OHSU

CTRC Guide: Scheduling Participant Visits

Scheduling Participants

To schedule a study visit, send email requests to OCTRI Scheduling ().

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.
2.  Tubes, labels or other supplies provided by the study (if any).

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.

Medications

 

Study Medications

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

Inpatient

  • 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.

Outpatient

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 (octrisch@ohsu.edu) when you confirm the visit.

Laboratory Days Hours Delivery Method
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

Caregivers

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.

Visitors

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. 

Protocol Modifications

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
  • Discharge