International Standards for Clinical Trials: Manual of ICH Efficacy Guidelines
With countries around the world instituting International Council for Harmonization (ICH) efficacy guidelines in whole or in part, it’s essential to know the different regulatory requirements if you are conducting trials in more than one country.
Ensure compliance with International Standards for Clinical Trials: Manual of ICH Efficacy Guidelines, a compilation of the 34 ICH guidances that are critical to conducting clinical trials.
In addition to ICH E6 on good clinical practice, the manual includes the most recently approved guidance on general considerations for clinical studies (E8[R1]) and those for adaptive clinical trials, the extrapolation of data in pediatric trials and the clinical evaluation of antihypertensive drugs. It also incorporates early guidelines and drafts of new topics under consideration, including those on trials in geriatric patients (E7) and safety data reporting.
Plus, this manual includes valuable resources to help you stay compliant, such as ICH concept papers, discussion papers and training materials. You’ll get an explanation of the formal process by which ICH develops new and revised guidelines and a table showing each guideline’s approval date and which countries have implemented it.
Searching for the latest guidelines and where in the world each are relevant on your own is possible … but time-consuming and confusing. You’ll waste valuable time, encounter a great deal of hassle and likely make multiple mistakes. Meanwhile a quick look in International Standards for Clinical Trials will get you well on your way.
- Status of the next revision of ICH E6 and documents explaining ICH plans for the revision
- How the first revision of ICH E8 — General Considerations for Clinical Trials — brought risk management to the forefront of clinical trial thinking
- Additional considerations for statistical principles in clinical trials (ICH E9[R1])
- Status of a draft guideline on extrapolating data from adult trials for use in pediatric trials (ICH E11A)
- Plans for a new guideline on adaptive clinical trials (E20)
- ICH member nations that have officially implemented each guideline along with the date of implementation
- How ICH’s five-step process for developing guidelines works
- Resources, such as video presentations, concept papers, case studies and training modules
Don’t spend hours searching the ICH website. This one-of-a-kind reference from CenterWatch’s team of regulatory experts puts it all right in your hands.
Who Will Benefit
- Legal leadership and staff
- Regulatory officers and staff
- Compliance officers and staff
- Research and development staff
- Principal investigators
- Data managers
- Clinical research coordinators
- Clinical research monitors
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