Engelsk

Study Completion

1 Formulär  
  1. StudyEvent: ODM
    1. Study Completion
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Site #
Beskrivning

Study centre number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient #
Beskrivning

patient ID

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

visit date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Study Completion
Beskrivning

Study Completion

Alias
UMLS CUI-1
C2348577
a. Discharge Summary attached?
Beskrivning

Discharge summary

Datatyp

boolean

Alias
UMLS CUI [1]
C0743221
b. Did patient complete study?
Beskrivning

Completion of study by subject

Datatyp

boolean

Alias
UMLS CUI [1]
C2348577
If b. = YES, complete below (indicate all that apply):
Beskrivning

If b. = YES, complete below (indicate all that apply):

Alias
UMLS CUI-1
C2348577
Resolution of underlying condition requiring anticoagulation
Beskrivning

Resolution of underlying condition requiring anticoagulation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514893
UMLS CUI [1,2]
C0277554
UMLS CUI [1,3]
C0449867
UMLS CUI [1,4]
C1514873
Patient transferred to oral or subcutaneous anticoagulation therapy
Beskrivning

Oral or subcutaneous anticoagulation therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0003281
UMLS CUI [2,2]
C0443315
Patient completed 14 days of study drug
Beskrivning

Study drug trial period complete

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C2347804
If b. = NO, indicate reason(s) below: (indicate all that apply)
Beskrivning

If b. = NO, indicate reason(s) below: (indicate all that apply)

Alias
UMLS CUI-1
C2348577
UMLS CUI-2
C1272696
Major bleed (as defined per protocol)
Beskrivning

Major bleed

Datatyp

boolean

Alias
UMLS CUI [1]
C3160769
Bleeding unresponsive to usual clinical interventions
Beskrivning

Bleeding unresponsive to treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0205269
Infusion interrupted for more than 24 consecutive hours
Beskrivning

Interruption of infusion procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512900
UMLS CUI [1,2]
C0574032
Adverse event (specify)
Beskrivning

Adverse event

Datatyp

boolean

Alias
UMLS CUI [1]
C0877248
Adverse event - specify:
Beskrivning

Adverse event - specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1521902
Intercurrent Illness (specify)
Beskrivning

Intercurrent Illness

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
Intercurrent Illness - specify:
Beskrivning

Intercurrent Illness - specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1521902
Protocol violation (specify)
Beskrivning

Protocol violation

Datatyp

boolean

Alias
UMLS CUI [1]
C1709750
Protocol violation - specify:
Beskrivning

Protocol violation - specify

Datatyp

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C1521902
Surgery (specify)
Beskrivning

Surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0543467
Surgery - specify:
Beskrivning

Surgery - specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1521902
Clinical efficacy of drug insufficient or lacking
Beskrivning

Lack of drug efficacy | drug efficacy insuficient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0235828
UMLS CUI [1,2]
C0304229
UMLS CUI [2,1]
C0598333
UMLS CUI [2,2]
C0231180
Patient request to withdraw
Beskrivning

Withdrawal by subject

Datatyp

boolean

Alias
UMLS CUI [1]
C1710677
Other (specify)
Beskrivning

Other reason why study not completed by subject

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C3840932
Other - specify:
Beskrivning

Other reason why study not completed by subject - specify

Datatyp

text

Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C3840932
UMLS CUI [1,4]
C1521902
I HAVE READ THESE CASE REPORT FORMS AND CONFIRM THAT THE INFORMATION GIVEN IS ACCURATE AND COMPLETE
Beskrivning

I HAVE READ THESE CASE REPORT FORMS AND CONFIRM THAT THE INFORMATION GIVEN IS ACCURATE AND COMPLETE

Alias
UMLS CUI-1
C2346576
Signed:
Beskrivning

Principal Investigator

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beskrivning

Date of Investigator Signature

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Study Completion

1 Formulär
  1. StudyEvent: ODM
    1. Study Completion
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study centre number
Item
Site #
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
patient ID
Item
Patient #
integer
C2348585 (UMLS CUI [1])
visit date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Study Completion
C2348577 (UMLS CUI-1)
Discharge summary
Item
a. Discharge Summary attached?
boolean
C0743221 (UMLS CUI [1])
Completion of study by subject
Item
b. Did patient complete study?
boolean
C2348577 (UMLS CUI [1])
Item Group
If b. = YES, complete below (indicate all that apply):
C2348577 (UMLS CUI-1)
Resolution of underlying condition requiring anticoagulation
Item
Resolution of underlying condition requiring anticoagulation
boolean
C1514893 (UMLS CUI [1,1])
C0277554 (UMLS CUI [1,2])
C0449867 (UMLS CUI [1,3])
C1514873 (UMLS CUI [1,4])
Oral or subcutaneous anticoagulation therapy
Item
Patient transferred to oral or subcutaneous anticoagulation therapy
boolean
C0003281 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0003281 (UMLS CUI [2,1])
C0443315 (UMLS CUI [2,2])
Study drug trial period complete
Item
Patient completed 14 days of study drug
boolean
C0304229 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Item Group
If b. = NO, indicate reason(s) below: (indicate all that apply)
C2348577 (UMLS CUI-1)
C1272696 (UMLS CUI-2)
Major bleed
Item
Major bleed (as defined per protocol)
boolean
C3160769 (UMLS CUI [1])
Bleeding unresponsive to treatment
Item
Bleeding unresponsive to usual clinical interventions
boolean
C0019080 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
Interruption of infusion procedures
Item
Infusion interrupted for more than 24 consecutive hours
boolean
C1512900 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
Adverse event
Item
Adverse event (specify)
boolean
C0877248 (UMLS CUI [1])
Adverse event - specify
Item
Adverse event - specify:
text
C0877248 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Intercurrent Illness
Item
Intercurrent Illness (specify)
boolean
C0009488 (UMLS CUI [1])
Intercurrent Illness - specify
Item
Intercurrent Illness - specify:
text
C0009488 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Protocol violation
Item
Protocol violation (specify)
boolean
C1709750 (UMLS CUI [1])
Protocol violation - specify
Item
Protocol violation - specify:
text
C1709750 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Surgery
Item
Surgery (specify)
boolean
C0543467 (UMLS CUI [1])
Surgery - specify
Item
Surgery - specify:
text
C0543467 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Lack of drug efficacy | drug efficacy insuficient
Item
Clinical efficacy of drug insufficient or lacking
boolean
C0235828 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0598333 (UMLS CUI [2,1])
C0231180 (UMLS CUI [2,2])
Withdrawal by subject
Item
Patient request to withdraw
boolean
C1710677 (UMLS CUI [1])
Other reason why study not completed by subject
Item
Other (specify)
boolean
C2348577 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
Other reason why study not completed by subject - specify
Item
Other - specify:
text
C2348577 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Item Group
I HAVE READ THESE CASE REPORT FORMS AND CONFIRM THAT THE INFORMATION GIVEN IS ACCURATE AND COMPLETE
C2346576 (UMLS CUI-1)
Investigator's Signature
Item
Signed:
text
C2346576 (UMLS CUI [1])
Date of Investigator Signature
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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