Description:

This CRF is an ongoing form to capture all adverse events experienced by the patient regardless of the course. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ACE96AD5-85FB-D37F-E040-BB89AD43168A

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ACE96AD5-85FB-D37F-E040-BB89AD43168A

Keywords:
Versions (2) ▾
  1. 9/19/12
  2. 7/15/17
Uploaded on:

July 15, 2017

DOI:
No DOI assigned. To request one please log in.
License:
Creative Commons BY-NC 3.0
Model comments:

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for:

Item comments for:

In order to download data models you must be logged in. Please log in or register for free.

No Instruction available.

  1. StudyEvent: Adverse Events
    1. No Instruction available.
Adverse Events
Prior Course (Cycle) AE?
CTCAE Term
System Organ Class (SOC)
Grade
Attribution to Research
Atrribution to IND
Attribution to Investigational Device Exemption (IDE)
Attribution to Commercial
Attribution to Radiation
Attribution to Surgery
Attribution to Disease
Attribution to Other
Unexpected Adverse Event
Dose-Limiting Toxicity?
Serious
Action
Therapy
Outcome
Expedited Report to IRB?
Expedited Report to Sponsor?
Expedited Report to FDA?
Expedited Report to OBA?
Expedited Report to Manufacturer

Similar models