Version 2.0 of the NESTcc Research Methods and Data Quality Frameworks are now available for download
These updated versions of the Research Methods and Data Quality Frameworks incorporate NESTcc’s knowledge gained from test-cases and early NEST Mark implementations, along with the subcommittee’s extensive RWD experience. They include a broader range of data sources for quality assessment, consider recent FDA draft guidance documents, and offer additional RWE examples and best practices. They reflect the evolution in RWE innovation, aiming to provide a comprehensive resource for medical device ecosystem stakeholders.
NESTcc engaged the medical device ecosystem in a public comment period in early 2025 to gather feedback on a draft version of these Frameworks. Based on the valuable input received, NESTcc has finalized and released these updated Frameworks.
- Download the Research Methods Framework (v2.0)
- Download the Data Quality Framework and Appendix (v2.0)
Looking for Version 1?
The first versions of both the Research Methods Framework and the Data Quality Framework were released in February 2020. For those interested in reviewing version 1.0 of the and Frameworks, they remain available for reference.