ID

16630

Descrizione

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.

collegamento

https://ictr.wisc.edu/CaseReptTempt

Keywords

versioni (2)
  1. 27/07/16 27/07/16 -
  2. 18/11/16 18/11/16 -
Caricato su

27 luglio 2016

DOI

Per favore, per richiedere un accesso.

Licenza

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

Inglese

Serious Adverse Event Part I: CRF Wisconsin Madison

1 moduli  
Header
Descrizione

Header

PI Name
Descrizione

PI Name

Tipo di dati

text

Protocol or IRB Number
Descrizione

Protocol or IRB Number

Tipo di dati

integer

Protocol Short Title
Descrizione

Protocol Short Title

Tipo di dati

text

Subject Initials
Descrizione

Subject Initials

Tipo di dati

text

Subject ID
Descrizione

Subject ID

Tipo di dati

integer

Serious Adverse Event
Descrizione

Serious Adverse Event

Event Start Date
Descrizione

Event Start Date

Tipo di dati

date

Event End Date
Descrizione

Event End Date

Tipo di dati

date

Date Reported
Descrizione

Date Reported

Tipo di dati

date

Reported to Research Staff Bv
Descrizione

Reported to Research Staff Bv

Tipo di dati

text

Death Date (if applicable)
Descrizione

Death Date (if applicable)

Tipo di dati

date

Death Occurred
Descrizione

Death Occurred

Tipo di dati

text

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

SAE

Tipo di dati

boolean

SAE Description/Narrative
Descrizione

SAE Description/Narrative

Tipo di dati

text

Treating Physician Comments (if applicable)
Descrizione

Treating Physician Comments (if applicable)

Tipo di dati

text

PI Comments
Descrizione

PI Comments

Tipo di dati

text

Outcome
Descrizione

Outcome

Tipo di dati

text

Consent Form Change Required?
Descrizione

Consent Form Change Required?

Tipo di dati

boolean

SAE Classification: Fatal (resulted in death)
Descrizione

SAE Classification

Tipo di dati

boolean

SAE Classification: A life-threatening occurrence
Descrizione

SAE Classification

Tipo di dati

boolean

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

SAE Classification

Tipo di dati

boolean

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

SAE Classification

Tipo di dati

boolean

SAE Classification: Results in congenital anomaly/birth defect
Descrizione

SAE Classification

Tipo di dati

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.
Descrizione

SAE Classification

Tipo di dati

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.
Descrizione

SAE Classification

Tipo di dati

boolean

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Similar models

Serious Adverse Event Part I: CRF Wisconsin Madison

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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
Ritorna all'inizio della pagina 

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