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This document serves as a form for researchers at the University of Alabama to request modifications to an already approved research protocol by the IRB, detailing the changes, rationale, and expected
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How to fill out modification of an approved
How to fill out Modification of an Approved Protocol
01
Gather the original approved protocol document.
02
Clearly identify the specific sections of the protocol that require modification.
03
Prepare a detailed description of each proposed change, including the rationale behind it.
04
Update any relevant timelines, milestones, or deliverables affected by the modifications.
05
Ensure that all changes comply with regulatory requirements and institutional policies.
06
Review the modified protocol with relevant stakeholders for feedback.
07
Complete the required modification form, including all necessary documentation.
08
Submit the modification request to the appropriate review board or authority for approval.
Who needs Modification of an Approved Protocol?
01
Researchers conducting studies that require changes to previously approved protocols.
02
Institutions or organizations overseeing research that need to adapt to new regulations or insights.
03
Study sponsors or funding bodies that mandate compliance with updated research standards.
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People Also Ask about
How to amend an IRB?
How do I make a change to my 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.).
Can changes to a study protocol via a protocol amendment be implemented at the site?
Changes to a study protocol, via a protocol amendment, can be implemented at the site as soon as it is submitted to the IRB. All members serving on an IRB that oversees human research at an institution must be employed by or affiliated with that institution.
Which of the following would require an amendment to be submitted to the IRB?
The IRB requires an amendment to note any changes related to an approved study. The Amendment application must describe the modification(s) requested including reasons for the change, whether the modification will increase or decrease the risk of harm to the subject, and whether the consent form requires modification.
What is a protocol modification?
Throughout the course of the study, the protocol may be modified. Modifications may include addition or discontinuation of study procedures, changes in investigational product administration, revision of study visit schedule, and others.
Can an IRB approved protocol be changed?
A principal investigator may not implement any changes to an approved study (including to the protocol or informed consent document) without prior IRB review and approval, unless the change is necessary to eliminate apparent immediate hazards to the subjects.
Can an IRB approved protocol be changed?
A principal investigator may not implement any changes to an approved study (including to the protocol or informed consent document) without prior IRB review and approval, unless the change is necessary to eliminate apparent immediate hazards to the subjects.
How to do an IRB amendment?
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.).
How long do IRB amendments take?
Amendment Request Instructions Your amendment will take 3-to 5 days for administrative preparation and 10-working days for IRB review. An amendment approval letter will be emailed as a PDF document to the researcher(s).
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What is Modification of an Approved Protocol?
Modification of an Approved Protocol refers to changes or adjustments made to a research protocol that has already received approval from a relevant ethical or regulatory body, ensuring continued compliance with standards.
Who is required to file Modification of an Approved Protocol?
Researchers or principal investigators who are conducting studies under an approved protocol must file a modification whenever they propose changes that could affect the study's conduct, safety, or compliance.
How to fill out Modification of an Approved Protocol?
To fill out a Modification of an Approved Protocol, researchers should complete the designated modification form provided by the approving body, detailing the specific changes, the rationale for those changes, and any impact on the study's methodology or outcomes.
What is the purpose of Modification of an Approved Protocol?
The purpose of modifying an approved protocol is to ensure that any necessary updates, improvements, or unforeseen changes are formally documented and reviewed, maintaining the integrity and ethics of the research.
What information must be reported on Modification of an Approved Protocol?
Information to be reported includes a description of the modifications, rationale for changes, details about how those changes impact the study's objectives, methodology, participant safety, and any potential implications for data analysis.
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