The following is an outline of the process to request data with recommendations on how to obtain data most efficiently at the lowest cost.
Step 1: Consult with the CDW for Research Team
An initial consultation is provided to all studies free of charge. All investigators, particularly new investigators or those with early experience working with EHR data, are encouraged to set up a consultation with the CDW for Research to discuss feasibility, scope, cost estimates, and how to optimize the data request. 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. Email firstname.lastname@example.org to request a consultation.
Step 2: Obtain IRB Approval for Your Study
All CDW for Research data requests other than simple counts must have IRB approval before the CDW for Research can begin working on a request.
It is the responsibility of the investigator to let the CDW for Research know when the study is IRB approved. Our team does not recieve notification of IRB approval or determinations.. The CDW for Research does not being work until notification of IRB approval is received from the investigator.
A CDW for Research Data Request Form may be submitted prior to IRB approval; however, your study must be approved by the IRB – and all data requested from the CDW for Research must be reflected in the approved protocol – before the CDW team can begin to work on your request.
The CDW for Research team will confirm that all variables requested are reflected in the approved IRB before starting the project. Researchers may request more variables in their IRB than they request from the CDW for Research. For example, a research team may conduct a chart review itself and only require the CDW for Research to pull a cohort list with 5 of the 20 variables listed in their full IRB protocol. Teams should be specific about which variables they are the requesting from the CDW for Research in their IRB and only include variables they are requesting from the CDW for Research in their data request form. Discrepancies between IRB protocols and CDW for Research data requests will be returned to investigators and will cause delay in processing CDW requests.
Step 3: Develop and Submit a CDW for Research Data Request
Submit a data request using the CDW for Research Data Request Form.
Process to Obtain Approval to Access Data from Different Sources
Investigators may need to acquire special permission to access certain data. The table below outlines additional permissions (beyond IRB approval or exemption) that may be required before the CDW for Research may begin to fulfill a data request.
|Data Source||Special Approval to Access Data Required?||How to Get Approval|
|BMC Epic Clinical Data||No||N/A|
|BMC Legacy Systems||No||N/A - Note: Legacy systems data are not actively maintained; data can be cumbersome to extract and are not monitored for quality.|
|Community Health Center (CHC) OCHIN EHR Data||Yes||Access to OCHIN data requires signed approval from each individual CHC's CEO. For help facilitating the approval process, please contact Allyson Richmond, Program Manager, Boston Healthnet, Allyson.Richmond@bmc.org|
Step 4: The CDW for Research Reviews the Submitted Data Request
The CDW for Research team aims to review all data request forms for completeness and feasibility within 5 business days of submission. A member of the CDW for Research will contact you with questions. In some cases (for example, when the request provides too few details for adequate evaluation), the CDW for Research will require a consultation.
Step 5: Investigator Recieves Data and Confirms Data Completeness/Accuracy
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.
Authorization to access data
Investigators are responsible for monitoring data access and data security per applicable regulations and guidance. Authorization to access data provided by the CDW for Research is determined by BUMC IRB. Investigators are expected to monitor data access per the study’s IRB protocol upon receiving the data set from the CDW for Research. Investigators are responsible for managing IRB amendments to add study team members.
Data extract questions or modification requests
CDW for Research analysts are available to respond to questions about your data set – or make routine modifications – within two weeks of supplying your data set.Analyst time making routine modifications is subject to fees. Questions and modification requests submitted within the two-week deadline will receive expedited priority. Requests received beyond the two week priorty period will be added to the existing data request work queue and may require the investigator to complete a new CDW for Research Data Request Form.
Step 6: Investigator Receives Final Invoice
See Fees and Billing for information on invoicing.