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Southern Illinois Healthcare Institutional Review Board Research Project Amendment Summary Instructions: Complete all sections of this form. Handwritten forms will NOT be accepted. Obtain all necessary
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How to fill out research project amendment summary
How to fill out research project amendment summary:
01
Begin by reviewing the original research project documentation, including the proposal and any previous amendments. This will provide you with a clear understanding of the project's objectives and scope.
02
Identify the specific changes or amendments that need to be made to the research project. This could include changes to the research design, methodology, participants, sample size, data collection tools, or any other aspect of the project.
03
Consult with the principal investigator or research team members to discuss the proposed amendments. Ensure that everyone is on the same page and understands the rationale behind the changes.
04
Open the research project amendment summary template, if available. This template is usually provided by the research institution or funding agency and contains specific sections to be completed.
05
In the "Project Information" section, include the title of the research project, the principal investigator's name, the project ID, and the date of the original proposal.
06
In the "Summary of Amendments" section, clearly state each proposed amendment in a concise and specific manner. Provide a brief explanation of why each amendment is necessary and how it will contribute to the research project.
07
If applicable, provide any supporting documentation or references that justify the proposed amendments. This could include published studies, literature reviews, statistical analyses, or any other relevant information.
08
In the "Impact Assessment" section, discuss any potential impacts or implications of the proposed amendments on the research project. Consider factors such as timeframes, resources, budget, and ethical considerations.
09
Obtain the necessary signatures and approvals from the principal investigator, co-investigators, and any other relevant stakeholders. This ensures that all parties are in agreement with the proposed amendments and have taken the necessary steps to implement them.
10
Submit the completed research project amendment summary to the appropriate department or research institution, following their specific submission guidelines and deadlines.
Who needs research project amendment summary?
01
Principal Investigators: As the leaders of the research project, principal investigators need the amendment summary to document and justify any changes made to the original project proposal.
02
Research Teams: All members of the research team should have access to the amendment summary to understand the modifications made to the project. This ensures that everyone is informed and can collaborate effectively.
03
Research Institutions or Funding Agencies: These entities require the amendment summary to assess the changes made to the project and evaluate their impact on the research objectives, budget, and compliance with ethical guidelines.
04
Regulatory Authorities: If the research project falls under specific regulations or guidelines, regulatory authorities may request the amendment summary to ensure that the necessary approvals have been obtained and that the project remains in compliance throughout its duration.
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What is research project amendment summary?
Research project amendment summary is a document that outlines any changes or updates to a research project, such as changes in study design, new collaborators, or modifications to protocols.
Who is required to file research project amendment summary?
The principal investigator or lead researcher is usually responsible for filing a research project amendment summary.
How to fill out research project amendment summary?
To fill out a research project amendment summary, the researcher must provide details about the changes made to the project, the reasons for the changes, and any potential impacts on the study.
What is the purpose of research project amendment summary?
The purpose of a research project amendment summary is to ensure transparency and accountability in research projects, by documenting any changes made and ensuring they comply with ethical and regulatory standards.
What information must be reported on research project amendment summary?
Information that must be reported on a research project amendment summary includes details of the changes made, reasons for the changes, potential impacts on the study, and any approvals obtained for the changes.
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