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This document serves as a request to the Institutional Review Board for either an extension of approval or modification of an already approved research protocol, specifically for student research
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How to fill out request for extension of
How to fill out Request for Extension of Approval or Modification of Previously Approved Protocol
01
Obtain the Request for Extension of Approval or Modification of Previously Approved Protocol form from the appropriate regulatory body or institution website.
02
Review the instructions provided with the form carefully to ensure compliance with all requirements.
03
Fill in the general information section, including the protocol title, principal investigator's name, and contact information.
04
Indicate the type of request (extension or modification) and the reason for the request.
05
Provide a detailed description of the proposed modifications, if applicable, including any changes to the study design or methodology.
06
Include updated versions of any supporting documents, such as consent forms or recruitment materials, to align with the requested changes.
07
Check to ensure that the form is complete and all required signatures are obtained (e.g., from co-investigators or institutional review boards).
08
Submit the completed form and supporting documents to the relevant review board or authority as per institutional guidelines.
09
Await confirmation of receipt and any further instructions from the review board.
Who needs Request for Extension of Approval or Modification of Previously Approved Protocol?
01
Researchers seeking to continue a study that requires additional time beyond the originally approved protocol.
02
Investigators who need to make modifications to an existing protocol due to changes in the research design, recruitment strategies, or regulatory requirements.
03
Institutions that must comply with ethical and regulatory standards in maintaining ongoing research projects.
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People Also Ask about
What is considered a modification?
modification noun (CHANGE) a change to something, usually to improve it: Modification of the engine to run on lead-free fuel is fairly simple.
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.
What is an example of modification?
A car needs modification — in the form of snow tires — to be ready for the winter. Computer programs need modification all the time, because of new products or viruses. When you think of the word modification, think "change."
What is the legal definition of modification?
In a legal context, the term "modification" generally refers to the act of changing, altering, or amending something that is already established, such as a contract , statute , court order , or legal document. It involves making revisions or adjustments to the existing terms , provisions, conditions , or language.
What is a request modification?
A change in a court order is called a modification. Either parent can request that the Child Support Services Department review his or her child support case for modification. Generally, a modification must be based upon a "substantial change of circumstances" since the last order was made by the court.
What is the meaning of request for modification?
Request for Modification means a written request by Vendor for a modification of any of the terms of this Agreement or a Purchase Order.
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What is Request for Extension of Approval or Modification of Previously Approved Protocol?
It is a formal request submitted by researchers to extend the approval period of an existing research protocol or to modify aspects of a previously approved protocol.
Who is required to file Request for Extension of Approval or Modification of Previously Approved Protocol?
Researchers or principal investigators who wish to continue or change their approved research activities must file this request.
How to fill out Request for Extension of Approval or Modification of Previously Approved Protocol?
The form should be completed by providing detailed information about the proposed changes or the reasons for extension, including any updates to the study protocol, consent forms, and relevant documentation.
What is the purpose of Request for Extension of Approval or Modification of Previously Approved Protocol?
The purpose is to ensure that any changes to the research are accurately reviewed and approved to maintain compliance with ethical standards and regulatory requirements.
What information must be reported on Request for Extension of Approval or Modification of Previously Approved Protocol?
Information required typically includes the research protocol title, study objectives, specific changes proposed, rationale for changes, potential impact on participants, and updated consent information if applicable.
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