Screening Visit

Administrative Information
Description

Administrative Information

Alias
UMLS CUI-1
C1320722
Trial
Description

Trial name

Data type

text

Alias
UMLS CUI [1]
C1629065
Type of Wound
Description

Type of Wound

Data type

integer

Alias
UMLS CUI [1]
C1276783
Site name
Description

Study site

Data type

text

Alias
UMLS CUI [1]
C2825164
Examination performed
Description

Examination performed

Data type

boolean

Alias
UMLS CUI [1]
C0031809
If no, provide reason
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
Does the Patient have a Superficial Infection?
Description

Superficial Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0043241
UMLS CUI [1,2]
C0205124
Does the Patient have a Deep Wound Infection?
Description

Deep Wound Infection

Data type

boolean

Alias
UMLS CUI [1]
C0406103
Patient Information
Description

Patient Information

Alias
UMLS CUI-1
C1955348
Kind of other Wound Type
Description

other Wound Type

Data type

text

Alias
UMLS CUI [1,1]
C1276783
UMLS CUI [1,2]
C0205394
Patient Caption
Description

Patient Caption

Data type

text

Alias
UMLS CUI [1,1]
C2825231
UMLS CUI [1,2]
C0030705
Negative Pressure Wound Device present
Description

Negative Pressure Wound Device

Data type

boolean

Alias
UMLS CUI [1]
C1956078
Specimen for Culture obtained
Description

Specimen collection for culture

Data type

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0430400
Signs and Symptoms
Description

Signs and Symptoms

Data type

integer

Alias
UMLS CUI [1]
C0037088
Visit Name
Description

Visit Name

Data type

text

Alias
UMLS CUI [1]
C2826704
Visit Number
Description

Visit Number

Data type

integer

Alias
UMLS CUI [1]
C1549755
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Clinical Event Intensity
Description

Event Intensity

Data type

integer

Alias
UMLS CUI [1]
C0518690
If not assessed, please provide a comment
Description

not assessed,comment

Data type

text

Alias
UMLS CUI [1,1]
C3846720
UMLS CUI [1,2]
C0947611
If not assessed, please provide a comment
Description

not assessed,comment

Data type

text

Alias
UMLS CUI [1,1]
C3846720
UMLS CUI [1,2]
C0947611
Please specify Other Sign or Symptom
Description

Other Sign or Symptom,specify

Data type

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C3845569
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Surgery performed
Description

Surgery performed

Data type

boolean

Alias
UMLS CUI [1]
C0543467
Kind of Surgical Procedure
Description

Surgery time

Data type

integer

Alias
UMLS CUI [1,1]
C0683312
UMLS CUI [1,2]
C0543467
Surgical Procedure
Description

Surgical Procedure

Data type

integer

Alias
UMLS CUI [1]
C0543467
Other procedure
Description

Other procedure

Data type

text

Alias
UMLS CUI [1]
C0543467
Alcohol and Smoking History
Description

Alcohol and Smoking History

Alias
UMLS CUI-1
C0038586
UMLS CUI-2
C0262926
Alcohol Usage
Description

Alcohol Usage

Data type

integer

Alias
UMLS CUI [1]
C0001948
Smoking status
Description

Smoking status

Data type

integer

Alias
UMLS CUI [1]
C1519386
Cumulative pack years
Description

Cumulative pack years

Data type

integer

Alias
UMLS CUI [1]
C1277691
Time since Smoking Cessation
Description

Time since Smoking Cessation

Data type

integer

Alias
UMLS CUI [1]
C0453997
Time unit ex-smoker
Description

Time unit ex-smoker

Data type

integer

Alias
UMLS CUI [1,1]
C0337671
UMLS CUI [1,2]
C1519795
UMLS CUI [1,3]
C0449238
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Type of Substance
Description

Type of Substance

Alias
UMLS CUI-1
C0038586
UMLS CUI-2
C0332307
Type of Substance
Description

Type of Substance

Data type

integer

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0332307
Alcohol Use
Description

Alcohol Use

Data type

boolean

Alias
UMLS CUI [1]
C0001948
Kind of Other Substance
Description

Kind of Other Substance

Data type

text

Alias
UMLS CUI [1,1]
C0439861
UMLS CUI [1,2]
C0205394
Cumulative Number of Units
Description

(1 unit = 1/2 pint beer (285mL); 125 mL wine; 25mL spirit)

Data type

integer

Alias
UMLS CUI [1,1]
C2986497
UMLS CUI [1,2]
C0449961
Frequency
Description

Frequency

Data type

integer

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0439603
Eligibility determination
Description

Eligibility determination

Alias
UMLS CUI-1
C0013893
Subject complies with all inclusion / exclusion criteria
Description

In case of failed criterion, please complete 'Completion / Withdrawal form'

Data type

boolean

Alias
UMLS CUI [1]
C0013893
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Failed IE criteria
Description

Failed IE criteria

Alias
UMLS CUI-1
C1516637
UMLS CUI-2
C0231175
Failed criterion
Description

e.g. 2, 3a etc.

Data type

text

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C0231175
Criteria type
Description

Criteria type

Data type

integer

Alias
UMLS CUI [1]
C1516637
Medical and surgical history
Description

Medical and surgical history

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0489540
Any relevant medical and surgical history?
Description

Please give information on medical and surgical history where relevant for the disease under study, e.g. immune deficiency, intra-abdominal surgeries/ pathological findings, hepatic or renal impairment etc. Concomitant Medication (within the last two weeks prior to study start) has to be documented on the referring eCRF

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0489540
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Medical / surgical event
Description

Medical / surgical event

Alias
UMLS CUI-1
C1948041
UMLS CUI-2
C0262926
Condition, Illness, Diagnosis for Surgical Procedure
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
End Date
Description

End Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Ongoing at screening visit
Description

Ongoing at screening visit

Data type

boolean

Alias
UMLS CUI [1]
C0549178
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Examination performed
Description

Examination performed

Data type

boolean

Alias
UMLS CUI [1]
C0031809
if 'no', provide reason
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
Weight
Description

