Guide to CTRC Nursing Services
How to Access CTRC Nursing Services
for Your Clinical Research Protocol
We are committed to facilitating interdisciplinary clinical investigation and provision of holistic, specialized nursing care within an environment that patients, families, and investigators recognize as exceptional.
Who can benefit from this guide?
This guide was developed for study coordinators, investigators, and research staff who are utilizing CTRC Nursing Services for a clinical research protocol.
What types of information does the guide contain?
This guide contains detailed information about how to set up an inpatient or outpatient research protocol with the OCTRI Clinical & Translational Research Center.
- Contact information for CTRC staff
- Information about CTRC inpatient and outpatient locations
- Setting up a study, including a list of procedures and documentation that must be completed before scheduling participant visits
Explanations of how to schedule participants, prepare physician orders, and coordinate specimen handling
- Guide to managing post-study documentation, including data that goes into Epic
Personnel List and Scheduling
This email address is routinely monitored by CTRC research assistants during business hours (M-F 0700-1530). This is the best single point of access to CTRC nursing services.
Personnel & Responsibility List
Setting up a Study: Prior to Scheduling Participants
Prior to scheduling participants on your study in the CTRC, we have an implementation process designed to fully prepare us to meet your study and participant needs. The OCTRI Research Navigator Program will guide you through the process of accessing OCTRI services for IRB approval and obtaining fee agreements for grant applications. Once your study has received OCTRI approval, it will be assigned an OCTRI protocol number. Please use this number for all interactions about your study with CTRC staff so that we can be "on the same page" with you!
We can begin scheduling your study visits as soon as the following steps are completed, usually in this order. Detailed descriptions of each step are provided later in this guide:
- IRB and OCTRI approvals finalized
- The completed Nursing Services Request Form has been provided to the CTRC
- The Study Initiation meeting held
- Physicians' orders have been finalized
- The In-service date is scheduled (preferably 1-2 weeks prior to the first visit)
Welcome Letter and Nursing Services
Shortly after receiving your OCTRI protocol number, the PI will receive an electronic Welcome Letter and Nursing Services Request Form (NSRF) from one of the CTRC Nurse Managers. Please fill out the NSRF and return it to us at your earliest convenience. This form provides us with a detailed assessment of the services you are requesting from us. Once we have your NSRF, we are ready to set up the Study Initiation Meeting with you.
Study Initiation Meeting
A Nursing Services Coordinator from the CTRC will set up the Initiation Meeting with you when you are ready to prepare for the participant visits on your protocol in the CTRC. Attendees to the meeting should be a CTRC staff member, the PI and/or study coordinator(s).
The Initiation Meeting is a forum for an informal discussion of the procedures you are requesting from the CTRC nursing staff. Some topics we will cover include:
- Detail of procedures for each visit
- Timing and location of visits
- Specimen handling needs
- Research pharmacy involvement
- Bionutrition involvement
- Physician's orders
Protocol-Specific Physician Orders
For all procedures completed for your protocol in the CTRC, we will need Physicians' orders. The orders must be on paper (OHSU Physicians' Order forms #PO 1500) with an original signature by the PI or co-PI with privileges to practice medicine at OHSU. In the event the PI is not an MD/DO, please ensure the Physician Orders are signed by the Physician of Record. We are not able to use EPIC for any research related orders.
The CTRC has electronic templates available to assist you in development of your orders:
- Standing orders
- Outpatient orders
- Inpatient orders
- Our staff is available to work with you in developing the orders for your protocol. Please draft your orders using the templates, and then send them to OCTRI Scheduling(firstname.lastname@example.org) electronically for review. Once they are finalized, they can be saved electronically and used for applicable participant visits. our templates are formatted to print on the OHSU Physicians' Order forms (#PO 1500). Load these blank forms into your printer to print your final orders for each participant visit. We have blank copies of Physicians Order forms available if you need them, or they may be ordered from Workflowone. Physician's orders must be printed on these forms. Many studies can be conducted with a single signed order called a Standing order that will cover all participants in the study. We will discuss this possibility with you at your initiation meeting.
In addition to the study procedures, orders must also include:
- Principal Investigator
- Covering medical staff
- Participant name, DOB, MRN/subject ID (except for Standing orders)
- Code status
- Protocol number and title
- Participant diagnosis
- Procedure date(s)
- Medical staff original signature/date signed
Internal Documents Utilized to Support your Protocol
Our staff will create documents which we use to help us prepare for and perform your protocol. We require a minimum of one full week to create the internal documents once your orders are finalized.
- Nursing flow sheets
- Protocol guide
- Lab requisitions
- Specimen and chart labels
- Example of a flow sheet for a pharmacokinetics study:
- Example of a flow sheet for a simple outpatient study with multiple visits:
We will need your finalized orders to prepare our flow sheets and other documents. These documents along with the Physician's Orders will be reviewed at the In-service.
The final step to implementation of your study in the CTRC is the In-service. We like to plan for the In-service to occur 1-2 weeks prior to the first scheduled study visit. Once a date is identified, your CTRC nursing services coordinator will send an In-service appointment request via email to the PI and study staff, members of the CTRC nursing staff, lab staff, bionutrition staff and to the research pharmacy if needed. At the In-service, we cover the following.
- Study staff and CTRC introductions
- Study background, what you hope to learn, and details of the participant population.
- Procedures of the study, orders and flow sheets
- Needs of the lab, bionutrition, research pharmacy
- Orientation to any special equipment, or special needs of the participant
To schedule a study visit, send email requests to OCTRI Scheduling (email@example.com).
