ID

16632

Beskrivning

ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Serious Adverse Event Part II. 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.

Länk

https://ictr.wisc.edu/CaseReptTempt

Nyckelord

Versioner (2)
  1. 2016-07-27 2016-07-27 -
  2. 2016-11-20 2016-11-20 -
Uppladdad den

27 juli 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Serious Adverse Event Part II: CRF Wisconsin Madison

Engelsk

Serious Adverse Event Part II: CRF Wisconsin Madison

1 Formulär  
Header
Beskrivning

Header

PI Name
Beskrivning

PI Name

Datatyp

text

Protocol or IRB Number
Beskrivning

Protocol or IRB Number

Datatyp

integer

Protocol Short Title
Beskrivning

Protocol Short Title

Datatyp

text

Subject Initials
Beskrivning

Subject Initials

Datatyp

text

Subject ID
Beskrivning

Subject ID

Datatyp

integer

Serious Adverse Event
Beskrivning

Serious Adverse Event

Report to the IRB
Beskrivning

Report to the IRB

Datatyp

text

Course start date (Enter date that course of treatment was initiated, if applicable)
Beskrivning

Course start date

Datatyp

date

AE Description/Details
Beskrivning

AE Description/Details

Datatyp

text

Category
Beskrivning

(refer to the Safety Profiler website to search the Category and Toxicity of the SAE symptom reported: http://safetyprofiler-ctep.nci.nih.gov/CTC/CTC.aspx )

Datatyp

text

Grade/Severity
Beskrivning

Grade/Severity

Datatyp

text

Unexpected?
Beskrivning

Unexpected

Datatyp

boolean

Dose Limiting Toxicity (DLT)
Beskrivning

Dose Limiting Toxicity (DLT)

Datatyp

text

Action Taken
Beskrivning

Action Taken

Datatyp

text

Therapy
Beskrivning

Therapy

Datatyp

text

Protocol Attribution
Beskrivning

Protocol Attribution

Datatyp

text

Detailed Attribution
Beskrivning

Detailed Attribution

Datatyp

text

If Disease, please specify
Beskrivning

Specification

Datatyp

text

If Investigational Treatment, please specify
Beskrivning

Specification

Datatyp

text

If Non-Investigational Treatment, please specify
Beskrivning

Specification

Datatyp

text

If Other, please specify
Beskrivning

Specification

Datatyp

text

Principal Investigator Signature
Beskrivning

Principal Investigator Signature

Datatyp

text

Date
Beskrivning

Date

Datatyp

date

Tillbaka till toppen

Similar models

Serious Adverse Event Part II: CRF Wisconsin Madison

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
Item
Report to the IRB
text
Report to the IRB
Code List
Report to the IRB
CL Item
Immediately (1)
CL Item
Next Continuing Review (2)
CL Item
Not Applicable (3)
Course start date
Item
Course start date (Enter date that course of treatment was initiated, if applicable)
date
AE Description/Details
Item
AE Description/Details
text
Category
Item
Category
text
Item
Grade/Severity
text
Grade/Severity
Code List
Grade/Severity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Life Threatening (4)
CL Item
Death (Fatal) (5)
Unexpected
Item
Unexpected?
boolean
Item
Dose Limiting Toxicity (DLT)
text
Dose Limiting Toxicity (DLT)
Code List
Dose Limiting Toxicity (DLT)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (3)
Item
Action Taken
text
Action Taken
Code List
Action Taken
CL Item
Dose Reduced (1)
CL Item
Dose Interrupted, then Reduced (2)
CL Item
None (3)
CL Item
Regimen Interrupted (4)
CL Item
Therapy discontinued (5)
CL Item
Not Applicable (leave blank) (6)
Item
Therapy
text
Therapy
Code List
Therapy
CL Item
None (1)
CL Item
Supportive (2)
CL Item
Symptomatic (3)
CL Item
Vigorous Supportive (4)
Item
Protocol Attribution
text
Protocol Attribution
Code List
Protocol Attribution
CL Item
Definite (1)
CL Item
Probable (2)
CL Item
Possible (3)
CL Item
Unlikely (4)
CL Item
Unrelated (5)
Item
Detailed Attribution
text
Detailed Attribution
Code List
Detailed Attribution
CL Item
Disease/Condition  (1)
CL Item
Investigational Treatment (2)
CL Item
Non-investigational Treatment (3)
CL Item
Other (4)
Specification
Item
If Disease, please specify
text
Specification
Item
If Investigational Treatment, please specify
text
Specification
Item
If Non-Investigational Treatment, please specify
text
Specification
Item
If Other, please specify
text
Principal Investigator Signature
Item
Principal Investigator Signature
text
Date
Item
Date
date
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial