New Coordinator CRU Orientation CRU Background Info CRU

New Coordinator CRU Orientation

CRU Background Info CRU staff must learn about 100 new protocols per year. Many are multi-year trials, meaning we have several hundred open studies at any given time.

CRU Background Info CRU sees an average of ___ patients per day CRU lab often processes hundreds of blood tubes in one day.

What does this mean for you? The staff in the CRU have a lot to keep straight! This is why it is imperative that you follow all instructions, policies and procedures that we discuss today. Not doing so can compromise safety and efficiency for your subject and accuracy of data for your sponsor- not good.

How do I set up my study to see subjects in the CRU? Determine which CRU services you will need. If you are not sure, you can schedule a consultation with the CRU through I-Cart Fill out a CRU application on I-Cart: www. icart. icts. uiowa. edu

How do I set up my study to see subjects in the CRU? Schedule study start up meeting with CRU leadership and CRU nurse liaison (assigned by CRU NM/ANM) At that time, CRU staff can give you a tour of the CRU and walk you through conducting a patient visit.

What will it cost? The costs of the various services you request will be provided to you when you complete your I-Cart application. Your study sponsor or funding source will be responsible for covering these costs. If you just want to see what the cost of CRU services will be, and not actually submit an application, there is an option at the end of the I-Cart application to “get estimate” instead of “submit”.

Process for training CRU staff on your protocol Most sponsors require documentation that the CRU staff were trained on your protocol. CRU staff cannot review training slides from sponsors, as these generally contain far more information than is pertinent to the CRU.

Process for training CRU staff on your protocol To do this, we ask that you create a simple presentation with 5 -10 slides that explains what the CRU’s role will be in your study. Contact Nicole Kressin for an example of this. You will then come to our staff meeting, which is held every other Wednesday at 2 pm, and give a 5 -10 minute presentation. Nicole will include your presentation in the meeting minutes and email this out to all CRU staff and you. This will be your documentation that the CRU staff were trained.

CRU Policies Please review official CRU policies, letters for sponsors, etc. , on The Point: https: //thepoint. healthcare. uiowa. edu Select “Research”, then “CRU”

CRU Orders Any study activity to be carried out by CRU staff will require a signed doctor’s order. Currently, CRU uses paper orders, not Epic. You may write your orders or your CRU nurse liaison will do this for you. CRU charges by the hour for this service. Please review the CRU orders policy on the following slide carefully.

CRU Orders Policy Please review this policy on The Point prior to conducting any study visits in the CRU.

What to do before your patient visit…

Schedule your patient using Outlook Calendar Refer to CRU policy ICTS-CRU-SCH 3. 1 “Scheduling subjects in the CRU” for instructions.

Bring orders and any supplies (such as blood tubes) needed for the visit to CRU to be checked in by noon the day before your visit Log your orders in this book under the date your visit will take place. Make sure to find the correct day and month. There is a separate page for each calendar day. Leave all items in this tub.

Labeling tubes and shipping kits Refer to CRU policy 2. 2 ICTS-CRU-Lab Supplies Labeling for instructions

Before your visit- other information CRU staff will not perform any study activities on a patient until consent is obtained and verified by a CRU staff member. If consent was obtained before the study visit, please either attach a record of consent to your orders before you check them in or make sure one has been scanned into Epic. If you are going to consent the patient in CRU during the visit, please indicate that on the orders. Please indicate on the orders who the first contact from the study team for the patient will be on the day of the visit by circling that person’s name on the order sheet.

The day of your visit Arrival in CRU, conducting your visit

Arrival in CRU When your patient checks in, the CRU charge nurse will page the contact person circled on your orders. If no one is circled, CRU will assume that your team will be present at the time the subject checks into CRU. You do not need to call us back to let us know you got the page. It is always best to watch on Epic for your patient to be checked in for a visit, or to be present in CRU when you know you have a patient checking in. Please contact Nicole Kressin if you need help viewing this in Epic. Room assignments are available for viewing at the “Dashboard” (the large monitor) in the CRU nurses’ station. If you have questions or concerns, please speak with the charge nurse. The charge nurse’s name and pager will be listed on the white board near where you dropped off your orders.

CRU Staff Assignments The white board hanging above the charge desk will indicate staffing assignments for the day as shown: If your subject is receiving an infusion, one of the assigned infusion nurses will care for them. If your subject is having other procedures, one of the clinic nurses or MA’s will complete those. Please do not go into the infusion bay or lab to look for someone to help you. It is imperative that staff working in these areas have minimal interruptions.

Conducting your visit We request when VSS are taken, research team not be present in room and talking to subject. The room is crowded and additional activity may produce inaccurate data. Please try to minimize interruptions of CRU staff as much as possible. Interruptions slow our staff down and make it more likely that an error or deviation will be made. If you have a question or concern, please speak with the charge nurse, or the CRU staff after they have completed your participant’s procedures.

Conducting your visit If you have a participant ready to be seen but no CRU staff are available, place papers here: Turn on flashing light. A CRU staff member will see your subject as soon as possible.

After your visit The CRU staff will scan your orders and nurse’s notes into the patient’s Epic chart at the end of the day. Please pick up your paperwork from your visit. Notes and orders are in the file cabinet by the dashboard, lab requisitions are in the cabinet in front of the lab.

Unexpected situations No-shows, cancellations, add-ons, changes to written orders

Cancellations and No-Shows If a subject cancels or no-shows for an appointment, we ask study staff to retrieve all visit-specific materials. If a subject is immediately rescheduled, and identical materials are to be used, communicate to CRU staff the change, and re -date all materials.

Add-ons Add-on subjects are those who are scheduled after noon the day before their requested visit. May be sent to scheduling, however, add-on requests must be approved by the charge nurse, nurse manager or assistant manager.

Standard of Care Orders If there are standard of care labs/tests on CRU orders, this must be discussed with CRU Nurse Manager, ANM, or charge nurse to be approved. Approved Standard of Care Orders (ie: labs) must be entered into EPIC per study team member by noon the day before the visit.

Changes to Orders The same rules that apply to Epic also apply to paper orders- a LIP must sign off on any changes. Only licensed personnel (RN’s, MA’s, etc. ), may take verbal orders from a LIP. If any part of orders are to be eliminated, the PI or ordering provider should line through, time, date, and initial. If the PI/LIP wishes to add orders, please have them hand write, and time, date and initial the change. Study team should keep orders updated or contact their CRU nurse liaison if needed

End of Study When your study visits have ended for the study, please notify CRU staff that we can close the study. Please also pick up your lab manual and any other study-related materials stored in CRU.

CRU Website For more information on the CRU, please visit our website: https: //www. icts. uiowa. edu/research/clinicalresearch-unit