Epic Registration of Clinical Trials

What

All interventional clinical trials (e.g., trials involving drugs or devices) are required to be registered in Epic.

When

Please contact the  Applications Team as early as possible in your research and grant application planning process. The actual technical set up of this function generally takes about one business day, but advance notice is required to ensure that you meet study deadlines.

How

Requests should be submitted through the Mount Sinai Self Service Portal. You will be asked to provide the GCO#, IRB#, and NCT# on the request form.

Instructions for submitting a request:

1. Login to the Self Service Portal
2. Select Make a Request
3. Select Applications from the Category Browser
4. Select Clinical from the Subcategories
5. Select Epic Research Study Record (RSH)
6. Fill out the required fields and select Order Now to complete

Technical Support
ITHELPDESK@mountsinai.org
Call 4HELP

What

When a patient signs the Informed Consent and HIPAA forms for an interventional clinical trial, the patient must be linked to the research study in Epic.

The patient will have a Medical Record Number (MRN) in Epic that can be linked to a trial as soon as he or she is registered in the system as a new patient. A patient record with the MRN is created as soon as a patient requests an MSHS appointment for the first time at a MSHS location that uses the Epic EHR system.

The clinical research study coordinator should update the patient’s research study status in Epic to reflect an Active research status. In Epic, the Active research study statuses are Enrolled, or Identified, or Interested, or Consent Signed.

How

For detailed instructions, refer to the following documents:

• Link a Patient to a Research Study
• Link a Patient to a Research Study During Check In
• Link a Patient Encounter to a Research Study After Scheduling

It is the policy of the Mount Sinai Health System (MSHS) that the signed informed consent forms (ICFs) of patients enrolled in an intervention clinical trial are scanned into Epic. Exceptions are HIV or Psychiatry research studies.

Note, Principal Investigators are required to maintain the original signed ICF in the research binder.

Questions – Contact Research Compliance at (646) 605-7120.

What

To ensure appropriate billing, all research visits or encounters that are associated with an interventional research protocol are required to be linked to the research study.

How

Refer to Link a Research Study to a Patient Encounter.

What

Research clinical services (labs, diagnostic tests, etc.) as well as investigational drugs or biologics from Investigational Drug Services (IDS) must be ordered in Epic.

How

Investigational Drug Service (IDS) Orders – IDS must be notified as soon as a GCO# is established in order to initiate the process of creating a medication record in Epic. Ordering of all research medications can be done by searching by the “GCO#”. Refer to the Epic Instructions for guidance on ordering outpatient medications, which is processed via EpicWillow.  All outpatient prescriptions must be communicated to IDS at least 24 hours in advance.

Oncology Studies – For oncology studies that utilize Epic Beacon, IDS must be notified when there is a patient in screenings so the Beacon Treatment Plan can be built.

Exception

If you are utilizing the BioMedical Engineering and Imaging Institute (BMEII) for imaging, orders and scheduling must be conducted through Calpendo. For more information, refer to SOP 103, the SOP for Scheduling a Research Study.

Questions – Contact Christopher.Cannistraci@mssm.edu

What

Requests for temporary research monitor/auditor access to Epic can be made to Health Information Management (HIM).

When

The requester will need to submit a list of patients to HIM at least one week prior to the scheduled date of review.

How

Requests can be made by contacting the ROI Manager.  Study teams will need to provide the GCO number, IRB letter, and list of records. For more information, refer to HIM MI-19.3 – Providing EPIC Access to Outside Reviewers.

What

Because all interventional clinical trials (e.g., trials involving drugs or devices) are required to be registered in Epic by research teams (PI or designee), clinical trials also must be closed out in Epic when they end.

In addition, a research team’s clinical research coordinator is responsible for updating a patient’s study status in Epic when that participation status changes, including when the clinical trial has ended.

When

A study team’s clinical research coordinator must go into Epic and update a patient’s study status to the appropriate status from among the following, Declined, or Completed, or Disqualified, or Withdrawn, or Off-Study, as soon as possible after a patient withdraws or completes a study, and after a study ends.

To close out a clinical trial in Epic, you need to request that the Epic Applications Team do so. The Epic Application Team’s technical work generally takes about one business day. The study team should submit their request to Epic Applications team via the IT Help Desk at least week prior to the close of the study, to allow enough time for the MSHS Epic team to schedule and complete this work as soon as the study closes.

How

For directions on how to update a patient’s study status in Epic for a clinical trial because the patient has withdrawn from a study, completed it, or because the clinical trial has ended, please see this tipsheet for “Linking a Patient to a Study“.

To close out a clinical trial altogether, call email ITHELPDESK@mountsinai.org and provide them with the following information:

Short Study Name (to uniquely identify protocol): __________________

Brief Description (Intervention, etc.): __________________

And at least one of the following:

Study Code (GCO#): __________________

NTC #: __________________

IRB Approval #: __________________