The following is an outline of the process to request data with recommendations on how to obtain data most efficiently at the lowest cost.

Please refer to the CDW Policies and Procedures Manual for a detailed description of all CDW policies and procedures.

Step 1: Consult with a CDW Analyst

An initial, one-hour 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 a CDW analyst 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 [email protected] to request a consultation.

Step 2: Obtain IRB Approval for Your Study

All CDW requests other than simple counts must have IRB approval before the CDW can begin working on a request.

It is the responsibility of the investigator to let the CDW know when the study is IRB approved. Analysts do not monitor initial IRB approval or amendment approvals. The CDW does not being work until notification of IRB approval is received from the investigator.

A CDW 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 must be reflected in the approved protocol – before the CDW team can begin to work on your request.

CDW analysts 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 example, a research team may conduct a chart review itself and only require the CDW to pull 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 and only include variables they are requesting from the CDW in their data request form. Discrepancies between IRB protocols and CDW requests will be returned to investigators and will cause delay in processing CDW requests.

Step 3: Develop and Submit a CDW Data Request

Submit a data request using the CDW 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 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, [email protected]

Step 4: The CDW Reviews the Submitted Data Request

The CDW reviews all data requests forms for completeness and feasibility within 5 business days of submission. Revisions and clarifications may be requested. In some cases (for example, when the request provides too few details for adequate evaluation), the CDW will require a consultation; in this case, investigators may incur charges for analyst time.

Step 5: Investigator Recieves Data and Confirms Data Completeness/Accuracy

CDW analysts deliver all data sets using BMC’s secure box.com system. CDW analysts grant access to the data set to investigators and their designees. These designees must be listed on the approved IRB protocol. The CDW 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 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. Investigators are responsible for managing IRB amendments to add study team members.

Data extract questions or modification requests

CDW analysts are available to respond to questions about your data set – or make routine modifications – within two weeks of supplying your data set. Questions and modification requests submitted within the two-week deadline will receive expedited priority.

Requests received beyond the two week period require the investigator to complete a new CDW Data Request Form, and the request will be added to the existing data request queue.

Analyst time making routine modifications is subject to fees. In the event the investigator requests modifications that differ substantially from what was previously discussed during the initial request process, the analyst will provide an updated cost estimate. Examples of substantial modifications include new project components, additional variables, different dates, and complex changes to codes or variable definitions.

Step 6: Investigator Receives Final Invoice

Investigators receive notification of final invoiced payment the month following final data set delivery.

Once a request has been closed out (two weeks after data delivery if no modifications are requested), all subsequent questions, even if about the existing data set, require entry of a new request form in the queue (Step 3 above) and new invoices will be generated.