SAFETY PROGRAM TO ADDRESS ETHICAL ISSUES IN CLINICAL TRIALS

Ethical issues in clinical trials are of worth concern, hence for we propose a safety program that will help in achieving excellence in the conduct of the trials. Our paper presents a clear outline of the safety program under headings as: organizational structure remodeling, site staff training and educational programs, a plan for incident reporting and data collection.The proposed Safety Program has been designed on evidence based practice and is dedicated to achieve patient safety and quality assurance in clinical trials. The proposed program will help institutions to develop guidelines for better research outcomes, improve quality of projects, help in data management, provide training opportunities to site staff, ensure professional excellence and will help stakeholders to collaborate for patient safety.