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Agreement with Sponsor for Research on New Product or Process

Riverside California Agreement with Sponsor for Research on New Product or Process

Name: Riverside California Agreement with Sponsor for Research on New Product or Process
Brand: US Legal Forms
Rating: 4.56 (283 reviews)

Category:

Contracts - Sponsorship

State:

Multi-State

County:

Riverside

Control #:

US-13195BG

Format:

Instant download

Description

This form is an agreement with a sponsor for research on a new product or process.

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How to fill out Riverside California Agreement With Sponsor For Research On New Product Or Process?

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FAQ

A sponsor-investigator is an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. A sponsor-investigator is responsible for all regulatory requirements as both a sponsor and an investigator.

All research requires a sponsor. The sponsor is the individual, company, institution or organisation that takes on legal responsibility for the initiation, management and/or financing of the research.

Investigator-initiated studies (IIS) are studies conceived, initiated, conducted and sponsored under the full responsibility of a non-Roche Sponsor, such as an individual investigator, institution, university, collaborative group, cooperative group or association.

The sponsor should identify risks to critical trial processes and data. Risks should be considered at both the system level (e.g., standard operating procedures, computerized systems, personnel) and clinical trial level (e.g., trial design, data collection, informed consent process).

In other words, in an investigator-initiated trial, the researcher is both the investigator and the sponsor, and therefore must handle the responsibilities for both roles.

A person, company, institution, group, or organization that oversees or pays for a clinical trial and collects and analyzes the data. Also called trial sponsor.

A sponsor is the entity or person who takes the responsibility for a clinical investigation. The sponsor may be, but is not required to be the investigator the individual who actually conducts the clinical investigation.

The sponsor, usually through the clinical investigator, provides the IRB with information necessary to make a judgment on the risk of a device study.

The sponsors shall make such reports to FDA regarding information relevant to the safety of the drug as are required under § 312.32. The sponsor shall make annual reports on the progress of the investigation in accordance with § 312.33.

Investigator Sponsored Studies are defined as unsolicited research originating from an external sponsor entity, institution or organization and include studies also known as investigator sponsored trials (IST), expert initiated research (EIR) or any other term which may reference investigator-sponsored or investigator-

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Riverside California Agreement with Sponsor for Research on New Product or Process

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How to fill out Riverside California Agreement With Sponsor For Research On New Product Or Process?

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What is an investigation sponsor?

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