Patient Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Physical examination
Description

Physical examination

Alias
UMLS CUI-1
C0031809
Body system
Description

Body system

Data type

integer

Alias
UMLS CUI [1,1]
C0460002
UMLS CUI [1,2]
C0031809
Result
Description

Result

Data type

integer

Alias
UMLS CUI [1]
C1274040
if 'abnormal', brief description
Description

Description of finding

Data type

text

Alias
UMLS CUI [1,1]
C0747585
UMLS CUI [1,2]
C0678257
if 'abnormal', assessment of clinical significance
Description

clinical significance

Data type

boolean

Alias
UMLS CUI [1]
C2826293
Kind of other examination
Description

other examination

Data type

text

Alias
UMLS CUI [1]
C0260879
Diagnosis of Current Intra-Abdominal Infection
Description

Diagnosis of Current Intra-Abdominal Infection

Alias
UMLS CUI-1
C1112209
UMLS CUI-2
C0521116
Study Qualifying Intra-Abdominal Diagnosis
Description

Study Qualifying Intra-Abdominal Diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C1514624
UMLS CUI [1,2]
C1112209
Abscess
Description

Abscess

Data type

integer

Alias
UMLS CUI [1]
C0000833
Was this Infection a Complication of a Previous Abdominal Surgery?
Description

Cause of Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C3714514
UMLS CUI [1,2]
C0015127
Is this infection considered a failure of previous treatment?
Description

Cause of Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C3714514
UMLS CUI [1,2]
C0015127
Date of Previous Surgery
Description

Date of Previous Surgery

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0543467
Site of Source of Infection
Description

Site of Source of Infection

Alias
UMLS CUI-1
C0449426
UMLS CUI-2
C1515974
Site of Source of Infection
Description

Site of Source of Infection

Data type

integer

Alias
UMLS CUI [1,1]
C0449426
UMLS CUI [1,2]
C1515974
Other Location
Description

Other Location

Data type

text

Alias
UMLS CUI [1]
C1515974
Radiological Examination
Description

Radiological Examination

Alias
UMLS CUI-1
C0043299
Any Radiological Examination in Relation to the Diagnosis?
Description

Radiological Examination

Data type

boolean

Alias
UMLS CUI [1]
C0043299
Kind of Radiological Examination
Description

Radiological Examination

Data type

text

Alias
UMLS CUI [1]
C0043299
Radiological Findings
Description

Radiological Findings

Data type

text

Alias
UMLS CUI [1,1]
C0043299
UMLS CUI [1,2]
C0243095
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Infection-related Examination
Description

Infection-related Examination

Alias
UMLS CUI-1
C3714514
UMLS CUI-2
C0031809
Examination performed
Description

Examination performed

Data type

boolean

Alias
UMLS CUI [1]
C0031809
if 'no', provide reason
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Infection related Signs and Symptoms
Description

Infection related Signs and Symptoms

Alias
UMLS CUI-1
C0037088
UMLS CUI-2
C3714514
Signs and Symptoms
Description

Signs and Symptoms

Data type

integer

Alias
UMLS CUI [1]
C0037088
Please specify Other Sign or Symptom
Description

Other Sign or Symptom

Data type

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0205394
Clinical Event Intensity
Description

Clinical Event Intensity

Data type

integer

Alias
UMLS CUI [1]
C0518690
Vital Signs examination
Description

Vital Signs examination

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0031809
Examination performed
Description

Examination performed

Data type

boolean

Alias
UMLS CUI [1]
C0031809
if 'no', provide reason
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
Supine Blood Pressure Systolic
Description

Supine Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Clinically relevant?
Description

Relevance

Data type

boolean

Alias
UMLS CUI [1]
C2347946
Supine Blood Pressure Diastolic
Description

Supine Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Clinically relevant?
Description

Relevance

Data type

boolean

Alias
UMLS CUI [1]
C2347946
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Clinically relevant?
Description

Relevance

Data type

boolean

Alias
UMLS CUI [1]
C2347946
Respiratory Rate
Description

Respiratory Rate

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Clinically relevant?
Description

Relevance

Data type

boolean

Alias
UMLS CUI [1]
C2347946
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Temperature
Description

Temperature

Alias
UMLS CUI-1
C0005903
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Time of measurement
Description

HH:MM

Data type

time

Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0040223
Method of Measurement
Description

Method of Measurement

Data type

integer

Alias
UMLS CUI [1,1]
C1299991
UMLS CUI [1,2]
C0039476
Kind of Other Method
Description

Other Method

Data type

text

Alias
UMLS CUI [1,1]
C1299991
UMLS CUI [1,2]
C0205394
Clinically relevant?
Description

Relevance

Data type

boolean

Alias
UMLS CUI [1]
C2347946
Laboratory Tests
Description

Laboratory Tests

Alias
UMLS CUI-1
C1880016
UMLS CUI-2
C0022885
Clinical Chemistry sample collected
Description

Clinical Chemistry sample collected

Data type

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
If 'no', please provide reason
Description

Not done reason

Data type

integer

Alias
UMLS CUI [1]
C2826287
Other, please specify
Description

Other, please specify

Data type

text

Alias
UMLS CUI [1]
C3845569
Collection Date
Description

Collection Date

Data type

date

Alias
UMLS CUI [1]
C1302413
Collection time
Description

Collection time

Data type

time

Alias
UMLS CUI [1]
C4064021
Central Lab ID
Description

Central Laboratory ID

Data type

text

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C2986056
Sample sent to central lab
Description

Sample sent to central lab

Data type

boolean

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1515023
UMLS CUI [1,3]
C1880016
If 'no', please provide reason
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
Hematology sample collected
Description

Hematology sample collected

Data type

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0018941
If 'no', please provide reason
Description

