ID

16630

Descripción

ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Serious Adverse Event Part I. 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 (2)
  1. 27/7/16 27/7/16 -
  2. 18/11/16 18/11/16 -
Subido en

27 de julio de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Serious Adverse Event Part I: CRF Wisconsin Madison

Inglés

Serious Adverse Event Part I: 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

Serious Adverse Event
Descripción

Serious Adverse Event

Event Start Date
Descripción

Event Start Date

Tipo de datos

date

Event End Date
Descripción

Event End Date

Tipo de datos

date

Date Reported
Descripción

Date Reported

Tipo de datos

date

Reported to Research Staff Bv
Descripción

Reported to Research Staff Bv

Tipo de datos

text

Death Date (if applicable)
Descripción

Death Date (if applicable)

Tipo de datos

date

Death Occurred
Descripción

Death Occurred

Tipo de datos

text

Did the SAE occur at your site or at a site for which the PI is responsible?
Descripción

SAE

Tipo de datos

boolean

SAE Description/Narrative
Descripción

SAE Description/Narrative

Tipo de datos

text

Treating Physician Comments (if applicable)
Descripción

Treating Physician Comments (if applicable)

Tipo de datos

text

PI Comments
Descripción

PI Comments

Tipo de datos

text

Outcome
Descripción

Outcome

Tipo de datos

text

Consent Form Change Required?
Descripción

Consent Form Change Required?

Tipo de datos

boolean

SAE Classification: Fatal (resulted in death)
Descripción

SAE Classification

Tipo de datos

boolean

SAE Classification: A life-threatening occurrence
Descripción

SAE Classification

Tipo de datos

boolean

SAE Classification: Requires inpatient hospitalization or prolongation of existing hospitalization
Descripción

SAE Classification

Tipo de datos

boolean

SAE Classification: Results in persistent or significant disability/incapacity
Descripción

SAE Classification

Tipo de datos

boolean

SAE Classification: Results in congenital anomaly/birth defect
Descripción

SAE Classification

Tipo de datos

boolean

SAE Classification: A significant medical incident that, based upon appropriate medical judgment, may jeopardize the subject and require medical or surgical intervention to prevent one of the outcomes listed above.
Descripción

SAE Classification

Tipo de datos

boolean

SAE Classification: Loss of confidentiality that results in criminal or civil liability for participation or damage to financial standing, employability, insurability or reputation of the participant.
Descripción

SAE Classification

Tipo de datos

boolean

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Similar models

Serious Adverse Event Part I: 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
Item Group
Serious Adverse Event
Event Start Date
Item
Event Start Date
date
Event End Date
Item
Event End Date
date
Date Reported
Item
Date Reported
date
Reported to Research Staff Bv
Item
Reported to Research Staff Bv
text
Death Date (if applicable)
Item
Death Date (if applicable)
date
Item
Death Occurred
text
Death Occurred
Code List
Death Occurred
CL Item
Within 24 hours of investigational therapy  (1)
CL Item
Within 7 days of investigational therapy  (2)
CL Item
Within 30 days of investigational therapy  (3)
CL Item
After 30 days of investigational therapy (4)
SAE
Item
Did the SAE occur at your site or at a site for which the PI is responsible?
boolean
SAE Description/Narrative
Item
SAE Description/Narrative
text
Treating Physician Comments (if applicable)
Item
Treating Physician Comments (if applicable)
text
PI Comments
Item
PI Comments
text
Item
Outcome
text
Outcome
Code List
Outcome
CL Item
Fatal/ Died  (1)
CL Item
Intervention for AE Continuing  (2)
CL Item
Not Recovered/Not Resolved (3)
CL Item
Recovered/Resolved with Sequelae  (4)
CL Item
Recovered/Resolved without Sequelae (5)
CL Item
Recovering/Resolving (6)
Consent Form Change Required?
Item
Consent Form Change Required?
boolean
SAE Classification
Item
SAE Classification: Fatal (resulted in death)
boolean
SAE Classification
Item
SAE Classification: A life-threatening occurrence
boolean
SAE Classification
Item
SAE Classification: Requires inpatient hospitalization or prolongation of existing hospitalization
boolean
SAE Classification
Item
SAE Classification: Results in persistent or significant disability/incapacity
boolean
SAE Classification
Item
SAE Classification: Results in congenital anomaly/birth defect
boolean
SAE Classification
Item
SAE Classification: A significant medical incident that, based upon appropriate medical judgment, may jeopardize the subject and require medical or surgical intervention to prevent one of the outcomes listed above.
boolean
SAE Classification
Item
SAE Classification: Loss of confidentiality that results in criminal or civil liability for participation or damage to financial standing, employability, insurability or reputation of the participant.
boolean
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