ID

15280

Description

Study documentation part: Visits 1 (Screening), Study week -4 to 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.

Keywords

Versions (3)
  1. 9/17/15 9/17/15 - Julian Varghese
  2. 9/22/15 9/22/15 - Julian Varghese
  3. 5/24/16 5/24/16 -
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May 24, 2016

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Creative Commons BY-NC 3.0 Legacy
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Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069

English

Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

4 forms  
Administration and Instructions for CRF Completion
Description

Administration and Instructions for CRF Completion

Subject ID
Description

Format: [3-digit centre number] - [3-digit subject number]

Data type

text

Alias
UMLS CUI [1]
C2348585
Patient Name (initials acceptable)
Description

Patient Name

Data type

text

Alias
UMLS CUI [1]
C1299487
Instructions for CRF Completion
Description

General advices: Please fill in the CRF pages promptly and legibly with an indelible black ballpoint. In case of missing values, please use the following abbreviations for documentation: NA = not available, not assessed, not applicable ND = not done NK = not known Necessary corrections on the CRF have to be carried out in accordance with GCP (which means: cross out with one line the wrong entry, write down the correct information next to the former entry and confirm with date and initials). The utilization of tipp-ex/whiteout is not allowed. Input format for date is dd-mm-yyyy, missing parts of date have to be marked with NK (e. g. “NK-01-2007”). Please be aware of the fact that the investigator or an authorised member of the investigator's staff has to sign at the designated positions to confirm completeness and correctness of entered data. The CRFs are provided as PDF documents. Please enter the Subject ID on the first page of the PDF and print out the required pages to start with documentation. The Subject ID will be printed in the header of each page automatically. • The original has to be sent to the destination address for CRFs. • A copy is kept at your trial site. Corrections after having sent the original to the destination address have to be carried out as follows: • Complete/correct the documentation on your trial site's copy. • Send these corrections to the destination address for CRFs and keep a copy of the corrected page(s) at your trial site.

Data type

text

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C1442085
Date of written Informed Consent
Description

Date of written Informed Consent

Data type

date

Demographic Data
Description

Demographic Data

Age
Description

Age

Data type

integer

Measurement units
  • years
Alias
UMLS CUI [1]
C0001779
years
Sex
Description

Sex

Data type

integer

Alias
UMLS CUI [1]
C0150831
Blood pregnancy test
Description

Blood pregnancy test

Blood Pregnancy Test done, specify test date
Description

Blood Pregnancy Test done, specify test date

Data type

date

Alias
UMLS CUI [1,1]
C0850355
UMLS CUI [1,2]
C0011008
Result:
Description

Result:

Data type

text

Alias
UMLS CUI [1]
C0427777
Blood pregnancy test not done, reason:
Description

Blood pregnancy test not done, reason:

Data type

text

Alias
UMLS CUI [1,1]
C0850355
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Testing for JC virus antibodies
Description

Testing for JC virus antibodies

JC virus antibodies test done, specify test date:
Description

JC virus antibodies test done, specify test date:

Data type

date

Alias
UMLS CUI [1,1]
C3511565
UMLS CUI [1,2]
C0011008
Result:
Description

Result:

Data type

text

Alias
UMLS CUI [1,1]
C3511565
UMLS CUI [1,2]
C2346633
JC virus antibodies test not done, reason
Description

JC virus antibodies test not done, reason

Data type

text

Alias
UMLS CUI [1,1]
C3511565
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Medical History
Description

Medical History

Medical History Description: Please state diagnosis, if known
Description

Medical History Description: Please state diagnosis, if known

Data type

text

Alias
UMLS CUI [1]
C0011900
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C2826738
End Date
Description

End Date

Data type

date

Alias
UMLS CUI [1]
C2826747
Ongoing at Start of Study
Description

Medical History Ongoing

Data type

text

Alias
UMLS CUI [1]
C2826680
MS Medical History
Description

MS Medical History

Date of MS diagnosis
Description

Date of MS diagnosis

Data type

date

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0011008
Date of MS diagnosis unknown
Description

Date of MS diagnosis unknown

Data type

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0439673
Date of first MS symptoms
Description

Date of first MS symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0574845
Date of first MS symptoms unknown
Description

Date of first MS symptoms unknown

Data type

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0574845
UMLS CUI [1,3]
C0439673
Number of relapses since MS diagnosis
Description

Number of relapses since MS diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0856120
UMLS CUI [1,2]
C0449788
Number of relapses since MS diagnosis unknown
Description

Number of relapses since MS diagnosis unknown

Data type

text

Alias
UMLS CUI [1,1]
C0856120
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0439673
Number of relapses in the last 12 months
Description

Number of relapses in the last 12 months

Data type

text

Alias
UMLS CUI [1,1]
C0856120
UMLS CUI [1,2]
C0449788
Number of relapses in the last 12 months unknown
Description

Number of relapses in the last 12 months unknown

Data type

boolean

Alias
UMLS CUI [1,1]
C0856120
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0439673
Onset date of most recent relapse
Description

Onset date of most recent relapse

Data type

date

Alias
UMLS CUI [1,1]
C0856120
UMLS CUI [1,2]
C1513491
UMLS CUI [1,3]
C0574845
Onset date of most recent relapse unknown
Description

