ID

42150

Beschreibung

ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Device Accountability Log. Case Report Form (CRF)/Source Document templates were created for University of Wisconsin-Madison researchers. These templates are consistent with the FDA's CDASH (Clinical Data Acquisition Standards Harmonization) standards. The CDASH standards identify those elements that should be captured on a Case Report Form (CRF). The forms serve only as templates, and must be edited to meet the study data collection needs as described in the protocol.

Link

https://ictr.wisc.edu/CaseReptTempt

Stichworte

Versionen (4)
  1. 26.07.16 26.07.16 -
  2. 18.11.16 18.11.16 -
  3. 13.04.21 13.04.21 - Dr. rer. medic Philipp Neuhaus
  4. 17.11.21 17.11.21 -
Hochgeladen am

13. April 2021

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Device Accountability Log: CRF Wisconsin Madison

Englisch

Device Accountability Log: CRF Wisconsin Madison

1 Formulare  
Header
Beschreibung

Header

PI Name
Beschreibung

PI Name

Datentyp

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C1521895
Protocol or IRB Number
Beschreibung

Protocol or IRB Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348563
Protocol Short Title
Beschreibung

Protocol Short Title

Datentyp

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C1705824
Number of Page
Beschreibung

Number of Page

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0449788
Total amount of pages
Beschreibung

Total amount of pages

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0449788
Device Accountability Log: Device Receipt
Beschreibung

Device Accountability Log: Device Receipt

Date Received
Beschreibung

Date Received

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1514756
Batch # or Device Type
Beschreibung

Batch # or Device Type

Datentyp

text

Alias
UMLS CUI [1]
C3641829
UMLS CUI [2]
C0449497
Lot #, Serial #, or Model Number(s)
Beschreibung

Lot #, Serial #, or Model Number(s)

Datentyp

integer

Alias
UMLS CUI [1,1]
C1115660
UMLS CUI [1,2]
| C2348188
UMLS CUI [2]
C3274659
Received by (staff initials)
Beschreibung

Received by (staff initials)

Datentyp

text

Alias
UMLS CUI [1,1]
C1709850
UMLS CUI [1,2]
C2986440
Device Accountability Log: Device Use
Beschreibung

Device Accountability Log: Device Use

Date used
Beschreibung

Date used

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Subject Study ID
Beschreibung

Subject Study ID

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Dispensed by (staff initials)
Beschreibung

Dispensed by (staff initials)

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Device Accountability Log: Device Return/Repair/Destruction
Beschreibung

Device Accountability Log: Device Return/Repair/Destruction

Device Position
Beschreibung

RET = Returned DES = Destroyed REP = Repaired

Datentyp

text

Alias
UMLS CUI [1,1]
C0025080
UMLS CUI [1,2]
C0733755
Date of final Device Disposition
Beschreibung

Date of final Device Disposition

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0743223
UMLS CUI [1,3]
C0025080
Reason
Beschreibung

Reason

Datentyp

text

Alias
UMLS CUI [1]
C0392360
Confirmed by (staff initials)
Beschreibung

Confirmed by (staff initials)

Datentyp

text

Alias
UMLS CUI [1,1]
C0521093
UMLS CUI [1,2]
C2986440
Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
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Ähnliche Modelle

Device Accountability Log: CRF Wisconsin Madison

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header
PI Name
Item
PI Name
text
C0027365 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
Protocol or IRB Number
Item
Protocol or IRB Number
integer
C2348563 (UMLS CUI [1])
Protocol Short Title
Item
Protocol Short Title
text
C2348563 (UMLS CUI [1,1])
C1705824 (UMLS CUI [1,2])
Number of Page
Item
Number of Page
integer
C1704732 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Total amount of pages
Item
Total amount of pages
integer
C1704732 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item Group
Device Accountability Log: Device Receipt
Date Received
Item
Date Received
date
C0011008 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
Batch # or Device Type
Item
Batch # or Device Type
text
C3641829 (UMLS CUI [1])
C0449497 (UMLS CUI [2])
Lot #, Serial #, or Model Number(s)
Item
Lot #, Serial #, or Model Number(s)
integer
C1115660 (UMLS CUI [1,1])
| C2348188 (UMLS CUI [1,2])
C3274659 (UMLS CUI [2])
Received by (staff initials)
Item
Received by (staff initials)
text
C1709850 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Item Group
Device Accountability Log: Device Use
Date used
Item
Date used
date
C0011008 (UMLS CUI [1])
Subject Study ID
Item
Subject Study ID
integer
C2348585 (UMLS CUI [1])
Dispensed by (staff initials)
Item
Dispensed by (staff initials)
text
C2986440 (UMLS CUI [1])
Item Group
Device Accountability Log: Device Return/Repair/Destruction
Device Position
Item
Device Position
text
C0025080 (UMLS CUI [1,1])
C0733755 (UMLS CUI [1,2])
Date of final Device Disposition
Item
Date of final Device Disposition
date
C0011008 (UMLS CUI [1,1])
C0743223 (UMLS CUI [1,2])
C0025080 (UMLS CUI [1,3])
Reason
Item
Reason
text
C0392360 (UMLS CUI [1])
Confirmed by (staff initials)
Item
Confirmed by (staff initials)
text
C0521093 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
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