Clinical Trials

About this category:

Clinical Trials documents provide legal protection and outline the details, risks, benefits, and procedures of the trial, as well as a record of the trial's results.

Templates in this category:

FDA Transfer of an Investigational Application

This legal template specifies the process and requirements for transferring an investigational application to the Food and Drug Administration (FDA) under the laws of the United States of America. It outlines the necessary steps and documentation needed for a smooth transfer of the application.

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6

Clinical Trial Contract (Sponsor-friendlying Party)

This legal template is a contract designed for clinical trials conducted in the United States, specifically for agreements between the sponsor and a friendly party involved in the trial. It outlines the terms and conditions of their relationship to ensure compliance with relevant laws and regulations.

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2

Clinical Trials: Informed Consent Template

This legal template provides a standardized format for an informed consent document used in clinical trials conducted under United States law. It ensures that participants are adequately informed of the study's purpose, procedures, potential risks, benefits, and their rights to make an informed decision about participating.

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14
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5

Clinical Trial Contract (Institution-friendly)

This legal template is a document that outlines the terms and conditions for a clinical trial conducted by an institution under USA law. It focuses on protecting the interests of the institution and ensuring compliance with relevant regulations and ethical guidelines.

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1

Clinical Trial Contract (Sponsor-friendlying Party, Simple)

This legal template involves a simple contract between a sponsor and a third-party interested in sponsoring a clinical trial in the USA. The template outlines the responsibilities and obligations of both parties involved in the trial.

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7
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5

Clinical Trials Representations & Warranties For Life Sciences Companies

This legal template is a document that outlines the representations and warranties required by life sciences companies conducting clinical trials in the USA. It covers legal obligations and responsibilities related to trial design, data integrity, participant safety, regulatory compliance, and more.

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17
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1