ID

16618

Descripción

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

Palabras clave

Versiones (1)
  1. 26/7/16 26/7/16 -
Subido en

26 de julio de 2016

DOI

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Licencia

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

Inglés

Device Accountability Log (per subject): CRF Wisconsin Madison

1 formularios  
Header
Descripción

Header

PI Name
Descripción

PI Name

Tipo de datos

text

Protocol or IRB Number
Descripción

Protocol or IRB Number

Tipo de datos

integer

Protocol Short Title
Descripción

Protocol Short Title

Tipo de datos

text

Subject Initials
Descripción

Subject Initials

Tipo de datos

text

Subject ID
Descripción

Subject ID

Tipo de datos

integer

Number of Page
Descripción

Number of Page

Tipo de datos

integer

Total Number of Pages
Descripción

Total Number of Pages

Tipo de datos

integer

Drug Dispensation & Accountability Log
Descripción

Drug Dispensation & Accountability Log

Lot Number(s)
Descripción

Lot Number(s)

Tipo de datos

integer

Randomization Number
Descripción

Randomization Number

Tipo de datos

integer

Drug Dispensation & Accountability Log: Dispensed to Subject
Descripción

Drug Dispensation & Accountability Log: Dispensed to Subject

Number of Containers Dispensed
Descripción

Number of Containers Dispensed

Tipo de datos

integer

Number of Units Dispensed
Descripción

Number of Units Dispensed

Tipo de datos

integer

Date Dispensed
Descripción

Date Dispensed

Tipo de datos

date

Dispensed by (staff initials)
Descripción

Dispensed by (staff initials)

Tipo de datos

text

Expected Date of First Dose
Descripción

Expected Date of First Dose

Tipo de datos

date

Drug Dispensation & Accountability Log: Returned by Subject
Descripción

Drug Dispensation & Accountability Log: Returned by Subject

Number of Containers Returned
Descripción

Number of Containers Returned

Tipo de datos

integer

Number of units returned
Descripción

Number of units returned

Tipo de datos

integer

Date Returned
Descripción

Date Returned

Tipo de datos

date

Verified by (staff initials)
Descripción

Verified by (staff initials)

Tipo de datos

text

Drug Dispensation & Accountability Log: Compliance
Descripción

Drug Dispensation & Accountability Log: Compliance

Actual number of units used/taken
Descripción

Actual number of units used/taken

Tipo de datos

integer

Estimated number of units to be used/taken
Descripción

Estimated number of units to be used/taken

Tipo de datos

integer

% compliance
Descripción

% compliance

Tipo de datos

integer

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Similar models

Device Accountability Log (per subject): CRF Wisconsin Madison

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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