1. CRU Orientation Nicole Kressin, MSN, RN

2. CRU Background Info
What is the CRU? Why do we do things the way we do, and what does it mean for you?

3. What is the CRU?
The CRU offers the physical space and experienced interdisciplinary support staff to conduct and complete clinical research at the University of Iowa.

4. CRU Fast Facts CRU staff must learn about 100 new protocols per year.
As of spring 2016, we had over 300 active protocols

5. CRU Fast Facts CRU typically sees between 30 and 50 patients per day.
CRU regularly interacts with over 100 study coordinators.
CRU lab often processes hundreds of blood tubes in one day.

6. CRU Fast Facts
Clinical Research Nursing was recognized by the American Association of Nurses in 2016 as a clinical specialty.
The CRU staff have over 200 years of clinical research experience.

7. What does this mean for you?
The staff in the CRU are incredibly skilled and knowledgeable, but have a lot to keep straight!
Always reference your CRU study number on all communications with the CRU. We will not know what study you are talking about otherwise.
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.

8. What does this mean for you?
The CRU staff are experts in clinical tasks, such as research blood draws, IV insertion, etc.
YOU are expected to be the expert on your protocol, study equipment, etc.- not us!
This is the purpose of a study coordinator- to be the person that knows the protocol backwards and forwards and ensures it is followed by support staff.

9. Basic Safety
JCAHO guidelines, incident reporting, professional dress

10. Joint Commission (JCAHO) Compliance
JCAHO is an organization that accredits and certifies healthcare organizations
JCAHO guidelines MUST be followed at all times. If not followed, we risk losing UIHC’s accreditation

11. Joint Commission (JCAHO) Compliance
A few basic things to know:
Staff may not eat or drink in patient rooms, including exam rooms and consult rooms
Beverages are only allowed in designated areas in the nurse’s station.
Staff must wear closed-toe shoes in patient care areas
Follow all hygiene and waste disposal guidelines carefully

12. Incident Reporting
If a patient, visitor or staff member is injured or if unsafe conditions are recognized in the CRU, please fill out a Patient Safety Net (PSN) form.
Examples of when to use: patient fall, you hit your head, patient ID band not checked prior to performing a procedure.
Please contact Nicole Kressin or Julie Cayler if any safety-related issue arises. We will guide you through the PSN reporting process.
The purpose of this is NOT to get anyone in trouble! Reporting safety issues is part of our safety culture and is viewed as an opportunity for improvement and documentation of incidents in case needed in the future.

13. Professional Dress
Because we are seeing patients and located in the hospital, some patients will expect to see you follow the hospital’s professional dress code: no jeans, sandals, no tight, stained, ripped clothing or athletic wear, neat and professional grooming at all times.
Please remember that today’s current fashions, such as leggings with short tops, may seem risque to many patients. Conservative is almost always better when working with the public.

14. CRU Study Startup CRU study approval process
Process for training CRU staff on your protocol
CRU Policies & Order writing

15. CRU Study Approval Process
The CRU startup/approval process takes a minimum of several weeks.
CRU costs can be considerable depending on the study.
It’s best to submit your CRU application early in the study startup process so that you can ensure your budget will cover everything.

16. CRU Study Approval Process
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:
If you need help with I-Cart, please contact me or Julie.

17. CRU Study Approval Process
A CRU nurse will review your I-Cart application for accuracy with the protocol.
Expect questions during this time!
Your protocol and I-Cart application will then go to our medical director for final review and approval.
You will receive an with your signed cost analysis.

18. CRU Study Approval Process
Schedule a 30-minute study start up meeting with CRU leadership and CRU nurse liaison (assigned by CRU Manager)
During your startup meeting, plan to discuss:
Order writing- allow at least 2 weeks to complete
Workflows for your study
Complete study startup checklist

19. 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.

20. Process for training CRU staff on your protocol
To do this, you will create a simple presentation with 5-10 slides that explains what the CRU’s role will be in your study. (Example located on The Point)
You will then come to our staff meeting, which is held every other Wednesday at 2 pm, and give a 5-10 minute presentation.
Your presentation will be included in the meeting minutes that are ed out to all CRU staff and you. This will be your documentation that the CRU staff were trained.

