Research Data Request Instructions

New Research Request Process Instructions#

Step 1 – CPHS New Project Application via IRBManager#

Register with the Committee for the Protection of Human Subjects (CPHS) online submission portal, IRB Manager. You will need to start a “New Project Application”.

You will not be able to submit the protocol at this point. You will be required to include a department letter of support with your application before being able to submit. HCAI will issue a Letter of Support in Step 4, to be included with your protocol submission.

Complete the protocol to the best of your ability and save the protocol as a draft. Print a PDF copy of your draft protocol, to be included with your HCAI Research Data Request submission.

Please Note: HCAI confidential patient-level data does not qualify to be requested as Exempt data. If you submit a “Determination for Exempt Research/Not Research” determination from CPHS with your HCAI Research Data Request application, you will be directed to submit a “New Project Application”.

Step 2 – HCAI Research Data Request via HCAI’s Data Request Portal#

Register/Login to HCAI’s Data Request Portal to access the Research Data Request Form. Select the Request a Research Data Request option from the Data Request Portal landing page.

When the form loads you will be presented with two options: “New” and “Supplemental”. Select the “New” option. 

Please Note: For instructions regarding the Supplemental Data Request Process, click here. 

Documents Required for Initial Request Submission#

You are required to attach several additional documents as part of your initial request submission. The required documents are outlined below.

1. PDF of your draft California Protection of Human Services (CPHS) Protocol.
   • Note: CPHS and HCAI are separate entities. For questions regarding IRB Manager, please email cphs@chhs.ca.gov.
2. Variable Justification Grids for each data set. You can download the most recent justification grids here.
   • Note: ED and AS datasets have identical variables available. Only one Justification Grid is required for both ED/AS.
3. A Letter of Sponsorship, on university letterhead, for this specific research project, from the appropriate Department Chair at the sponsoring university/institution.
   • Note: Must be current within 12 months of the request. Sample.
4. An IT Security Letter from the University IT department, signed by the Chief Information Officer or equivalent, on official university letterhead.
   • Note: Must be current within 12 months, letter used for CPHS is fine if current. Sample.
5. A copy of the IRS 501(c)(3) certificate, or other IRS-issued documentation, verifying the University is a non-profit.
   • Note: For-profit universities are not eligible for this data.
6. A Memorandum of Understanding (MOU) or a Data Use Agreement (DUA) between the primary University and any collaborating University, if employees from the collaborating university will have the access to patient-level data. The MOU should outline why the universities are collaborating on the project, how access to the data will be granted to the non-sponsoring university, and the roles and responsibilities of both parties.
   • Note: If you are collaborating with an external University, but they will not have access to the data, an MOU is not required. Please note the collaboration in your request and include the level of analysis data that will be shared, if any, along with the reason for the collaboration.
7. If a student interested in a fee waiver, a Fee Reduction Request Letter.
   • Note: The Letter should be on official letterhead, and signed by the student requestor and their faculty advisor. The letter should confirm the project is tied to the fulfillment of their academic requirements, in accordance with HCAI Pricing Policy.
8. If using a contractor, please attach a copy of the contract.

Note: You must meet the upload requirement to submit your request.

Step 3 – HCAI Preliminary Review#

Each Research Data Request undergoes an initial review to ensure the request meets HCAI’s requirements. The assigned analyst will perform a preliminary review, and work with you on any changes or clarifications that may be required.

Once your request passes the assigned analyst’s preliminary review, the request will be reviewed by HCAI’s Privacy Officer (PO). The PO may reach out with additional corrections or clarifications.

Once the request passes PO review, the assigned analyst will upload a Letter of Support to the HCAI Data Request Portal.

Areas to be Reviewed#

The following are common areas that may cause an analyst to return the request for further information. This is not an exhaustive list so please review your request completely.

