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PRINCIPAL INVESTIGATOR MANUAL Form
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People also ask
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Who can be an investigator in a clinical trial?
In clinical trials, principal investigators generally are doctors, though can sometimes be nurse practitioners (NPs), as both professions demand a deep understanding of health and medicine. -
What is the difference between sponsor and investigator?
In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. “Sub-investigator” includes any other individual member of that team (21 CFR 321.3). Sponsor means a person who takes responsibility for and initiates a clinical investigation (21 CFR 312.3). -
Is a principal investigator required to comply with the IRB for?
Principal investigators (PI) are responsible for obtaining Institutional Review Board (IRB) approval before beginning any human subjects research. When you submit a protocol to the IRB for review as the PI, you agree to comply with federal regulations and University policies and procedures for the study duration. -
What is the main responsibility of a principal investigator?
Principal Investigator (PI) – A Principal Investigator is the primary individual responsible for the preparation, conduct, and administration of a research grant, cooperative agreement, training or public service project, contract, or other sponsored project in compliance with applicable laws and regulations and ... -
What is the investigator responsible for?
Investigators are ultimately responsible for the conduct of research. Investigators may delegate tasks to appropriately trained and qualified members of their research team. However, investigators must maintain oversight and retain ultimate responsibility for the conduct of those to whom they delegate responsibilities. -
What are the requirements of a principal investigator?
To pursue a career as a principal investigator, you need a bachelor's degree in a subject related to your field of research. Many organizations require principal investigators to also have a master's degree or a doctorate. Acquire a grant writing position to learn how to write successful grant proposals. -
What is investigator manual?
What is the Purpose of the Investigator Manual? The Investigator Manual is designed to guide you through policies and procedures governing research with human subjects, and the requirements for submitting research proposals for review to the Maine Medical Center (MMC) Institutional Review Board (IRB). -
What role can the investigator play?
Investigators play a crucial role in protecting the rights and welfare of human subjects and are responsible for carrying out sound ethical research consistent with research plans approved by an IRB.
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