CDW: How to Request Data

CDW-R provides research data extraction request development support to identify available data elements to answer research questions; assist with ensuring data needs are accurately reflected on your BMC/BUMC INSPIR application; determine if a subsequent manual chart review would be required for your study; and prepare to submit a formal CDW-R research data extraction request.

All investigators, particularly new investigators or those with early experience working with EHR data, are encouraged to contact CDW-R in advance of IRB submission to confirm available data and discuss feasibility, scope, cost estimates, and how to optimize the data request. Reach out to cdw@bmc.org with questions.

• For efficient service, please provide the following when contacting CDW-R: The BMC/BUMC IRB H- Number, a summary of the services/data you anticipate needing from the CDW-R team, and your specific questions.
• For inquiries that cannot be addressed by email, CDW-R offers one (1) initial consultation at no charge for every study. Subsequent consultations and request development support services are billed at our hourly fees. This consultation can take place prior to your study’s IRB approval – and can be helpful to determine what data should be included in your IRB submission.

BMC/BUMC Institutional Review Board (IRB) Review and Determination

All research data extraction and provisioning services other than aggregate, simple counts must have IRB approval before the CDW-R will add the data request to our work queue.

• Contact the BMC/BUMC IRB for protocol development support.
• While you may submit the research data extraction request form before receiving IRB approval, CDW-R will not add the request to our work queue until the IRB approves you for access to all requested data. Discrepancies between IRB protocols and CDW-R data requests will be returned to investigators and will cause delays in entering the data request into the CDW-R work queue.
• It is the responsibility of the investigator to let the CDW-R know when the study is IRB-approved for access to the data. CDW-R does not receive notification of IRB approval or determinations.
• Please make sure that your IRB submission lists all variables needed for your research study. Researchers may include more variables in their IRB than they request from the CDW-R. For example, a research team conducting a subsequent manual chart review may only require the CDW-R to pull a cohort list with 5 of the 20 variables listed in their full IRB protocol. Be specific in your IRB about which variables you need from CDW-R.

Additional Special Approvals

Some data sources require additional permissions before you can access the data for use within research studies. This includes obtaining special approvals from the IRB and/or external entities. Securing special approvals and executing agreements ensures that your study is fully compliant with research regulations as well as legal and institutional requirements before data extraction begins. Identifying what special approvals are required for your research study early helps prevent delays in the data request process.

• Review data that require special approvals to access for research purposes.

Execute Required Data Sharing Agreements or Contracts

Some research requires a data sharing agreement or other relevant contract before study team members can access the data and/or before BMC study team members can share data outside of BMC.

The CDW-R does not manage data sharing agreements; Principal Investigators and study teams are responsible for taking the necessary steps to ensure the appropriate agreements are in place before any data are shared outside of BMC.

• From BMC Research Contracts and Industry Agreements: If data are being transferred to any collaborator or third party outside of Boston Medical Center (including sending data to BU, BUMC study staff/collaborators, and/or BUMC students), a data sharing agreement is required. BUMC is defined as investigators from Boston University School of Medicine, Boston University School of Public Health, and Boston University Goldman School of Dental Medicine. Before sharing any data, contact BMC Research Contracts.
• Before sharing any data, contact BMC Research Contracts for steps to execute the appropriate agreement.

Include all information requested in the CDW-R Research Data Extraction Request.

• Requests that are missing minimum necessary information as outlined in the data request form will not be entered into the CDW-R work queue.
• All the information must be provided at the time of data request submission for a research data extraction request to be considered finalized and added to the CDW-R work queue:
  1. All data extraction request details as described in the form, including relevant ICD codes, CPT codes and procedure names, data definitions, Epic form names, report names, order/referral names, labs, and medication names. Avoid using acronyms.
  2. IRB information for the study protocol that grants access to all requested data.
  3. Funding information, including an account number to be used for CDW-R data extraction and provisioning services.
  4. Documentation of any special approvals such as data sharing agreements or permission to use external data sources.

CDW-R Data Request Review Process

• Preliminary Administrative Review: The CDW-R team aims to review all data request forms within 10 business days of submission for completeness, feasibility, and to ensure all required main components have been satisfied (including confirmation of IRB protocol approval/determination, confirmation of any special approvals, a fully completed CDW-R data extraction request form, and identification of an account number to pay for services). A CDW-R team member will contact the study team with the outcome of this preliminary review and steps required to formally enter the CDW-R work queue.
• Formal Data Request Content Review: If all required main request components have been satisfied, request will undergo a full, formal review to assess request content, ensure alignment with the study's IRB, and determine any clarifications required to facilitate data extraction. In cases where the request lacks sufficient information or funding resources, a consultation may be required and the request will not be entered into the CDW-R request queue.

Wait times begin when a data request officially enters the CDW-R work queue. Research teams should plan for several weeks between submission of a finalized CDW-R data extraction request (including confirmation of IRB protocol approval/determination, confirmation of any special approvals, a fully completed CDW-R data extraction request form, and identification of an account number to pay for services) and receipt of the data. Research teams are encouraged to plan accordingly.

Expected wait times by request type are provided on our website homepage. We will do our best to work within study timeframes but this may not always be possible given the number and complexity of requests in our work queue.

CDW for Research analysts deliver all data sets using BMC’s secure box.com system. CDW for Research analysts grant access to the data set to investigators and their designees. These designees must be listed on the approved IRB protocol. The CDW for Research does not email password-protected excel files to investigators.

• Data Delivery: CDW-R analysts deliver all data via OneDrive.
• Authorization to Access Data: PIs are responsible for monitoring data access and data security per applicable regulations and guidance, including ensuring any necessary data sharing agreements are executed before sharing data outside BMC.org.
  PIs are expected to monitor data access per the study’s IRB protocol and are responsible for managing IRB amendments to add study team members as needed.
• Data Questions or Modification Requests: CDW-R analysts are available to answer questions or make routine modifications to your dataset within two weeks of data delivery. Requests for substantial revisions and/or requests made outside the two-week period require the submission of a new Research Data Extraction Request form and will be subject to CDW-R wait times.

See Fees and Billing for information on invoicing.