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Clinical Trials Resource Group

Clinical Trials Resource Group

Activity #9: Patient Scheduling and Registration

9.1 9.2 9.3 9.4 9.5
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Activity#9: Scheduling and Registration

9.1 Review Scheduling and Registration Training Materials

IMPORTANT:

Until the Epic EMR conversion in April 2014, Invision registration and other details outlined in CTSC SOP#10A and 10B remain

 Study Subjects (subjects and controls), their Encounters and Orders have to be associated with the Research Study in Epic EMR. Such association achieves the following:

  • Creates Bill Hold to separate billing streams to Study Accounts and Insurance Accounts
  • Identifies all research study subjects (controls included)
  • Tracks study procedures and services for Health Information Management Disclosures
  • Creates notification for billers to issue correct claims

CTSC Clinical Trials Resource Group and EMR Trainign team offer extensive training on EMR Research Functionality.

A new LMS course is designed to provide step-by-step review of EMR-based subject tracking process (Course # 08074)

Additional materials:
UCDHS EMR New Destinations website (includes Quick Study Guide and helpful Q&A)
Policy 2382 “Research Subjects Patient Registration, Healthcare Information Collection, Sharing and Maintenance”.
Policy 2317 "Documentation of Research Patient Status in the Electronic Medical Record (EMR)".

CTSC SOP #13 "Create and Manage Research Studies in EMR/Epic"

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9.2  Associate the Patient with the Research Study

A patient should be associated with the study after he/she signs the Informed Consent.  The initial signed Consent Form and all Consent revisions (if a patient was re-consented), must be uploaded into the EMR for each patent enrolled in the study. Health Information Management is responsible for the upload. The signed paper copies may be sent to HIM by interoffice mail or can be scanned directly into the OnBase document handling system by the research team (refer to the Guidebook Activity 8.5).

The study team is responsible for continuous update of the “Status” field. Status choices include:

  • Prescreening: Review of medical records (only used in cases when several studies may "ompete" for the same patient")
  • Enrolled: Study registration completed
  • Active on Treatment: Treatment initiated
  • Follow up: No longer on active treatment, but will continue to monitor
  • Off Study: Follow-up completed; Adverse event, or compliance lost to follow-up
  • Screen Failed: Patient did not meet eligibility criteria

If “Enrolled”, “Active on Treatment” or “Follow-up” are selected, then the Patient Header will display “Research: Active (this will alert EMR users that the patient may have research related activities).

For more Information, see UCDHS EMR New Destinations website (includes Quick Study Guide and helpful Q&A) and CTSC SOP #13 
A new LMS course is designed to provide step-by-step review of EMR-based subject tracking process (Course # 08074)

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9.3  Associate Encouter with the Research Study

Associating Encounters to the Study results in bill hold, which means that all charges related to this encounter are being held for the coordinator review. You can link past or future encounters. Associating encounters also provides visual cues to clinical staff. "Orders Only" encounters could be linked in the same fashion as "Office Visit" encounters.There are two ways to associate encounters with the study: via the Research Functionalities and via the Scheduling Module (Cadence). In either case, the charges for that encounter will be held for the coordinator review.

For more Information, see UCDHS EMR New Destinations website (includes Quick Study Guide and helpful Q&A) and CTSC SOP #13 
A new LMS course is designed to provide step-by-step review of EMR-based subject tracking process (Course # 08074)

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9.4  Associate Orders with the Research Study

 Associating Orders to the Study creates a visual cue (“Beaker”) which appears next to the associated order. The orders are still need to be associated to the primary diagnosis and V70.7 diagnosis code (“Examination of clinical research participant”.

For blinded studies, where results of laboratory testing are not recorded in EMR, complete Secured Fax and Secured Print Forms. Obtain and fill out  the Requisition Form from Pathology Client Services. Bulk Account number is required, and can be generated either by using EMR Research File (by pressing "Generate Records necesasry for Billing") or by contacting Patient Financial Services. This Requisition MUST have "Study Code" (Dept - IRBnum) and accompany the sample to the laboratory. Forms can be found on Clinical Trials website – Tools for Study Management .

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9.5  Billing Review 

Research Patients Needing Billing Review” Report is used to verify that technical and professional charges for research patients are being routed to the correct account. Coordinator selects a patient from the report and clicks “Billing Review” to review the charges. If a charge was incorrectly assigned to insurance or the study, this can be corrected using “Research Correction” option. In addition, Restrictions in this report could be changed to show previously completed charges.

Important: The 4 calendar day window for charge review is the billing system’s default. This includes holidays and weekends. The study staff has 4 days from the time of discharge to provide the review of both Inpatient Charges and Outpatient Charges. After the 4-day window closes, the charges are reported to the Department Managers as outstanding.

 

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