Non-Interventional Studies

Non-Interventional Studies

Non-interventional studies (also known as observational studies) are research investigations where researchers observe, track, and analyze health outcomes in a real-world setting without assigning specific treatments or interventions. Patients receive care per routine practice, not a research protocol, making these studies ideal for studying safety, patterns, or effectiveness. 

Key Aspects of Non-Interventional Studies (NIS):

  • No Protocol Treatment Assignment: The decision to treat a patient is separate from the decision to include them in the study.
  • Routine Care Observation: Doctors treat patients according to standard practice (e.g., in clinical settings).
  • Purpose: These studies, such as prospective cohorts or retrospective studies, are primarily used to gain insights into how medicinal products are used, their long-term effectiveness, and safety.
  • Real-World Evidence (RWE): They are essential for gathering real-world data (RWD), reflecting diverse populations, and identifying rare outcomes or long-term effects.
  • Not Clinical Trials: Because they do not interfere with patient treatment, they are generally not considered clinical trials, which often eliminates the need for the same rigorous, pre-approval processes.
  • Data Collection Methods: These can include reviewing medical records, conducting surveys, or monitoring patients, often using epidemiological methods for analysis. 
Common examples include post-marketing surveillance studies (Phase 4), epidemiological studies, and large observational registries.

On demand, online courses on the principles and practical aspects of non-interventional studies.

Fantastic rates available for groups of 5 or more participants

 

Non-interventional studies, General Principles (Module 1) – personalized, narrated and read-only tracks, suitable for both inexperienced and experienced. Provides a generic core basic training (takes approx. 45 mins).

Non-interventional studies, Practical Aspects (Module 2) – personalized, narrated and read-only tracks ideal for those who need a generic but more in-depth knowledge of running NIS (takes approx. 45 mins).

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NIS Essentials for Investigators – narrated and read-only tracks, suitable for both inexperienced and experienced investigators and their teams (takes approx. 25 mins).

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About our courses

• The training is online, on demand. Do it anywhere! All that is needed is a strong continuous internet signal.
• Globally log in at any time 24/7, 365 days a year.
• Delivery by html 5 allows PC, laptop, iPad, iPhone and android mobile devices to be used.
• We can provide tracking of user activity, progress reporting by user and group.
• Certification is provided for satisfactory completion.
• The training is personalized using the participant’s first name.
• Help for participants in the event of problems.
• Valuable e-resources in the courses.
• Costs per course depend on the number of participants with excellent packages for multiple users.
• Fix costs and get the best prices with a 2-year agreement or longer.
• We take data privacy seriously. You may view our GDPR privacy notice at https://brookwoodacademy.org/Privacy_Statement


Non-interventional studies - General Principles

Non-interventional studies - General Principles

A generic core basic training on NIS principles              ..

£100.00

Non-interventional studies - Practical Aspects

Non-interventional studies - Practical Aspects

An overview of planning and running NIS studies.              ..

£100.00

NIS Essentials for Investigators

NIS Essentials for Investigators

An overview of NIS essentials for the investigator site.            ..

£100.00

e-book Essential Guide to Non Interventional Studies

e-book Essential Guide to Non Interventional Studies

General principles and practical aspects for those involved in NIS studies.      ..

£15.00

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