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Non-Interventional Studies (NIS) are clinical research exploits that take advantage of treatment programs that are already in full swing. They are contrary to interventional research which involves the administration of therapeutic agents or devices in a controlled/uncontrolled clinical setting for evaluation of efficacy and safety. NIS exploits usually look at the effect of proven treatment plans and products on patients’ responses clinically and behaviorally.
This course differentiates between these classes of clinical research and teaches the elements of ethical NIS. As legislation that guides NIS changes globally, roughly every six months, it is necessary to highlight important elements of the processes and how to do due diligence concerning them.
In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
Lesson 1: What is Clinical Research?
Lesson 2: What Are the Main Principles of Research Ethics?
Lesson 3: Real-World Evidence
Lesson 4: Quality Assurance in Non-Interventional Studies
Lesson 5: Verification and Validation
Lesson 6: Observational Studies: Regulatory Considerations
Lesson 7: Regulatory Submissions of Non-Interventional Post-Authorization Safety Studies: Challenges for Data Interpretation and Comparisons with Clinical Data