The format for participant scheduling by location are as follows:
Scheduling staff will respond to your requests as soon as possible, usually within 24 hours, but up to 48 hours. If you need a more immediate response, please send your message "High Importance." You will get a response same day, or next business day if you inquire after 1530.
Please schedule your participants as far in advance as possible, since all visits are subject to staff and space availability.
Preparing for a Study Visit
Once you have a study visit confirmed in the CTRC, please provide the following:1. Physician's orders:
- Participant specific orders, signed by the PI/credentialed study staff, to the scheduled unit (2SE or 10D) 2 business days prior to the visit. If you are not able to deliver original orders to the unit within this timeframe, please fax them to the unit and bring the originals at a later time, but no later than the start of the visit. There is a locked mailbox at the entrance doors of 2SE for Physician's orders drop off when 2SE is closed.
- Standing Orders, signed by the Principal Investigator for your applicable visits must be available where the visit takes place in advance of the visit.
3. Copy of the signed Informed Consent Form, unless it is viewable in EPIC.
Medical Staff Coverage
A medical staff person who is listed on the Informed Consent Form must be available by phone or pager anytime a participant is in the CTRC. For some studies, based on risk of the intervention, the medical staff must be on campus to respond to a medical emergency during the participant visits. We will assess the need for such requirements on a study by study basis.
Study medications for participants are delivered to our areas by the Research Pharmacy Services (RPS) at specified times each day. For 2SE, the times are approximately 0900 and 1330. If these times do not meet your study needs, please make arrangements directly with RPS and communicate your plan to us.
Medications Brought from Home
When a participant is to be admitted as an Inpatient, there are special OHSU-mandated procedures for any medications they take while admitted. Please refer to OHSU Healthcare Policy on O-Zone: Use of Patient's Personal Medication.
The medications must come to the unit in their original and labeled containers.
- They will be sent to the OHSU Pharmacy for verification.
- Powders, liquids and inhalers must be in new sealed containers (otherwise, they cannot be verified).
- No narcotics, or any schedule 2 or 3 medications are allowed to come from home. They must be ordered for the participant from the OHSU Pharmacy. Please provide our staff with a valid Industrial account number to cover the cost of these medications.
- All medication orders must be included in the Physician's orders for the participant.
Outpatients may bring medications from home. Administration of these medications during the research visit must be coordinated with the nursing staff. These medications do not require pharmacy verification.
Informed Consent Form
The Informed Consent Form must be signed by all required parties prior to the start of any study procedures.
- You may schedule participants for the consenting visit in our areas, but our staff may not begin the admission process or the study procedures until the consenting process is complete.
- For minimally-invasive procedures, our staff will seek confirmation from the participant that s/he has signed as Informed Consent Form prior to beginning any procedures.
- For any procedures more than minimally invasive, our staff must first view the signed consent. if your study has multiple visits, our staff is required to view the consent for each visit.
- By having your participant consents scanned into EPIC, our staff will be able to view them prior to each visit. We suggest you send copies of the signed consent to HIS as soon as possible in order to simplify the consent verification process.
Lab Specimen Handling
The three labs most commonly used by OCTRI Clinical Research Studies are listed below with their hours of operation and methods of specimen delivery.
For specimen-processing needs after hours and on weekends, please alert OCTRI Scheduling (firstname.lastname@example.org) when you confirm the visit.
|OCTRI Core Laboratory||
M - F
(except OHSU holidays)
|0700 - 1700||Hospital Transportation, Hand deliver to lab|
|OHSU Clinical Pathology||All days||All hours||Hospital Transportation, Pneumatic tube|
|OHSU Lipid Laboratory||M - F||0930-1730||Hospital Transportation, Pneumatic tub|
Caregivers, Family Members, and Visitors
For participants who need to come to 2SE with care givers, please make those arrangements with the scheduler at the same time you schedule your participation visit. We will do our best to provide suitable accommodation for the caregiver, based on your recommendations. If our two bed room is available, it may be the best fit for your participant and family member or caregiver. If it is not available, we may be able to offer the family member or caregiver another room on the unit for sleeping or a recliner chair in the participant's room. Food is provided for caregivers from the OHSU Hospital menu.
As a general rule, a participant may have visitors during their study visit on 2SE. Visitors may not stay overnight, and are expected to leave the unit by 2300. Food is not provided to visitors, but there are numerous food service areas on the OHSU campus where they may purchase meals and snacks. Pediatric visitors present special concerns to our unit in terms of their safety. We require children to be closely attended at all times, be escorted if they leave the unit, and leave the unit by 2300.
The CTRC staff may exclude a visitor at their discretion if the visitor's presence interferes with study procedures.
If there are IRB approved modifications to your protocol that affect nursing staff activities in caring for your participants, we will need to meet with you briefly to discuss them. We will also need revised Physician's orders to reflect the change, and may need to modify our internal documents as well. It is up to the study staff to alert CTRC staff of these changes and the date when they are to be effective.
Epic Usage in the CTRC
EPIC is not yet providing a platform for research activities, so we use it in a very limited capacity. No orders of any kind are in EPIC for our research studies. We currently do the following in EPIC for inpatients only:
- Adult admission database
- Medication administration record
- Documentation flow sheet
- Plan of care
Post-Study Flow Sheet & Document Handling
Any health information that is created or received by OHSU is considered Protected Health Information (PHI) and is stored electronically in a secure environment by OHSU Health Information Services (HIS).
- All source documents are forwarded to HIS at the end of the study, unless you have made special arrangements with us to do otherwise.
- All source documents can be viewed in Epic, OHSU's electronic medical record.
- Documents that are not part of the permanent medical record or that cannot be entered into the medical record due to IRB requirements will be provided to you directly.
- If you require copies of any documents, please let the nursing staff know.