0 Beoordelingen
ID

16630

Beschrijving

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

Trefwoorden

Versies (2)
  1. 27-07-16 27-07-16 -
  2. 18-11-16 18-11-16 -
Geüploaded op

27 juli 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

    Geen commentaren

    U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

    Serious Adverse Event Part I: CRF Wisconsin Madison

    Engels

    Serious Adverse Event Part I: CRF Wisconsin Madison

    1 Formulieren  
    Header
    Beschrijving

    Header

    PI Name
    Beschrijving

    PI Name

    Datatype

    text

    Protocol or IRB Number
    Beschrijving

    Protocol or IRB Number

    Datatype

    integer

    Protocol Short Title
    Beschrijving

    Protocol Short Title

    Datatype

    text

    Subject Initials
    Beschrijving

    Subject Initials

    Datatype

    text

    Subject ID
    Beschrijving

    Subject ID

    Datatype

    integer

    Serious Adverse Event
    Beschrijving

    Serious Adverse Event

    Event Start Date
    Beschrijving

    Event Start Date

    Datatype

    date

    Event End Date
    Beschrijving

    Event End Date

    Datatype

    date

    Date Reported
    Beschrijving

    Date Reported

    Datatype

    date

    Reported to Research Staff Bv
    Beschrijving

    Reported to Research Staff Bv

    Datatype

    text

    Death Date (if applicable)
    Beschrijving

    Death Date (if applicable)

    Datatype

    date

    Death Occurred
    Beschrijving

    Death Occurred

    Datatype

    text

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

    SAE

    Datatype

    boolean

    SAE Description/Narrative
    Beschrijving

    SAE Description/Narrative

    Datatype

    text

    Treating Physician Comments (if applicable)
    Beschrijving

    Treating Physician Comments (if applicable)

    Datatype

    text

    PI Comments
    Beschrijving

    PI Comments

    Datatype

    text

    Outcome
    Beschrijving

    Outcome

    Datatype

    text

    Consent Form Change Required?
    Beschrijving

    Consent Form Change Required?

    Datatype

    boolean

    SAE Classification: Fatal (resulted in death)
    Beschrijving

    SAE Classification

    Datatype

    boolean

    SAE Classification: A life-threatening occurrence
    Beschrijving

    SAE Classification

    Datatype

    boolean

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

    SAE Classification

    Datatype

    boolean

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

    SAE Classification

    Datatype

    boolean

    SAE Classification: Results in congenital anomaly/birth defect
    Beschrijving

    SAE Classification

    Datatype

    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.
    Beschrijving

    SAE Classification

    Datatype

    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.
    Beschrijving

    SAE Classification

    Datatype

    boolean

    Terug naar het begin van de pagina

    Similar models

    Serious Adverse Event Part I: CRF Wisconsin Madison

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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
    Terug naar het begin van de pagina 

    Help

    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