ERMS


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Overview

ERMS is a web-based clinical research management tool used to assist Emory Healthcare and Emory University with their joint research billing compliance program. It facilitates communication of subject enrollment and study visit activity by the research team with the billing departments, as well as identifies all clinical trials occurring at Emory and Emory affiliates for the purpose of ensuring patient safety.

There are four types of studies entered in ERMS:

  1. Meets the NIH or FDA definition of a clinical trial. The ERMS Activation Form (DOCX) (for Enrollment Notification, v7, 6.18.21), (if there are no EHC billables) must be submitted to OCR@Emory.edu before the study is activated in ERMS.
  2. Has EHC or GHS billable items or services, requiring a PRA.
  3. Managed by OCR Invoicing team.
  4. Conducted under expanded access protocols for multiple patients.

For questions related to applicability of ERMS, please contact OCR at OCR@emory.edu

Access

Training is required to gain access to ERMS. To register for the ERMS training course, please visit our Courses page. If you have already received training and are not able to see your study in ERMS, contact OCR at OCR@emory.edu.

Training

Emory Research Management System (ERMS) is a course offered by the Office for Clinical Research to instruct clinical research staff on how to navigate ERMS and how to work with the different modules, e.g., study, subject, and visit tracking modules. The course is an instructor-led demonstration and simulation. Students participate in, practice and complete modules within ERMS.

Note: Training is required to gain access to a study in ERMS. The course is for faculty and staff who will be enrolling subjects and or tracking subject's visits.

  • Renewal: No, but highly recommended as new modules are added.
  • CME/CEU offered? No.
  • Course Frequency: Every month.
  • Course Dates: Review the OCR Calendar for upcoming ERMS courses.
  • Course Pre-requisites: Must have an Emory University Network ID and password before attending class. Also, review the ERMS User Guide (PDF) prior to class.
  • Course Registration:
    • Login into Emory Learning Management System (ELMS).
    • Enter your Emory University Network ID and password.
    • Click "Find Learning."
    • In the Search by Keyword box, enter "ERMS." The course titled ERMS Training (205034) will appear.
    • Click "Enroll" for the course start date you would like to attend.
    • Click "Submit Enrollment."
    • You will receive a confirmation for the Emory Learning Management System (ELMS) that you are enrolled in the course.
    • A member of the OCR Education and Outreach team will email you information regarding course preparation closer to the course date.

If you have any questions, please contact OCR at OCR@Emory.edu or 404-778-4960.

Frequently Asked Questions

There are four types of studies entered in ERMS:

  1. Meets the NIH or FDA definition of a clinical trial. The document Request for Clinical Trial Activation in ERMS for Subject Enrollment Notification ONLY (DOCX) (if there are no EHC billables) document must be submitted to OCR@Emory.edu before the study is activated in ERMS.
  2. Has EHC or GHS billable items or services, requiring a PRA.
  3. Managed by OCR Invoicing team.
  4. Conducted under expanded access protocols.

For questions related to applicability of ERMS, please contact OCR at OCR@emory.edu

  1. Emory studies that have a Prospective Reimbursement Analysis (PRA) completed and budget developed, both clinical trials and non-clinical trials.

    • Patients are to be entered on the same day of consent.
    • Visits are to be tracked on the same day as the research subject's visit.
    • Consents are to be sent to OCR on the same day of consent if the subject is enrolled at an Emory site.
  2. Emory studies that are clinical trials with no Emory Healthcare billable procedures or services.

    • Patients are to be entered on the same day of consent.
    • Consents are to be sent to OCR on the same day of consent if the subject is enrolled at an Emory location.
    • Visit tracking is required if OCR Invoicing is managing the clinical trial.
  3. Emory studies that are non-clinical trials with no Emory Healthcare billable procedures and services, but OCR completes the invoicing for the department. OCR will invoice for non-federally funded studies. Federally funded studies are invoiced by your RAS unit.

    • If the study is non-federally funded, OCR's Invoicing department will work with you to ensure the study is activated in ERMS.
    • Patients are to be entered on the same day of consent.
    • Consents are not required.
    • Visits are to be tracked on the same day as the research subject's visit.

The fax coversheet should accompany a signed copy of the subject's consent when faxed to the Office for Clinical Research (OCR). The signed subject consent should be sent to OCR on the same day as the patient is consented. Once received, OCR will scan the documents into the subject's Emory Electronic Medical Record.

Note: The signed subject consent is not required for subjects receiving services exclusively at CHOA, Grady Health System, Grady CIN, Ponce Clinic, Hughes Spalding, or the VA.

OCR Fax Number: (404) 778-4989. Documents may also be scanned and emailed to OCR_ICFS@emory.edu.

Training is required to gain access to ERMS. To register for the ERMS training course, please visit our Courses page. University students are unable to gain access to the system.

If your study was reviewed by OCR for initial submission, you will be notified when the study is activated in ERMS. However, notify OCR at OCR@Emory.edu if you do not see your study in ERMS.

Subjects are to be entered in ERMS on the same day the subject signs the consent. Please review the Late ERMS Enrollment Escalation Procedures (PDF) for additional information.

No. ERMS is a web-based financial communication tool. It will not inform EeMR of subjects you enter in ERMS that are on a clinical trial or subjects that have billable procedures.

Yes, if it is considered as one of the types of studies entered in ERMS.

Contact OCR and provide us with the details of the error at OCR@Emory.edu. Only OCR staff can remove or delete a subject from ERMS.

It depends. If a subject is re-consented after being off-studied in ERMS, the subject must be re-entered in ERMS with a new enrollment number.

However, if the subject is just signing an amended consent, re-print the ERMS Fax Coversheet by selecting it as an amended consent. Then, submit both documents to OCR_ICFS@Emory.edu or fax them to us at 404-778-4989.

Do not change the initial consent date in ERMS.

No, you will still need to put your subject in ERMS but you do not need to fax the coversheet and ICF.

This would mean that your study may not have any Emory Healthcare billable items/services. Verify with OCR at OCR@Emory.edu to ensure your study did not require a PRA or development of a budget, or invoicing.

Visits tracked and submitted in ERMS cannot be deleted. Therefore, re-track the visit with the correct visit date and/or billable procedures, adding and removing only what is needed. In addition, enter a note in the clinic and hospital comment sections notifying us of the previous error.

Enter the subject's off-study date and reason. Do not re-submit the ERMS Fax Coversheet when you off study a subject in ERMS. OCR receives the notification electronically when you enter the off-study date and reason.

No. These are two different systems. If your study is funded by Georgia CTSA (GACTSA), please reference the GACTSA website.