ID

15278

Beskrivning

Study documentation part: Visit 2 (Core Study), Study week 0 Study Details: A 24-week, multicenter, exploratory, two arm study to assess the effect of Dimethyl fumarate on ImmuneModulatory Action on T cells in patients with relapsing remitting Multiple Sclerosis. Principal Investigator PD Dr. Luisa Klotz, University Hospital Münster EudraCT - No.: 2014-003481-25. Clinical Trial No.r: NCT02461069.

Nyckelord

Versioner (5)
  1. 2015-09-22 2015-09-22 - Julian Varghese
  2. 2015-11-17 2015-11-17 - Julian Varghese
  3. 2016-02-11 2016-02-11 - Julian Varghese
  4. 2016-05-22 2016-05-22 -
  5. 2016-05-24 2016-05-24 -
Uppladdad den

24 maj 2016

DOI

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Creative Commons BY-NC 3.0
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Visit 2 (Core Study) Lab and Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069

Engelsk

Visit 2 (Core Study) Lab and Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

1 Formulär  
Visit Details
Beskrivning

Visit Details

Date of visit
Beskrivning

Visit date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Did the patient experience a relapse since screening? If yes, please document p. 29
Beskrivning

Did the patient experience a relapse since screening? � if yes, please document p. 29

Datatyp

boolean

Alias
UMLS CUI [1]
C0856120
Did the patient have an infection since screening? If yes, please document on Adverse Event form
Beskrivning

Did the patient have an infection since screening? If yes, please document on Adverse Event form

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
Further Visit Information
Beskrivning

1) Please document any Adverse Event occurring after signing the informed consent on the Adverse Events Form (p. 35 ff.). An Adverse Event is the appearance or worsening of any undesirable sign, symptom, or medical condition even if the event is not considered to be related to study drug. Medical conditions/diseases that are present before study entry are only considered Adverse Events if they worsen after study entry. 2) Please list all concomitant medications and significant non-drug therapies on the Concomi- tant Medication Form (p. 32). 3) Please document the date of the first Tecfidera® administration on the Study Medication Form (p. 30 f.).

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0920316
UMLS CUI [1,3]
C1442085
Laboratory Urine Pregnancy Test (Please perform the test only on suspicion of pregnancy.)
Beskrivning

Laboratory Urine Pregnancy Test (Please perform the test only on suspicion of pregnancy.)

Test done, specify: Test Date:
Beskrivning

Urine pregnancy test done, specify: Test Date:

Datatyp

date

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C0011008
Urinary Pregnancy Test Result
Beskrivning

Urinary Pregnancy Test Result

Datatyp

text

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C0456984
Urine pregnancy test not done, reason
Beskrivning

Urine pregnancy test not done, reason

Datatyp

text

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0392360
Date of blood sampling
Beskrivning

Date of blood sampling

Date of blood sampling
Beskrivning

Date of blood sampling

Datatyp

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
Hematology
Beskrivning

Hematology

Leucocytes
Beskrivning

Leucocytes

Datatyp

float

Alias
UMLS CUI [1]
C0023516
Leucocytes measurement unit
Beskrivning

Leucocytes measurement unit

Datatyp

text

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C1519795
Leucocytes Count not done
Beskrivning

Leucocytes Count Procesdure not done

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C1272696
Lymphocytes
Beskrivning

Lymphocytes

Datatyp

text

Alias
UMLS CUI [1]
C0024264
Lymphocytes Count Procesdure not done
Beskrivning

Lymphocytes Count Procesdure not done

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024264
UMLS CUI [1,2]
C1272696
Liver Function
Beskrivning

Liver Function

Aspartate transaminase (AST) (SGOT)
Beskrivning

AST

Datatyp

float

Alias
UMLS CUI [1]
C0201899
AST Measurement Unit
Beskrivning

AST Measurement Unit

Datatyp

text

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C1519795
AST measurement not done
Beskrivning

AST measurement not done

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C1272696
Alanine transaminase (ALT) (SGPT)
Beskrivning

ALT

Datatyp

float

Alias
UMLS CUI [1]
C0201836
ALT Measurement Unit
Beskrivning

ALT measurement unit

Datatyp

text

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1519795
ALT measurement not done
Beskrivning

ALT measurement not done

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1272696
Gamma Glutamyl Transpeptidase Measurement
Beskrivning

GGT

Datatyp

float

Alias
UMLS CUI [1]
C0202035
GGT Measurement Unit
Beskrivning

GGT Measurement Unit

Datatyp

text

Alias
UMLS CUI [1,1]
C0202035
UMLS CUI [1,2]
C1519795
GGT Measurement not done
Beskrivning

GGT Measurement not done

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0202035
UMLS CUI [1,2]
C1272696
Renal function
Beskrivning

