Choosing the Right Real-World Data (hashtag#RWD) Starts With Asking the Right Questions

Not all data is created equal, and when it comes to real-world evidence (#RWE), selecting the right data source can make or break the quality, credibility, and impact of your research.

From defining your study objective to assessing completeness, interoperability, privacy, and quality controls, a structured evaluation framework ensures the data you use is #fitforpurpose and capable of delivering meaningful insights.

Swipe through to explore a step-by-step guide on how to assess, validate, and select the most relevant and reliable RWD sources for your research.

1. CHOOSING THE RIGHT
REAL-WORLD DATA
Selecting the right RWD source isn’t just about availability,
it’s about quality and relevance to ensure your research
questions are answered accurately and effectively.
Use this framework to evaluate your RWD source

2. What’s the intended use - population-level insights, patient-level
outcomes, or regulatory-grade evidence?
DEFINE RESEARCH
OBJECTIVE
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ASSESS
RELEVANCE
Does the dataset cover the therapeutic area, demographics, geography,
and time frame?Does it meet minimum sample size and representativeness requirements?
How recent is the data? Is there a lag in data availability that could
affect relevance?
2
EVALUATE COMPLETENESS
& COMPLEXITY
Are diagnoses, treatments, labs, and outcomes captured?
Does the dataset support longitudinal follow-up or only
cross-sectional analysis?
3
CHECK DATA ACCURACY
& STANDARDS
How is the data captured (manual entry, automated feeds, or hybrid)
Are standards followed (e.g., CDISC, OMOP, SNOMED)?
Any audits, validation checks, or reconciliation processes in place?
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3. Are privacy, liability, and governance rules clearly defined
and compliant (HIPAA, GDPR, etc.)?
REVIEW GOVERNANCE,
PRIVACY & ACCESSIBILITY
Are access rights transparent and data use limitations documented?
Is the dataset openly available, restricted, or requires partnerships?
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Can it be linked with other datasets?
CHECK INTEROPERABILITY
& PERIODICITY
How often is the data updated? Is traceability ensured?
6
Are continuous quality monitoring processes in place (e.g., programmed
checks, trend analysis, dashboards)?
CONFIRM QUALITY
MONITORING
Is there risk-based monitoring for critical data points?
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If all criteria met     Approve as fit-for-use.
APPROVE, IMPROVE,
OR REJECT
If gaps are identified         Implement improvements (new standards, data
refresh, privacy updates, training).
If critical flaws Reject or supplement with additional RWD sources.
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