CTRC Guide: 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. 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:
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 :
- Example of a flow sheet for a :
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