Login to MyKarger

New to MyKarger? Click here to sign up.

Login with Facebook

Forgot your password?

Authors, Editors, Reviewers

For Manuscript Submission, Check or Review Login please go to Submission Websites List.

Submission Websites List

Institutional Login
(Shibboleth or Open Athens)

For the academic login, please select your country in the dropdown list. You will be redirected to verify your credentials.


Guide for Investigator Initiated Trials

Editor(s): Fortwengel G. (Hannover) 

Status: available   
Publication year: 2011
Buy this book
Digital Version: CHF 49.00, EUR 46.00, USD 58.00
Print Version: CHF 49.00, EUR 46.00, USD 58.00
The final prices may differ from the prices shown due to specifics of VAT rules, postage and handling.
Order this title

You already have online access to this title. If you would like to buy a personal digital or print copy, please click here.

An essential manual for beginners and senior researchers alike
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 ‘International Conference on Harmonization and Good Clinical Practice’. This makes the publication at hand an essential ‘cookbook’ for both academic faculty new to clinical trials as well as seasoned sponsors-investigators.