The FDA has published guidance as part of its Real World Evidence Program to enhance regulatory decision-making on the effectiveness and safety of drug and biological products. This guidance provides sponsors and other interested parties with considerations when proposing to use electronic health records (EHRs) or medical claims data in clinical studies.
The guidance provides directions on selecting the right data sources, the key study elements to consider and emphasises the importance of data traceability and quality control throughout the data life cycle.
We summarise the key information in our latest snapshot below:
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For more detailed information, refer to the FDA’s guidance document here and get in touch with one of our Life Sciences experts today.
