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1Research protocol 4th National Registry of Cardiovascular Surgery (CCV) in Argentina Version N 3 8 of JULY 2021-Page 2 2 Confidentiality notice: The concepts and information included in this document
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Safe and effective protocol is a set of guidelines and procedures that ensure the safety and effectiveness of a certain product, treatment, or procedure.
The entity responsible for the development and implementation of the product, treatment, or procedure is required to file the safe and effective protocol.
To fill out the safe and effective protocol, one needs to provide detailed information about the product, treatment, or procedure, including its purpose, mechanism of action, potential risks and benefits, and any relevant data or evidence supporting its safety and effectiveness.
The purpose of safe and effective protocol is to ensure that products, treatments, or procedures are developed and implemented in a way that minimizes risk to patients or users and maximizes their effectiveness.
Information such as the product, treatment, or procedure being tested, the study design and methods, participant demographics, safety monitoring procedures, data analysis plan, and potential risks and benefits must be reported on the safe and effective protocol.
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