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Benoit First Nation Participation Waver Childs Name: ___ Age: ___ Parent or Guardian: ___Signature:___ (for Participants under 18 years of age) Address: ___ ___ Allergies: ___ MCP #: ___ Please advise

How to fill out an investigator initiated study

How to fill out an investigator initiated study

1. Develop a research question or hypothesis that you want to investigate.
2. Identify a study population and determine the sample size needed for statistical significance.
3. Create a study protocol outlining the study design, procedures, and data collection methods.
4. Obtain ethical approval from an Institutional Review Board (IRB) or Research Ethics Committee (REC).
5. Recruit participants for the study and obtain informed consent.
6. Collect and analyze data according to the study protocol.
7. Interpret the results and draw conclusions based on the findings.
8. Prepare a manuscript for publication in a scientific journal.

Who needs an investigator initiated study?

1. Researchers looking to investigate a specific research question or hypothesis.
2. Institutions wanting to generate new knowledge in a particular field of study.
3. Funding agencies seeking to support innovative research projects.
4. Healthcare professionals interested in improving patient care through research.

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What is an investigator initiated study?

An investigator initiated study is a research project that is designed, initiated, and managed by a clinician or researcher, rather than a pharmaceutical company or other sponsor. The investigator is responsible for the study's design, methodology, and conduct.

Who is required to file an investigator initiated study?

Researchers and clinicians who intend to conduct an investigator initiated study must file the study, often through their institution’s regulatory or ethics board, to ensure adherence to ethical standards and regulations.

How to fill out an investigator initiated study?

To fill out an investigator initiated study, the investigator should complete a study protocol, which includes details about the study design, objectives, methodology, and participant recruitment. The protocol must then be submitted for ethical review and approval.

What is the purpose of an investigator initiated study?

The purpose of an investigator initiated study is to explore clinical hypotheses, advance medical knowledge, and evaluate new treatments or interventions from a researcher’s perspective, often addressing questions not covered by industry-sponsored trials.

What information must be reported on an investigator initiated study?

Information that must be reported on an investigator initiated study includes study objectives, design, methodology, statistical analysis plans, enrollment numbers, safety data, and outcomes. Adverse events and other significant findings during the study must also be documented.