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AnnexTechnical Guidance on Clinical Evaluation of Medical Devices I. Purpose The clinical evaluation of medical devices is the assessment procedure conducted by registration applicants to validate

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1. Healthcare professionals: Doctors, nurses, surgeons, and other medical practitioners who provide clinical care to patients can benefit from technical guidance on clinical practices. It helps them stay updated with the latest standards and procedures, ensuring the delivery of safe and effective healthcare services.
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What is technical guidance on clinical?

Technical guidance on clinical refers to the instructions and recommendations provided to healthcare professionals for conducting and managing clinical trials effectively.

Who is required to file technical guidance on clinical?

The sponsor or principal investigator of a clinical trial is typically responsible for filing technical guidance on clinical.

How to fill out technical guidance on clinical?

Technical guidance on clinical can be filled out by providing detailed information about the trial protocol, study objectives, participant eligibility criteria, and other relevant details.

What is the purpose of technical guidance on clinical?

The purpose of technical guidance on clinical is to ensure that clinical trials are conducted in a safe, ethical, and scientifically rigorous manner.

What information must be reported on technical guidance on clinical?

Technical guidance on clinical must include details about the study design, interventions, endpoints, statistical analysis plan, and monitoring procedures.