Not done reason

Data type

integer

Alias
UMLS CUI [1]
C2826287
Other, please specify
Description

Other, please specify

Data type

text

Alias
UMLS CUI [1]
C3845569
Collection Date
Description

Collection Date

Data type

date

Alias
UMLS CUI [1]
C1302413
Collection time
Description

Collection time

Data type

time

Alias
UMLS CUI [1]
C4064021
Central Lab ID
Description

Central Laboratory ID

Data type

text

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C2986056
Sample sent to central lab
Description

Sample sent to central lab

Data type

boolean

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1515023
UMLS CUI [1,3]
C1880016
If 'no', please provide reason
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
Urinalysis sample collected
Description

Urinalysis sample collected

Data type

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0042014
If 'no', please provide reason
Description

Not done reason

Data type

integer

Alias
UMLS CUI [1]
C2826287
Other, please specify
Description

Other, please specify

Data type

text

Alias
UMLS CUI [1]
C3845569
Collection Date
Description

Collection Date

Data type

date

Alias
UMLS CUI [1]
C1302413
Collection time
Description

Collection time

Data type

time

Alias
UMLS CUI [1]
C4064021
Central Lab ID
Description

Central Laboratory ID

Data type

text

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C2986056
Sample sent to central lab
Description

Sample sent to central lab

Data type

boolean

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1515023
UMLS CUI [1,3]
C1880016
If 'no', please provide reason
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Local Lab at Screening
Description

Local Lab at Screening

Alias
UMLS CUI-1
C0587081
Clinical Chemistry sample collected
Description

Clinical Chemistry sample collected

Data type

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
If 'no', please provide reason
Description

Not done reason

Data type

integer

Alias
UMLS CUI [1]
C2826287
Other, please specify
Description

Other, please specify

Data type

text

Alias
UMLS CUI [1]
C3845569
Collection Date
Description

Collection Date

Data type

date

Alias
UMLS CUI [1]
C1302413
Collection time
Description

Collection time

Data type

time

Alias
UMLS CUI [1]
C4064021
Serum Creatinine
Description

Serum Creatinine

Data type

float

Alias
UMLS CUI [1]
C0201976
not done
Description

not done

Data type

boolean

Alias
UMLS CUI [1]
C1272696
Lab unit
Description

Unit used

Data type

integer

Alias
UMLS CUI [1]
C1519795
other lab unit
Description

other unit

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0205394
lower limit of normal
Description

lower limit of normal

Data type

integer

Alias
UMLS CUI [1]
C1518030
Upper limit of normal
Description

ULN

Data type

integer

Alias
UMLS CUI [1]
C1519815
Was this value clinically signifcant?
Description

Significance

Data type

boolean

Alias
UMLS CUI [1]
C2826633
AST (GOT)
Description

AST (GOT)

Data type

integer

Alias
UMLS CUI [1]
C0201899
not done
Description

not done

Data type

boolean

Alias
UMLS CUI [1]
C1272696
other lab unit
Description

other unit

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0205394
lower limit of normal
Description

lower limit of normal

Data type

integer

Alias
UMLS CUI [1]
C1518030
Upper limit of normal
Description

ULN

Data type

integer

Alias
UMLS CUI [1]
C1519815
Was this value clinically signifcant?
Description

Significance

Data type

boolean

Alias
UMLS CUI [1]
C2826633
ALT (GPT)
Description

ALT (GPT)

Data type

integer

Alias
UMLS CUI [1]
C0201836
not done
Description

not done

Data type

boolean

Alias
UMLS CUI [1]
C1272696
other lab unit
Description

other unit

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0205394
lower limit of normal
Description

lower limit of normal

Data type

integer

Alias
UMLS CUI [1]
C1518030
Upper limit of normal
Description

ULN

Data type

integer

Alias
UMLS CUI [1]
C1519815
Was this value clinically signifcant?
Description

Significance

Data type

boolean

Alias
UMLS CUI [1]
C2826633
ALP
Description

ALP

Data type

integer

Alias
UMLS CUI [1]
C0201850
not done
Description

not done

Data type

boolean

Alias
UMLS CUI [1]
C1272696
other lab unit
Description

other unit

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0205394
lower limit of normal
Description

lower limit of normal

Data type

integer

Alias
UMLS CUI [1]
C1518030
Upper limit of normal
Description

ULN

Data type

integer

Alias
UMLS CUI [1]
C1519815
Was this value clinically signifcant?
Description

Significance

Data type

boolean

Alias
UMLS CUI [1]
C2826633
Total Bilirubin
Description

Total Bilirubin

Data type

float

Alias
UMLS CUI [1]
C0201913
not done
Description

not done

Data type

boolean

Alias
UMLS CUI [1]
C1272696
other lab unit
Description

other unit

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0205394
lower limit of normal
Description

lower limit of normal

Data type

integer

Alias
UMLS CUI [1]
C1518030
Upper limit of normal
Description

ULN

Data type

integer

Alias
UMLS CUI [1]
C1519815
Was this value clinically signifcant?
Description

Significance

Data type

boolean

Alias
UMLS CUI [1]
C2826633
Creatinine Clearance
Description

Creatinine Clearance

Data type

float

Measurement units
  • mL/min
Alias
UMLS CUI [1]
C0373595
mL/min
Was this value clinically signifcant?
Description

Significance

Data type

boolean

Alias
UMLS CUI [1]
C2826633
Hematology sample collected
Description

Hematology sample collected

Data type

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0018941
If 'no', please provide reason
Description

