ID

16611

Descrição

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

Palavras-chave

  1. 26/07/2016 26/07/2016 -
  2. 18/11/2016 18/11/2016 -
  3. 13/04/2021 13/04/2021 - Dr. rer. medic Philipp Neuhaus
  4. 17/11/2021 17/11/2021 -
Transferido a

26 de julho de 2016

DOI

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Licença

Creative Commons BY-NC 3.0

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Device Accountability Log: CRF Wisconsin Madison

Device Accountability Log: CRF Wisconsin Madison

Header
Descrição

Header

PI Name
Descrição

PI Name

Tipo de dados

text

Protocol or IRB Number
Descrição

Protocol or IRB Number

Tipo de dados

integer

Protocol Short Title
Descrição

Protocol Short Title

Tipo de dados

text

Number of Page
Descrição

Number of Page

Tipo de dados

integer

Total amount of pages
Descrição

Total amount of pages

Tipo de dados

integer

Device Accountability Log: Device Receipt
Descrição

Device Accountability Log: Device Receipt

Date Received
Descrição

Date Received

Tipo de dados

date

Batch # or Device Type
Descrição

Batch # or Device Type

Tipo de dados

text

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

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

Tipo de dados

integer

Received by (staff initials)
Descrição

Received by (staff initials)

Tipo de dados

text

Device Accountability Log: Device Use
Descrição

Device Accountability Log: Device Use

Date used
Descrição

Date used

Tipo de dados

date

Subject Study ID
Descrição

Subject Study ID

Tipo de dados

integer

Dispensed by (staff initials)
Descrição

Dispensed by (staff initials)

Tipo de dados

text

Device Accountability Log: Device Return/Repair/Destruction
Descrição

Device Accountability Log: Device Return/Repair/Destruction

Device Position
Descrição

RET = Returned DES = Destroyed REP = Repaired

Tipo de dados

text

Date of final Device Disposition
Descrição

Date of final Device Disposition

Tipo de dados

date

Reason
Descrição

Reason

Tipo de dados

text

Confirmed by (staff initials)
Descrição

Confirmed by (staff initials)

Tipo de dados

text

Comments
Descrição

Comments

Tipo de dados

text

Similar models

Device Accountability Log: CRF Wisconsin Madison

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Header
PI Name
Item
PI Name
text
Protocol or IRB Number
Item
Protocol or IRB Number
integer
Protocol Short Title
Item
Protocol Short Title
text
Number of Page
Item
Number of Page
integer
Total amount of pages
Item
Total amount of pages
integer
Item Group
Device Accountability Log: Device Receipt
Date Received
Item
Date Received
date
Batch # or Device Type
Item
Batch # or Device Type
text
Lot #, Serial #, or Model Number(s)
Item
Lot #, Serial #, or Model Number(s)
integer
Received by (staff initials)
Item
Received by (staff initials)
text
Item Group
Device Accountability Log: Device Use
Date used
Item
Date used
date
Subject Study ID
Item
Subject Study ID
integer
Dispensed by (staff initials)
Item
Dispensed by (staff initials)
text
Item Group
Device Accountability Log: Device Return/Repair/Destruction
Device Position
Item
Device Position
text
Date of final Device Disposition
Item
Date of final Device Disposition
date
Reason
Item
Reason
text
Confirmed by (staff initials)
Item
Confirmed by (staff initials)
text
Comments
Item
Comments
text

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