Research Study Registration

UH Registration of Research Studies is required for all studies that indicate UH as a performance site on the WIRB/IRB submitted applications. The facilities are as follows:

• University Hospital
• UH Clinics in the Doctor's Office Center (DOC)
• Ambulatory Care Center (ACC)
• NJMS-UH Cancer Center
• Lattimore Clinic
• ADMC Bldg. 5
• the Stanley S. Bergen Building

The WIRB/IRB will not approve a study that has indicated UH is a performance site until they are notified by the Billing Compliance Analyst (BCA) in the Office of Clinical Research (OCR) that the UH study registration has been approved.

There are 2 kinds of Registrations; 1) Subject Encounter, 2) Chart Review.   Please complete only one type of registration.

1. For studies that have subject encounters and/or utilize UH as a performance site (whether or not a billable service is used):
   
   • Complete the UH Research Study Registration Form.
   • Complete the NEW Schedule of Events (SOE) template. NOTE: this template will now be required, no other format will be accepted. For assistance completing the template please contact Sonia Kleiner at 973-972-9691 or kleiness@umdnj.edu
   • Obtain a copy of the study budget from the final sponsor budget, grant budget or your protocol budget.
   
   
2. For Chart Reviews (studies that DO NOT have subject encounters but utilize subject data only), i.e. questionnaires, surveys, use of standard of care results/data etc.:
   
   • Complete the UH Chart Review Registration form
   
   
3. Submit:

   For studies that have subject encounters:
   The UH Research Study Packet to include:
   

   1. UH Research Study Registration Form
   2. Sponsor-approved/Department-approved Budget
   3. Schedule of events (You MUST use THIS template!)
   
   For Chart Reviews:

   The completed UH Chart Review Registration Form.

   Send the packet to the interim UH Billing Compliance Analyst (BCA) electronically, via fax or through inter-office mail:
   (TBA)
   Billing Compliance Analyst
   Sonia Kleiner
   tel: (973) 972-9691
   fax: (973) 972-9670
   mailing address: CC F-1218
   Newark, NJ 07109



4. The BCA reviews the documents to ensure that the information provided is accurate. The budget will be reviewed against the schedule of events to ensure that sufficient funds have been requested to cover research costs.


5. The BCA will notify the WIRB/IRB once the UH Research Study Packet is approved. NOTE: The WIRB/IRB will not finalize review of the protocol until it has received notification of approved UH Registration Packet. Once you receive WIRB/IRB approval you must forward the following documents to the BCA. Registration is not considered complete until these documents are received by Billing Compliance Analyst (BCA) electronically, via fax or through inter office mail:
   1. IRB approval letter
   2. Banner index # for the study (Subjects cannot be registered without a banner index # registered with BCA.)
   3. All modifications that involve changes to UH services utilized by the research study must be forwarded to the BCA.


6. The BCA notifies the Medical Records Director of UH Chart Review Registration approvals; however, access to medical records is granted to study team members only if they are able to present the WIRB/IRB approval notice to the Medical Records Director at the time access is needed. Every study team member who needs to access electronic medical records needs approval from Medical Informatics Committee. Please fill ”Access Request Form“ and ”Confidentiality Agreement“, found on the UH Medical Staff home page, and send it as per instructions in ”Procedures & Contacts“ document on the same page.
    
   Upon Medical Informatics Committee approval, access is provided by HS&T.