Renal function

Creatinine
Beskrivning

Creatinine, Serum

Datatyp

float

Alias
UMLS CUI [1]
C0201976
Serum Creatinine Measurment Unit
Beskrivning

Creatinine, Serum Measurment Unit

Datatyp

text

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1519795
Serum Creatinine Measurment not done
Beskrivning

Serum Creatinine Measurment not done

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1272696
Blood urea nitrogen
Beskrivning

Blood Urea Nitrogen

Datatyp

float

Alias
UMLS CUI [1]
C0005845
Blood urea nitrogen measurement unit
Beskrivning

Blood urea nitrogen measurement unit

Datatyp

text

Alias
UMLS CUI [1,1]
C0005845
UMLS CUI [1,2]
C1519795
Blood urea nitrogen measurement not done
Beskrivning

Blood urea nitrogen measurement not done

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005845
UMLS CUI [1,2]
C1272696
Medical Examination
Beskrivning

Medical Examination

Medical Examination performed at:
Beskrivning

Medical Examination performed at:

Datatyp

date

Alias
UMLS CUI [1,1]
C0582103
UMLS CUI [1,2]
C0011008
Heart rate (in bpm):
Beskrivning

HEART RATE

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Systolic blood pressure
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Temperature
Beskrivning

Temperature

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Expanded disability status scale (EDSS)
Beskrivning

Expanded disability status scale (EDSS)

EDSS performed at
Beskrivning

EDSS performed at

Datatyp

date

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0011008
Visual testing
Beskrivning

Converted FS Score

Datatyp

integer

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0042789
Brianstem testing
Beskrivning

Brainstem testing

Datatyp

integer

Pyramidal testing
Beskrivning

Pyramidal testing

Datatyp

text

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0228060
Cerebellar testing
Beskrivning

Cerebellar testing

Datatyp

text

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0742034
Bowel/Bladder
Beskrivning

Bowel/Bladder

Datatyp

integer

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C2707247
Cerebral testing
Beskrivning

Cerebral testing

Datatyp

text

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0006104
Ambulation Score
Beskrivning

Ambulation Score

Datatyp

text

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0080331
EDSS step
Beskrivning

EDSS score

Datatyp

float

Alias
UMLS CUI [1]
C0451246
Signature
Beskrivning

Signature

Study Drug Prescription information
Beskrivning

Please hand out a prescription for the study drug to the patient and document the amount of prescribed study medication on the Drug Accountability Form (Investigator Site File).

Datatyp

text

Alias
UMLS CUI [1]
C2239117
Please hand out a Patient's Diary to the patient.
Beskrivning

Please hand out a Patient's Diary to the patient.

Datatyp

text

Alias
UMLS CUI [1]
C0018700
Date
Beskrivning

Investigator Signature Date

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Name/Signature Investigator
Beskrivning

