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Research Data Access and Data Requests

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Research Requests for Data Containing Protected Health Information

Basic science, clinical, and translational research are crucial elements of our research initiatives and educational programs. Any research involving protected health information (PHI) must obtain IRB approval, comply with the guidelines set by the primary data owner, follow our Institutional Compliance Data Use Requirements, and adhere to the HIPAA Privacy Rule. The following information is provided to ensure that all data requests comply with the HIPAA Privacy Rule's minimum requirements. All research team members must familiarize themselves with the relevant policies and acknowledge their commitment to adhere to them.

Instructions for Requesting Medical Record Data

 General Requirements for Obtaining Medical Records Data:   

  • REDCap Account:  REDCap is a secure web application for building and managing online surveys and databases. While REDCap can be used to collect virtually any type of data in any environment (including compliance with 21 CFR Part 11, FISMA, HIPAA, and GDPR), it is specifically geared to support online and offline data capture for research studies and operations. All patient data used for research must be stored in REDCap. All Faculty, Staff, Trainees and Collaborators are eligible to have REDCap accounts.
  • IRB Review is required.
    • Requesting aggregate data from the Medical Group or Sentara to determine the feasibility of a study does not require IRB Review or Approval.
  • Projects involving students as the research subjects must receive approval from Student Affairs prior to protocol submission to the IRB office.
  • All research team members conducting Human Subjects Research (as defined by the IRB) must have current CITI Program Training. Research team members may self-enroll in the courses. For questions regarding course requirements, contact the IRB.   
  • Data Privacy Forms must be signed by the principal investigator (PI) and all research team members.
  • The project protocol must contain well defined data elements - the HIPAA Privacy Rule requires that use or disclosure of data will be limited to the amount of data that is “minimally necessary” to answer the study question and accomplish the study aims. Thus, the number of participants in the cohort should be estimated using a statistical power calculation that is included in the study protocol. The participants should then be defined in the data request by the inclusion/exclusion criteria and the date ranges of study. Also, requested study variables should be justified by the study’s methods and aims. 
  • Students must work with Dr. David Mu to facilitate their requests and must have a faculty mentor.

How do I Request Electronic Medical Records Data for Research from Sentara?

Note:  A REDCap account is required.  Accounts can be requested at https://redcap.link/account-request.

  1. Complete the Data Request Intake Form. This is required for all research data requests, including those submitted to RISE. The intake form will automatically capture the required acknowledgments/data use attestations for the PI.  The PI is responsible for having all research team members sign the form once the project is approved.   Team members can sign electronically via REDCap.  
  2. PLEASE NOTE THE FOLLOWING:
  1. All approved intake forms will be assigned a project number from the Research Office.
  2. OBTAINING DATA
    1. For RISE Projects:  
      1. Once the project requester has the project number, the intake form will go to RISE to determine if this is a project they want to accept:
      2. If so, RISE can proceed with the data pull from Sentara's portal (or other sources) with the assigned project number;
      3.  If not, RISE will reject the project and it will be routed back to Research Office  to determine if/when they can make a direct request through the portal.
    2. For Sentara (EPIC Clarity) Data (including chart review requests):   
      1. Once the project requester has the project number, contact the Research Data Coordinator at evmsresearch@evms.edu.
      2. All students and residents must have a faculty supervisor who will have ultimate responsibility for ensuring the proper conduct of the proposed research.
      3. All data requests made by the Faculty, Staff or Students must be submitted using the Sentara Health Research Center’s portal  and will be coordinated by the Research Office.
        1. Requests should include clear definitions for each Epic variable. Epic variables must be specific (i.e., all medications of interest must be listed by name, all procedures and/or diagnoses of interest must be specified and codes included, any calculated variables must include how the variable will be calculated and what Epic variables are required to calculate the variable of interest). Where possible, researchers should note how the data are documented in the Epic record.
        2. Requests must include a detailed plan for data transfer, data security, and data destruction following HIPAA guidelines.
        3. All requested data will be delivered directly into the project requestor’s REDCap project. A copy of the Codebook and the Data Import Tool Worksheet need to be provided to Sentara via the SHRC portal (see CodeBook and Import Tool Section below).
      1.      Questions regarding the proper method for requesting data from Sentara can be addressed to the EVMS Research Office at evmsresearch@evms.edu.
    1. REDCap CodeBook and Import Tool
      1. To Print the CodeBook
        1. Open Your project in REDCap
        2. Click on Codebook Under Project Home and Design
        3. Click Print Page and then Print to PDF
      1. To Download the Data Import Tool Template
        1. Click Data Import Tool under Applications
        2. Click Download your Data Import Template (Records in Rows)
    1. IRB approval does not confer Sentara or other data holder approval and data holders may deny any data request. For denied requests, contact the Research Office at evmsresearch@evms.edu.
  1. All requests for data will be reviewed by Sentara or the data holder to ensure compliance with their policies and guidelines.
  • An active IRB approval is required for the Medical Group and Sentara to allow use or disclosure of data for a formal research analysis (beyond preparatory to research). The approved protocol must include each member of the research team. An approved IRB addendum is required if additional research personnel are added or the project is amended at a later time.

