ID

16618

Beskrivning

ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Device Accountability Log (per subject). 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.

Länk

https://ictr.wisc.edu/CaseReptTempt

Nyckelord

Versioner (1)
  1. 2016-07-26 2016-07-26 -
Uppladdad den

26 juli 2016

DOI

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Creative Commons BY-NC 3.0
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Device Accountability Log (per subject): CRF Wisconsin Madison

Engelsk

Device Accountability Log (per subject): CRF Wisconsin Madison

1 Formulär  
Header
Beskrivning

Header

PI Name
Beskrivning

PI Name

Datatyp

text

Protocol or IRB Number
Beskrivning

Protocol or IRB Number

Datatyp

integer

Protocol Short Title
Beskrivning

Protocol Short Title

Datatyp

text

Subject Initials
Beskrivning

Subject Initials

Datatyp

text

Subject ID
Beskrivning

Subject ID

Datatyp

integer

Number of Page
Beskrivning

Number of Page

Datatyp

integer

Total Number of Pages
Beskrivning

Total Number of Pages

Datatyp

integer

Drug Dispensation & Accountability Log
Beskrivning

Drug Dispensation & Accountability Log

Lot Number(s)
Beskrivning

Lot Number(s)

Datatyp

integer

Randomization Number
Beskrivning

Randomization Number

Datatyp

integer

Drug Dispensation & Accountability Log: Dispensed to Subject
Beskrivning

Drug Dispensation & Accountability Log: Dispensed to Subject

Number of Containers Dispensed
Beskrivning

Number of Containers Dispensed

Datatyp

integer

Number of Units Dispensed
Beskrivning

Number of Units Dispensed

Datatyp

integer

Date Dispensed
Beskrivning

Date Dispensed

Datatyp

date

Dispensed by (staff initials)
Beskrivning

Dispensed by (staff initials)

Datatyp

text

Expected Date of First Dose
Beskrivning

Expected Date of First Dose

Datatyp

date

Drug Dispensation & Accountability Log: Returned by Subject
Beskrivning

Drug Dispensation & Accountability Log: Returned by Subject

Number of Containers Returned
Beskrivning

Number of Containers Returned

Datatyp

integer

Number of units returned
Beskrivning

Number of units returned

Datatyp

integer

Date Returned
Beskrivning

Date Returned

Datatyp

date

Verified by (staff initials)
Beskrivning

Verified by (staff initials)

Datatyp

text

Drug Dispensation & Accountability Log: Compliance
Beskrivning

Drug Dispensation & Accountability Log: Compliance

Actual number of units used/taken
Beskrivning

Actual number of units used/taken

Datatyp

integer

Estimated number of units to be used/taken
Beskrivning

Estimated number of units to be used/taken

Datatyp

integer

% compliance
Beskrivning

% compliance

Datatyp

integer

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Similar models

Device Accountability Log (per subject): CRF Wisconsin Madison

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
Subject Initials
Item
Subject Initials
text
Subject ID
Item
Subject ID
integer
Number of Page
Item
Number of Page
integer
Total Number of Pages
Item
Total Number of Pages
integer
Item Group
Drug Dispensation & Accountability Log
Lot Number(s)
Item
Lot Number(s)
integer
Randomization Number
Item
Randomization Number
integer
Item Group
Drug Dispensation & Accountability Log: Dispensed to Subject
Number of Containers Dispensed
Item
Number of Containers Dispensed
integer
Number of Units Dispensed
Item
Number of Units Dispensed
integer
Date Dispensed
Item
Date Dispensed
date
Dispensed by (staff initials)
Item
Dispensed by (staff initials)
text
Expected Date of First Dose
Item
Expected Date of First Dose
date
Item Group
Drug Dispensation & Accountability Log: Returned by Subject
Number of Containers Returned
Item
Number of Containers Returned
integer
Number of units returned
Item
Number of units returned
integer
Date Returned
Item
Date Returned
date
Verified by (staff initials)
Item
Verified by (staff initials)
text
Item Group
Drug Dispensation & Accountability Log: Compliance
Actual number of units used/taken
Item
Actual number of units used/taken
integer
Estimated number of units to be used/taken
Item
Estimated number of units to be used/taken
integer
% compliance
Item
% compliance
integer
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