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Basic Science, Clinical, and Translational Research are important parts of the EVMS learning process. All students are encouraged to engage in research that aligns with their interests and goals. Any research that uses patient data must adhere to the guidelines developed by the owner of the primary data as well as the EVMS Institutional Compliance Data Use Requirements. All research team members must familiarize themselves with the relevant policies and acknowledge their willingness to adhere them.

All Patient data used outside of the clinical setting must be stored in REDCap. All EVMS Faculty, Staff, Trainees and Collaborators are eligible to have accounts on the EVMS REDCap instance. Accounts can be requested at https://redcap.link/account-request.

REDCap

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. REDCap is the preferred research data storage tool at EVMS. Accounts are available for all EVMS Faculty, Staff, Trainees and Collaborators. Follow the link above for additional information.

HADSI Research Training and Resources

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

EVMS Intake form for data requests.

How do I Access Electronic Medical Records Data for Research?

AllScripts - EVMS Medical Group

General Requirements

  • Create REDCap Account (Appendix A) (Account Request Form)
  • Complete Data Use Tracking, Use Requirements and Attestation Form
  • IRB Review  (Requesting Aggregate Data from EVMS Medical Group to determine the feasibility of a study does not require IRB Review or Approval)
    ie. Asking how many XYZ cases are seen in clinic or How many African American men have been seen for XYZ.
  • CITI Course Training (Appendix D)
  • Well Defined Data Elements
  • Data Privacy Attestation Statement (Appendix C)
  • External IRBs : The EVMS Medical Group Application for Research Activity Access Form

Submission Requirements

  1. Request must be submitted by Dept. Admin. or Practice Mgr. to EVMS Medical Group Admin. and Dir. of Compliance and Clinical Audit
  2. Study information must include: Name, IRB Number, Principle Investigator(s), Contact Information, and length of study or expiration date of approved protocol
  3. IRB Approval Letter
  4. Name, job title, and role of individuals requesting access
  5. Brief description or the protocol and list of variables being requested
  6. Defined patient population of interest
  7. External IRBs : The EVMS Medical Group Application for Research Activity Access Form

General Key Considerations:

  • Students must work with Dr. David Mu
  • Students must have a faculty mentor

IRB Considerations:

  • Projects involving EVMS students as the research subjects must receive approval from Student Affairs prior to documentation submission to the IRB office

EPIC Clarity - SENTARA Health Systems

General Requirements

  • Create REDCap Account (Appendix A) (Account Request Form)
  • Complete Data Use Tracking, Use Requirements and Attestation Form
  • IRB Review (Requesting Aggregate Data from Sentara to determine the feasibility of a study does not require IRB Review or Approval)
    ie. Asking how many XYZ cases are seen in the ED or How many African American men are treated for stroke per month.
  • CITI Course Training ()
  • Well Defined Data Elements
  • Data Privacy Attestation Statement (Appendix C)
  • External IRBs : The EVMS Medical Group Application for Research Activity Access Form

Submission Requirements

To notify Sentara of your request:

  • Contact the Research Data Coordinator at EVMSResearch@evms.edu
  • Have Electronic versions of your IRB Application, Approval Letter, Protocol and Consent Form (if applicable) ready to upload when requested.
    (see Appendix B for tips on writing a Research Protocol)

General Key Considerations:

  • Students must work with Dr. David Mu
  • Students must have a faculty mentor

IRB Considerations:

  • Projects involving EVMS students as the research subjects must receive approval from Student Affairs prior to documentation submission to the IRB office

 SENTARA Tip List

  1. All data requests made by EVMS Faculty, Staff or Students must be submitted using the Sentara Health Research Center’s portal and coordinated by the EVMS Office of Research.
  2. Questions regarding the proper method for requesting data from Sentara can be addressed to the EVMS Office of Research at evmsresearch@evms.edu.
  3. IRB approval does not confer Sentara approval; all proposals will be reviewed to ensure compliance with Sentara policies and guidelines.
  4. An active IRB approval is required for Sentara to allow use or disclosure of data for a formal research analysis. The approved protocol should include each member of the research team and an approved IRB addendum is required if additional research personnel are added or the project is amended.
  5. All students and residents must have a faculty supervisor who will have ultimate responsibility for ensuring the proper conduct of the proposed research.
  6. 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. 
  7. All requested data will be delivered directly into the requestors REDCap project.
    A copy of the Codebook and the Data Import Tool Worksheet need to be provided to Sentara via the SHRC portal.

    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

    Import Tool

    1. Click Data Import Tool under Applications
    2. Click Download your Data Import Template (Records in Rows)

  8. 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.
  9. Requests must include a detailed plan for data transfer, data security, and data destruction following HIPAA guidelines.

Other (VHI, TriNetX)

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

  • Submit a Service Request Form to HADSI, indicating VHI as data source and provide a protocol with a list of requested variables: https://www.evms.edu/research/centers_institutes_departments/healthcare_analytics_and_delivery_science_institute/service_request_forms/
  • HADSI 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 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.

  • Request/Submit a TriNetX Account Request Form to HADSI: https://www.evms.edu/research/centers_institutes_departments/healthcare_analytics_and_delivery_science_institute/service_request_forms/
  • Requesters will receive confirmation email with account credentials and required training
  • Users can then access TriNetX data via: https://live.trinetx.com/

 

MedDRA now available at EVMS

EVMS 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 biologic 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 2pm EDT. Please register at the following site: https://www.meddra.org/training/schedule/1165/What%20is%20MedDRA%20and%20How%20is%20it%20Used%3F.

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

Per our agreement with MedDRA, please do not share these with non-EVMS associates.

MedDRA includes standardized terms for:

  • symptoms, 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 agancies:

  • 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