Research map: Key Real-World Data Management Practices for Registry Evaluation and Quality Assurance

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Papers in this map

  1. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for Reporting Observational Studies · Erik B von Elm · 2007 · 22379 citations · Cited by this paper
  2. Present and Future Post-marketing Drug Safety Assessment in Japan: A PMDA Perspective · 2026 · Related
  3. Systematic review or scoping review? Guidance for authors when choosing between a systematic or scoping review approach · Zachary Munn · 2018 · 11594 citations · Cited by this paper
  4. Impacts of Random and Fixed Effect Models on Type I and Type II Errors in Bioequivalence Hypotheses in Crossover Trial Designs: A Comprehensive Simulation Study · 2026 · Related
  5. Data quality assessment · Leo L. Pipino · 2002 · 1675 citations · Cited by this paper
  6. Trends and Regulatory Insights on Illicit Pharmaceutical and Cosmetic Imports: Evidence from Malaysia’s Operation Pangea 2020–2023 · 2026 · Related
  7. The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE) · Sinéad Langan · 2018 · 664 citations · Cited by this paper
  8. The CARE Program: An Initiative of Patient-Focused Drug Development for Rare Diseases by NMPA · 2026 · Related
  9. Harnessing the Power of Real‐World Evidence (RWE): A Checklist to Ensure Regulatory‐Grade Data Quality · Rebecca Anne Miksad · 2017 · 201 citations · Cited by this paper
  10. How Digital Health Technologies have been Used to Support Regulatory Drug Approval · 2026 · Related
  11. Quality Standards for Real-World Research. Focus on Observational Database Studies of Comparative Effectiveness · Nicolás Roche · 2014 · 153 citations · Cited by this paper
  12. Feasibility of a Monthly Morphine Milligram Equivalent Metric for Opioid Surveillance Using the National Claims Database of Japan: A Repeated Cross-Sectional Study in a Low-Consumption Setting · 2026 · Related
  13. A Questionnaire to Assess the Relevance and Credibility of Observational Studies to Inform Health Care Decision Making: An ISPOR-AMCP-NPC Good Practice Task Force Report · Marc L. Berger · 2014 · 132 citations · Cited by this paper
  14. Measuring Centralized Patient Outreach Recruitment Strategies and their Costs in Clinical Trials · 2026 · Related
  15. Use of real‐world evidence in regulatory decisions for rare diseases in the United States—Current status and future directions · Jasmanda Wu · 2020 · 119 citations · Cited by this paper
  16. Arbitrated Indirect Treatment Comparisons · 2026 · Related
  17. Quality assessment of real-world data repositories across the data life cycle: A literature review · Siaw‐Teng Liaw · 2020 · 102 citations · Cited by this paper
  18. Implementing Project Optimus in Oncology Dosage Optimization: Where are We Now? · 2026 · Related
  19. Data Quality in Rare Diseases Registries · Yllka Kodra · 2017 · 94 citations · Cited by this paper
  20. Accelerating Global Access for Indication Extension Through Regulatory Reliance Pilot: The First Indication Extension Pilot in Oncology · 2026 · Related
  21. Data linkage in pharmacoepidemiology: A call for rigorous evaluation and reporting · Nicole L. Pratt · 2019 · 62 citations · Cited by this paper
  22. Raising the Bar for Real-World Data in Oncology: Approaches to Quality Across Multiple Dimensions · Emily H. Castellanos · 2024 · 46 citations · Cited by this paper
  23. Assessing Real-World Data Quality: The Application of Patient Registry Quality Criteria to Real-World Data and Real-World Evidence · Richard E Gliklich · 2020 · 32 citations · Cited by this paper
  24. Clinical registries data quality attributes to support registry-based randomised controlled trials: A scoping review · Khic-Houy Prang · 2022 · 28 citations · Cited by this paper
  25. Assessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force · Rachael Fleurence · 2024 · 28 citations · Cited by this paper
  26. A data preparation framework for cleaning electronic health records and assessing cleaning outcomes for secondary analysis · Zhuqi Miao · 2022 · 24 citations · Cited by this paper
  27. Data Governance for Real-World Data Management: A Proposal for a Checklist to Support Decision Making · Oriol Solà-Morales · 2023 · 21 citations · Cited by this paper
  28. The challenges and opportunities in using real-world data to drive advances in healthcare in East Asia: expert panel recommendations · Gracy Crane · 2022 · 20 citations · Cited by this paper
  29. Regulatory and HTA Considerations for Development of Real‐World Data Derived External Controls · Lesley H. Curtis · 2023 · 19 citations · Cited by this paper
  30. The majority of observational studies in leading peer-reviewed medicine journals are not registered and do not have a publicly accessible protocol: a scoping review · Sophie Leducq · 2024 · 11 citations · Cited by this paper
  31. Data quality – The foundation of real-world studies · Arun Bhatt · 2023 · 10 citations · Cited by this paper
  32. Application of a Data Quality Framework to Ductal Carcinoma In Situ Using Electronic Health Record Data From the All of Us Research Program · Lewis E. Berman · 2024 · 5 citations · Cited by this paper
  33. A Robust Prioritization Framework of Data Quality Dimensions to Improve ML-Driven Healthcare Systems Using AHP and Sensitivity Analysis · Areen Metib Al-Hgaish · 2025 · 2 citations · Cited by this paper
  34. Enhancing confidence in complex health technology assessments by using real-world evidence: highlighting existing strategies for effective drug evaluation · Alison Antoine · 2025 · 2 citations · Cited by this paper
  35. Development and application of a healthcare data quality indicator framework from the perspective of data-as-a-product · Min Cai · 2026 · 1 citation · Cited by this paper
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