What is a sponsor initiated study?

The sponsor investigator initiates and conducts a clinical trial alone or with a team. It's under the sponsor investigator's immediate direction that the investigational product (if any) is administrated, dispensed to or used by a subject.

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Agreement with Sponsor for Research on New Product or Process

Philadelphia Pennsylvania Agreement with Sponsor for Research on New Product or Process

Name: Philadelphia Pennsylvania 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:

Philadelphia

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 Philadelphia Pennsylvania Agreement With Sponsor For Research On New Product Or Process?

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5.1. 1 The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s).

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 study sponsor is exactly what it sounds they sponsor, or take responsibility for and initiates a clinical research study. A study sponsor can be a pharmaceutical company, governmental agency, academic institution, person, group or private organization.

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

The major responsibilities and activities of a project sponsor include: Negotiate funding for the project and be a spokesperson to the senior management. Provide direction and guidance for project empowerment, key business strategies and project initiatives.

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

The sponsor investigator initiates and conducts a clinical trial alone or with a team. It's under the sponsor investigator's immediate direction that the investigational product (if any) is administrated, dispensed to or used by a subject.

The person(s) in charge of a clinical trial or a scientific research grant. The PI prepares and carries out the clinical trial protocol (plan for the study) or research paid for by the grant. The PI also analyzes the data and reports the results of the trial or grant research.

In addition, the PI also agrees to conduct the trial according to the written protocol, obtain approval of the institutional review board (IRB) prior to initiating the trial and at any time the protocol is amended, maintain adequate records of the trial, protect subjects through the informed consent process, and notify

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.

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Philadelphia Pennsylvania Agreement with Sponsor for Research on New Product or Process

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What is the Philadelphia Agreement?

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What are the objectives of the Philadelphia Agreement?

How long is the agreement valid?

What happens if either party breaches the agreement?

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