For academic medical faculty unfamiliar with national and international regulations, the prospect of initiating and managing a clinical trial can be intimidating. The development of protocols and case report forms, compliance with regulatory requirements, the monitoring of clinical trials as well as the responsibilities of documentation are just some of the tasks the sponsor-investigator is faced with. This book covers the entire spectrum of a clinical trial, reviewing the different stages step by step: financial planning, crucial aspects of trial design, the authorization process and, finally, documentation. Moreover, it contains helpful tips, a practical glossary, instructions and a large number of resources related to the relevant regulations and forms conforming to the aInternational Conference on Harmonization and Good Clinical Practicea. This makes the publication at hand an essential acookbooka for both academic faculty new to clinical trials as well as seasoned sponsors-investigators.Forms. and. Templates. Drug Accountability Log After terminating or completing a clinical trial, there are several options to document the use of all IMPs. The sponsor-investigator has the responsibility for how to handle cases of destruction, anbsp;...
|Title||:||Guide for Investigator Initiated Trials|
|Publisher||:||Karger Medical and Scientific Publishers - 2011-04-04|