Get the free IRB PROTOCOL AMENDMENT FORM 120117 - University of Maine - machias

Institutional Review Board Protocol Amendment Form Protocol # Study Title: Name of Applicant:1 Principal Investigator:2 Address: Address: Email: Email: Telephone: Telephone: 1 Primary contact person;

How to fill out irb protocol amendment form

How to fill out an IRB protocol amendment form:

1. Start by reviewing the instructions: Before filling out the form, it is important to carefully read and understand the instructions provided. Familiarize yourself with the specific requirements and guidelines for completing the IRB protocol amendment form.
2. Identify the protocol amendment: Determine the nature of the amendment you are proposing. Understand why the amendment is necessary and what changes you intend to make to the existing IRB protocol. This could include adding or removing study procedures, changing recruitment methods, modifying consent forms, or addressing any other pertinent changes.
3. Gather supporting documents: Collect any relevant supporting documents that need to accompany the amendment form. This may include revised consent forms, updated study materials, data collection instruments, or any other pertinent documents that reflect the proposed changes.
4. Complete the necessary sections: Fill out each section of the IRB protocol amendment form accurately and completely. This typically includes providing information about the primary investigator, study title, study site(s), and a detailed description of the proposed amendment. Make sure to clearly articulate the reasons for the amendment and provide any additional information requested.
5. Provide documentation: Attach the supporting documents to the amendment form as required. Ensure that all the necessary documents are included and properly labeled for easy reference.
6. Seek input from collaborators or consultants: If applicable, collaborate with other team members, consultants, or stakeholders who may have valuable input regarding the proposed amendment. Incorporate any relevant feedback or suggestions into the amendment form before submission.
7. Review and double-check: Before submitting the form, carefully review each entry, supporting document, and detail to ensure accuracy and completeness. Verify that all required fields have been properly filled out and that there are no inconsistencies or errors.
8. Submit the amendment form: Once you are confident that the form is accurate and complete, submit it following the specified submission process and timeline. Pay attention to any additional submission requirements, such as obtaining electronic signatures or routing the form through a specific department or committee.

Who needs an IRB protocol amendment form?

Researchers and investigators who have an approved Institutional Review Board (IRB) protocol that requires modifications or changes would need to fill out an IRB protocol amendment form. This form is typically required when there is a revision to the study design, participant populations, data collection methods, or any other aspect of the research that deviates from the original approved protocol. Both principal investigators and co-investigators involved in the study may be responsible for submitting a protocol amendment form. It is necessary to consult with the IRB office or regulatory authorities at your institution to determine the specific requirements and procedures for submitting an amendment form.

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What is irb protocol amendment form?

The IRB protocol amendment form is a document used to request changes to an existing research protocol.

Who is required to file irb protocol amendment form?

Researchers and investigators conducting human subjects research are required to file the IRB protocol amendment form.

How to fill out irb protocol amendment form?

The IRB protocol amendment form should be completed by providing details of the proposed changes to the research protocol and submitting it to the Institutional Review Board for review.

What is the purpose of irb protocol amendment form?

The purpose of the IRB protocol amendment form is to ensure that any changes made to an existing research protocol adhere to ethical and regulatory standards for the protection of human subjects.

What information must be reported on irb protocol amendment form?

The IRB protocol amendment form typically requires details of the proposed changes, justification for the changes, and any potential risks or impacts on human subjects.