Not done reason

Data type

integer

Alias
UMLS CUI [1]
C2826287
Other, please specify
Description

Other, please specify

Data type

text

Alias
UMLS CUI [1]
C3845569
Collection Date
Description

Collection Date

Data type

date

Alias
UMLS CUI [1]
C1302413
Collection time
Description

Collection time

Data type

time

Alias
UMLS CUI [1]
C4064021
WBC
Description

WBC

Data type

float

Alias
UMLS CUI [1]
C0023508
not done
Description

not done

Data type

boolean

Alias
UMLS CUI [1]
C1272696
other lab unit
Description

other unit

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0205394
lower limit of normal
Description

lower limit of normal

Data type

integer

Alias
UMLS CUI [1]
C1518030
Upper limit of normal
Description

ULN

Data type

integer

Alias
UMLS CUI [1]
C1519815
Was this value clinically signifcant?
Description

Significance

Data type

boolean

Alias
UMLS CUI [1]
C2826633
Neutrophil count
Description

Neutrophil count

Data type

float

Alias
UMLS CUI [1]
C0948762
not done
Description

not done

Data type

boolean

Alias
UMLS CUI [1]
C1272696
other lab unit
Description

other unit

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0205394
lower limit of normal
Description

lower limit of normal

Data type

integer

Alias
UMLS CUI [1]
C1518030
Upper limit of normal
Description

ULN

Data type

integer

Alias
UMLS CUI [1]
C1519815
Was this value clinically signifcant?
Description

Significance

Data type

boolean

Alias
UMLS CUI [1]
C2826633
Hematocrit
Description

Hematocrit

Data type

float

Alias
UMLS CUI [1]
C0518014
not done
Description

not done

Data type

boolean

Alias
UMLS CUI [1]
C1272696
other lab unit
Description

other unit

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0205394
lower limit of normal
Description

lower limit of normal

Data type

integer

Alias
UMLS CUI [1]
C1518030
Upper limit of normal
Description

ULN

Data type

integer

Alias
UMLS CUI [1]
C1519815
Was this value clinically signifcant?
Description

Significance

Data type

boolean

Alias
UMLS CUI [1]
C2826633
Hemoglobin
Description

Hemoglobin

Data type

float

Alias
UMLS CUI [1]
C0019046
not done
Description

not done

Data type

boolean

Alias
UMLS CUI [1]
C1272696
other lab unit
Description

other unit

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0205394
lower limit of normal
Description

lower limit of normal

Data type

integer

Alias
UMLS CUI [1]
C1518030
Upper limit of normal
Description

ULN

Data type

integer

Alias
UMLS CUI [1]
C1519815
Was this value clinically signifcant?
Description

Significance

Data type

boolean

Alias
UMLS CUI [1]
C2826633
Platelet count
Description

Platelets

Data type

float

Alias
UMLS CUI [1]
C0005821
not done
Description

not done

Data type

boolean

Alias
UMLS CUI [1]
C1272696
other lab unit
Description

other unit

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0205394
lower limit of normal
Description

lower limit of normal

Data type

integer

Alias
UMLS CUI [1]
C1518030
Upper limit of normal
Description

ULN

Data type

integer

Alias
UMLS CUI [1]
C1519815
Was this value clinically signifcant?
Description

Significance

Data type

boolean

Alias
UMLS CUI [1]
C2826633
Pregnancy Test done
Description

Pregnancy Test done

Data type

boolean

Alias
UMLS CUI [1]
C0032976
If 'no', please provide reason
Description

Not done reason

Data type

integer

Alias
UMLS CUI [1]
C2826287
Other reason
Description

Other reason

Data type

text

Alias
UMLS CUI [1]
C3840932
Method of Testing
Description

Method of Testing

Data type

integer

Alias
UMLS CUI [1]
C0871511
Result of testing
Description

Result

Data type

integer

Alias
UMLS CUI [1]
C0427777
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Microbiology
Description

Microbiology

Alias
UMLS CUI-1
C0085672
Was a specimen collected?
Description

Microbiology specimen collection

Data type

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0025952
If no, please provide reason
Description

Not done reason

Data type

integer

Alias
UMLS CUI [1]
C2826287
Please specify inability
Description

inability

Data type

text

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1521902
Please specify other reason
Description

inability

Data type

text

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C3845569
Date of collection
Description

Specimen collection date

Data type

date

Alias
UMLS CUI [1]
C1302413
Time of Collection
Description

Specimen collection time

Data type

time

Alias
UMLS CUI [1]
C4064021
Culture Processing Type
Description

Culture Processing Type

Data type

integer

Alias
UMLS CUI [1,1]
C0200949
UMLS CUI [1,2]
C0037793
UMLS CUI [1,3]
C0332307
Site of sample
Description

Specimen collection site

Data type

integer

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C1515974
Intra-Abdominal, please specify
Description

Intra-Abdominal, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C1512910
UMLS CUI [1,2]
C1521902
Other site, please specify
Description

Other site, please specify

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C3845569
Culture outcome
Description

Culture outcome

Data type

integer

Alias
UMLS CUI [1,1]
C2242979
UMLS CUI [1,2]
C0587081
Isolate name
Description

Isolate name

Data type

text

Alias
UMLS CUI [1]
C1764827
Pathogen Type
Description

Pathogen Type

Data type

integer

Alias
UMLS CUI [1]
C0450254
Isolate Classification
Description

Isolate Classification

Data type

integer

Alias
UMLS CUI [1,1]
C1764827
UMLS CUI [1,2]
C0008902
Disc Zone ATM-AVI
Description

(mm, Aerobic Pathogens only)

Data type

text

Alias
UMLS CUI [1,1]
C1283010
UMLS CUI [1,2]
C0004521
UMLS CUI [2,1]
C1283010
UMLS CUI [2,2]
C3489748
Sample sent to Central Lab?
Description

Sample sent to Central Lab

Data type

boolean

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C0370003
UMLS CUI [1,3]
C1515023
Central Lab Accession ID Number
Description

Central Laboratory Accession ID Number

Data type

text

Alias
UMLS CUI [1,1]
C2826726
UMLS CUI [1,2]
C1880016
If no, reason
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
Backup Sample sent to Central Lab (if necessary)?
Description

Backup Sample sent to Central Laboratory

Data type

boolean

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1515023
UMLS CUI [1,3]
C1880016
CRF Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611

