How to Intake Clinical Data Requests as a Clinical Data Provider

Please follow the instructions below to complete the intake and fulfillment of clinical data requests for clinical, quality, and research purposes for delivery to both internal and external parties.

To view the requests that are pending action from your team, login to ServiceNow and click on My Groups Tasks – Unassigned. This displays the current outstanding tasks that have not been assigned to one of your team members.

Data sets and reports must be transmitted and delivered in accordance with UCSF Minimum Security Standards. For assistance with identifying a solution for the transmission and delivery of clinical data sets to internal UCSF and external third parties, please submit an IT Consultation Request.

Instructions for Intake of Clinical TPO and Quality Assurance/Quality Improvement Data Requests:

Instructions for Intake of Research De-identified Data Requests:

Instructions for Intake of Research Limited Data Requests:

Instructions for Intake of Research Identified Data Requests:

Section 1: Research Limited Data Sets for UCSF, UC-Irvine, UC-Davis, UC-San Diego, and UC-Los Angeles Faculty, Staff, and Students

  1. Administer a Data Use Agreement.
    1. Email the requestor a copy of the appropriate Data Use Agreement:
      1. For UCSF data requests, use the UCSF Data Use Agreement.
      2. For SFGH data requests, use the SFGH Data Use agreement.
    2. The data use agreement must be signed by the requestor and the UCSF Principal Investigator (PI) associated with the study seeking use of a limited data set.
    3. If the DUA is signed by both the requestor and the PI:
      1. Attach a copy of the signed DUA to the Check DUA catalog task ticket.
      2. For SFGH requests, email a copy of the signed DUA to the SFGH Administrator specified on the form.
      3. Close the catalog task ticket for the DUA check with a status of Closed.Complete.
    4. If the DUA is not able to be signed by the requestor or the PI:
      1. Notify the requestor and PI that the limited data request cannot be fulfilled without a signed Data Use Agreement.
      2. Close the catalog task ticket for the DUA check with a status of Closed.Incomplete.
      3. Close the request item ticket for the data extraction request with a status of Closed.Incomplete.
  2. Check the Institutional Review Board (IRB) protocol approval.
    1. Review the IRB protocol application and approval letter associated with the IRB protocol number provided by the requestor through the Clinical Data Request Form.
    2. Verify that the IRB protocol application and approval are sufficient to cover the parameters of the data extraction request using the Recommended IRB Approval Verification Checklist.
    3. If the IRB protocol is sufficient:
      1. Close the catalog task ticket for the IRB check with a status of Closed.Complete.
    4. If the IRB protocol is not sufficient:
      1. Notify the requestor and PI of the required modifications to the IRB protocol application, request that they submit a modification application through iRIS to modify the protocol application, and notify you once the modification application is approved.
      2. Update the status of the catalog task ticket for the IRB check to Pending.Customer.
      3. Once the client notifies you that their modification application is approved, re-check the IRB per step 2b above.
      4. If the client does not submit a modification request or is unable to obtain approval for their modification request:
        1. Ask the client whether they wish to modify the parameters of their data extraction request in accordance with the specifications of their approved IRB protocol; OR
        2. If the client does not wish to modify the parameters of their data extraction request, close the catalog task ticket with a status of Closed.Incomplete and close the request item ticket for the data extraction request with a status of Closed.Incomplete.
  3. Extract the data.
    1. Extract the requested data set from the requested patient data sources.
  4. Record disclosures.
    1. For UCSF data extractions, record one disclosure record for each patient record delivered to the client through the APeX Quick Disclosure module. Please contact Harlan Wong for details on getting setup to record disclosure records through APeX Quick Disclosure.
  5. Deliver the data to the client.
    1. If the specifications of the data extraction request are changed by the client during the request fulfillment process, verify that the Clinical Data Request Form reflects the updated specifications and that the IRB protocol application permits the delivery of the modified data extraction request.
    2. Deliver the data sets to the requestor and PI. Ensure that you are delivering the data to the client through the method specified in the client’s IRB protocol.
    3. Close the Fulfill Request and Record Disclosures catalog task ticket and request item ticket for the request with a status of Closed.Complete.

Section 2: Research Limited Data Sets for Non-UC Third Parties AND

Research Identified Data Sets for External Non-UC Third Parties and Internal UCSF Faculty, Staff, and Students

