Problem
Clinical trials are conducted with sound scientific evidence, compliance to ethical principles and clear detailed protocols. Conducting clinical research involves considering the benefits of recognizing risk factors along with ensuring rights, safety and well-being of trial participants. Obtaining informed consent and maintaining confidentiality of subjects in a study is of paramount importance.
Required
A. Explain in detail the importance of GCP in clinical trial
B. Why it is critical to compliance with GCP regulation?
C. What are the circumstances that may cause sponsor to fail the clinical study if not followed GCP regulations?
D. In your own opinion describe if you were to present open a IND in US, what are the main elements require for sponsor to adhere before IND become effective.