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Introduction

The Content working group is made up of representatives from the NRDS committee and additional subject matter experts nominated by NRDS Committee members.  It is co-led by a NCI and NCTN/ETCTN representative.  The purpose of the Content working group is to identify a set of CDEs for use in Rave by the NCTN and the ETCTN.  The working group will meet weekly.

CDUS Content Review

Tuesday October 27th, 2015 NRDS Content WG Meeting

The outcome of the October 27th meeting is that the set of content as reviewed and finalized by the Content WG for caAERS/OPEN is ready to send for CTSU for analysis and evaluation.  CTSU will respond to all requests for changes based on their ability to accommodate the working group suggestions.

  • This change will impact only the 27 caAERS forms, 1 OPEN Demography form and a small number of elements used to populate and derive the caAERS/OPEN forms.
      1. Adverse Events
      2. Expedited Reporting Evaluation
      3. Late Adverse Events
      4. Late AE Reporting
      5. SAE Additional Information
      6. SAE Attribution
      7. SAE Concomitant Medications
      8. SAE Information
      9. SAE Laboratory Tests and Results
      10. SAE Participant Information
      11. SAE Pre-Existing Conditions
      12. SAE Prior Therapy
      13. SAE Additional Information
      14. SAE Attribution
      15. SAE Concomitant Medications
      16. SAE Information
      17. SAE Laboratory Tests and Results
      18. SAE Participant Information
      19. SAE Pre-Existing Conditions
      20. SAE Prior Therapy
      21. SAE Protocol Agent Intervention
      22. SAE Protocol Device Intervention
      23. SAE Protocol Radiation Intervention
      24. SAE Protocol Surgery Intervention
      25. SAE Report Initiation
      26. SAE Reporting Period Information
      27. SAE Submission
      28. OPEN Demography

NRDS caAERS Integration Content Review

Please find attached the following spreadsheets for your review and comments:

  1. Draft caAERS AE before and after recommended changes
  2. Draft caAERS SAE before and after recommended changes
  3. Draft NCTN/ETCTN Curation Style Guide

A few things to keep in mind during the review process:

  • The review period will be from Thursday August 6th, 2015 to Thursday August 20th, 2015
    • If an extension is needed, please contact the NRDS Project Manager: Neesha Desai (neesha.desai@nih.gov)
    • Each spreadsheet has a column to collect comments from your group, as well as a reason for the requested changes.  Please use the two columns to provide your comments.
    • Email the spreadsheets with your comments to the NRDS Project Manager:  Neesha Desai (neesha.desai@nih.gov) by Thursday August 20th, 2015.
    • Note remember that all comments provided must represent your organization. 
  • Note to NCTN Statistical Center PIs:  Please be sure to discuss within your Stats Center the code changes being proposed to ensure the benefits outweigh any potential challenges. One change in particular to review is changing all numeric responses of ‘1’ or ‘2’ to a character response of ‘Y’ or ‘N’ (for Yes and No).  There are 30 coded indicator value sets impacted by this 1,2 to Y,N coding.  All of these changes can be found on both the caAERS AE and SAE CRF before/after spreadsheets.

Working Group Members

*NCI/NCTN/ETCTN Co-Lead

Organization
Representative
Email
AllianceKristina LaumannHillman.Shauna@mayo.edu
COGJustin DavisJDavis@childrensoncologygroup.org
COGDan Jamesondjameson@childrensoncologygroup.org
COGSmita SubramanianSSubramanian@childrensoncologygroup.org
COGThalia Beelestbeeles@childrensoncologygroup.org
ECOG-ACRINJudi Manolamanola.judi@jimmy.harvard.edu
NCICChad Winchcwinch@ctg.queensu.ca
NRG

Rebecca Paulus

PaulusR@NRGOncology.org

NRGVanita Patelpatelv@nrgoncology.org
NRGAmy Krystkiewicz KrystkiewiczA@NRGOncology.org
SWOGCathy Rankincrankin@fhcrc.org
SWOGAngela Smithangelas@crab.org
TheradexPeter Clarkpclark@theradex.com
NCIAndrea Denicoffdenicofa@dctod.nci.nih.gov
NCIGwen Deengwen.deen@nih.gov
NCIMike Montellomontellom@mail.nih.gov
NCIHolly Massettmassetth@mail.nih.gov
NCIDianne Reeves*

reevesd@mail.nih.gov

NCITina Taylor*tina.m.taylor@saic.com

Events and Meetings

Team Calendars
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NRDS Quick Links
NRDS Quick Links

Panel
titleContent WG Documentation
Panel
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