (IACUC) to request and describe amendments to existing animal research protocols, including changes

How to fill out protocol amendment form

How to fill out Protocol Amendment Form

1. Begin by heading to the appropriate section of the Protocol Amendment Form.
2. Read the instructions carefully to understand the required information.
3. Fill in the general study information, such as title, protocol number, and principal investigator.
4. Clearly outline the proposed amendments, detailing the reasons for each change.
5. Include any updated documents, such as revised protocols or consent forms, if applicable.
6. Provide details on how the amendments will impact the study, including safety and ethical considerations.
7. Review the completed form for accuracy and completeness.
8. Submit the form to the appropriate regulatory or overseeing body for approval.

Who needs Protocol Amendment Form?

1. Researchers who are conducting clinical trials or studies that require modifications to the existing protocol.
2. Institutional Review Boards (IRBs) or Ethics Committees that oversee the study's compliance with regulations.
3. Sponsors or funding agencies that require documentation of changes for continued support.

People Also Ask about

How do I amend a protocol?

Amendments must include all revised information letters, consent forms, recruitment tools, data collection tools, etc. Proposed changes to the approved study documents must be highlighted or indicated using track changes to facilitate REB review.

When to submit a protocol amendment?

If the protocol is intended as a longitudinal study or is operating within the planned study timeline and if changes are otherwise closely related to the previously approved study, then submitting an amendment is likely appropriate.

How much does a protocol amendment cost?

How much does a protocol amendment cost? Research shows protocol amendments cost between $141,000 and $535,000 each, with Phase III trials having higher costs. These figures represent direct costs only and don't include indirect expenses from timeline delays and operational disruptions.

How much does an amendment cost?

Average cost for amended tax return. The fee for filing an amended tax return can vary significantly, but a general range is between $200 and $1,500.

How do I amend a protocol?

Amendments must include all revised information letters, consent forms, recruitment tools, data collection tools, etc. Proposed changes to the approved study documents must be highlighted or indicated using track changes to facilitate REB review.

How much does it cost to get a drug approved by the FDA?

When to submit a change in protocol amendment: A sponsor of an IND application is expected to submit a protocol amendment in cases when there are changes in the existing protocol that significantly affect safety of subjects, scope of the investigation, or scientific quality of the study.

What is an example of a protocol amendment?

Typically, changes that affect the scientific nature of the protocol will need to be reviewed by the PRC. Examples include a change in the primary objective, adding a drug to a therapeutic regimen, or changes that affect the statistics of the study.

For pdfFiller’s FAQs

What is Protocol Amendment Form?

The Protocol Amendment Form is a document used to request changes or modifications to an existing research protocol, typically in clinical trials.

Who is required to file Protocol Amendment Form?

The investigator or sponsor of the clinical trial is required to file the Protocol Amendment Form whenever there are changes to the study protocol that need approval.

How to fill out Protocol Amendment Form?

To fill out the Protocol Amendment Form, provide details of the proposed changes, reason for the amendments, and any necessary supporting documents. Ensure that all sections are completed as per the guidelines.

What is the purpose of Protocol Amendment Form?

The purpose of the Protocol Amendment Form is to formally document and seek approval for changes to a clinical trial protocol, ensuring compliance with regulatory requirements.

What information must be reported on Protocol Amendment Form?

The information that must be reported includes the specific changes being made, rationale for the changes, impacts on the study, and updated protocol sections, if applicable.