Protocol #1130 a Phenotypic Registry of COPD Patients

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

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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. 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. 8. 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.

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