In our industry, compliance with health authority regulations is essential, but how do Sponsors and CROs manage this for transfers of eTMF that require data harmonization and data privacy protection? We discuss some best practices for transfers, GxP
In our industry, compliance with health authority regulations is essential, but how do Sponsors and CROs manage this for transfers of eTMF that require data harmonization and data privacy protection? We discuss some best practices for transfers, GxP validated systems, data integrity checks and new tools like CDISC eTMF Exchange Mechanism Standard (eTMF-EMS).
Why migrations matter?
- Records retention
- Industry retention surveys
- The importance of maintaining eTMF data integrity
Lay a foundation that meets regulations and guidances
Regulations
- Brief overview of Regulations -- Regulation (EU) No. 536/2014 (EU CTR) and others
- CDISC eTMF Exchange Mechanism Standard
- CDISC TMF Reference Model
- HSRAA resources
Build your process
- Transfer components
- Follow a transfer project plan as your blueprint
- Ensure you meet your deliverables
- Check the data integrity of your transfers
- Continual improvement
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