Clinical Management of Non-Interventional Studies

Non-Interventional Studies (NIS) are clinical research exploits that take advantage of treatment programs that are already in full swing. They are contrary to clinical trials 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.

Curriculum

Lesson 1: What is Clinical Research?

• How Does Clinical Research Differ from Standard Care?
• Why Do We Perform Clinical Research?
• Introduction: Key Points to Remember

Lesson 2: What Are the Main Principles of Research Ethics?

• What Is Informed Consent and Why Is It Needed?
• Why Do People Participate in Clinical Research and What Are the Benefits and Risks Involved?
• Research Ethics: Key Points to Remember

Lesson 3: Real-World Evidence

• Real-World Data: A Key Component for Healthcare Decision-making
• The Need for Broader Data
• The Low-down On Non-Interventional Studies

Lesson 4: Quality Assurance in Non-Interventional Studies

• Measures of Quality Assurance at Different Stages of NIS
• Measures in The Planning Phase
• Study Plan
• Quality Plan
• Design of Case Record Forms (CRF, electronic-CRF)
• Ensuring the Representativeness
• Training
• Ensuring The Transparency
• Measures for Data Collection and Data Entry
• The First Check of Completeness

Lesson 5: Verification and Validation

• Measures During the Analysis
• Measures During the Creation of NIS Reports
• Measures for Archiving NIS
• Data Protection
• Validation of Systems
• Direct Access to Computerized Systems

Lesson 6: Observational Studies: Regulatory Considerations

• Regulations for NIS Studies

Lesson 7: Regulatory Submissions of Non-Interventional Post-Authorization Safety Studies: Challenges for Data Interpretation and Comparisons with Clinical Data

• Data Availability and Safety Endpoints
• Demographics
• Efficacy or Effectiveness
• Selection Bias

Glossary

Quiz