Overview of Clinical Research Unit (CRU) at University of Iowa
The Clinical Research Unit (CRU) at the University of Iowa provides physical space and expert interdisciplinary support for conducting clinical research. The CRU offers a range of services and follows strict protocols to ensure safety, efficiency, and accuracy in data collection. With a team of experienced staff and specialized nursing professionals, the CRU handles a large volume of studies and patient interactions daily, prioritizing adherence to standards and guidelines.
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Presentation Transcript
CRU Orientation Julie Cayler, Research Manager- CRU
Objectives What is the CRU? Basic Clinic Safety and UIHC policies Study Start Up Preparing for a CRU Visit Understanding Workflow on the Day of the CRU Visit How to Handle Unexpected Situations
CRU Background Info What is the CRU? Why do we do things the way we do, and what does it mean for you?
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.
CRU Fast Facts We have approximately 100 active protocols
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.
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 150 years of combined clinical research experience.
What does this mean for you? The staff in the CRU are incredibly skilled and knowledgeable, but have a lot of protocols to follow! 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 standards and guidelines that we discuss today. Not doing so can compromise safety and efficiency for your subject and accuracy of data for your sponsor.
Expectations of team roles The CRU staff: experts in clinical tasks, such as blood draws, IV insertion, infusions, timed PK draws, lab processing, etc. We are here to support your study. Coordinators: experts on your specific protocol, study equipment, etc. You know the protocol backwards and forwards. Coordinators ensure the protocol is followed by support staff.
We are on stage as a team during the research visit for our customer.
Basic Safety JCAHO guidelines, incident reporting, professional dress
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
Joint Commission (JCAHO) Compliance A few basic things to know: Staff may not eat or drink in the lab or clinic There are two areas that are designated: 1)infusion bay desk-but NOT the counter top where specimens are placed 2)clinic work station area
Joint Commission (JCAHO) Compliance-continued Staff must wear closed-toe shoes in patient care areas and laboratory Follow all hand hygiene and isolation policies carefully UIHC guidelines are located on the POINT
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, wrong medication. Please contact Julie Cayler or Jackie Wangui-Verry if any safety-related issue arises. We will guide you through the PSN reporting process if necessary.
Professional Dress Because we are seeing patients and located in the hospital, patients will expect to see you follow UIHC professional dress code: no jeans, sandals, no tight, stained, ripped clothing or athletic wear, neat and professional grooming at all times.
CRU Study Startup CRU study approval process Process for training CRU staff on your protocol CRU Policies & Order writing
CRU Study Approval Process The CRU startup/approval process takes a minimum of 2-3 weeks. The Protocol Review Oversight Committee (RPOC) meets weekly to review new requests. CRU costs can be considerable depending on the complexity of 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.
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: www.icart.icts.uiowa.edu
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. Your study team will receive an email with a signed cost analysis.
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: CRU order details Workflows for your study Complete study startup checklist handout*
Process for training CRU staff on your protocol Most sponsors require documentation that the CRU staff were trained on your protocol. CRU staff will not 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, 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 a staff meeting and give a 5-10 minute presentation. Your presentation will be included in the meeting minutes that are emailed 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 or an EPIC order. Currently CRU uses both paper and Epic orders.
CRU Orders Policy Please review this policy on The Point prior to conducting any study visits in the CRU. Hand out* CRU stocks A-1a Doctor s Orders sheets, please call the charge nurse at 6-1061 to obtain the blank order sheets.
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. Hand Out*
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. Place all items in this tub.
Labeling tubes and shipping kits Refer to CRU policy 2.2 ICTS-CRU-Lab Supplies Labeling for instructions. Hand out*
Documentation of Consent $STAMP_APPRV_DT $STAMP_EXP_DT FOR IRB USE ONLY $STAMP_IRB $STAMP_IRB_ID IRB ID#: $STAMP_IRB_ID RECORD OF INFORMED CONSENT (To be scanned in to electronic medical record as External Document) Subject Name: ______________________________________UIHC Hospital# ___________________ The person indicated above has signed a consent document agreeing to be a research subject in the research project indicated by the IRB number listed above. If you have any questions about the clinical care of this person related to their participation in this research project, contact the Research Team Contact listed below. RESEARCH TEAM 24/7 Contact Information Provide the following information for projects involving treatment(s) or procedures that could result in complications or side effects: Research Team Contact Name: ___________________________________________________________ Research Team Contact Number/pager# ___________________________________________________ PROJECT INFORMATION: Date Subject Signed Consent: ___ ___ / ___ ___ / ___ ___ ___ ___ Month Day Year Are subjects in this study taking a study drug? No Yes Provide listing of study drug(s) and indicate if they are investigational as used in this project. Describe the key potential complications from the study drug(s) Any other information that may be important to emergency personnel: Research Member Who Obtained Consent: I verify that the subject named above has provided consent to participate in this study. The original signed consent document is stored with the project records. ___________________________________ ____________________________________ Printed Name Signature Date: ___ ___ / ___ ___ / ___ ___ ___ ___ 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, 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.
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!
The day of your visit Arrival in CRU, staff assignments, flag system, conducting your visit, after your visit
Arrival in CRU The charge nurse 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. 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 from your office.
Time Out Process A verbal time out process is utilized prior to the start of all visits. A member of the study team and the CRU staff carrying out the visit procedures will take a time out to double check and confirm the correct subject, the physician orders, the sequence of the procedures and the study supply labels together. T This occurs once the subject is checked in, the study team member has arrived in clinic, and PRIOR to initiating the research visit.
CRU Staff Assignments If your subject is receiving an infusion, one of the assigned infusion nurses will care for them. The white board hanging above the charge desk will indicate staffing assignments for the day as shown: If your subject is having other procedures, one of the clinic nurses or MA s will complete those.
Conducting your visit If you have a participant ready to be seen but no CRU staff are available at that moment, place papers here: Turn on flashing light. A CRU staff member will see your subject as soon as they are available. Please take your subject to their assigned room or the waiting room (indicate where the subject will be) while you wait for staff. We take from the bottom, subjects are then seen in order of readiness.
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 when a CRU staff member is available.
Conducting your visit To help protect subject confidentiality, please do not go into the infusion bay unless you are seeing your subject. The nurses in the bay are generally not able to leave the bay to assist you with a visit in the clinic. Utilize the drop box (next slide). Please do not to hang out in the nurse s station or infusion bay area. These areas are always on stage for our subjects.
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.
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 black cabinet at the back of the lab.
Unexpected situations Cancellations and no-shows, add-ons, standard of care orders, changes to written orders
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.
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 a manager
Standard of Care Orders If there are standard of care labs/tests on CRU orders, discuss 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
Changes to Orders- Follow your Scope of Practice 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. It is the study team s responsibility to keep orders current.
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 CRU services, facilities and staff, please visit our website: https://www.icts.uiowa.edu/research/clinic al-research-unit
