Clinical Trial Agreement

About this category:

A Clinical Trial Agreement is a legally binding document that outlines the responsibilities of each party in a clinical trial.

Templates in this category:

Clinical Trial Contract (Institution-friendly)

This document is a template contract between a commercial sponsor and a research institution or individual clinical investigator to conduct a medical research study involving human subjects, containing provisions that are reasonable and consistent with standard industry practices.

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Clinical Trial Contract (Sponsor-friendlying Party)

This document is a template for a contract between a commercial sponsor and a research institution or individual clinical investigator to conduct a medical research study involving human subjects, with terms and provisions favoring the commercial sponsor.

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Clinical Trial Contract (Sponsor-friendlying Party, Simple)

This template provides a contract between a commercial sponsor and a research institution or individual clinical investigator to conduct a medical research study involving human subjects, with provisions for scope, responsibilities, compensation, compliance, confidentiality, IP ownership, and publication rights.

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Clinical Trials Representations & Warranties For Life Sciences Companies

This Standard Clause provides an outline template form of representation for life sciences companies regarding their clinical trials to be included in underwriting contracts in a registered securities offering, with integrated notes and drafting tips.

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Clinical Trials: Informed Consent Template

This online document is a template for an FDA-regulated clinical trial informed consent that meets FDA requirements and industry standards.

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FDA Transfer of an Investigational Application

This document provides a template letter for the transfer of ownership of an IND on file with the FDA, as well as a template letter for the new sponsor to accept the transfer and assume ownership, with integrated notes and drafting tips.

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Investigational Drug (Non-Emergency) Expanded Access Contract (Single-Patient, Company-friendly)

This template outlines the responsibilities of a company and a medical institution/individual clinical investigator/physician in supplying an investigational drug to treat a seriously ill patient under FDA's expanded access regulations.

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Investigator-Initiated Clinical Trial Contract (Commercial-friendly Entity)

This template contract provides a sample of an online document outlining the agreement between two parties for a human-subjects medical research study.

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Investigator-Initiated Clinical Trial Contract (Institution-friendly)

This template contract outlines the responsibilities and rights of two parties in a human-subject medical research study concerning a drug or biologic.

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