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Agreement with Sponsor for Research on New Product or Process

Wayne Michigan Agreement with Sponsor for Research on New Product or Process

Name: Wayne Michigan 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:

Wayne

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 Wayne Michigan Agreement With Sponsor For Research On New Product Or Process?

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FAQ

The sponsor is responsible for ensuring that the clinical study is conducted in accordance with the protocol, GCP, and applicable regulatory requirements. Specifically, the sponsor is responsible for: Implementing a system to manage quality throughout all stages of the trial process.

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.

A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO (Contract Research Organization) , but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.

During protocol development, the sponsor should identify those processes and data that are critical to ensure human subject protection and the reliability of trial results. The sponsor should identify risks to critical trial processes and data.

2 The sponsor should not supply an investigator/institution with the investigational product(s) until the sponsor obtains all required documentation (e.g. approval/favourable opinion from IRB/IEC and regulatory authority(ies)).

Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols

5.1. 2 The sponsor is responsible for securing agreement from all involved parties to ensure direct access to all trial related sites, source data/documents , and reports for the purpose of monitoring and auditing by the sponsor, and inspection by domestic and foreign regulatory authorities.

The trial Sponsor is responsible for the initiation, management and financing (or arranging the financing) of the trial and carries the medico-legal responsibility associated with its conduct.

Listen to pronunciation. (KLIH-nih-kul TRY-ul SPON-ser) 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.

For starters, a Sponsor is exactly what it sounds like ? they sponsor the clinical research study. A Sponsor may or may not choose to use a CRO, which is a clinical research organization or contract research organization. Basically, a CRO is the ?middle man? between the Sponsor and the research sites.

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Wayne Michigan Agreement with Sponsor for Research on New Product or Process

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FAQ

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