ID

16630

Beschreibung

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

Stichworte

Versionen (2)
  1. 27.07.16 27.07.16 -
  2. 18.11.16 18.11.16 -
Hochgeladen am

27. Juli 2016

DOI

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Lizenz

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

Englisch

Serious Adverse Event Part I: 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

Serious Adverse Event
Beschreibung

Serious Adverse Event

Event Start Date
Beschreibung

Event Start Date

Datentyp

date

Event End Date
Beschreibung

Event End Date

Datentyp

date

Date Reported
Beschreibung

Date Reported

Datentyp

date

Reported to Research Staff Bv
Beschreibung

Reported to Research Staff Bv

Datentyp

text

Death Date (if applicable)
Beschreibung

Death Date (if applicable)

Datentyp

date

Death Occurred
Beschreibung

Death Occurred

Datentyp

text

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

SAE

Datentyp

boolean

SAE Description/Narrative
Beschreibung

SAE Description/Narrative

Datentyp

text

Treating Physician Comments (if applicable)
Beschreibung

Treating Physician Comments (if applicable)

Datentyp

text

PI Comments
Beschreibung

PI Comments

Datentyp

text

Outcome
Beschreibung

Outcome

Datentyp

text

Consent Form Change Required?
Beschreibung

Consent Form Change Required?

Datentyp

boolean

SAE Classification: Fatal (resulted in death)
Beschreibung

SAE Classification

Datentyp

boolean

SAE Classification: A life-threatening occurrence
Beschreibung

SAE Classification

Datentyp

boolean

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

SAE Classification

Datentyp

boolean

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

SAE Classification

Datentyp

boolean

SAE Classification: Results in congenital anomaly/birth defect
Beschreibung

SAE Classification

Datentyp

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.
Beschreibung

SAE Classification

Datentyp

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.
Beschreibung

SAE Classification

Datentyp

boolean

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Serious Adverse Event Part I: 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
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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