Practical Real World Evidence (RWE)
Practical Insights and Considerations when Conducting Primary and Secondary Data Non-Interventional Studies
#27 Practical RWE – Publications
#27 Practical RWE – Publications “Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research”[as per §36 [...]
#26 Practical RWE – Data Retention and Archiving
#26 Practical RWE – Data Retention and Archiving Data retention and archiving in non-interventional studies (NIS) are foundational practices that support the integrity of the scientific process, comply with [...]
#25 Practical RWE – Study Closure
#25 Practical RWE – Study Closure Closing a non-interventional (observational) study involves several key activities to ensure the study is concluded ethically (and respectfully), the data is handled appropriately, [...]
#24 Practical RWE – Safety Reporting
#24 Practical RWE – Safety Reporting The drug safety data generated by clinical trials demonstrates that the benefit-risk profile of the new drug (or approved drug with a proposed [...]
#23 Practical RWE – Monitoring
#23 Practical RWE – Monitoring Clinical trial regulations and ICH GCP require that clinical trials be monitored at an intensity proportionate to the risks (and potential risks) posed to [...]
#22 Practical RWE – Informed Consent
#22 Practical RWE – Informed Consent Informed consent in the context of RWE studies in Europe is subject to various regulations and ethical standards, which can differ based on [...]
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]