• CPHS protocol and HCAI data request must match.  This includes requested datasets and years of data, purpose and narrative, data storage plans, data access plans, personnel, and Principal Investigator (PI).  
• The PI must be from the sponsoring university.
• All personnel who will have access to patient level data must be listed in the application.
• Data access roles must be defined for each research team member accessing patient level files (organizational affiliation, job title, role on project).
• Only the sponsoring university may host the data and grant access. Host universities cannot make copies of the data but access can be granted via non-downloadable VPN for outside entities. Data cannot be downloaded from host servers for use outside of host university.
• Data Security must be appropriately addressed per HCAI’s Security Guidelines. You can review HCAI’s guidelines here.
• HCAI follows a minimum data necessary policy in regards to releasing data. Please properly explain why the project requires the specific dataset you have requested and how the data will support your project goals. Please address: requested datasets, years, variables, and ability to subset the data or not.
• If data will be linked to any non-HCAI data sets, include the approval letter for use of the data set. Ensure that linkage methodology is clear (i.e., finder file used at HCAI, or probabilistic linkage, etc.)  Any language that clearly states that the data will not be used to reidentify an individual during linkage is useful for the HCAI decision process.
• Graduate students requesting data, your Faculty Advisor must also sign the request form in Step 7. List yourself as the PI, and your faculty advisor as Co-PI on the request form.
• Any contracted outside organizations must have a current contract included that explains contractual obligations, how the data will be accessed, and what the role is for the outside party utilizing the data for analysis or monitoring.
  • Note: All contractors must be listed in the original data request or updated in the supplemental application if added later.

Step 4 – Receive Letter of Support and submit CPHS Research Protocol#

Once the request passes the preliminary analyst review, the assigned analyst will upload a Letter of Support to the HCAI Data Request Portal. This should be used as the department support letter when submitting your CPHS Protocol.

Turnaround time to receive the Letter of Support will vary based on the caliber of the initial submission and the number of corrections needed. HCAI recommends allowing 2-4 weeks to receive your Letter of Support.

Step 5 – CPHS Approval#

Once HCAI issues the Letter of Support, you will work directly with CPHS through IRBManager to receive approval for your CPHS protocol. For questions regarding IRBManager, or the CPHS process, please email cphs@chhs.ca.gov.

Please note, CPHS approval is not the final approval necessary for receipt of data.

Each request must undergo additional HCAI review and may be subject to VSAC review. Data will only be delivered when a request has been approved by all relevant entities. You can find information about whether or not you need VSAC approval below. 

Step 6 – HCAI Final Review and Data Use Agreement#

Once your CPHS Research Protocol has been approved by CPHS, you will need to upload a PDF copy of your final approved protocol and the CPHS issued approval letter.

It is the responsibility of the requestor to reach out to HCAI once their CPHS protocol has been approved.

The assigned analyst will perform a final review to determine if any further changes or clarifications are needed before the request can move forward through final approvals.

The assigned analyst will upload the Data Use Agreement (DUA) for you to sign. Please ensure all Active Data Users are listed on the data request form and the DUA. Once you return the signed DUA to the assigned analyst, they will move the request forward to the next stage of the approval process.

The request will be reviewed by HCAI’s Chief Data Officer who will issue the final determination.

Step 7 – HCAI Approval and Signed Data Request Form#

When the request has been approved by HCAI, the PI will be contacted to sign the final approved request form. You will need to upload a PDF of the signed request form to the request portal before HCAI can arrange data delivery.

Note: If you are only requesting PDD, ED, or AS data, you will be contacted to arrange payment (skip to step 9). If you are requesting Linked Death or Linked Birth data of any kind, you will undergo an additional approval process outlined below.

Step 8 – VSAC – Requests containing Linked Birth or Linked Death data#

Requests for Linked Birth or Linked Death data must also go through the California Department of Public Health’s (CDPH) Vital Statistics Advisory Committee (VSAC) approval process.

You will need to register with CDPH’s online submission portal. You can Log in or Register here. For more information, you can visit CDPH’s website here. You will work directly with CDPH to receive their approval.

It is the responsibility of the requestor to reach out to HCAI once their CDPH application has been approved.

Note: VSAC determines approval for use of the birth certificate and death certificate data that comprise part of the Linked Birth and Linked Death data.  All questions related to the VSAC approval process can be directed to HIRS@CDPH.CA.GOV

Step 9 – Processing Payment#

Beginning October 1st, 2020, HCAI began charging for Research Data. You can view the full pricing policy here.

HCAI accepts all major credit cards and checks.

Credit Card Payments can be made via the Data Request Portal. When the Payment Processing stage is reached, a ‘Pay Now’ button will become available. The ‘Pay Now’ button will redirect you to the secure payment site.

Check Payments can be addressed to the Department of Health Care Access and Information or HCAI. Be sure to include the invoice number, CS000XXXX, and a copy of the invoice with the check.

Please mail the check to the address below:

Health Care Access and Information
Administrative Services Division
2020 W El Camino, Suite 1000 
Sacramento, CA  95833

Inability to comply with these instructions may cause delays in processing of your payment.

