Emory Research Management System

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 Request for Clinical Trial Activation in ERMS for Subject Enrollment Notification ONLY (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 questions related to applicability of ERMS, please contact OCR at OCR@emory.edu

How do I receive access to my study in ERMS?

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.

When will my study be activated in ERMS?

Once OCR receives the "Notice of Award" or ERMS activation form, OCR activates the study in ERMS and in EeMR. OCR uploads the study level documents, including the following: 1) Prospective Reimbursement Analysis (PRA), 2) Clinical Research Key Points Summary, and 3) IDS Drug Data Sheet.

What is the ERMS process?

Once a clinical research subject signs an informed consent document, the subject must be entered in ERMS on the same day the consent is signed, especially if there are EHC billables or a drug or device given or implanted on the first visit.  If the research subject is not entered in ERMS on the same day, it directly impacts patient safety. The ERMS on-study notification triggers the following:
  • Entry of the patient in EeMR
  • Entry of research information in the Clinical Trials tab
  • Activation of the Clinical Trials banner
  • Upload of the patient signed consent
Please review the Late ERMS Enrollment Escalation Procedures policy for additional information.

What are the steps in ERMS?

  1. Enter subject into ERMS on the same day the subject signs the informed consent document (ICD) for the study.
  2. Please fax the signature page of the ICD with the initial pharmacy order. For clinic-based subjects, fax to 404-427-0265. For hospital-based subjects, fax to 404-712-0299.
  3. Print the fax coversheet from ERMS. (If you are enrolling subjects at a non-Emory site, you do not have to print the fax coversheet or send the signed consent).
  4. Submit the fax coversheet along with the entire Informed Consent document with appropriate signatures to OCR either via fax at 404-778-4989 or via email to OCR@emory.edu. If you are enrolling subjects at a non-Emory site, i.e., CHOA, Grady, or VA, or if the IRB has deemed your study as "sensitive," you do not have to submit the fax coversheet or signed consent.
  5. Track the subject's visit on the same day of the study visit.
  6. When a subject is no longer in the study, please complete the off-study date in ERMS and indicate a reason for completion as either Early Termination, Screen Failure, Completed Study, or Participant Withdrew Consent.

 

If I cannot see my study in ERMS, who should I contact?

After training is completed, you need to initially send a list of studies to OCR including the IRB number and PI name.  Once you are notified that you have access to your studies, login into ERMS at https://erms.emory.edu to verify your access. If you are unable to see your studies contact OCR at OCR@Emory.edu.