Similar models

Screening Visit

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Information
C1320722 (UMLS CUI-1)
Trial name
Item
Trial
text
C1629065 (UMLS CUI [1])
Item
Type of Wound
integer
C1276783 (UMLS CUI [1])
Code List
Type of Wound
CL Item
Surgical Incision Site (1)
CL Item
Laparoscopic Incision Site (2)
CL Item
Percutaneous Drainage Site (3)
CL Item
Other (99)
Study site
Item
Site name
text
C2825164 (UMLS CUI [1])
Examination performed
Item
Examination performed
boolean
C0031809 (UMLS CUI [1])
Not done reason
Item
If no, provide reason
text
C2826287 (UMLS CUI [1])
Superficial Infection
Item
Does the Patient have a Superficial Infection?
boolean
C0043241 (UMLS CUI [1,1])
C0205124 (UMLS CUI [1,2])
Deep Wound Infection
Item
Does the Patient have a Deep Wound Infection?
boolean
C0406103 (UMLS CUI [1])
Item Group
Patient Information
C1955348 (UMLS CUI-1)
other Wound Type
Item
Kind of other Wound Type
text
C1276783 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Patient Caption
Item
Patient Caption
text
C2825231 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
Negative Pressure Wound Device
Item
Negative Pressure Wound Device present
boolean
C1956078 (UMLS CUI [1])
Specimen collection for culture
Item
Specimen for Culture obtained
boolean
C0200345 (UMLS CUI [1,1])
C0430400 (UMLS CUI [1,2])
Item
Signs and Symptoms
integer
C0037088 (UMLS CUI [1])
Code List
Signs and Symptoms
CL Item
Erythema (1)
CL Item
Induration (2)
CL Item
Tenderness (3)
CL Item
Warmth (4)
CL Item
Fluctuation (5)
CL Item
Swelling (6)
CL Item
Wound Pain (7)
CL Item
Dehiscence (8)
CL Item
Purulent Discharge (9)
CL Item
Non Purulent Discharge (10)
CL Item
Other (11)
Visit Name
Item
Visit Name
text
C2826704 (UMLS CUI [1])
Visit Number
Item
Visit Number
integer
C1549755 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Item
Clinical Event Intensity
integer
C0518690 (UMLS CUI [1])
Code List
Clinical Event Intensity
CL Item
Absent (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not Assessed (99)
not assessed,comment
Item
If not assessed, please provide a comment
text
C3846720 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
not assessed,comment
Item
If not assessed, please provide a comment
text
C3846720 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Other Sign or Symptom,specify
Item
Please specify Other Sign or Symptom
text
C0037088 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Surgery performed
Item
Surgery performed
boolean
C0543467 (UMLS CUI [1])
Item
Kind of Surgical Procedure
integer
C0683312 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Code List
Kind of Surgical Procedure
CL Item
Initial Procedure (1)
CL Item
Reintervention (2)
Item
Surgical Procedure
integer
C0543467 (UMLS CUI [1])
Code List
Surgical Procedure
CL Item
Laparotomy (1)
CL Item
Percutaneous Draingae of Abscess (2)
CL Item
Laparoscopy (3)
CL Item
Wound Debridement without Laparotomy (4)
CL Item
Other (99)
Other procedure
Item
Other procedure
text
C0543467 (UMLS CUI [1])
Item Group
Alcohol and Smoking History
C0038586 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Item
Alcohol Usage
integer
C0001948 (UMLS CUI [1])
Code List
Alcohol Usage
CL Item
never (0)
CL Item
current (1)
CL Item
former (2)
Item
Smoking status
integer
C1519386 (UMLS CUI [1])
Code List
Smoking status
CL Item
never smoker (1)
CL Item
ex-smoker (2)
CL Item
smoker (3)
Cumulative pack years
Item
Cumulative pack years
integer
C1277691 (UMLS CUI [1])
Time since Smoking Cessation
Item
Time since Smoking Cessation
integer
C0453997 (UMLS CUI [1])
Item
Time unit ex-smoker
integer
C0337671 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Code List
Time unit ex-smoker
CL Item
Years (1)
CL Item
Months (2)
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Type of Substance
C0038586 (UMLS CUI-1)
C0332307 (UMLS CUI-2)
Item
Type of Substance
integer
C0038586 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Type of Substance
CL Item
Wine (1)
CL Item
Beer  (2)
CL Item
Spirits  (3)
CL Item
Other (4)
Alcohol Use
Item
Alcohol Use
boolean
C0001948 (UMLS CUI [1])
Kind of Other Substance
Item
Kind of Other Substance
text
C0439861 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Cumulative Number of Units
Item
Cumulative Number of Units
integer
C2986497 (UMLS CUI [1,1])
C0449961 (UMLS CUI [1,2])
Item
Frequency
integer
C0001948 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Code List
Frequency
CL Item
per Day (1)
CL Item
per Week (2)
Item Group
Eligibility determination
C0013893 (UMLS CUI-1)
Subject complies with all inclusion / exclusion criteria
Item
Subject complies with all inclusion / exclusion criteria
boolean
C0013893 (UMLS CUI [1])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Failed IE criteria
C1516637 (UMLS CUI-1)
C0231175 (UMLS CUI-2)
Failed eligibility criteria
Item
Failed criterion
text
C1516637 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Item
Criteria type
integer
C1516637 (UMLS CUI [1])
Code List
Criteria type
CL Item
inclusion (1)
CL Item
exclusion (2)
Item Group
Medical and surgical history
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
medical and surgical history
Item
Any relevant medical and surgical history?
boolean
C0262926 (UMLS CUI [1,1])
C0489540 (UMLS CUI [1,2])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Medical / surgical event
C1948041 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Diagnosis
Item
Condition, Illness, Diagnosis for Surgical Procedure
text
C0011900 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Ongoing at screening visit
Item
Ongoing at screening visit
boolean
C0549178 (UMLS CUI [1])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Examination performed
Item
Examination performed
boolean
C0031809 (UMLS CUI [1])
Not done reason
Item
if 'no', provide reason
text
C2826287 (UMLS CUI [1])
Patient Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Item
Body system
integer