Step 10 – Data Delivery#

Data is sent via HCAI’s internal Secure File Transfer system. You can find complete instructions here.

All data is prepared upon notice of payment. Please allow at least 2 weeks for data delivery after your request is paid.

Post Approval – Data Due Date #

HCAI patient-level data must be returned or destroyed upon the completion of the research project, or if your CPHS protocol expires. After a request has been approved, HCAI issues a Data Due Date, upon which the data should be destroyed or returned to HCAI.

Data Due Dates can be extended annually, to align with your CPHS protocol expiration date.

Please follow the steps below to request a Data Due Date Extension through the HCAI Data Request Portal.

1. Submit Continuing Renewal request with CPHS to extend your protocol expiration date.
2. Log into the HCAI Data Request Portal.
3. Select ‘My Requests’ at the top of the Data Request Portal landing page.
4. Select the specific request for which you are requesting a Data Due Date Extension. You only need to submit a Data Due Date Extension for the parent request for your project.
5. You will see an ‘Extend Due Date’ box with two buttons, select the ‘Request Due Date Extension’ button.
6. The system will automatically notify your assigned analyst that you have requested a Data Due Date Extension.
7. Receive approval for your Continuing Review from CPHS.
8. Upload a copy of the CPHS Continuing Review approval letter to your Original Request.
9. HCAI will extend your Data Due Date to match your CPHS protocol expiration date.

Please follow the steps below to request a Data Due Date Extension if your request was not submitted via the HCAI Data Request Portal.

1. Submit Continuing Renewal request with CPHS.
2. Send a Data Due Data Extension request letter, on official letterhead and signed by the PI, to dataandreports@hcai.ca.gov. Please include the request number, the project name, and the date your CPHS protocol will be reviewed by the CPHS board.
3. Receive approval for your Continuing Review from CPHS.
4. Provide a copy of the CPHS Continuing Review approval letter to dataandreports@hcai.ca.gov. Please include your HCAI request number in the email so that we can effectively identify your request.
5. HCAI will extend your Data Due Date to match your CPHS protocol expiration date.

Supplemental Research Request Process Instructions#

Step 1 – Submit CPHS Amendment for additional data#

Before you can submit a Supplemental Request with HCAI, you must submit an amendment to your CPHS protocol, via IRBManager, to include the additional data, as well as any other changes to your project. You must submit the approved CPHS amendment and the CPHS approval letter with your Supplemental application.

Your CPHS amendment and HCAI application must be consistent in requested datasets and years of data. Inconsistencies between both forms may cause delays in processing.

For questions regarding IRBManager, or the amendment process, please email cphs@chhs.ca.gov.

Note: Your CPHS protocol must be current to request HCAI data. If your protocol is set to expire within 3 months prior to submitting a Supplemental request, it is recommended to submit for Continuing Renewal with CPHS before proceeding with the HCAI Supplemental Request.

Step 2 – Original HCAI (formerly OSHPD) Data Request#

If your original request was submitted outside of HCAI’s Data Request Portal, your request will need to be digitized by HCAI staff. Please email DataandReports@hcai.ca.gov with:

• HCAI Request Number
• CPHS Protocol Number
• PI Name
• Project Name
• Organization

If your original request was submitted via the HCAI portal, skip to Step 3.

Step 3 – Submitting Supplemental Request#

Login to HCAI’s Data Request Portal to access the Research Data Request Form. Select the Request a Research Data Request option from the Data Request Portal landing page.

When the form loads you will be presented with two options: “New” and “Supplemental”. Select the “Supplemental” option. 

A drop-down menu will appear. You will need to select your original request number from the drop-down menu. The full request form will now load. 

Supplemental Data Request Form #

Once you have selected your original request from the drop-down menu, the full request form will load. Your original request form and all prior information will load, but you will not be able to edit the fields. This is for your reference and is not meant to be altered. If you scroll down, you will find the Supplemental Request Information section where you can address any changes to your project.

You will need to indicate which type of supplemental request you are submitting. The options are:

Data Year/ Data File Update: If you would like the same variables and datasets you received in your original request, but updated to the most recent years of data available, or if you need to add a new data set to your project.

Variable Update: Adding additional variables you have not previously requested.

You can select either or both. Making a selection will unlock fields farther down the request form that will allow you to elaborate on the data you are requesting.

