NIS Training Solutions

The non-interventional study ‘world’ can be a confusing one.  Unlike clinical trials, these types of studies currently don’t benefit from globally harmonized definitions and guidelines (e.g., ICH E6).  As a result, there is no common terminology.  We often use many terms to mean the same thing e.g., observational study, registry study, registry, observentional study, low interventional study, pharmoepidemiology study, drug utilization study, non-interventional study and so on.

There is also no common regulatory pathway for non-interventional studies.  The regulatory requirements in each country are different.

Our goal is to provide training solutions tailored to your needs.  Ultimately, we’re here to share our experience and knowledge in a way that is meaningful, actionable and gives you confidence/ added confidence that you’re doing the right thing.

Training Format
Face-to-face, Virtual, eLearning
Examples of generic topics covered  What is a non-interventional study (NIS)?
How do NIS differ from clinical trials?
What are the regulatory requirements for NIS?
Do we need to consent patients?
Do we need to monitor NIS?
Does addition of a blood draw make an NIS ‘interventional’?

Countries covered (63)

(The country list is always expanding)
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Tunisia, Turkey, UAE, UK, Ukraine, Uruguay, USA, Vietnam
Examples of country-specific NIS considerations covered
  • Regulatory bodies
  • Summary of the country-specific regulatory requirements for
    • Voluntary NIS
    • Mandated single country PASS
    • Mandated multi-country PASS
    • Other (e.g., research using existing data, genetic research, biobanking etc)
  • Regulatory Submissions
  • Study conduct considerations
  • Applicable legislation and guidelines
  • Useful links

Learn more about our NIS eLearning modules (see below).  You can also ‘try before you buy’.

Module 1
An Introduction to Non-Interventional Studies
Course objectives

By the end of this course, you’ll be better equipped to:

  • Describe when non-interventional studies occur in a drug’s clinical development
  • Define a non-interventional study
  • Describe key terminology related to non-interventional studies
  • Explain the difference between a non-interventional study and a clinical trial
Duration
20 minutes
Intended audience
Anyone involved, or interested in, the design, planning, conduct and/or auditing of non-interventional studies
Cost
  • £250 per module per user
  • Discount available for bulk purchase
Module 2
Types of Non-Interventional Studies
Course objectives

By the end of this module, you’ll be better equipped to describe:

  • Active surveillance, including intensive monitoring schemes, prescription event monitoring, and registries
  • Observational studies, including cross- sectional, cohort, and case-control studies, and
  • Drug utilisation studies
Duration
20 minutes
Intended audience
 Anyone involved in the design and planning of non-interventional studies
Cost
  • £250 per module per user
  • Discount available for bulk purchase
Module 3
Regulatory Requirements for Non-Interventional Studies
Course objectives

By the end of this module, you’ll be better equipped to:

  • Define the pillars that make up the Declaration of Helsinki
  • Describe how Best Practice Guidance relates to non-interventional studies
  • Outline regional regulations regarding non-interventional studies
  • Explain how non-interventional studies play a part in mandated safety reporting
Duration
20 minutes
Intended audience
Anyone involved in the design, planning, conduct and/or auditing of non-interventional studies
Cost
  • £250 per module per user
  • Discount available for bulk purchase
Module 4
Initiating, Executing and Closing a Non-Interventional Study
Course objectives

By the end of this module, you’ll be better equipped to:

  • Explain the protocols associated with non-interventional studies
  • Define key items in study start-up
  • Describe how non-interventional studies are typically monitored and how data are collected
  • Describe how the close-out of a non-interventional study is completed
Duration
20 minutes
Intended audience
Anyone involved in the conduct and/or auditing of non-interventional studies
Cost
  • £250 per module per user
  • Discount available for bulk purchase