C0460002 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Code List
Body system
CL Item
Other (10)
CL Item
Neurological (9)
CL Item
Musculoskeletal (8)
CL Item
Abdomen (Wound Exam. at sep.eCRF) (7)
CL Item
Cardiovascular (6)
CL Item
Respiratory (5)
CL Item
Lymph Nodes (4)
CL Item
Head, Eyes, Ears, Nose, Throat (3)
CL Item
Skin (2)
CL Item
General Appearance (1)
Item
Result
integer
C1274040 (UMLS CUI [1])
Code List
Result
CL Item
not done (3)
CL Item
abnormal (2)
CL Item
normal (1)
Description of finding
Item
if 'abnormal', brief description
text
C0747585 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
clinical significance
Item
if 'abnormal', assessment of clinical significance
boolean
C2826293 (UMLS CUI [1])
other examination
Item
Kind of other examination
text
C0260879 (UMLS CUI [1])
Item Group
Diagnosis of Current Intra-Abdominal Infection
C1112209 (UMLS CUI-1)
C0521116 (UMLS CUI-2)
Item
Study Qualifying Intra-Abdominal Diagnosis
integer
C1514624 (UMLS CUI [1,1])
C1112209 (UMLS CUI [1,2])
Code List
Study Qualifying Intra-Abdominal Diagnosis
CL Item
cIAI Not Confirmed at Surgery (8)
CL Item
Intra-Abdominal Abscess (including of Liver and Spleen provided that there is Extension beyond the Organ with Evidence of Intraperitoneal Involvement) (7)
CL Item
Secondary Peritonitis (but not Spontaneous Bacterial Peritonitis sassociated with Cirrhosis and Chronic Ascites) (6)
CL Item
Traumatic Perforation of Intestines, only if operated > 12 Housr after Perforation occurs (5)
CL Item
Acute Gastric and Duodenal Perforations, only if operated on > 24 Hours after Perforartion occurs (4)
CL Item
Appendiceal Perforation or Peri-Appendiceal Abscess (3)
CL Item
Diverticular Disease with Perforation or Abscess (2)
CL Item
Cholecystitis with Gangrenous Rupture or Perforation or Progression of the Infection beyond the Gallbladder Wall (1)
Item
Abscess
integer
C0000833 (UMLS CUI [1])
Code List
Abscess
CL Item
Multiple Abscesses (2)
CL Item
Single Abscess (1)
Cause of Infection
Item
Was this Infection a Complication of a Previous Abdominal Surgery?
boolean
C3714514 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Cause of Infection
Item
Is this infection considered a failure of previous treatment?
boolean
C3714514 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Date of Previous Surgery
Item
Date of Previous Surgery
date
C0011008 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Item Group
Site of Source of Infection
C0449426 (UMLS CUI-1)
C1515974 (UMLS CUI-2)
Item
Site of Source of Infection
integer
C0449426 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Code List
Site of Source of Infection
CL Item
Other (9)
CL Item
Large Intestine (8)
CL Item
Pancreas (7)
CL Item
Appendix (6)
CL Item
Small Intestine (5)
CL Item
Liver (4)
CL Item
Spleen (3)
CL Item
Gall Bladder (2)
CL Item
Stomach (1)
Other Location
Item
Other Location
text
C1515974 (UMLS CUI [1])
Item Group
Radiological Examination
C0043299 (UMLS CUI-1)
Radiological Examination
Item
Any Radiological Examination in Relation to the Diagnosis?
boolean
C0043299 (UMLS CUI [1])
Radiological Examination
Item
Kind of Radiological Examination
text
C0043299 (UMLS CUI [1])
Radiological Findings
Item
Radiological Findings
text
C0043299 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Infection-related Examination
C3714514 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Examination performed
Item
Examination performed
boolean
C0031809 (UMLS CUI [1])
Not done reason
Item
if 'no', provide reason
text
C2826287 (UMLS CUI [1])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Infection related Signs and Symptoms
C0037088 (UMLS CUI-1)
C3714514 (UMLS CUI-2)
Item
Signs and Symptoms
integer
C0037088 (UMLS CUI [1])
Code List
Signs and Symptoms
CL Item
Other,specify (10)
CL Item
Chills and rigors (9)
CL Item
Ascites (8)
CL Item
Abdominal mass (7)
CL Item
Abdominal guarding (6)
CL Item
Rebound tenderness (5)
CL Item
Tenderness to palpation (4)
CL Item
Vomiting (3)
CL Item
Nausea (2)
CL Item
Abdominal Pain (1)
Other Sign or Symptom
Item
Please specify Other Sign or Symptom
text
C0037088 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
Clinical Event Intensity
integer
C0518690 (UMLS CUI [1])
Code List
Clinical Event Intensity
CL Item
Not Assessed (99)
CL Item
Severe (3)
CL Item
Moderate (2)
CL Item
Mild (1)
CL Item
Absent (0)
Item Group
Vital Signs examination
C0518766 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Examination performed
Item
Examination performed
boolean
C0031809 (UMLS CUI [1])
Not done reason
Item
if 'no', provide reason
text
C2826287 (UMLS CUI [1])
Supine Blood Pressure Systolic
Item
Supine Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Relevance
Item
Clinically relevant?
boolean
C2347946 (UMLS CUI [1])
Supine Blood Pressure Diastolic
Item
Supine Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Relevance
Item
Clinically relevant?
boolean
C2347946 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Relevance
Item
Clinically relevant?
boolean
C2347946 (UMLS CUI [1])
Respiratory Rate
Item
Respiratory Rate
integer
C0231832 (UMLS CUI [1])
Relevance
Item
Clinically relevant?
boolean
C2347946 (UMLS CUI [1])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Temperature
C0005903 (UMLS CUI-1)
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Time of measurement
Item
Time of measurement
time
C0242485 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Method of Measurement
integer
C1299991 (UMLS CUI [1,1])
C0039476 (UMLS CUI [1,2])
Code List
Method of Measurement
CL Item
Other (99)
(Comment:en)
CL Item
Tympanic (4)
(Comment:en)
CL Item
Rectal (3)
(Comment:en)
CL Item
Axillary (2)
(Comment:en)
CL Item
Oral (1)
(Comment:en)
Other Method
Item
Kind of Other Method
text
C1299991 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Relevance
Item
Clinically relevant?
boolean
C2347946 (UMLS CUI [1])
Item Group
Laboratory Tests