  1. Check the Institutional Review Board (IRB) protocol approval.
    1. Review the IRB protocol application and approval letter associated with the IRB protocol number provided by the requestor through the Clinical Data Request Form.
    2. Verify that the IRB protocol application and approval are sufficient to cover the parameters of the data extraction request using the Recommended IRB Approval Verification Checklist.
    3. If the IRB protocol is sufficient:
      1. Close the catalog task ticket for the IRB check with a status of Closed.Complete.
    4. If the IRB protocol is not sufficient:
      1. Notify the requestor and PI of the required modifications to the IRB protocol application, request that they submit a modification application through iRIS to modify the protocol application, and notify you once the modification application is approved.
      2. Update the status of the catalog task ticket for the IRB check to Pending.Customer.
      3. Once the client notifies you that their modification application is approved, re-check the IRB per step 2b above.
      4. If the client does not submit a modification request or is unable to obtain approval for their modification request:
        1. Ask the client whether they wish to modify the parameters of their data extraction request in accordance with the specifications of their approved IRB protocol; OR
        2. If the client does not wish to modify the parameters of their data extraction request, close the catalog task ticket with a status of Closed.Incomplete and close the request item ticket for the data extraction request with a status of Closed.Incomplete.
  2. Extract the data.
    1. Extract the requested data set from the requested patient data sources.
  3. Record disclosures.
    1. For UCSF data extractions, record one disclosure record for each patient record delivered to the client through the APeX Quick Disclosure module. Please contact Harlan Wong for details on getting setup to record disclosure records through APeX Quick Disclosure.
  4. Deliver the data to the client.
    1. If the specifications of the data extraction request are changed by the client during the request fulfillment process, verify that the Clinical Data Request Form reflects the updated specifications and that the IRB protocol application permits the delivery of the modified data extraction request.
    2. Deliver the data sets to the requestor and PI. Ensure that you are delivering the data to the client through the method specified in the client’s IRB protocol.
    3. Close the Fulfill Request and Record Disclosures catalog task ticket and request item ticket for the request with a status of Closed.Complete.

Section 3: Research Identified Data Sets for UC-Irvine, UC-San Diego, UC-Davis, and UC-Los Angeles Third Parties

  1. Check the Institutional Review Board (IRB) protocol and UCOP Reliance Registry approvals.
    1. Review the UCOP Reliance Registry approval letter. A copy of this letter should be (I would change ‘should be’ to ‘is’ if the letter is always provided) provided by the requestor.
      1. Verify that approval from the UCSF IRB is designated on the approval letter and that the Principal Investigator is listed as a collaborator.
      2. If this information is not listed on the UCOP Reliance Registry approval letter, notify the requestor that their UCOP Reliance Registry application will need to be modified to include UCSF as a site for their study and the UCSF Principal Investigator as a collaborator on the study. Change the status of the catalog task ticket to Pending.Customer.
      3. The requestor notifies you when their modified UCOP Reliance Registry application is approved and provides a copy of the new approval letter.
      4. Re-review the modified approval letter. If the approval letter is sufficient, proceed with the remainder of the IRB protocol approval check.
      5. If the requestor is not able to provide a sufficient UCOP Reliance Registry approval, close any open catalog task tickets and the request item ticket for the request with statuses of Closed.Incomplete.
    2. Review the IRB protocol application and approval letter associated with the IRB protocol number provided by the requestor through the Clinical Data Request Form.
    3. Verify that the IRB protocol application and approval are sufficient to cover the parameters of the data extraction request using the Recommended IRB Approval Verification Checklist.
    4. If the IRB protocol is sufficient:
      1. Close the catalog task ticket for the IRB check with a status of Closed.Complete.
    5. If the IRB protocol is not sufficient:
      1. Notify the requestor and PI of the required modifications to the IRB protocol application, request that they submit a modification application through iRIS to modify the protocol application, and notify you once the modification application is approved.
      2. Update the status of the catalog task ticket for the IRB check to Pending.Customer.
      3. Once the client notifies you that their modification application is approved, re-check the IRB per step 2b above.
      4. If the client does not submit a modification request or is unable to obtain approval for their modification request:
        1. Ask the client whether they wish to modify the parameters of their data extraction request in accordance with the specifications of their approved IRB protocol; OR
        2. If the client does not wish to modify the parameters of their data extraction request, close the catalog task ticket with a status of Closed.Incomplete and close the request item ticket for the data extraction request with a status of Closed.Incomplete.
  2. Extract the data.
    1. Extract the requested data set from the requested patient data sources.
  3. Record disclosures.
    1. For UCSF data extractions, record one disclosure record for each patient record delivered to the client through the APeX Quick Disclosure module. Please contact Harlan Wong for details on getting setup to record disclosure records through APeX Quick Disclosure.
  4. Deliver the data to the client.
    1. If the specifications of the data extraction request are changed by the client during the request fulfillment process, verify that the Clinical Data Request Form reflects the updated specifications and that the IRB protocol application permits the delivery of the modified data extraction request.
    2. Deliver the data sets to the requestor and PI. Ensure that you are delivering the data to the client through the method specified in the client’s IRB protocol.
    3. Close the Fulfill Request and Record Disclosures catalog task ticket and request item ticket for the request with a status of Closed.Complete. 

Section 4: Research De-identified Data Sets for All Internal and External Parties

  1. Extract the data.
    1. Extract the requested data set from the requested patient data sources.
  2. Deliver the data to the client.
    1. If the specifications of the data extraction request are changed by the client during the request fulfillment process, verify that the Clinical Data Request Form reflects the updated specifications.
    2. Deliver the data sets to the requestor and PI.
    3. Close the Fulfill Request catalog task ticket and request item ticket for the request with a status of Closed.Complete.

Section 5: Clinical and Quality Reports/Data Sets for All Internal and External Parties

  1. Generate the report/data set.
    1. Extract the requested data set from the requested patient data sources.
  2. Deliver the report/data set to the client.
    1. If the specifications of the data extraction/report request are changed by the client during the request fulfillment process, verify that the Clinical Data Request Form reflects the updated specifications.
    2. Deliver the data sets/report to the requestor.
    3. Close the Fulfill Request catalog task ticket and request item ticket for the request with a status of Closed.Complete.