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STANDARD OPERATING PROCEDURE (SOP) FOR CLINICAL RESEARCH Last Revised: 12/2017 Title: Transfer Sponsor Investigator Initiated Protocols Prior Version: None SOP NUMBER: GA106Page 1 of 51. PURPOSE:
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How to fill out investigator initiated research
How to fill out investigator initiated research
01
Determine the research question or objective of the study.
02
Prepare a research protocol that outlines the study design and methodology.
03
Identify potential funding sources for the research.
04
Submit the research proposal to the relevant ethics committee for approval.
05
Once approved, recruit participants or gather necessary data for the study.
06
Conduct the research according to the approved protocol.
07
Collect and analyze the data obtained from the study.
08
Interpret the results and draw conclusions.
09
Prepare a research report or manuscript for publication.
10
Submit the research report to appropriate journals or conferences for dissemination.
Who needs investigator initiated research?
01
Investigators or researchers who want to conduct a study on a specific topic.
02
Medical professionals who want to explore new treatment options or interventions.
03
Academic institutions or research organizations interested in advancing scientific knowledge.
04
Pharmaceutical companies or other industries looking to develop new drugs or products.
05
Government agencies or regulatory bodies seeking evidence for policy-making.
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What is investigator initiated research?
Investigator initiated research is research projects that are conceived and conducted by the investigator without external sponsorship or direction.
Who is required to file investigator initiated research?
Investigators conducting the research are required to file investigator initiated research.
How to fill out investigator initiated research?
Investigators must describe the research question, methods, results, and conclusions in a detailed report.
What is the purpose of investigator initiated research?
The purpose of investigator initiated research is to address research questions that are important to the investigator without the constraints of external funding sources.
What information must be reported on investigator initiated research?
Investigators must report details of the research question, methods used, results obtained, and conclusions drawn.
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