The author shares their extensive knowledge of clinical trials operations, research compliance and quality assurance with individuals interested in pursuing a career in providing access to clinical trials to patients as part of medical care. Well-designed and -conducted clinical trials are our best chance to develop safe and effective treatments. Building a successful clinical trials program is important in order to evaluate new treatments and provide access to the community. In turn, novel treatments can be brought to the market in an efficient manner. This manual describes the different aspects of clinical trial investigator sites to assist in conducting clinical trials in compliance with all applicable laws, regulations, standards and guidance. It includes a selection of essential templates to assist in operational efficiency.
Key Features
- Discussion of legal and regulatory intent
- Best practice approach to clinical research compliance
- Source and essential document templates
- Manual for entry-level as well as experienced clinical research professionals
- Potential to serve as textbook for clinical trial formal training programs