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Federal regulations require that a PI cannot implement any changes to IRBapproved research, during the period for which approval has already been given, without prior IRB review and approval (except
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How to fill out changes to research made

01
Identify the specific changes that need to be made to the research.
02
Gather any new data or information that is necessary to update the research.
03
Review the existing research and determine how the changes will impact the overall findings.
04
Make the necessary edits or additions to the research document.
05
Clearly document and track all changes that have been made to the research.

Who needs changes to research made?

01
Researchers who have discovered errors in their original research.
02
Academic institutions that require updated research to reflect new findings or data.
03
Companies or organizations that rely on research for decision-making purposes.

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Changes to research made refer to any alterations or updates to previously conducted research, including modifications in methodology, study design, or findings.
Researchers and institutions involved in the study are required to file changes to research made, particularly those responsible for submitting research findings or regulatory documents.
To fill out changes to research made, researchers should follow the specific guidelines provided by the relevant regulatory body or institution, ensuring to provide detailed descriptions of the changes, the reasons for these changes, and any impacts on the results.
The purpose of changes to research made is to keep stakeholders informed, ensure transparency, maintain scientific integrity, and address any ethical or methodological concerns that arise during the research process.
Information that must be reported includes a description of the changes, the rationale for the changes, potential impacts on the research outcomes, and any subsequent measures taken to mitigate risks.
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