Secure Data Enclave — SDE

After confirming the SDE is a good fit for your project, you will need to gather updated paperwork:

1. Proof of data provider approval for using the SDE (if data provider is a non-Columbia entity). Typically this is in the form of a data agreement (DUA or DAA), modified to stipulate that the SDE will be used and signed by both the data provider and SPA. If no such formal approval exists, some sort of written approval by the data provider must be acquired.
   
   Generally, you should discuss with the data provider what data security information they need to include in their DUA/DAA. Please reach out to Research Services at [email protected] for the SDE Data Security Plan and assistance with language to provide Data Providers and Columbia IRB.
   
   If your data provider is within Columbia, please provide documentation of this.
    
2. Proof of IRB approval* for using the SDE. If you have an existing IRB protocol, it must be modified to stipulate the SDE is being used. For the "System ID numbers" sub-question, you should reference the CUIMC Security RSAM registration ID number, 3868, which confirms the SDE was certified by CUIMC Security for HIPAA compliance. You should also add all users that will be accessing the SDE to the IRB protocol, including any Research Staff and the DSO.
   
   After approval, you can provide proof via a PDF copy of the approval email or the downloaded protocol "data sheet".
   *Alternatively, you can provide proof of IRB protocol exemption.
    

To formally apply for the SDE, complete this Qualtrics SDE application form and submit it to CUIT Research Services. The form requires:

• Baseline project information
• Names and contact information for all PI(s), Research Staff and DSO
• Document upload: Proof of data provider approval with SPA signature for using the SDE (if data provider is a Columbia entity, attach proof of this instead)
• Document upload: Proof of IRB approval/exemption for using the SDE

After receiving a complete application, Research Services will generate a custom SDE User Agreement. All PI(s), Research Staff, and your DSO must sign this document (Adobe Signature is accepted).

This agreement, along with your ARC chartstring information for payment ($526/year/project), should be uploaded to this Qualtrics user agreement and payment form.

Research Services will set up a time to give you and your DSO training on how to use the SDE. Training covers basic operation of accessing and conducting analysis on the SDE, as well as overview of data security measures in place and expectations of enforcement.

After training, your DSO is permitted to upload your project's data in a manner compliant with the agreement of the data provider. At this point, PIs and Research Staff may begin their analysis on the SDE. 

If you haven't requested to have your project retired and deleted within a year's time, CUIT will reach out to confirm if you'd like to extend your SDE contract for another year, at the cost of $526/project/year.