ID

16618

Beschrijving

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.

Link

https://ictr.wisc.edu/CaseReptTempt

Trefwoorden

Versies (1)
  1. 26-07-16 26-07-16 -
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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

Engels

Device Accountability Log (per subject): CRF Wisconsin Madison

1 Formulieren  
Header
Beschrijving

Header

PI Name
Beschrijving

PI Name

Datatype

text

Protocol or IRB Number
Beschrijving

Protocol or IRB Number

Datatype

integer

Protocol Short Title
Beschrijving

Protocol Short Title

Datatype

text

Subject Initials
Beschrijving

Subject Initials

Datatype

text

Subject ID
Beschrijving

Subject ID

Datatype

integer

Number of Page
Beschrijving

Number of Page

Datatype

integer

Total Number of Pages
Beschrijving

Total Number of Pages

Datatype

integer

Drug Dispensation & Accountability Log
Beschrijving

Drug Dispensation & Accountability Log

Lot Number(s)
Beschrijving

Lot Number(s)

Datatype

integer

Randomization Number
Beschrijving

Randomization Number

Datatype

integer

Drug Dispensation & Accountability Log: Dispensed to Subject
Beschrijving

Drug Dispensation & Accountability Log: Dispensed to Subject

Number of Containers Dispensed
Beschrijving

Number of Containers Dispensed

Datatype

integer

Number of Units Dispensed
Beschrijving

Number of Units Dispensed

Datatype

integer

Date Dispensed
Beschrijving

Date Dispensed

Datatype

date

Dispensed by (staff initials)
Beschrijving

Dispensed by (staff initials)

Datatype

text

Expected Date of First Dose
Beschrijving

Expected Date of First Dose

Datatype

date

Drug Dispensation & Accountability Log: Returned by Subject
Beschrijving

Drug Dispensation & Accountability Log: Returned by Subject

Number of Containers Returned
Beschrijving

Number of Containers Returned

Datatype

integer

Number of units returned
Beschrijving

Number of units returned

Datatype

integer

Date Returned
Beschrijving

Date Returned

Datatype

date

Verified by (staff initials)
Beschrijving

Verified by (staff initials)

Datatype

text

Drug Dispensation & Accountability Log: Compliance
Beschrijving

Drug Dispensation & Accountability Log: Compliance

Actual number of units used/taken
Beschrijving

Actual number of units used/taken

Datatype

integer

Estimated number of units to be used/taken
Beschrijving

Estimated number of units to be used/taken

Datatype

integer

% compliance
Beschrijving

% compliance

Datatype

integer

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Similar models

Device Accountability Log (per subject): CRF Wisconsin Madison

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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