Best Practices for Clinical Trial Sites A Commonsense Approach to Clinical Research Operations, Quality and Compliance

Best Practices for Clinical Trial Sites A Commonsense Approach to Clinical Research Operations, Quality and Compliance | 40.99 MB

Title: Best Practices for Clinical Trial Sites A Commonsense Approach to Clinical Research Operations, Quality and Compliance
Author: A. M. Flores
Category: Biochemistry, Chemical & Biochemical, Medical
Language: English | 292 Pages | ISBN: 9781040975206

Description:
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

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