Health Medical Homework Help

Distinguish between medical treatment and clinical research

Explain how Clinical Trials relates to Regulatory Submissions and Health Care Products

Explain the history of clinical trial research by describing historical events related to clinical research

Explore what it means to be a participant in research.

Describe how the conduct of research and the ethical questions clinical trials raised in the last few decades led to the modern definition of human subject research and clinical trials.

Examine the principles of Good Clinical Practice (GCP) and describe who must follow GCP

Discuss how to set up an IRB and list the key regulatory requirements

Describe aspects of a Study Protocol and how to administer them including challenges

Explain the entire process of the Informed Consent Form Process

Cite articles related to the violation of regulations related to Informed Consent requirements

Explain the different phases of Clinical Trials for all health care products

Describe Conflicts of Interest in detail

Describe all types of regulatory filings/submissions

Describe different pathways to get access to investigational drugs and devices

Describe challenges in conducting Clinical Trials internationally

Describe Regulatory Issues that may occur post IRB approval

Describe the implications of Hot Topic- COVID-19