Frequently Asked Questions

What types of studies are entered in ERMS?

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

Back to top

For each type, what is to be placed in ERMS?

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.

 

 

Back to top

Where should I send the ERMS Faxcover Sheet and Informed Consent document?

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.

 

Back to top

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.  University students are unable to gain access to the system.

Back to top

What if I cannot find my study in ERMS?

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.

Back to top

When should subjects be entered 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 for additional information.

Back to top

Does ERMS register my subject in the medical record system, EeMR?

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.

Back to top

If my subject is enrolled at the VA, CHOA, or Grady, do I still have to enter the subject in ERMS?

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

Back to top

If I entered a subject in ERMS inadvertently, who do I contact?

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.

Back to top

If I re-consent a subject, do I re-enter the subject in 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.

Back to top

Do I need to fax or email the ICFs for subjects that are in a study that is taking place at a non-Emory site?

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

Back to top

What if there are no visits on the Visit Tracking Form page?

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.

Back to top

What if I tracked a visit incorrectly?

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 additon, enter a note in the clinic and hospital comment sections notifying us of the previous error.

Back to top

What if my subject has completed all visits?

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.

Back to top

Does ERMS interface with Georgia CTSA system?

No.  These are two different systems.  If your study is funded by Georgia CTSA (GACTSA), please reference their website at http://www.georgiactsa.org

Back to top