Practical Real World Evidence (RWE)
Practical Insights and Considerations when Conducting Primary and Secondary Data Non-Interventional Studies
#15 Practical RWE – Ethical and Moral Obligations: Informed Consent
#15 Practical RWE – Ethical and Moral Obligations: Informed Consent Informed consent for non-interventional studies is a crucial ethical requirement, deeply rooted in the principles established by the Nuremberg [...]
#14 Practical RWE – Documentation: 1572s
#14 Practical RWE – Documentation: 1572s It’s a question that still (frustratingly) comes up in the context of non-interventional studies conducted in Europe…”Do I need a signed 1572 from [...]
#13 Practical RWE – Documentation: Trial Master File vs Study Master File
#1 Practical RWE – The Importance of Harmonised Definitions (RWR, RWD, RWE) Definitions are crucial in the context of real-world research (RWR), real-world data (RWD), and [...]
#12 Practical RWE – Training: Study Team Training
#12 Practical RWE – Training: Study Team Training Study team training is crucial in both Real-World Evidence (RWE) studies and clinical trials, but the importance and focus of the [...]
#11 Practical RWE – Documentation: Non-Interventional Study Protocols
#11 Practical RWE – Documentation: Non-Interventional Study Protocols Having dedicated protocol templates for non-interventional studies (RWE studies) and clinical trials is a must rather than a ‘nice to [...]
#10 Practical RWE – Connecting the Dots: Regulatory Assumptions
#10 Practical RWE – Connecting the Dots: Regulatory Assumptions Let’s start by assuming that you have done your homework, which means: You’ve classified your study in each region e.g., non-interventional [...]
Practical RWE Topics
- Definitions: The Importance of Harmonised Definitions (RWR, RWD, RWE) [Link] [LinkedIn]
- Terminology: Real World Research (RWR), Real World Data (RWD), and Real World Evidence (RWE) [Link] [LinkedIn]
- Study Classification: What is it? [Link] [LinkedIn]
- Study Classification: Non-Interventional Study or Observational Study? [Link] [LinkedIn]
- Study Classification: Retrospective or Prospective? [Link] [LinkedIn]
- Study Classification: Non-Interventional Study or Low Intervention Clinical Trial? [Link] [LinkedIn]
- Study Classification: Interventional or Non-Interventional? [Link] [LinkedIn]
- Connecting the Dots: The Declaration of Helsinki [Link] [LinkedIn]
- Connecting the Dots: How to Identify Country-Specific Requirements for Non-Interventional Studies (NIS) [Link] [LinkedIn]
- Connecting the Dots: Regulatory Assumptions [Link] [LinkedIn]
- Documentation: Non-Interventional Study Protocols [Link] [LinkedIn]
- Training: Study Team Training [Link] [LinkedIn]
- Documentation: Trial Master File vs Study Master File [Link] [LinkedIn]
- Documentation: 1572s [Link] [LinkedIn]
- Ethical and Moral Obligations: Informed Consent [Link] [LinkedIn]
- Study Planning: Clinical Study Playbook (Roadmap) [Link] [LinkedIn]
- Study Planning: Insurance [Link] [LinkedIn]
- Start-Up: Study Start-Up [Link] [LinkedIn]
- Study Conduct: Regulatory Green Light [Link] [LinkedIn]
- Study Conduct: research Registration [Link] [LinkedIn]
- Study Conduct: Patient Recruitment [Link] [LinkedIn]
- Sudy Conduct: Informed Consent [Link] [LinkedIn]
- Study Conduct: Monitoring [Link] [LinkedIn]
- Study Conduct: Safety Reporting [Link] [LinkedIn]
- Study Close-Out: Closure [Link] [LinkedIn]
- Study Close-Out: Data Retention and Archiving [Link] [LinkedIn]
- Study Close-Out: Publication [Link] [LinkedIn]
