Regulatory & Compliance — Documentation
Spectrum support for Clinical Research is divided into four stages, the third of which is Conducting Your Study.
This stage includes tasks and activities that occur once you have met all set-up requirements and approval. It includes activities such as study enrollmenet, billing, and all study participant interactions.
- Laboratory CLIA/CAP certificates
- Document Management and Storage
Document management and storage with Iron Mountain – Contact Linda Walker , or call (650) 498-6498. - Download Sample (IND)
Sample Regulatory Binder Table of Contents for IND studies (.pdf, rev. 07/22/10) - Download Sample (IDE)
Sample Regulatory Binder Table of Contents for IDE studies (.pdf, rev. 07/22/10) -
Medicare IDE Preauthorization Packet
Next Steps
- Questions?
Email Spectrum OTC , or call (650) 498-6498