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Title

Acute Physiology and Chronic Health Evaluation II (APACHE IIASSIGN Risk Score (ASSIGN CVD 10-YEAR RISK)

CDISC Reference

Clinical

Classification Supplement

Classifications Supplement to the Study Data Tabulation Model Implementation Guide

for Human Clinical Trials
QRS Short Name

APACHE II(ASSIGN CVD 10-YEAR RISK)

QRS Permission StatusPublic Domain
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam

Dyslipidemia Standards Team and CDISC QRS Sub-Team

Supplement Version2.0
StatusFINAL
Date20222023-08XX-29XX
Notes
  • This supplement is intended to be used with other CDISC
user guides
  • User Guides for specific
therapeutic
  • Therapeutic/
disease areas
  • Disease Areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical
Trials
  • trials.


Revision History

Date

Version

Summary of Changes

2022

2023-

08

XX-

29

XX

2.0

Converted the

ASSIGN CVD 10-YEAR RISK Final

  • Converted the supplement to the current WIKI QRS supplement template.
  • Annotated CRF updated to the MSG V2.0 annotation guidelines
  • Added assumption 2 to include a record for every item on the instrument. The example was updated to include records for a subject where the instrument was not done.
  • Added assumption 3 to include a record for logically skipped items. The example was updated to include records for these items.
  • The QSEVAL assumption and variable was removed from this supplement, because this is not captured on the CRF and no assumptions are made on the potential values.
  • RSBLFL was updated to RSLOBXFL
    • 2016-06-291.0Initial Final Version
    • Updated RSTEST name

    2016-07-14

    1.0

    ASSIGN CVD 10-YEAR RISK Final

    • Based on the SDS Team decision to not release the draft CC domain, but include its definition in the RS domain, all references to the CC domain were revised to the RS domain throughout this document.

    2015-10-07

    1.0

    ASSIGN CVD 10-YEAR RISK Draft

    2015-01-05

    1.0

    ASSIGN CVD 10-YEAR RISK Draft

    © 2023 © 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

    1 Introduction

    This document describes the CDISC implementation of the Acute Physiology and Chronic Health Evaluation II (APACHE II) instrument.

    ...