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ORIENTATION CHECKLIST FOR CRU SERVICES
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version 1, October 2, 2023
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PROTOCOL
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Medical Back up Name and Contact
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SEPCOM Application
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IRB Application
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CRU Budget
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New Amendments
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Provide in timely manner via email to GHUCCTS CRU Admin
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IRB Approval
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Must be on file to see patients on the CRU
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IRB Annual Renewal / Continuing Review
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Must be current and on file to see patients on the CRU.
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DOCUMENTATION
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CRU Initiation Meeting
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Source Documentation:
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Provide SIV Slides and any CRFs if available.
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Protocol Packets
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SIGNED Protocol Packets by PI on File: Must be signed prior to encountering participants.
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Show CRU Staff signed informed consent
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Coordintator Guide reviewed in full
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APPOINTMENTS
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Review CRU Website Calendar for Availability prior to submitting appointment request in Webcamp.
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Connect to GlobalProtect VPN Client for WebCamp access
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Schedule an Appointment
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-Patient Legal Name and correct DOB: Include preferred name in comment section.
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-Enter Correct Visit Profile: Contact CRU for help as needed.
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-Include window of time needed for Cognitive Testing.
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-Special Resources: Contact CRU Management, s.a. extended hour visits.
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-For long visits please request 8:00am appointment to ensure visits can be completed by close of business at 4:30pm.
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-For staff meetings (1st Wednesday of every month) participants must be discharged by 2pm. No LPs or other invasive procedures on these Wednesdays.
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-Need prior approval (at least one-week advanced notice) from management for appropriate staffing if visits are to exceed normal business hours (M-F: 8:00am-4:30pm).
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-For unanticipated extended visits, a member of the study team will need to finish the visit on the CRU along with one of the CRU staff.
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ADMISSIONS: In-Patient care is coordinated with CRU and MGUH Patient Access. One -two weeks advance notice is required. For cancellations please provide updates to CRU and MGUH Patient Access and unit manager as soon as possible.
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ADMISSION RESERVATION REQUEST https://georgetown.app.box.com/s/h0zay5lrjno3i2h43n3ex6zd3esj2drl
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Email Nurse Manager of in patient unit (ex: 7 Main East) with admission dates
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LABS
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Kit/ procedural trays provided: Check for expiration date. Label tubes with Study ID #.
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Requisition forms completed
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Shipping box: Label inside tab with IRB # & Pt int. Provide appropriate shipping box: ambient, frozen or combo box
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Airbill
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Deliver kits to CRU before 3pm the day prior to appt
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Verify G-97 and Downtime Lab forms are congruent prior to submitting.
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G-97 submit to MGUH at least 24 hr prior to Date of Service
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SIGNED Downtime Lab form submit to MGUH at least 24 hr prior to Date of Service
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Cut off time for Lab processing 2:30pm except on Staff Meeting Dates cut off is 1:00pm.
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PATIENT REGISTRATION
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New Patient to MGUH reqistration
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Pyxis Account Form
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Admission Reservation Request Form for in patient stays at MGUH
Submit to Patient Placement 1-2 weeks ahead of anticipated admission.
Obtain paper work from Pt Admissions, and have patient sign once admitted.
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Email Admitting Unit Nurse Manager for in-patient stays at MGUH 1-2 weeks ahead of anticipated admission.
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Confirm bed placement with Patient Placement 48 business hours ahead of anticipated admission.
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Include any special dietary needs with appointment requests.
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EQUIPMENT
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CRU Equipment Log
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Sponsor provide equipment
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MGUH Biomed inspection
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Shipping box retained by study team
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STUDY INVESTIGATIONAL PRODUCTS
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Medication Orders must be signed and delivered to Research Pharmacy and cc'd to CRU appt email 1 business day ahead of appointment
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Delays in dosing for serial PKs of >/= 6 hours may need to be rescheduled if pt is not dosed by 10am at the latest.
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Study Team to pick up oral IP from Research Pharmacy
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Study Team to return oral IP to Research Pharmacy in timely manner.
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All IPs should be stored inthe CRU Medicaiton Room; never left in the PI room for security reasons.
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Study Coordinators to verify patient compliance.
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CRU Nurses perform Safety Check prior to all dosing of IP.
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Confirm pregnancy test results with CRU staff prior to dosing. Test must be negative.
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