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This document is used to request modifications or addendums to previously approved research studies at Western Carolina University, detailing required changes to the study, personnel, and related

How to fill out request for modification or

How to fill out Request for Modification or Addendum to Previously Approved Study

1. Obtain the Request for Modification or Addendum form from the appropriate regulatory body.
2. Review the previously approved study protocol to understand the changes needed.
3. Clearly identify the changes being proposed in the study, including any modifications to procedures, participant criteria, or data analysis methods.
4. Provide a rationale for each change, explaining why it is necessary or beneficial for the study.
5. Complete all required sections of the form, ensuring all information is accurate and thorough.
6. Attach any relevant supporting documents that may be required, such as revised protocols, consent forms, or data collection instruments.
7. Review the completed form for clarity, accuracy, and completeness before submission.
8. Submit the form and any attachments to the appropriate ethics review board or regulatory body as per their submission guidelines.

Who needs Request for Modification or Addendum to Previously Approved Study?

1. Researchers who wish to modify an existing study protocol after obtaining approval.
2. Study sponsors seeking to make changes to study parameters based on new findings or logistical considerations.
3. Investigators conducting clinical trials who need to update their trial design or procedures.
4. Institutions seeking to ensure compliance with ethical and regulatory standards through modifications to approved studies.

People Also Ask about

Who can initiate study amendments?

A principal investigator (PI) can initiate an amendment from the Manage Post Award Amendments: Search screen of the Non Research module. In the Non Research module for amendments, PIs see only their own awards (those on which they are a PI) that are eligible for amendments.

What is modification in research?

Modifications are study changes that should be submitted to the IRB for approval prior to implementing except when an immediate change is needed to eliminate or alleviate an apparent hazard or risk to subjects. Study changes without prior IRB approval must be submitted as Reportable New Information.

Which of the following would require an amendment to be submitted to the IRB?

To submit a change to your approved IRB protocol: Submit an amendment form explaining the changes being made. Submit an updated application with the changes underlined. Submit any other documents that require updating due to the changes being made (informed consent(s), recruitment materials, etc.).

For pdfFiller’s FAQs

What is Request for Modification or Addendum to Previously Approved Study?

A Request for Modification or Addendum to Previously Approved Study is a formal submission to update or change aspects of a research study that has already received approval from a relevant ethics review board or regulatory agency.

Who is required to file Request for Modification or Addendum to Previously Approved Study?

Investigators or research teams who wish to make changes to their previously approved research study are required to file this request.

How to fill out Request for Modification or Addendum to Previously Approved Study?

To fill out the request, the investigator must provide details on the proposed changes, justification for the modifications, and any potential impact on the study's objectives, methodology, and participant involvement.

What is the purpose of Request for Modification or Addendum to Previously Approved Study?

The purpose is to ensure that any changes to the study are reviewed for ethical considerations, compliance with regulations, and to maintain the integrity of the research.

What information must be reported on Request for Modification or Addendum to Previously Approved Study?

The request should report the nature of the modifications, rationale for changes, any new risks to participants, proposed revisions to consent forms, and timelines for the implementation of the changes.