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The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.

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The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.

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The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist

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The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist

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Standardized guidelines for all aspects of the trial

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Informed consent form (ICF) and the clinical protocol

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Learned the term Comparator--aka Placebo

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Have heard this term thrown around before now I know what it is!

Investigator's Brochure

A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects

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Consent must be documented before the clinical phase of the trial. 

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Consent must be documented before the clinical phase of the trial. 

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A glossary or Terms. :) Very much needed...

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A glossary or Terms. :) Very much needed...

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The purpose of the Insurance Statement is to document compensation to subjects for trial-related injury. 

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The purpose of the Insurance Statement is to document compensation to subjects for trial-related injury. 

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GCP - These standardized guidelines are also recognized internationally

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Essential documents are crucial to ensuring clinical trials are conducted within compliance in accordance with GCP guidelines

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Essential documents are crucial to ensuring clinical trials are conducted within compliance in accordance with GCP guidelines

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As someone new to this field, the glossary is super helpful with all the acronyms

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Documents needed to conduct a clinical trial