Get the free Protocol Amendment Form - iuhealth

This document is used to submit amendments to an existing research protocol, detailing changes such as personnel, animal numbers, species, and procedures.

How to fill out protocol amendment form

How to fill out Protocol Amendment Form

1. Obtain the Protocol Amendment Form from the appropriate regulatory agency or institution.
2. Read the instructions provided with the form carefully to understand the requirements.
3. Fill in the title of the study at the top of the form.
4. Provide the original protocol number assigned to the study.
5. List the specific changes being proposed in the amendment clearly and concisely.
6. Include a rationale for each proposed change to justify the amendment.
7. Attach any relevant documentation or supplementary materials that support the amendment.
8. Ensure that all necessary signatures and approvals are included at the end of the form.
9. Review the completed form for accuracy and completeness before submission.
10. Submit the form to the designated authority for review and approval.

Who needs Protocol Amendment Form?

1. Researchers conducting clinical trials that require modifications to the existing study protocol.
2. Institutional Review Boards (IRBs) needing to evaluate changes to protocols.
3. Sponsors of clinical studies who need to inform regulatory authorities about protocol updates.
4. Any party involved in the oversight or regulatory compliance of clinical research studies.

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 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?

A Protocol Amendment Form is a document used to propose changes or modifications to an existing protocol in research or clinical studies.

Who is required to file Protocol Amendment Form?

Researchers, sponsors, or any party involved in conducting a study that requires changes to its original protocol are required to file a Protocol Amendment Form.

How to fill out Protocol Amendment Form?

To fill out a Protocol Amendment Form, provide details of the proposed changes, including the rationale for the amendment, the specific sections of the protocol affected, and any necessary regulatory information.

What is the purpose of Protocol Amendment Form?

The purpose of the Protocol Amendment Form is to formally document changes to a study protocol to ensure compliance with regulatory requirements and to maintain the integrity of the research.

What information must be reported on Protocol Amendment Form?

The information that must be reported includes the title of the study, the reason for the amendment, the specific changes being made, and any potential impacts on the study timeline or participant safety.