PharmaSchool Resources

The PharmaSchool Website provides a wide variety of free online resources to clinical researchers across the World. The resources below also support some of our In-house and Online Learning Courses.

JargonBuster | Blogs | Sample Size Calculators | GCP & Regulations Updates

JargonBuster

The PharmaSchool JargonBuster is an online searchable dictionary of clinical research terms. You can either select the letter to display a list of terms or search by term.

Search the list of terms by letter: A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
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Investigational Medicinal Product Dossier (IMPD)
A document submitted as part of the Clinical Trial Authorisation application. The IMPD should give information on quality of any IMP to be used in the clinical trial, including reference products and placebos. It should also provide data from non-clinical studies and the previous clinical use of the IMP or justify in the application why information is not provided. Source: EU document: Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial

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Clinical Research Blogs

From time to time PharmaSchool staff contribute Blogs and Articles to various journals, publications and other media. Please find below the links to some of these articles.

Blog: Risk Based Monitoring – Myths and Misconceptions

Blog - What does RBM mean for the future of the CRA?

Blog - What is Power and How Do We Calculate Sample Size?

Blog - Reporting Risk in Clinical Trials

Sample Size Calculators

On our very popular Clinical Trial Designs Course and the Statistics for Non-Statisticians Course we do workshops looking into Power and Sample Size. In these Workshops we use sample size software and have had many requests to make this more widely available. Please find some of these calculators below.

Sample Size Calculator for Binary outcomes (Difference Comparison) >

Sample Size Calculator for Continuous outcomes (Difference Comparison) >

Sample Size Calculator for Binary outcomes (Non-inferiority) >

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PharmaSchool Regulatory Updates

PharmaSchool GCP & Regulatory Updates are notifications about changes, additions and new documents relating to the conduct of Clinical Trials. These are updated as and when new information is available. To access the searchable database of updates please click below:

GCP & Regulations Updates

 

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