CRF Template

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<Name of Study / Study # / Logo>

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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<Name of Study / Study # / Logo>

Table of Contents

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<Name of Study / Study # / Logo>

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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<Name of Study / Study # / Logo>

Instructions - Screening

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Site Number <Name of Study / Study # / Logo> Screening #

Screening
Date and time of screening
D D M M M Y Y Y Y H H

: M

(24 hour clock)

Inclusion Criteria

Reason 1 Reason 2 Reason 3 Reason 4 Reason 5 Reason 6

Yes Yes Yes Yes Yes Yes

No No No No No No

Exclusion Criteria

Reason 1 Reason 2 Reason 3 Reason 4 Reason 5 Reason 6

Yes Yes Yes Yes Yes Yes

No No No No No No

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<Name of Study / Study # / Logo>

Instructions - Randomization

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Site Number <Name of Study / Study # / Logo> Enrolment #

Randomization

Patient eligibility confirmed?

Yes

No

Was consent obtained? If no, go to reasons not consented/randomized

Yes

No

Date and time of consent

: M

(24 hour clock) Date and time of randomization


D D M M M Y Y Y Y H H

: M

(24 hour clock)

Reason patient not consented/randomized? No family present Refused consent Missed the patient Other specify

______________________________________________________ _____________________________________________________

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<Name of Study / Study # / Logo>

Instructions - APACHE II

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Site Number <Name of Study / Study # / Logo> Enrolment #

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<Name of Study / Study # / Logo>

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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Site Number <Name of Study / Study # / Logo> Enrolment #

Patient Baseline
Sex
Male Female

Weight

pounds kilograms

Ethnicity

Caucasian Unknown

Native Canadian Other

East Indian

Asian/ Pacific Islander

African/Black North American

Diabetic

Yes No

Type 1

Type 2

Type of Admission

Medical

Surgical Elective

Surgical Emergency

Primary ICU diagnosis

Comorbidities

Hospital admission/ Emergency Presentation Date and Time ICU Admission Date and Time

: M

(24 hour clock)


M M M Y Y Y Y M

: M

(24 hour clock) Mechanical Ventilation Start Date and Time


M M M Y Y Y Y M

: M

(24 hour clock) Date and time of Onset of Dialysis

: M

(24 hour clock)

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<Name of Study / Study # / Logo>

Instructions - Baseline Nutrition

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Site Number <Name of Study / Study # / Logo> Enrolment #

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

(24 hour clock) Date and time enteral nutrition stopped


D D M M M Y Y Y Y H H : M M

(24 hour clock)

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

(24 hour clock) Date and time parenteral nutrition stopped


D D M M M Y Y Y Y H H : M M

(24 hour clock)

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<Name of Study / Study # / Logo>

Instructions - Microbiology

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Site Number <Name of Study / Study # / Logo> Enrolment #

Microbiology Page __ of __
Complete 1 box per positive sample

Sample type
Blood Endotracheal aspiration BAL or PBC* Wound Cath tip/line Urine* Stool Other

Accession Number Date and Time of Culture:

M M

H : M

(24 hour clock)


Organism 1 Susceptibilities 1

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

Accession Number Date and Time of Culture:

M M

H : M

(24 hour clock)


Organism 1 Susceptibilities 1

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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<Name of Study / Study # / Logo>

Instructions - Antibiotic

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Site Number <Name of Study / Study # / Logo> Enrolment #

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

Date and Time Antibiotic Ordered:

M M

Time Not Available

(24 hour clock) Date and Time First Dose Received: D


D M M M Y Y Y Y H H : M M

(24 hour clock) Date and Time Last Dose Received: D D


M M M Y Y Y Y H H : M M
Ongoing at ICU discharge

(24 hour clock)

Antibiotic (use taxonomy reference #): Dose


g mg units

Route
IV PO / NG

Frequency
OD BID TID QID

q
H H : M M

hrs

Date and Time Antibiotic Ordered:

M M

Time Not Available

(24 hour clock) Date and Time First Dose Received: D


D M M M Y Y Y Y H H : M M

(24 hour clock) Date and Time Last Dose Received: D D


M M M Y Y Y Y H H : M M
Ongoing at ICU discharge

(24 hour clock)

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<Name of Study / Study # / Logo>

Instructions - Outcomes

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Site Number <Name of Study / Study # / Logo> Enrolment #

Outcomes

Mechanical ventilation discontinuation:

M M

H : M

(24 hour clock)

Termination date of dialysis

M M

H : M

(24 hour clock) ICU discharge:


D D M M M Y Y Y Y H H : M M

(24 hour clock)

Hospital discharge:

M M

H : M

(24 hour clock)

Death:

M M

H : M

(24 hour clock) N/A

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<Name of Study / Study # / Logo>

Instructions - Follow-Up

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Site Number <Name of Study / Study # / Logo> Enrolment #

Follow up
3 Month 6 Month

Were you able to conduct the follow up survey?

Yes

Date of interview
D D M M M Y Y Y Y

Interview completed by

Patient

Family/Caregiver

No, patient died

Date of death
D D M M M Y Y Y Y

Unknown

No, patient refused

Date of refusal
D D M M M Y Y Y Y

No, patient lost to follow up

Date of last known to be alive


D D M M M Y Y Y Y

No, missed timeline requirement

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<Name of Study / Study # / Logo>

Instructions - Comments

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Site Number <Name of Study / Study # / Logo> Enrolment #

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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<Name of Study / Study # / Logo>

Instructions - Investigator Confirmation

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Site Number <Name of Study / Study # / Logo> Enrolment #

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

Full signature of investigator

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