ID

16611

Description

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

Keywords

Versions (4)
  1. 7/26/16 7/26/16 -
  2. 11/18/16 11/18/16 -
  3. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  4. 11/17/21 11/17/21 -
Uploaded on

July 26, 2016

DOI

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License

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

English

Device Accountability Log: CRF Wisconsin Madison

1 forms  
Header
Description

Header

PI Name
Description

PI Name

Data type

text

Protocol or IRB Number
Description

Protocol or IRB Number

Data type

integer

Protocol Short Title
Description

Protocol Short Title

Data type

text

Number of Page
Description

Number of Page

Data type

integer

Total amount of pages
Description

Total amount of pages

Data type

integer

Device Accountability Log: Device Receipt
Description

Device Accountability Log: Device Receipt

Date Received
Description

Date Received

Data type

date

Batch # or Device Type
Description

Batch # or Device Type

Data type

text

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

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

Data type

integer

Received by (staff initials)
Description

Received by (staff initials)

Data type

text

Device Accountability Log: Device Use
Description

Device Accountability Log: Device Use

Date used
Description

Date used

Data type

date

Subject Study ID
Description

Subject Study ID

Data type

integer

Dispensed by (staff initials)
Description

Dispensed by (staff initials)

Data type

text

Device Accountability Log: Device Return/Repair/Destruction
Description

Device Accountability Log: Device Return/Repair/Destruction

Device Position
Description

RET = Returned DES = Destroyed REP = Repaired

Data type

text

Date of final Device Disposition
Description

Date of final Device Disposition

Data type

date

Reason
Description

Reason

Data type

text

Confirmed by (staff initials)
Description

Confirmed by (staff initials)

Data type

text

Comments
Description

Comments

Data type

text

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Similar models

Device Accountability Log: CRF Wisconsin Madison

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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