ID

16618

Description

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

Keywords

Versions (1)
  1. 7/26/16 7/26/16 -
Uploaded on

July 26, 2016

DOI

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License

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

English

Device Accountability Log (per subject): 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

Subject Initials
Description

Subject Initials

Data type

text

Subject ID
Description

Subject ID

Data type

integer

Number of Page
Description

Number of Page

Data type

integer

Total Number of Pages
Description

Total Number of Pages

Data type

integer

Drug Dispensation & Accountability Log
Description

Drug Dispensation & Accountability Log

Lot Number(s)
Description

Lot Number(s)

Data type

integer

Randomization Number
Description

Randomization Number

Data type

integer

Drug Dispensation & Accountability Log: Dispensed to Subject
Description

Drug Dispensation & Accountability Log: Dispensed to Subject

Number of Containers Dispensed
Description

Number of Containers Dispensed

Data type

integer

Number of Units Dispensed
Description

Number of Units Dispensed

Data type

integer

Date Dispensed
Description

Date Dispensed

Data type

date

Dispensed by (staff initials)
Description

Dispensed by (staff initials)

Data type

text

Expected Date of First Dose
Description

Expected Date of First Dose

Data type

date

Drug Dispensation & Accountability Log: Returned by Subject
Description

Drug Dispensation & Accountability Log: Returned by Subject

Number of Containers Returned
Description

Number of Containers Returned

Data type

integer

Number of units returned
Description

Number of units returned

Data type

integer

Date Returned
Description

Date Returned

Data type

date

Verified by (staff initials)
Description

Verified by (staff initials)

Data type

text

Drug Dispensation & Accountability Log: Compliance
Description

Drug Dispensation & Accountability Log: Compliance

Actual number of units used/taken
Description

Actual number of units used/taken

Data type

integer

Estimated number of units to be used/taken
Description

Estimated number of units to be used/taken

Data type

integer

% compliance
Description

% compliance

Data type

integer

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Similar models

Device Accountability Log (per subject): 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
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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