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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. Consultation Request (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. CRDW Staff Consultation
    • b. 1. Access to a Feasibility, 2. Dashboard, 3. Counts provided, 4. Datamart access
    • c. 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) questionary 3. VM (virtual machine) configuration form 4. Cost estimate
    • d. 1. Finalized Request 2. DUA Form in DocuSign
    • e. DGC (Data Governance Committee) approved?
      • If yes, proceed to process step 2f
      • If no, proceed to step 2a
    • f. iLAB Billing Payment
    • g. ONBOARDING
      • a. LDS (Limited Data Set) DATA
        • 1. ETL / data extraction
        • 2. Citrix desktop / VM building / Storage provision
        • 3. User group (RAD) access
        • 4. Demonstration / training
        • Access granted
      • b. DEIDENTIFIED DATA
        • 1. ETL / data extraction
        • 2. De-identification
        • 3. DUA Training
        • 4. Data Access Staging
        • 5. DLP / Security Check
        • 6. Access granted
  • 3. TENANT FORM (Smartsheet entry; email)
    • a. CRDW Staff Consultation
    • b. 1. Tenancy Agreement DTA (Data Transfer Agreement) form 2. VM configuration form 3. Cost estimate
    • c. Finalized Tenancy Request DTA Form in DocuSign
    • d. DGC approved?
      • If yes, proceed to process step 3e
      • If no, proceed to process step 3a
    • e. iLAB Billing Payment
    • f. ONBOARDING
    • g. 1. Data staging / INGRESS 2. VM building 3. Storage provision 4. User group (RAD) provision

Data egress request

  • a. CRDW Staff Consultaion
  • b. Finalized Request Egress Form in DocuSign
  • c. DGC approved?
    • If yes, proceed to process steps d (to be determined)
    • If no, proceed to process step b
  • d. iLAB Billing Payment (to be determined)
  • e. EGRESS
  • f. 1. DATA staging 2. DLP (Data Loss Prevention) / Security check 3. EGRESS