Supplemental Questions#

You will need to answer a series of questions regarding any changes to your study. This includes:

• Changes in project sponsorship
• Changes in data security or storage
• Changes to the scope of the project
• Changes to personnel or access to data
  • Note: If addressing changes in access to data, please list all current active data users. This makes it clear who still has access to data and who has been removed from the project.

Answering ‘Yes’ to a question will trigger a text box for you to outline the changes and may trigger additional questions.

Additional Documents #

You will need to submit a similar set of documents with your Supplemental Request as you did with your original request. Once you meet the required number of documents, you will be able to submit your request. The documents you will need to upload are:

1. Approved CPHS Amendment for addition of data
2. CPHS Amendment Approval Letter
3. Updated letter of sponsorship from the appropriate Department Chair at the sponsoring university/institution on university letterhead, current within 5 years.
4. Updated Data Security Letter from sponsoring university IT department Chief Information Officer or equivalent, current within 1 year.
5. Updated Justification Grids for each dataset

Note: You must submit the most recent version of the Justification Grids from the HCAI website. Variables and other information in the Justification Grids are updated often. Using outdated grids can cause a delay in data delivery and you will be asked to fill out new grids. The latest grids can be found here.

Step 4 – HCAI Review and Data Use Agreement#

The assigned analyst will work with you regarding any corrections or clarifications the request may need.

Once the request has passed the analyst’s review, they will upload the Data Use Agreement (DUA) for you to sign. Please ensure all Active Data Users are listed on the data request form and the DUA. Once you return the signed DUA to the assigned analyst, they will move the request forward to the next stage of the approval process.

Step 5 – HCAI Approval and signed Data Request Form#

The request will be reviewed by HCAI’s Chief Data Officer who will issue the final determination.

When the request has been approved, the PI will be contacted to sign the final approved request form. You will need to upload a PDF of the signed request form to the request portal before HCAI can arrange data delivery.

Note: If you are only requesting PDD, ED, or AS data, you will be contacted to arrange payment (skip to step 7). If you are requesting Linked Death or Linked Birth data of any kind, you will undergo an additional approval process outlined below.

Step 6 – VSAC – Additional Linked Data#

If you are requesting additional data that includes the Linked Birth or Linked Death files, additional review will be required. After receiving approval from HCAI, your request will need to be reviewed by CDPH’s Vital Statistics Advisory Committee (VSAC) for approval.

This does not apply to requests whose original request included Linked Birth or Linked Death data, but are not requesting additional linked data in the Supplemental Request.

You will need to register with CDPH’s online submission portal. You can Log in or Register here. For more information, you can visit CDPH’s website here. You will work directly with CDPH to receive their approval.

It is the responsibility of the requestor to reach out to HCAI once their CDPH application has been approved.

Note: VSAC determines approval for use of the birth certificate and death certificate data that comprise part of the Linked Birth and Linked Death data. All questions related to the VSAC approval process can be directed to HIRS@CDPH.CA.GOV.

Step 7 – Processing Payment#

Beginning October 1st, 2020, HCAI began charging for Research Data. You can view the full pricing policy here.

HCAI accepts all major credit cards and checks.

Credit Card Payments can be made via the Data Request Portal. When the Payment Processing stage is reached, a ‘Pay Now’ button will become available. The ‘Pay Now’ button will redirect you to the secure payment site.

Check Payments can be addressed to the Office of Statewide Planning and Development or OSHPD. Be sure to include the invoice number, CS000XXXX, and a copy of the invoice with the check.

Please mail the check to the address below:

Health Care Access and Information
Administrative Services Division
2020 W El Camino, Suite 1000 
Sacramento, CA  95833

Inability to comply with these instructions may cause delays in processing of your payment.

Step 8 – Data Delivery #

Data is sent via HCAI’s internal Secure File Transfer system. You can find complete instructions here.

All data is prepared upon notice of payment. Please allow at least 2 weeks for data delivery after your request is paid.

Post Approval – Data Due Date#

HCAI patient-level data must be returned or destroyed upon the completion of the research project, or if your CPHS protocol expires. After a request has been approved, HCAI issues a Data Due Date, upon which the data should be destroyed or returned to HCAI.

Data Due Dates can be extended annually, to align with your CPHS protocol expiration date. Supplemental Requests are subject to the Data Due Date of their parent request. You only need to submit a Data Due Date Extension for the parent request.

Instructions for submitting a Data Due Date Extension can be found here.