EDW Exception Process FAQ
General Exception Overview
In order to review electronic health record data for the purposes of research you are required to use an EDW report. When data are not available in the EDW, an exception to review the record directly may be granted on a study-by-study basis. Please review the Research Use of the Medical Records Data policy for more information.
- Fill out the out the REDCap request form to submit your initial request. Contact the support team with questions at email@example.com.
- Please be as detailed as possible when completing the form. The more information that we have, the more efficiently we can review the request.
- You will need an approved data security plan, which is submitted in REDCap and via your IRB application.
- Your IRB protocol and data security plan must specify that you will access the electronic health record during the study. Your exception request may not include any data elements that are not specifically outlined in your IRB approved protocol and consent form.
- Upon collection and review of the documents outlined above, an exception request will be submitted into the queue for review.
- The NMEDW Support Team will review your initial request and then forward to the EDW to determine if the data are available in the EDW. Should the EDW team have questions about your request, they will reach out to you via email.
- Should your request require further review by the FSMIT Steering Committee, additional information may be required.
- If your IRB protocol must be modified or your data security plan is not approved, an exception cannot be granted until they are submitted and approved.
- Once your exception is approved, the Principal Investigator (PI) of your study will need to sign an attestation. Please notify your PI to expect the attestation. The attestation will be sent to their email and will come from firstname.lastname@example.org.
- After the exception is approved and your PI signs the attestation form, you will need to update Study Tracker with staff members from the approved IRB authorized personnel list who will need access to the medical record under the approved exception. If they have never had an exception before, they will also receive an attestation to sign from REDCap.
- If you have submitted an NMHC Research Access Program application (employees of NU, permanent or temporary), approved exception information is shared directly with NMHC and your access request will be automatically updated. It does take 5 business days for the new access to be updated in Epic, but if you have questions about your status, you can contact email@example.com to request an update.
- If you have questions about your exception status, you can now find this information in Study Tracker on the Compliance tab and under the “Research Use of Electronic Medical Record Data Policy”.
You should contact FSMITfirstname.lastname@example.org if you have questions about your data security plan.
Please review this tip sheet for both a summary and instructions on how to use the new process. (You must be logged onto the VPN to view this tip sheet.)
What is the process once I have an approved exception request, but we need to add a new study team member?
Once an exception is approved, you will need to add study team members by logging into Study Tracker and adding them to your study. The staff you wish to add must be listed on the approved IRB authorized personnel list. If they have never had an exception before, they will also receive an attestation to sign from REDCap.
The IRB approved NMHC electronic health record access in my protocol. Does the permissible use policy apply to me?
Yes, this policy applies. IRB review and approval is required to work with human participants, but in order to access NMHC data directly in the health record, an exception is also required.
NMHC provides lab services for my participants. The participants may not be NMHC patients but are registered with the hospital and have an MRN for billing purposes. Do I need to use the EDW to acquire these lab values?
Yes, the policy applies to all clinical data retrieved from an NMHC electronic health record or other clinical systems that is to be used for research purposes.
No, that is not a valid reason for approving an exception to access the medical record directly. Consider applying for the EDW PDP or asking your department for report funding.
Please plan ahead when you are submitting grants and will require data from the EDW. Lack of planning is not a valid reason for an approved exception.
The process is the same as described above, but also requires your IRB approval letter stating that you have both a waiver of consent and a waiver of HIPAA authorization.
Types of Data & Chart Review
I need data from free text and/or notes (e.g., RN notes, progress notes, radiology reports). How do I get free text data from NMEDW?
The NMEDW contains free text and notes that can be provided to you in a report format. You may review the notes in the report to abstract notes, just as you would by accessing the chart in the EMR.
I need to browse the medical record to abstract information from free text fields. Using the EDW report format would take much longer than simply browsing the user interface of the EMR. Do I still need to use the EDW to be compliant with this policy?
Data abstraction from the EMR requires an approved exception to the permissible use policy.
I need to view the chart for the purposes of clinical care or quality. Do I have to use the NMEDW for clinical care or quality?
You should contact the covered entity for details about how to appropriately access their systems. If you are an NU staff member participating in clinical care or quality initiatives on behalf of NMHC, you will need an approved service arrangement. Please contact Abby Cosentino-Boehm at FSMResearchCompliance@northwestern.edu for more details
I need to view the chart for the purposes of serious adverse event reporting or research participant safety. Do I have to use the NMEDW for participant safety?
Monitoring the medical record for serious adverse event reporting or research participant safety may be done with an approved EDW exception.
We have an acute need to identify participants in real-time in the clinic. Can I access real-time data in the NMEDW for this purpose?
Data in the NMEDW are refreshed every 24-hours. If you have a need to review data urgently; for example, same-day labs or other data that is collected and needs to be reviewed within 24 hours, an exception may be granted for direct medical records access.
Is an EDW Exception approval required for viewing and/or downloading images from the medical record?
- If you require access to view images from the medical record: You will need to submit an Exception request via REDCap. The EDW cannot provide access to images at this point, so direct access to the medical record would be required to view them and an exception will be granted. Submit via the REDCap intake form.
- If you also require access to download the images to submit to a sponsor or other research need: You will need to submit a request via the EDW portal. To be clear, this is not an EDW process, but we do use the portal at this time to track requests and obtain NMHC data steward approval to release images. Once the data steward approves, NMHC will provide the images to you. To collect the image, send an email to Edwin Garcia with details for your request. Please include your data steward approval in your email.
The NMEDW contains the clinical data from NMHC systems, including image annotations. Images themselves are not currently in the EDW. Requests for this type of data should still be submitted through the exception process for review.
I need to acquire data from PDF files attached to the medical record. Can I access PDFs and scanned documents in the EDW?
No, the EDW does not currently contain scanned documents. Requests for this type of data should still be submitted through the exception process for review.
Yes, NMHC medical record information may be used to contact participants for recruitment, but you must use the EDW to create your contact list. In addition, be sure to review the Research Recruitment FAQ on the IRB website for more specific instructions about how to work with NMHC recruitment data: https://irb.northwestern.edu/resources-guidance/recruitment-materials-guidelines.html.
Can research monitors and quality assurance personnel continue to login to the electronic health record during treatment and the follow-up period?
Yes. Please contact the NMHC Access Program team to gain access to the NMHC electronic health record for your research monitor (email@example.com).
I have a site visit from my study’s sponsor, who must review source documents related to the study. Currently, as required by study sponsors and Good Clinical Practice guidelines, clinical research staff must access the medical record at the time of the visit in order to provide the necessary information.
You can continue to do so, provided the visit has been submitted and approved through the NMHC Access Program.