21. CRU Policies
Please review official CRU policies, letters for sponsors, etc., on The Point:
Select “Research”, then “CRU”

22. CRU Orders
Any study activity to be carried out by CRU staff will require a signed doctor’s order.
CRU uses both paper and Epic orders.
You may write your orders or your CRU nurse liaison will do this for you. CRU charges by the hour for this service.
If you need orders modified later on, your CRU nurse liaison may not be the one to do this as that person may have too much to do at the time. Contact Nicole or Julie directly if you need order modifications and we will determine the best person to complete based on current workloads.

23. CRU Orders Policy
Please review this policy on The Point prior to conducting any study visits in the CRU.
to get copies of your orders printed on the correct paper.

24. What to do before your patient visit…

25. Schedule your patient using Outlook Calendar
Refer to CRU policy ICTS-CRU-SCH 3.1 “Scheduling subjects in the CRU” for instructions.

26. 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.
We recommend you check in lab kits and orders as soon as they are available. Noon the day before is a hard cutoff, so it’s best not to wait.

27. Labeling tubes and shipping kits
Refer to CRU policy 2.2 ICTS-CRU-Lab Supplies Labeling for instructions

28. Documentation of Consent
CRU staff can 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.
You cannot scan a consent form into Epic, only a ROC. We need you communicate what you want from us when your subject arrives. Do you want us to start on them right away? Do you need to see them first? Are we to page you or someone else on your team? Do you want them in their room or in the waiting room?

29. Communicate what you want!
Please indicate on your orders what you want us to do when your patient arrives!
Who should we contact?
Do you need to see them before we do?
Feel free to attach a cover sheet with instructions, patient schedule, etc., if this is easier
This must be done for every single visit!
Not doing so is like walking in to Subway and saying “I want a sandwich” and then being surprised when staff do not give you the specific sandwich and toppings you wanted.

30. The day of your visit
Arrival in CRU, staff assignments, flag system, conducting your visit, after your visit

31. Arrival in CRU
The will contact whoever is indicated as the contact on your orders. If no one is indicated, we will contact your PI.
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 the CRU for help with seeing this.
Room assignments are available for viewing at the “Dashboard” (the large monitor) in the CRU nurses’ station. You can also view this ahead of time on Epic.
Study team is responsible for knowing their patient schedule each day. Pages are a courtesy to give you a heads up that someone has arrived, but you are ultimately responsible for knowing where your subjects are. On Epic you can view appointment times and room assignments ahead of time rather than waiting until the patient has checked in. You are responsible for carrying your pager at all times and ensuring that it is working properly. CRU cannot be responsible for a non-functioning pager, or for calling your cell phone because you choose not to carry your pager.

32. 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.

33. Flag System
Flags above each clinic exam room indicate the status of the room. Yellow cards on the computers are there to remind you to use the flags, and tell you what the colors mean.
When finished with visit, please flip the red flag out so we know not to put another patient in the room before cleaning!

34. Conducting your visit
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.
Try not to hang out in the nurse’s station waiting for subjects- wait in assigned room. Please stay out of the vitals room while VS are being taken- this room is crowded and the combination of chatting and activity/crowding can affect results. Please minimize use of computers in the nurses station and infusion bay. You are always welcome to use a computer in an empty exam or consult room but there are only a few computers for the nurses.

35. Conducting your visit
Remember to treat our staff and our space as you would want yourself and your office to be treated.
Do not go into the infusion bay, the lab or the lunch room to look for someone to help you in the clinic.
Try not to hang out in the nurse’s station. This is our staff’s only work space.

36. 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. Please take your subject to their assigned room or the waiting room while you wait for staff.

37. 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.

38. Unexpected situations
Cancellations and no-shows, add-ons, standard of care orders, changes to written orders

39. Cancellations and No-Shows
If a subject cancels or no-shows for an appointment, please notify the CRU charge nurse ASAP and retrieve all visit-specific materials. 

40. 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, n

41. Standard of Care Orders
If there are standard of care labs/tests on CRU orders, this must be discussed with CRU Nurse Manager 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.

42. Changes to Orders- Follow the Law!
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

43. 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.

44. CRU Website
For more information on CRU services, facilities and staff, please visit our website:

45. We appreciate your time!