OFFICE OF CLINICAL RESEARCH ADMINISTRATION (OCRA)

UH SUBJECT REGISTRATION

Click here to complete the: UH Subject Research Registration Form  (obtain current version of form for each registration).

All research visits that will utilize UH items & services must be registered with UH Admitting. 

Forward the completed form to:
 

Pam Tilley
University Hospital Admitting
tilleypa@uhnj.org
fax: 973-972-9398
UH C202

tel: 973-972-0910

Retrieve Orange Labels from UH C202

How to Register Research Subjects & Use Orange Labels

Definitions

  • Pure Research (PR): services performed solely for research on normal volunteers, control subjects and patients who would not otherwise be hospitalized or receive ambulatory items or services except for their participation in this research study. All associated costs are the responsibility of the PI through sponsor, department or other funds (industry, grants etc).
  • Routine Care in Clinical Research (RCCR):  services performed as part of the established or usual standards of care of the patient.  Results from these services are used for research purposes as approved in the IRB protocol & identified in the Budgeted Schedule of Events. All associated costs are responsibility of the third party payor or patient as described in the study consent form.
  • Standard of Care: conventional care given to patients entirely unrelated to a clinical trial.

1) Pure Research Only (inpatient & ambulatory care): each subject admission/visit that utilizes a UH service or item for pure research must be registered with UH Admitting using the UH Subject Registration Form.

 

2) Routine Care in Clinical Research Only (inpatient & ambulatory care): if a patient is receiving UH services or items for routine care in clinical research a Regular Inpatient or Ambulatory Care registration via normal process is required. Do not use UH Subject Registration Form. However, in order to meet billing compliance requirements, you must follow the instructions for proper identification of routine care in clinical research below.

 

3) Combination Ambulatory Care Visits: 2 registrations required

  1. If a patient is receiving UH services or items for pure research and routine care in clinical research during the same visit, two registrations are required; 1) Regular Ambulatory Care registration via normal process and 2) UH Subject Registration using the UH Subject Registration Form.
  2. If a patient is receiving standard of care unrelated to the research during the same visit that UH services or items for pure research and/or routine care in clinical research is performed, two registrations are required; 1) Regular Ambulatory Care registration via normal process and 2) UH Subject Registration using the UH Subject Registration Form.

4) Combination Inpatient Admissions: 2 registrations required

  1. If a patient is admitted for pure research and routine care in clinical research two registrations are required; 1) Regular Hospital registration via normal process and 2) UH Subject Registration using the UH Subject Registration Form.
  2. If a patient is admitted for standard of careand then enrolled into a study during the course of the admission, if a UH item or service is provided for pure research a research registration must be processed using the UH Subject Registration Form.  A regular Hospital registration would have already occurred.
  3. In order to meet billing compliance requirements, you must follow the instructions for proper identification of routine care in clinical research below for both a.& b. above.

The research registration process is essential to meeting proper billing compliance regulations and for tracking research activity at UH. HIPAA allows for the hospital to collect this information for registration purposes. The UH registration process meets all PHI privacy regulations and security of information measures. Given that the Subject Registration form has PHI it must be properly filed in the hospital chart for inpatients or research file for outpatients.

Billing Procedure: using ORANGE LABELS

 

  1. Once the subject is registered, when appropriate UH Admitting will generate research identification labels in the designated ORANGE color for “Clinical Research patient use only”. A member of the study team must retrieve the labels from the admitting office at UH C202.
  2. Billing for PURE RESEARCH: ORANGE labels must be affixed by the PI or designee to all UH service requisitions for PURE RESEARCH services that are billable to the research study. The labels will contain:
    • Patient/Subject UH assigned medical record number, DOB, Gender, Name
    • The name and ID of admitting physician (this person is the PI or a Co-I who is medically responsible for the conduct of the study)
    • The Research Account number (with the suffix 9900)
    • The date of Service for the label
    • The date that the labels were requested
    • Instructions for registrars so that they do not re-registers research subjects

 Scenarios for use of Orange labels:

  1. Visit/Admission is PURE RESEARCH - All procedures performed at visit/admission are for research. Subject must be registered with UH Admitting (Pam Tilley). All UH service requisitions require ORANGE LABELS.
  2. Mixed Visit/Admission: Patient is receiving standard care AND participating in research during visit/admission. Perform a normal UH admitting/visit registration AND a separate UH Research Registration. Only pure research related services require ORANGE LABELS. For example, if blood is drawn and 1 tests is for standard of care and 1 test is for research, there is only one needle stick, however the test for standard of care must be collected in a separate tube from the blood collected for research. Separate requisitions must be prepared, one with standard hospital information and the other with ORANGE LABEL, and the respective tubes, with the respective requisitions must be placed in separate bags.
  3. Subject is participating in a research study where all the tests/procedures are part of standard of care, however the results/data will be collected for research. ORANGE LABELS ARE NOT REQUIRED, but the services are now considered Routine Care in Clinical Research and the requisition must include ICD-9 code, V70.7, plus the chart must indicate that the visit includes Routine Care in Clinical Research. All associated costs are responsibility of the patient or third party carrier.

 Please contact the OCRA for further information:                      

Cynthia Hayes-Sanders, MS

Research Billing Compliance Analyst

TELE: 973-972-5171 

FAX: 973-972-8290

hayessce@uhnj.org