DDF17a Ethical Issues in Clinical Trials

To give an overview of the various ethical considerations associated with conducting clinical trials and associated policies and processes, including institutional oversight, pre-approval access, regulatory authority clearance, subject informed consent, investigatory conflict of interest, issues of fraud, and ensuring subject safety and well-being.

Participant profile: This workshop is intended for medical writers (and others) who are interested in clinical trials and would like to know more about the evolution of ethical principles associated with human subject participation. Global ethical aspects that are taken into consideration for studies will be reviewed. In addition, case examples of situational clinical trial and medical ethics will be provided for interactive discussion.