Subject Legal Name: Last name, First name



Subject Legal Name:

D.O.B.: Age:

Medical Record #:

Subject ID:

Gender:

Ethnicity:

Race:

Admitting Information “INPATIENT” or “OUTPATIENT”

Date of Admit/Visit (Day 0):

Time of Admit/Visit:

Date of Discharge:

Time of Discharge:

Visit Information:

Length of Stay (Number of Days):

Location of study:

Consent forms:

Protocol Information

Protocol Title:

Principal Investigator:

IRB Protocol Number:

IRB Expiration date:

Purpose

To determine efficacy of. . . .

Medical Information

Diagnosis:

Allergies:

Medications taken at home:

Dietary

Only complete if applicable

Dietary orders are written to be specific in designing the subject’s diet and for providing those foods consistent with the protocol needs. They may be as simple as a therapeutic diet or any variation of a research diet requiring controlling nutrient intake for macro/micronutrients or specific foods. Examples:

Outpatient single day study on 9A/B/ACC/CTC (subject is on unit for part of a day and does not stay overnight)

1. Outpatient single day study not on continuation study diet.

▪ Admission 2-3 hrs fasting:

Diet Order: (specify ad lib or list controlled nutrients)

Standard snack (fruit juice, canned fruit cup, cereal bar): Given to fasting subjects after a testing procedure of 2-3 hrs.

▪ Admission 4-5 hrs:

Diet Order: (specify ad lib or controlled nutrients)

Meal provided (specify Breakfast, Lunch, or Dinner)

▪ Full day admission:

Diet Order: (specify ad lib or controlled nutrients)

Meal provided (specify Breakfast, Lunch, or Dinner)

2. Outpatient single day study on continuation study diet (9A/B/ACC/CTC).

▪ Diet Order: specify ad lib or controlled nutrients

▪ Protocol Instructions

Provide detail of meals and/or other CCI Nutrition resources needed with any protocol-specific instructions

Pharmacy

Specific Pharmacy Orders need to be indicated here (if applicable)

For assistance or to initiate a new trial that involves medication, please contact the Investigational Drug Services Pharmacy at x26410 or email BWHRXIDS@.

Each order must indicate the following for each drug:

▪ Medication name (list both generic and brand name, if available)

▪ Dose

▪ Route

▪ Frequency

▪ Duration of therapy

Examples:

Outpatient non-infusion orders:

1. IDS pharmacy to fill out this section.

□ Weight: If dose is weight based: Current weight used for dosing? Or screening weight?

□ Dose calculation (please include if weight based):

Dosing weight :________lbs÷ 2.2 kg/lbs = _________(1) kg

________(1) kg (If weight is rounded)= _________ (2) kg

_________(2) x ** mg/kg = _________ mg (please note if rounded)

□ Picking up of meds: Study coordinator is responsible for picking up study medication(s) at IDS and bringing to outpatient center. Study coordinator should be at outpatient center with drug and patient ready at appointment time. Study coordinator will return unused medication (if necessary) to IDS after visit.

2. Emergency kit- do not dispense, kit located at ACC/CTC

• Epi-pen (epinephrine) 0.3mg x 1 auto-injector – administer by IM injection to lateral mid-thigh in case of anaphylaxis

• Diphenhydramine 50mg/ml (1 mL vial) x 1 vial – administer IM/ IV push. If administering by IV push, give over 1-2 minutes in case of drug reaction

• Hydrocortisone 100 mg/vial, administer IM/IV. If giving by IM injection, give in lateral mid-thigh. If administering by IV push, give over 1-3 minutes in case of drug reaction.

• Acetaminophen 325mg x 2 tablets – administer by mouth in case of drug reaction

Nursing/PA/Technician

List coordinator tasks, if any.

List CCI technician tasks such as Vitals, ECG, blood draws, if applicable.

For any Nursing/PA orders, examples can be found below:

Outpatient Non-infusion orders:

PRE-DOSE

1. Subject arrives at CTC/ACC. LIST COORDINATOR TASKS, IF ANY

2. Female Subjects: The study team/PI is responsible for obtaining pre-dose urine pregnancy testing. The PI MD has appointed the study staff to document the results of this test, which are below. OK for CCI staff to proceed with visit if negative.

Date/Time: __________          Result:    positive      negative     

Signature of study staff: ___________________

3. Obtain VS (T, HR, RR, BP, O2). Call MD for T> 100.0, HR ≤60 or ≥100, SBP ≤90 or ≥160, DBP ≤50 or ≥100, RR> 20, SaO2 ................
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