 How do I Request Electronic Medical Records Data from other Covered Entities?

  1. Complete the Data Request Intake Form. This form is required for all research data requests, including those submitted to RISE.  The intake form will automatically capture the required acknowledgments/data use attestations for the PI.  The PI is responsible for having all other research team members sign the forms once the project is approved.   Team members can sign electronically via REDCap.  
  2. Follow the procedure of the entity from which you are requesting the data.
  3. If you are asked to complete a Data Confidentiality Agreement, Data Use Agreement or other contract or agreement to use the data, please contact the Research Office at evmsresearch@evms.edu to coordinate with legal. You do not have authority to sign agreements on behalf of the organization. 

OTHER DEIDENTIFIED DATA SOURCES (VHI, TriNetX)

VHI:
Virginia Health Information (VHI) is a dataset, which includes de-identified, inpatient data from VA hospitals. This data has been purchased by the Brock Institute and has data support via RISE. Data includes patient demographics, hospital information, clinical diagnosis, costs, and readmissions.

To make a VHI request:

  • Submit a Service Request Form to RISE, indicating VHI as data source and provide a protocol with a list of requested variables: RISE Service Request Form.
  • RISE Data Manager will then check the availability of the requested variables and send a VHI/Brock Institute Agreement Form to the PI for signatures before beginning data extraction.

TriNetX:
TriNetX is global health research network that provides updated, de-identified and aggregated data from various health systems from around the world. TriNetX provides researchers the ability to explore a limited, de-identified set of patient data. This may be most helpful for identifying patient cohorts when preparing for a research study.

If you are interested in getting a training account for TriNetX, please do the following; 

  1. Go to: SENTARA Research Data Request Portal
  2. Pick Preliminary Analysis
  3. Complete, Sign and upload this Sentara attestation Form
    Download SENTARA Data Use Attestation
  4. Select Yes for “Are any research team members from EVMS?”
  5. Enter 9999 as “Office of Research Data Request Number(#) “
  6. Enter TriNetX Training Account in Question you are asking
  7. Enter your PWRPF Program (MD/Year, School of Public Health, etc.) for What data will you need?
  8. Click TriNetX for Data source

To make a TriNet X request:

  • Complete the Data Request Intake Form. Select one of the two TriNetX options under Request Type.
  • Requesters will receive a confirmation email with account credentials and required training.
  • Users can then access TriNetX data at: TriNetX Login.

RISE Research Training and Resources

  • RISE offers data analysis services and supports research to move the healthcare community forward.
  • Information about RISE Resources can be found at the link above. 

 

MedDRA (Medical Dictionary for Regulatory Activities)

MedDRA now available at Macon & Joan Brock Virginia Health Science at Old Dominion University

Macon & Joan Brock Virginia Health Sciences at Old Dominion University has an institutional license to MedDRA (Medical Dictionary for Regulatory Activities), a clinically validated international medical terminology used by regulatory authorities, including the FDA. It is also used by industry, academics, health professionals, and other organizations to communicate medical information.

MedDRA is a standardized dictionary of terms used to describe adverse events of drugs and therapeutic biological products in animal and clinical trials. Medical terms are linked to capture logical relationships, making it possible to create meaningful summaries and conduct analyses.

MedDRA Login Page: MedDRA

There is a training session for MedDRA on Aug. 4th at 2 pm EDT. Please register at the following site: https://www.meddra.org/training/schedule/1165/What%20is%20MedDRA%20and%20How%20is%20it%20Used%3F.

The institutional username (ID number) and password are available through the MyPortal at this link (Credentials).

Per our agreement with MedDRA, please do not share these with associates who do not attend the institute.

MedDRA includes standardized terms forsymptoms, signs, diseases, syndromes and diagnoses

  • medical device malfunctions
  • medication errors
  • medical, social and family history information
  • sites (e.g. application, implant and injection sites)
  • medical and surgical procedures
  • approved uses for medications and medical devices
  • types of investigations (e.g. liver function analyses, metabolism tests).

MedDRA terminology incorporates terminology from the following agencies:

  • Medicines and Healthcare products Regulatory Agency (MHRA)
  • World Health Organization Adverse Reaction Terminology (WHO-ART)
  • International Classification of Diseases (ICD)
  • International Classification of Diseases and Clinical Modification (ICD-CM)
  • Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART)
  • Japanese Adverse Reaction Terminology (J-ART).

(adapted from https://www.tga.gov.au/medical-dictionary-regulatory-activities-meddra)

Additional information about MedDRA is available at the following sites: 

https://www.meddra.org/ 

https://www.nlm.nih.gov/research/umls/sourcereleasedocs/current/MDR/index.html