ID

16618

Beschreibung

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

Stichworte

Versionen (1)
  1. 26.07.16 26.07.16 -
Hochgeladen am

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

Englisch

Device Accountability Log (per subject): CRF Wisconsin Madison

1 Formulare  
Header
Beschreibung

Header

PI Name
Beschreibung

PI Name

Datentyp

text

Protocol or IRB Number
Beschreibung

Protocol or IRB Number

Datentyp

integer

Protocol Short Title
Beschreibung

Protocol Short Title

Datentyp

text

Subject Initials
Beschreibung

Subject Initials

Datentyp

text

Subject ID
Beschreibung

Subject ID

Datentyp

integer

Number of Page
Beschreibung

Number of Page

Datentyp

integer

Total Number of Pages
Beschreibung

Total Number of Pages

Datentyp

integer

Drug Dispensation & Accountability Log
Beschreibung

Drug Dispensation & Accountability Log

Lot Number(s)
Beschreibung

Lot Number(s)

Datentyp

integer

Randomization Number
Beschreibung

Randomization Number

Datentyp

integer

Drug Dispensation & Accountability Log: Dispensed to Subject
Beschreibung

Drug Dispensation & Accountability Log: Dispensed to Subject

Number of Containers Dispensed
Beschreibung

Number of Containers Dispensed

Datentyp

integer

Number of Units Dispensed
Beschreibung

Number of Units Dispensed

Datentyp

integer

Date Dispensed
Beschreibung

Date Dispensed

Datentyp

date

Dispensed by (staff initials)
Beschreibung

Dispensed by (staff initials)

Datentyp

text

Expected Date of First Dose
Beschreibung

Expected Date of First Dose

Datentyp

date

Drug Dispensation & Accountability Log: Returned by Subject
Beschreibung

Drug Dispensation & Accountability Log: Returned by Subject

Number of Containers Returned
Beschreibung

Number of Containers Returned

Datentyp

integer

Number of units returned
Beschreibung

Number of units returned

Datentyp

integer

Date Returned
Beschreibung

Date Returned

Datentyp

date

Verified by (staff initials)
Beschreibung

Verified by (staff initials)

Datentyp

text

Drug Dispensation & Accountability Log: Compliance
Beschreibung

Drug Dispensation & Accountability Log: Compliance

Actual number of units used/taken
Beschreibung

Actual number of units used/taken

Datentyp

integer

Estimated number of units to be used/taken
Beschreibung

Estimated number of units to be used/taken

Datentyp

integer

% compliance
Beschreibung

% compliance

Datentyp

integer

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Ähnliche Modelle

Device Accountability Log (per subject): CRF Wisconsin Madison

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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