CRF Template
CRF Template
CRF Template
Table of Contents
General Instructions Screening APACHE II Randomization Baseline Baseline Nutrition Daily Data Daily Laboratory Measurements Daily Enteral Nutrition Daily Parenteral Nutrition Concomitant Medications Vasopressors Microbiology Antibiotics Outcomes Follow Up Comments Investigator Confirmation Appendicestaxonomies
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Table of Contents
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General Instructions
Note: Please see also the instructions at the CRF 1. Use only black ball-point ink when completing forms. 2. All data requested in the CRFs is to be taken from the patients hospital chart. Except for follow-up and the corresponding surveys that are completed over the phone. 3. Where data is expected there can be no blanks. If no data is available standard annotations should be documented. ND- not done ( data is unavailable because the measure wasnt taken or test not done) N/A not applicable ( measure was not required at the particular time point the form relates to) N/Knot known ( every effort has been made to find the data) 4. To perform a corrections made in the CRF never use correction fluid. Corrections should be made by crossing the initial entry out by a single line, ensuring the original data is legible. The correct entry should be placed beside this and confirmed with date, initialing the correction. e.g: 106 5. Standard date will be entered as dd/mmm/yyyy. 6. The study clock is the 24-hr clock. Midnight is 00:00 and the date of the new day. 7. Anywhere in the CRF that Other, specify is indicated, and has been checked, there must be an entry on the line provided.
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Instructions - Screening
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Screening
Date and time of screening
D D M M M Y Y Y Y H H
: M
Inclusion Criteria
No No No No No No
Exclusion Criteria
No No No No No No
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Instructions - Randomization
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Randomization
Yes
No
Yes
No
: M
: M
Reason patient not consented/randomized? No family present Refused consent Missed the patient Other specify
______________________________________________________ _____________________________________________________
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Instructions - APACHE II
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Instructions - Baseline
Sex Place a in the appropriate box (male or female) will be expected. Tick only one box. Weight Record weight. Place a in the appropriate measurement scale (pounds or kilograms) Ethnicity Place a in the appropriate box. Tick only one box. If ethnicity is other, a specification will be expected on the line provided. Diabetic Indicate with a in the appropriate box. If Yes Indicate with a either for Type I ( juvenile diabetic or insulin dependent) or for Type 2 (non-insulin dependent diabetes, adult onset or insulin resistant diabetes) Type of Admission Indicate the type of admisson to ICU. Place a in the appropriate box. Primary ICU Diagnosis Choose the most pertinent diagnosis that resulted in the patients admission to ICU. From the type of ICU admission choose the corresponding admission diagnosis from the taxonomy Comorbidities Enter all that apply from the taxonomy provided. If the comorbidity doesnt appear in the taxonomy then do not document it. Hospital admission/Emergency Presentation date and time A complete date and time will be expected. For the patient that is admitted to hospital through emergency this is the same as the date and time of admission to emergency. For the patient that is admitted to the hospital directly, this is the same as the date and time of admission to hospital. ICU admission data and time A complete date and time will be expected. Enter the date and time admitted to your ICU. This date cannot be before hospital admission/emergency presentation date and time Mechanical ventilation start date and time A complete date and time will be expected. Enter the date and time of invasive mechanical ventilation. For the patient that is mechanically ventilated prior to admission to your hospital this is the same as the admission date and time to your hospital.
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Patient Baseline
Sex
Male Female
Weight
pounds kilograms
Ethnicity
Caucasian Unknown
East Indian
Diabetic
Yes No
Type 1
Type 2
Type of Admission
Medical
Surgical Elective
Surgical Emergency
Comorbidities
Hospital admission/ Emergency Presentation Date and Time ICU Admission Date and Time
: M
: M
: M
: M
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Baseline Nutrition
Prescribed energy intake Prescribed protein intake
kilojoules kilocalories grams
Enteral Nutrition
Never received in ICU Enteral nutrition initiated prior to ICU admission & continued in ICU Date and time enteral nutrition stopped
D D M M M Y Y Y Y H H : M M
(24 hour clock) Enteral nutrition initiated in ICU admission & continued in ICU Date and time enteral nutrition started
D D M M M Y Y Y Y H H : M M
Parenteral Nutrition
Never received in ICU Parenteral nutrition initiated prior to ICU admission & continued in ICU Date and time parenteral nutrition stopped
D D M M M Y Y Y Y H H : M M
(24 hour clock) Parenteral nutrition initiated in ICU admission & continued in ICU Date and time parenteral nutrition started
D D M M M Y Y Y Y H H : M M
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Instructions - Microbiology
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Microbiology Page __ of __
Complete 1 box per positive sample
Sample type
Blood Endotracheal aspiration BAL or PBC* Wound Cath tip/line Urine* Stool Other
M M
H : M
Organism 2
Susceptibilities 2
Organism 3
Susceptibilities 3
Quantitative Results* >104 cfu/ml or >107 cfu/L <104 cfu/ml or <107 cfu/L None
Sample type
Blood Endotracheal aspiration BAL or PBC* Wound Cath tip/line Urine* Stool Other
M M
H : M
Organism 2
Susceptibilities 2
Organism 3
Susceptibilities 3
Quantitative Results* >104 cfu/ml or >107 cfu/L <104 cfu/ml or <107 cfu/L None
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Instructions - Antibiotic
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Antibiotic Page __ of __
Complete 1 box per antibiotic
Antibiotic (use taxonomy reference #): Dose
g mg units
Route
IV PO / NG
Frequency
OD BID TID QID
q
H H : M M
hrs
M M
Route
IV PO / NG
Frequency
OD BID TID QID
q
H H : M M
hrs
M M
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Instructions - Outcomes
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Outcomes
M M
H : M
M M
H : M
Hospital discharge:
M M
H : M
Death:
M M
H : M
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Instructions - Follow-Up
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Follow up
3 Month 6 Month
Yes
Date of interview
D D M M M Y Y Y Y
Interview completed by
Patient
Family/Caregiver
Date of death
D D M M M Y Y Y Y
Unknown
Date of refusal
D D M M M Y Y Y Y
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Instructions - Comments
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Comments
Comment Date Form/ Study Day #
Y Y Y Y
Comment details
M M
M M
M M
M M
M M
M M
M M
M M
M M
M M
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Investigator Confirmation
The treatment of this patient was conducted under my supervision according to the protocol during the entire study period. The statements and data contained in this case report form are complete and accurate to the best of my knowledge.
M M
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