ID

16632

Descripción

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.

Link

https://ictr.wisc.edu/CaseReptTempt

Palabras clave

Versiones (2)
  1. 27/7/16 27/7/16 -
  2. 20/11/16 20/11/16 -
Subido en

27 de julio de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Serious Adverse Event Part II: CRF Wisconsin Madison

Inglés

Serious Adverse Event Part II: 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

Report to the IRB
Descripción

Report to the IRB

Tipo de datos

text

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

Course start date

Tipo de datos

date

AE Description/Details
Descripción

AE Description/Details

Tipo de datos

text

Category
Descripción

(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 )

Tipo de datos

text

Grade/Severity
Descripción

Grade/Severity

Tipo de datos

text

Unexpected?
Descripción

Unexpected

Tipo de datos

boolean

Dose Limiting Toxicity (DLT)
Descripción

Dose Limiting Toxicity (DLT)

Tipo de datos

text

Action Taken
Descripción

Action Taken

Tipo de datos

text

Therapy
Descripción

Therapy

Tipo de datos

text

Protocol Attribution
Descripción

Protocol Attribution

Tipo de datos

text

Detailed Attribution
Descripción

Detailed Attribution

Tipo de datos

text

If Disease, please specify
Descripción

Specification

Tipo de datos

text

If Investigational Treatment, please specify
Descripción

Specification

Tipo de datos

text

If Non-Investigational Treatment, please specify
Descripción

Specification

Tipo de datos

text

If Other, please specify
Descripción

Specification

Tipo de datos

text

Principal Investigator Signature
Descripción

Principal Investigator Signature

Tipo de datos

text

Date
Descripción

Date

Tipo de datos

date

Volver a la parte superior de la página

Similar models

Serious Adverse Event Part II: 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
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
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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