Get the free Request for Modification of an Approved Protocol - uvic

This document serves as a formal request for modifications to an approved research protocol involving human participants, in accordance with university and ethical guidelines.

How to fill out request for modification of

How to fill out Request for Modification of an Approved Protocol

1. Obtain the Request for Modification form from the appropriate administrative office.
2. Fill in the title of the approved protocol at the top of the form.
3. Clearly describe the proposed modification in detail, ensuring you address the specific changes being made.
4. Provide a rationale for each modification to justify the need for the change.
5. Include any necessary supporting documents, such as revised protocols or appendices.
6. Review the entire form for completeness and accuracy to ensure all sections are correctly filled out.
7. Sign and date the form to certify the information provided.
8. Submit the completed Request for Modification form to the designated office or review board.

Who needs Request for Modification of an Approved Protocol?

1. Researchers or investigators who have an approved protocol and wish to make changes.
2. Institutions or organizations that require modifications to be officially documented due to regulatory compliance.
3. Any party involved in a study that needs to inform review boards about substantive changes.

For pdfFiller’s FAQs

What is Request for Modification of an Approved Protocol?

A Request for Modification of an Approved Protocol is a formal document submitted to amend or change the details of an already approved research protocol, typically in response to new information or changes in research circumstances.

Who is required to file Request for Modification of an Approved Protocol?

Typically, the principal investigator or the lead researcher on a study that has obtained prior approval from an ethics committee, institutional review board, or relevant regulatory body is required to file a Request for Modification of an Approved Protocol.

How to fill out Request for Modification of an Approved Protocol?

To fill out a Request for Modification, one must provide specific details of the proposed changes, rationale for the amendments, any potential impacts on study objectives, participant rights, and safety, as well as any required documentation that supports the modification.

What is the purpose of Request for Modification of an Approved Protocol?

The purpose of a Request for Modification is to ensure any changes to the study are reviewed and approved to maintain the integrity of the research and the safety and welfare of participants involved.

What information must be reported on Request for Modification of an Approved Protocol?

The information that must be reported includes the details of the proposed modification, justification for the change, potential impact on the study's methodology or outcomes, consent processes, and any other relevant documentation that could affect the study's approval or implementation.