C1880016 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Clinical Chemistry sample collected
Item
Clinical Chemistry sample collected
boolean
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Item
If 'no', please provide reason
integer
C2826287 (UMLS CUI [1])
Code List
If 'no', please provide reason
CL Item
Other (99)
CL Item
Missed sample collection (5)
CL Item
Patient not able to provide urine sample (4)
CL Item
Unable to obtain venous access (3)
CL Item
Hemolyzed sample (2)
CL Item
Insufficient amount collected (1)
Other, please specify
Item
Other, please specify
text
C3845569 (UMLS CUI [1])
Collection Date
Item
Collection Date
date
C1302413 (UMLS CUI [1])
Collection time
Item
Collection time
time
C4064021 (UMLS CUI [1])
Central Laboratory ID
Item
Central Lab ID
text
C1880016 (UMLS CUI [1,1])
C2986056 (UMLS CUI [1,2])
Sample sent to central lab
Item
Sample sent to central lab
boolean
C0370003 (UMLS CUI [1,1])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
Not done reason
Item
If 'no', please provide reason
text
C2826287 (UMLS CUI [1])
Hematology sample collected
Item
Hematology sample collected
boolean
C0200345 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Item
If 'no', please provide reason
integer
C2826287 (UMLS CUI [1])
Code List
If 'no', please provide reason
CL Item
Other (99)
CL Item
Missed sample collection (5)
CL Item
Patient not able to provide urine sample (4)
CL Item
Unable to obtain venous access (3)
CL Item
Hemolyzed sample (2)
CL Item
Insufficient amount collected (1)
Other, please specify
Item
Other, please specify
text
C3845569 (UMLS CUI [1])
Collection Date
Item
Collection Date
date
C1302413 (UMLS CUI [1])
Collection time
Item
Collection time
time
C4064021 (UMLS CUI [1])
Central Laboratory ID
Item
Central Lab ID
text
C1880016 (UMLS CUI [1,1])
C2986056 (UMLS CUI [1,2])
Sample sent to central lab
Item
Sample sent to central lab
boolean
C0370003 (UMLS CUI [1,1])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
Not done reason
Item
If 'no', please provide reason
text
C2826287 (UMLS CUI [1])
Urinalysis sample collected
Item
Urinalysis sample collected
boolean
C0200345 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Item
If 'no', please provide reason
integer
C2826287 (UMLS CUI [1])
Code List
If 'no', please provide reason
CL Item
Other (99)
CL Item
Missed sample collection (5)
CL Item
Patient not able to provide urine sample (4)
CL Item
Unable to obtain venous access (3)
CL Item
Hemolyzed sample (2)
CL Item
Insufficient amount collected (1)
Other, please specify
Item
Other, please specify
text
C3845569 (UMLS CUI [1])
Collection Date
Item
Collection Date
date
C1302413 (UMLS CUI [1])
Collection time
Item
Collection time
time
C4064021 (UMLS CUI [1])
Central Laboratory ID
Item
Central Lab ID
text
C1880016 (UMLS CUI [1,1])
C2986056 (UMLS CUI [1,2])
Sample sent to central lab
Item
Sample sent to central lab
boolean
C0370003 (UMLS CUI [1,1])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
Not done reason
Item
If 'no', please provide reason
text
C2826287 (UMLS CUI [1])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Local Lab at Screening
C0587081 (UMLS CUI-1)
Clinical Chemistry sample collected
Item
Clinical Chemistry sample collected
boolean
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Item
If 'no', please provide reason
integer
C2826287 (UMLS CUI [1])
Code List
If 'no', please provide reason
CL Item
Other (99)
CL Item
Missed sample collection (5)
CL Item
Patient not able to provide urine sample (4)
CL Item
Unable to obtain venous access (3)
CL Item
Hemolyzed sample (2)
CL Item
Insufficient amount collected (1)
Other, please specify
Item
Other, please specify
text
C3845569 (UMLS CUI [1])
Collection Date
Item
Collection Date
date
C1302413 (UMLS CUI [1])
Collection time
Item
Collection time
time
C4064021 (UMLS CUI [1])
Serum Creatinine
Item
Serum Creatinine
float
C0201976 (UMLS CUI [1])
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
Item
Lab unit
integer
C1519795 (UMLS CUI [1])
Code List
Lab unit
CL Item
other (99)
CL Item
microKat/L (8)
CL Item
L/L (7)
CL Item
g/L (6)
CL Item
mg/dL (5)
CL Item
g/dL (4)
CL Item
μmol/L (3)
CL Item
mmol/L (2)
CL Item
U/L (IU/L) (1)
other unit
Item
other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
lower limit of normal
Item
lower limit of normal
integer
C1518030 (UMLS CUI [1])
ULN
Item
Upper limit of normal
integer
C1519815 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
AST (GOT)
Item
AST (GOT)
integer
C0201899 (UMLS CUI [1])
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
other unit
Item
other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
lower limit of normal
Item
lower limit of normal
integer
C1518030 (UMLS CUI [1])
ULN
Item
Upper limit of normal
integer
C1519815 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
ALT (GPT)
Item
ALT (GPT)
integer
C0201836 (UMLS CUI [1])
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
other unit
Item
other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
lower limit of normal
Item
lower limit of normal
integer
C1518030 (UMLS CUI [1])
ULN
Item
Upper limit of normal
integer
C1519815 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
ALP
Item
ALP
integer
C0201850 (UMLS CUI [1])
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
other unit
Item
other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
lower limit of normal
Item
lower limit of normal
integer
C1518030 (UMLS CUI [1])
ULN
Item
Upper limit of normal
integer
C1519815 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
Total Bilirubin
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1])
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
other unit
Item
other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
lower limit of normal
Item
lower limit of normal
integer
C1518030 (UMLS CUI [1])
ULN
Item
Upper limit of normal
integer
C1519815 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
