Data Use Agreement Approval Process
The Data Use Agreement Negotiation Process occurs in parallel with the Clinical Study Agreement Negotiation Process.
**Timeline for approval is dependent upon external response time.**
1. PI completes DUA submission form
Required elements:
- Final Protocol
- HIPAA Waiver and/or Consent Form
2. WVU and WVU Medicine IT complete security assessment (if needed)
3. Data Elements and Storage Assessment: Depending on risk of data elements and storage, data will be addressed and/or classified in the following manner:
- High Risk Data will be sent for review by the Data Risk Committee
- High Risk Data storage will be assessed and classified as high or medium risk.
- Medium Risk Data will be classified as medium data storage risk.
- Low Risk Data will be classified as low data storage risk.
4. Following storage assessment, DUA negotiation will commence.
6. Confirmation of IRB Approval (HIPAA waivers, ICFs)
6. Final DUA approval
7. DUA approval provided for clinical study agreement negotiation