Name/Signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Visit 2 (Core Study) Lab and Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Visit Details
Visit date
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Multiple sclerosis relapse
Item
Did the patient experience a relapse since screening? If yes, please document p. 29
boolean
C0856120 (UMLS CUI [1])
Infection
Item
Did the patient have an infection since screening? If yes, please document on Adverse Event form
boolean
C0009450 (UMLS CUI [1])
Further Visit Information
Item
Further Visit Information
text
C0545082 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C1442085 (UMLS CUI [1,3])
Item Group
Laboratory Urine Pregnancy Test (Please perform the test only on suspicion of pregnancy.)
Urine pregnancy test done, specify: Test Date:
Item
Test done, specify: Test Date:
date
C0430056 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Urinary Pregnancy Test Result
text
C0430056 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Urinary Pregnancy Test Result
Code List
Urinary Pregnancy Test Result
CL Item
positive (positive)
CL Item
negative (negative)
Item
Urine pregnancy test not done, reason
text
C0430056 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Urine pregnancy test not done, reason
Code List
Urine pregnancy test not done, reason
CL Item
male participant (male participant)
CL Item
female participant with no childbearing potential (female participant with no childbearing potential)
CL Item
no suspicion of pregnancy (no suspicion of pregnancy)
CL Item
other (other)
Item Group
Date of blood sampling
Date of blood sampling
Item
Date of blood sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Hematology
Leucocytes
Item
Leucocytes
float
C0023516 (UMLS CUI [1])
Item
Leucocytes measurement unit
text
C0023508 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Leucocytes measurement unit
Code List
Leucocytes measurement unit
CL Item
10^3 /µL  (10^3 /µL )
CL Item
/mm^3 (/µL )
CL Item
other (other)
Leucocytes Count Procesdure not done
Item
Leucocytes Count not done
boolean
C0023508 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item
Lymphocytes
text
C0024264 (UMLS CUI [1])
Lymphocytes
Code List
Lymphocytes
CL Item
10^3 /µL  (10^3 /µL )
CL Item
/mm^3 (/µL )
CL Item
other (other)
Lymphocytes Count Procesdure not done
Item
Lymphocytes Count Procesdure not done
boolean
C0024264 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item Group
Liver Function
AST
Item
Aspartate transaminase (AST) (SGOT)
float
C0201899 (UMLS CUI [1])
Item
AST Measurement Unit
text
C0201899 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
AST Measurement Unit
Code List
AST Measurement Unit
CL Item
U/L (U/L)
CL Item
nkat/L (nmol/s*L )
CL Item
other (other)
CL Item
µkat/L (µmol/s*L )
AST measurement not done
Item
AST measurement not done
boolean
C0201899 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
ALT
Item
Alanine transaminase (ALT) (SGPT)
float
C0201836 (UMLS CUI [1])
Item
ALT Measurement Unit
text
C0201836 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
ALT measurement unit
Code List
ALT Measurement Unit
CL Item
U/L (U/L)
CL Item
nkat/L (nmol/s*L )
CL Item
other (other)
ALT measurement not done
Item
ALT measurement not done
boolean
C0201836 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
GGT
Item
Gamma Glutamyl Transpeptidase Measurement
float
C0202035 (UMLS CUI [1])
Item
GGT Measurement Unit
text
C0202035 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
GGT Measurement Unit
Code List
GGT Measurement Unit
CL Item
U/L (U/L)
CL Item
nkat/L (nmol/s*L )
CL Item
other (other)
CL Item
µkat/L (µmol/s*L )
GGT Measurement not done
Item
GGT Measurement not done
boolean
C0202035 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item Group
Renal function
Creatinine, Serum
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Item
Serum Creatinine Measurment Unit
text
C0201976 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Creatinine, Serum Measurment Unit
Code List
Serum Creatinine Measurment Unit
CL Item
mg/dL (mg/dL)
CL Item
µmol/L (µmol/L)
CL Item
other (other)
Serum Creatinine Measurment not done
Item
Serum Creatinine Measurment not done
boolean
C0201976 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Blood Urea Nitrogen
Item
Blood urea nitrogen
float
C0005845 (UMLS CUI [1])
Item
Blood urea nitrogen measurement unit
text
C0005845 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Blood urea nitrogen measurement unit
Code List
Blood urea nitrogen measurement unit
CL Item
mg/dL (mg/dL)
CL Item
µmol/L (µmol/L)
CL Item
other (other)
Blood urea nitrogen measurement not done
Item
Blood urea nitrogen measurement not done
boolean
C0005845 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item Group
Medical Examination
Medical Examination performed at:
Item
Medical Examination performed at:
date
C0582103 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
HEART RATE
Item
Heart rate (in bpm):
integer
C0018810 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Item Group
Expanded disability status scale (EDSS)
EDSS performed at
Item
EDSS performed at
date
C0451246 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Visual testing
integer
C0451246 (UMLS CUI [1,1])
C0042789 (UMLS CUI [1,2])
Visual testing
Code List
Visual testing
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
CL Item
5 (6)
CL Item
6 (7)
Item
Brianstem testing
integer
Brianstem testing
Code List
Brianstem testing
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
CL Item
5 (6)
Item
Pyramidal testing
text
C0451246 (UMLS CUI [1,1])
C0228060 (UMLS CUI [1,2])
Pyramidal testing
Code List
Pyramidal testing
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
Item
Cerebellar testing
text
C0451246 (UMLS CUI [1,1])
C0742034 (UMLS CUI [1,2])
Cerebellar testing
Code List
Cerebellar testing
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
X (X)
Item
Bowel/Bladder
integer
C0451246 (UMLS CUI [1,1])
C2707247 (UMLS CUI [1,2])
Bowel/Bladder
Code List
Bowel/Bladder
CL Item
Cerebellar testing (1)
Item
Cerebral testing
text
C0451246 (UMLS CUI [1,1])
C0006104 (UMLS CUI [1,2])
Cerebral testing
Code List
Cerebral testing
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
Item
Ambulation Score
text
C0451246 (UMLS CUI [1,1])
C0080331 (UMLS CUI [1,2])
Ambulation Score
Code List
Ambulation Score
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
EDSS score
Item
EDSS step
float
C0451246 (UMLS CUI [1])
Item Group
Signature
Study Drug Prescription information for patient
Item
Study Drug Prescription information
text
C2239117 (UMLS CUI [1])
Patient's Diary
Item
Please hand out a Patient's Diary to the patient.
text
C0018700 (UMLS CUI [1])
Investigator Signature Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Name/Signature Investigator
Item
Name/Signature Investigator
text
C2346576 (UMLS CUI [1])
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