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Clinical and Research Data Warehouse (CRDW)

Operating procedures

Operating procedures

Operating procedures (OP) for a Clinical Research Data Warehouse (CRDW) detail the steps for secure data transfer, accessing data, and facilitating user onboarding. These procedures provide clarity on how authorized personnel can access and interact with data, ensuring a smooth onboarding process for users. The OP establishes a straightforward framework for ethical data management in clinical research, covering practical aspects of data transfer, access, and user integration.

View text versions of the CRDW web request and data egress request with acronyms expanded below.

*IRB workflow

Text versions of CRDW web request and data egress request are below:

CRDW web request

  • 1. INFO Form (ServiceNow ticket; email)
    • a. Is it a TENANT request?
      • If yes, proceed to process step 3
      • If no, proceed to process step 1b
    • b. Is it a DATA request?
      • If yes, proceed to process step 2
      • If no, proceed to process step 1c
    • c. Submit a Help Desk ServiceNow ticket
  • 2. DATA ACCESS FORM (Smartsheet entry; email)
    • a. Honest broker / data analyst consultation
    • b. IRB (Institutional Review Board) exists?
      • If yes, proceed to follow directions in process step 2c
      • If no, proceed to the IRB workflow then continue to follow directions in process step 2c
    • c. 1. Collect IRB protocol and form 2. ETL (Extract, Transform Load) request template 3. VM (virtual machine) configuration form 4. Cost estimate
    • d. Access to a feasibility dashboard, counts provided, datamart access
    • e. Finalized request entered as DUA (Data Use Agreement) form in DocuSign
    • f. DGC (Data Governance Committee) approved?
      • If yes, proceed to process step 2g
      • If no, proceed to step 2a
    • g. iLAB entry
    • h. PAYMENT
    • i. ONBOARDING
      • a. LDS (Limited Data Set) DATA
        • 1. ETL and data access
        • 2. VM building / storage provision
        • 3. User group (RAD) provision
        • 4. Demonstration / training
      • b. DEIDENTIFIED DATA
        • 1. ETL
        • 2. De-identification
        • 3. Data access
  • 3. TENANT FORM (Smartsheet entry; email)
    • a. Honest broker / data analyst consultation
    • b. 1. Tenancy Agreement DTA (Data Transfer Agreement) form 2. VM configuration form 3. Cost estimate
    • c. Tenancy Agreement DTA form, DocuSign
    • d. DGC approved?
      • If yes, proceed to process step 3e
      • If no, proceed to process step 3a
    • e. iLAB entry
    • f. PAYMENT
    • g. ONBOARDING
    • h. 1. Data staging / INGRESS 2. VM building 3. Storage provision 4. User group (RAD) provision

Data egress request

  • a. Data egress request
  • b. Egress Form Data Analyst consultation
  • c. Egress Form DocuSign
  • d. DGC approved?
    • If yes, proceed to process steps e and f (to be determined)
    • If no, proceed to process step b
  • e. iLAB entry (to be determined)
  • f. PAYMENT (to be determined)
  • g. EGRESS
  • h. 1. DATA staging 2. DLP (Data Loss Prevention)/Security check 3. EGRESS