Informed consent in clinical research is a cornerstone of ethical regulatory compliance. It ensures that participants voluntarily decide whether to take part in a study after receiving adequate information about its purpose, procedures, risks, benefits, and alternatives. It is an ongoing process that promotes transparency, protects participants’ rights, and supports autonomous decision-making. Introduction Informed consent
Difference between Clinical Trial and Clinical Study Summary Clinical studies and clinical trials are both types of clinical research. Clinical research aims to study research findings and help translate them in treating patients for various diseases. It comprises different types of clinical studies all of which involve human participation. Clinical studies are a broader category
Current Regulatory Scenario for Conducting Medical Device Clinical Trials in India Medical devices complement the physician’s or surgeon’s expertise in examination, diagnosis, treatment, or follow-up. Access to medical devices helps a physician come up with the right diagnosis of the patient’s medical condition, or a surgeon to carry out a procedure accurately. These devices enjoy
