Data Use Agreement Approval Process
A Data Use Agreement (DUA) is a legal contract between the entity that owns the data, typically a dataset or database, and a secondary entity that will receive the data (eg, sharing data with a collaborator at another institution).
For all data sharing agreements related to clinical data, please submit a DUA request as detailed below.
- EXCEPTIONS: If your data is related to a clinical trial agreement that is completed or currently being negotiated, a separate DUA request is not necessary. A DUA is also not needed if you intend to share data internally with another WVU department.
The Data Use Agreement negotiation process occurs in parallel with the Clinical Study Agreement negotiation process.
DUA Agreement Process
1. Complete the DUA submission form. Note that required elements include Final Protocol and HIPAA Waiver and/or Consent Form.
- To submit the Data Use Agreement: After logging WRAP through the link above, click the Agreements Tab
- Select “Create Agreement”
- Complete the questions, and then submit the form.
- Once submitted, the form will need to be approved by the PI. Once the PI signs off, the form will route to the DUA team who will help put together the contract and work to get the contract negotiated, signed and executed through the following steps.
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.
5. Confirmation of IRB Approval (HIPAA waivers, ICFs)
6. Final DUA approval & execution
More detailed process guidance can be found here.
Please submit a service request here for assistance with sharing data internally at WVU. If you have any questions, please email DUA@hsc.wvu.edu.
**Timeline for approval is dependent upon external response time.*