Creatinine Clearance
Item
Creatinine Clearance
float
C0373595 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
Hematology sample collected
Item
Hematology sample collected
boolean
C0200345 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Item
If 'no', please provide reason
integer
C2826287 (UMLS CUI [1])
Code List
If 'no', please provide reason
CL Item
Other (99)
CL Item
Missed sample collection (5)
CL Item
Patient not able to provide urine sample (4)
CL Item
Unable to obtain venous access (3)
CL Item
Hemolyzed sample (2)
CL Item
Insufficient amount collected (1)
Other, please specify
Item
Other, please specify
text
C3845569 (UMLS CUI [1])
Collection Date
Item
Collection Date
date
C1302413 (UMLS CUI [1])
Collection time
Item
Collection time
time
C4064021 (UMLS CUI [1])
WBC
Item
WBC
float
C0023508 (UMLS CUI [1])
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
other unit
Item
other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
lower limit of normal
Item
lower limit of normal
integer
C1518030 (UMLS CUI [1])
ULN
Item
Upper limit of normal
integer
C1519815 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
Neutrophil count
Item
Neutrophil count
float
C0948762 (UMLS CUI [1])
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
other unit
Item
other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
lower limit of normal
Item
lower limit of normal
integer
C1518030 (UMLS CUI [1])
ULN
Item
Upper limit of normal
integer
C1519815 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
Hematocrit
Item
Hematocrit
float
C0518014 (UMLS CUI [1])
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
other unit
Item
other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
lower limit of normal
Item
lower limit of normal
integer
C1518030 (UMLS CUI [1])
ULN
Item
Upper limit of normal
integer
C1519815 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
other unit
Item
other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
lower limit of normal
Item
lower limit of normal
integer
C1518030 (UMLS CUI [1])
ULN
Item
Upper limit of normal
integer
C1519815 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
Platelets
Item
Platelet count
float
C0005821 (UMLS CUI [1])
not done
Item
not done
boolean
C1272696 (UMLS CUI [1])
other unit
Item
other lab unit
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
lower limit of normal
Item
lower limit of normal
integer
C1518030 (UMLS CUI [1])
ULN
Item
Upper limit of normal
integer
C1519815 (UMLS CUI [1])
Significance
Item
Was this value clinically signifcant?
boolean
C2826633 (UMLS CUI [1])
Pregnancy Test done
Item
Pregnancy Test done
boolean
C0032976 (UMLS CUI [1])
Item
If 'no', please provide reason
integer
C2826287 (UMLS CUI [1])
Code List
If 'no', please provide reason
CL Item
Other (2)
CL Item
Menopausal (1)
Other reason
Item
Other reason
text
C3840932 (UMLS CUI [1])
Item
Method of Testing
integer
C0871511 (UMLS CUI [1])
Code List
Method of Testing
CL Item
urine (2)
CL Item
serum (1)
Item
Result of testing
integer
C0427777 (UMLS CUI [1])
Code List
Result of testing
CL Item
positive (2)
CL Item
negative (1)
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])
Item Group
Microbiology
C0085672 (UMLS CUI-1)
Microbiology specimen collection
Item
Was a specimen collected?
boolean
C0200345 (UMLS CUI [1,1])
C0025952 (UMLS CUI [1,2])
Item
If no, please provide reason
integer
C2826287 (UMLS CUI [1])
Code List
If no, please provide reason
CL Item
Other (99)
CL Item
Attempt made but unable to obtain/produce sample (1)
inability
Item
Please specify inability
text
C1299582 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
inability
Item
Please specify other reason
text
C1299582 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
Specimen collection date
Item
Date of collection
date
C1302413 (UMLS CUI [1])
Specimen collection time
Item
Time of Collection
time
C4064021 (UMLS CUI [1])
Item
Culture Processing Type
integer
C0200949 (UMLS CUI [1,1])
C0037793 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Code List
Culture Processing Type
CL Item
Anaerobic (2)
CL Item
Aerobic (1)
Item
Site of sample
integer
C0200345 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Code List
Site of sample
CL Item
Other (99)
CL Item
Blood  (2)
CL Item
Intra-Abdominal  (1)
Item
Intra-Abdominal, please specify
integer
C1512910 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Code List
Intra-Abdominal, please specify
CL Item
Other (99)
CL Item
Surgical Swab (4)
CL Item
Peritoneal Fluid (3)
CL Item
Tissue (2)
CL Item
Pus (1)
Other site, please specify
Item
Other site, please specify
text
C1515974 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
Item
Culture outcome
integer
C2242979 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Code List
Culture outcome
CL Item
Not done (99)
CL Item
Growth (2)
CL Item
No Growth (1)
Isolate name
Item
Isolate name
text
C1764827 (UMLS CUI [1])
Item
Pathogen Type
integer
C0450254 (UMLS CUI [1])
Code List
Pathogen Type
CL Item
Fungal (2)
CL Item
Bacterial (1)
Item
Isolate Classification
integer
C1764827 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
Code List
Isolate Classification
CL Item
Contaminant (2)
CL Item
Pathogen (1)
Disc Zone ATM-AVI
Item
Disc Zone ATM-AVI
text
C1283010 (UMLS CUI [1,1])
C0004521 (UMLS CUI [1,2])
C1283010 (UMLS CUI [2,1])
C3489748 (UMLS CUI [2,2])
Sample sent to Central Lab
Item
Sample sent to Central Lab?
boolean
C1880016 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,3])
Central Laboratory Accession ID Number
Item
Central Lab Accession ID Number
text
C2826726 (UMLS CUI [1,1])
C1880016 (UMLS CUI [1,2])
Not done reason
Item
If no, reason
text
C2826287 (UMLS CUI [1])
Backup Sample sent to Central Laboratory
Item
Backup Sample sent to Central Lab (if necessary)?
boolean
C0370003 (UMLS CUI [1,1])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
Comment
Item
CRF Comment
text
C0947611 (UMLS CUI [1])