Onset date of most recent relapse unknown

Data type

text

Alias
UMLS CUI [1,1]
C0856120
UMLS CUI [1,2]
C1513491
UMLS CUI [1,3]
C0574845
UMLS CUI [1,4]
C0439673
MS Treatment History
Description

MS Treatment History

Active substance/nondrug therapy
Description

Name of the active substance:

Data type

integer

Alias
UMLS CUI [1]
C1254351
UMLS CUI [2]
C0599938
Treatment of MS relapse
Description

Treatment of MS relapse

Data type

boolean

Alias
UMLS CUI [1,1]
C0856120
UMLS CUI [1,2]
C0087111
Start Date
Description

TreatmentStartDate

Data type

date

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0808070
End Date
Description

TreatmentEndDate

Data type

date

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0806020
ongoing
Description

ongoingtreatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0549178
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Similar models

Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

4 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administration and Instructions for CRF Completion
Patient Study ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Patient Name
Item
Patient Name (initials acceptable)
text
C1299487 (UMLS CUI [1])
Instructions for CRF Completion
Item
text
C1516308 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
Date of written Informed Consent
Item
Date of written Informed Consent
date
Item Group
Demographic Data
Age
Item
Age
integer
C0001779 (UMLS CUI [1])
Item
Sex
integer
C0150831 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
male (m)
CL Item
female (f)
Item Group
Blood pregnancy test
Blood Pregnancy Test done, specify test date
Item
Blood Pregnancy Test done, specify test date
date
C0850355 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Result:
Item
text
C0427777 (UMLS CUI [1])
Item
Blood pregnancy test not done, reason:
text
C0850355 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Blood pregnancy test not done, reason:
Code List
Blood 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
other: (other:)
Item Group
Testing for JC virus antibodies
JC virus antibodies test done, specify test date:
Item
date
C3511565 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result:
text
C3511565 (UMLS CUI [1,1])
C2346633 (UMLS CUI [1,2])
Result:
Code List
Result:
CL Item
positive (1)
CL Item
negative (2)
JC virus antibodies test not done, reason
Item
JC virus antibodies test not done, reason
text
C3511565 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item Group
Medical History
Medical History Description: Please state diagnosis, if known
Item
Medical History Description: Please state diagnosis, if known
text
C0011900 (UMLS CUI [1])
Start Date
Item
Start Date
date
C2826738 (UMLS CUI [1])
End Date
Item
End Date
date
C2826747 (UMLS CUI [1])
Item
Ongoing at Start of Study
text
C2826680 (UMLS CUI [1])
Medical History Ongoing
Code List
Ongoing at Start of Study
CL Item
NO (N)
CL Item
YES (Y)
Item Group
MS Medical History
Date of MS diagnosis
Item
Date of MS diagnosis
date
C0026769 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Date of MS diagnosis unknown
Item
Date of MS diagnosis unknown
boolean
C0026769 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0439673 (UMLS CUI [1,4])
Date of first MS symptoms
Item
Date of first MS symptoms
date
C0026769 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Date of first MS symptoms unknown
Item
Date of first MS symptoms unknown
boolean
C0026769 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Number of relapses since MS diagnosis
Item
Number of relapses since MS diagnosis
integer
C0856120 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of relapses since MS diagnosis unknown
Item
Number of relapses since MS diagnosis unknown
text
C0856120 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Number of relapses in the last 12 months
Item
Number of relapses in the last 12 months
text
C0856120 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of relapses in the last 12 months unknown
Item
Number of relapses in the last 12 months unknown
boolean
C0856120 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Onset date of most recent relapse
Item
Onset date of most recent relapse
date
C0856120 (UMLS CUI [1,1])
C1513491 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
Onset date of most recent relapse unknown
Item
Onset date of most recent relapse unknown
text
C0856120 (UMLS CUI [1,1])
C1513491 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
C0439673 (UMLS CUI [1,4])
Item
Active substance/nondrug therapy
integer
C1254351 (UMLS CUI [1])
C0599938 (UMLS CUI [2])
Active substance/nondrug therapy
Code List
Active substance/nondrug therapy
CL Item
1 Alemtuzumab (1)
CL Item
2 Azathioprine (2)
CL Item
3 Cyclophosphamide (3)
CL Item
4 Dimethyl fumarate  (4)
CL Item
5 Fingolimod (5)
CL Item
6 Glatiramer acetate (6)
CL Item
7 Immunoglobulins (7)
CL Item
8 Interferon beta (8)
CL Item
9 Methylprednisolone* (9)
CL Item
10 Mitoxantrone (10)
CL Item
11 Natalizumab (11)
CL Item
12 Rituximab (12)
CL Item
13 Teriflunomide (13)
CL Item
14 Other active substance (14)
CL Item
15 Physiotherapy (15)
CL Item
16 Plasmapheresis (16)
CL Item
17 Other Non-drug therapy (17)
Treatment of MS relapse
Item
Treatment of MS relapse
boolean
C0856120 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
TreatmentStartDate
Item
Start Date
date
C0087111 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
TreatmentEndDate
Item
End Date
date
C0087111 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
ongoingtreatment
Item
ongoing
boolean
C0087111 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
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