Protocol #1130 – “A Phenotypic Registry of COPD Patients”

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Sample Space Only Orders
Start with SAC # then complete title in 12 or 14 font
Top margin should be 2½ inches to fit the NMH Physician Order Sheet
Orders should be in 10 font.
Notes: Green used for Notes/Reminders that will help you fully complete the orders for
your protocol.
Blue: Options you can choose from for your protocol’s orders.
Protocol #4300: Allergies and Home
NMH Account #:
PI: Dr. Kelly Carroll
phone: 5-5555 pager: 5-0000
Coordinator: Angela Tang
phone: 5-9876 pager: 5-1234
NOTE: List PI, coordinator(s) and others who should be contacted during study visits along with phone/pager
numbers.
OUTPATIENT CRU STANDING ORDERS
DAY 1 / TREATMENT WEEK 18
Date:_____________
PT INT:_________________
SUBJECT #:_________________________
NOTE: need a set of orders for each day the subject is at CRU
NOTE: If multiple visits will have duplicate orders, you can combine orders and list the visits. Leave a line for the
date to be filled in.
1. Admit to Outpatient CRU at Feinberg/Galter.
NOTE: List whether at Feinberg or Galter if possible.
2. Consent will have been previously obtained by study team and supplied to CRU staff./Consent obtained
upon subject arrival/ Page ___ at ___ to have subject consented.
NOTE: The CRU must have a signed subject consent before any treatment can begin.
3.
Diet: General diet/Fast for 8 hours prior to blood draw, defined as: no food or liquid after midnight right
before.
If did no fast:
 Cancel visit
NOTE: List any RESTRICTIONS (with clear definition), TIME frame for restriction, and ACTION to take if
restriction not followed.
4. Study coordinator to obtain vital signs (sitting blood pressure, heart rate (bpm), respiration rate and oral
temperature):
Notify MD if:
Standard criteria
 Temp greater than 101
 HR greater than 100 or less than 50
 BP greater than 160/90 or less than 90/50
 RR greater than 24 or less than 12
Protocol #4300 AT 2.16.11 Always put version date of draft orders and drafter’s initials
Page 1 of 2
Sample Space Only Orders
NOTE: List CRITERIA to use to determine if there is a problem and ACTION to take if criteria met. (see
example of standard criteria above)
5. Study coordinator to
 collect medical history pertaining to prior allergic reactions.
 administer Exhaled Nitric Oxide (FeNO) test.
6. Study coordinator to administer Allergy Skin Testing.
 Coordinator to notify MD if: a systemic allergic reaction (anaphylaxis including difficulty
breathing and swallowing, asthma reaction, and low blood pressure) occurs. Medication
(injectable epinephrine), antihistamines and a physician will be available in case of a reaction.
7.
8.
Study coordinator to
 administer questionnaires (SNOT-22 and Home Moisture Survey)
 collect urine and blood sample for routine laboratory testing.
 test and determine blood clotting time (INR)
 collect urine to perform pregnancy test.
 collect and review study drug supply.
 dispense new study drug supply.
Discharge from CRU to home, if stable.
Page Dr. Carroll at 5-0000 for questions regarding the study.
NOTE: List PI or Attending physician who should be called for questions about study.
Protocol #4300 AT 2.16.11 Always put version date of draft orders and drafter’s initials
Page 2 of 2
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