Developer & Quality Control Review Checklist for ADQRS Supplements - Acute Physiology and Chronic Health Evaluation II Clinical Classification (APACHE II)

PROCESS:  Two people - the developer and a quality-control reviewer - will need to review the checklist for each ADQRS supplement developed as follows:

1. After developing a ADQRS Supplement, the developer will review each item in the below checklist and complete the developer information in the header. (See DEVELOPER instructions below for how to complete the checklist.)
2. They will then give the supplement to a quality-control reviewer to review the supplement.
3. After both the developer and quality control reviewer are in agreement that the supplement is ready, the supplement will go thru ADQRS Subteam review.
4. After Subteam review, the quality-control reviewer will review each item in the below checklist and complete the quality-control reviewer information in the header. (See QUALITY-CONTROL REVIEWER instructions below for how to complete the checklist.)
5. Once the developer and quality-control reviewer are in agreement that all items in the checklist are complete, the supplement will then be ready to enter CDISC internal review.

DEVELOPER: 

For each item below, confirm the item is correct in the supplement. Check N/A boxes as applicable by placing the cursor over the check box and clicking the box.

QUALITY-CONTROL REVIEWER post-team review: 

For each item below:

1. Confirm the item is correct in the supplement and then check the box to the left of the item by placing the cursor over the check box and clicking the box. A check-mark will appear in the box and the item's font will turn light grey.
2. Confirm that each item marked as not applicable does not apply to the supplement.
3. If a condition is not met, add a note below the item explaining the concern.
4. Contact the developer to alert them to the concern(s) and check either "All items meet checklist review" or "Revisions needed" in the header.

SUPPLEMENT

• General
  
  • All blue text is updated.
  • Updated text has been left blue for review; permanent template text has been left black.  
  • Pink instructional statements have been removed.
  • All comments have been resolved.
  • Hyperlinks are all functional.
  • Document conforms to current template.
  • Consistent spacing after periods. (1 space after a period)
  • Consistent spacing around mathematical symbols (+,-,=, etc.). In-text mathematical expressions and equations should have a space before and after mathematical symbols; specifications tables should NOT have these spaces.
  • All parts of the page information header (document metadata) are correct and consistent including title, version and correct date.
  • Document has been proofread for spelling, grammar, and accuracy by reviewers who were not authors.
  • Tables within document have consistent formatting and style (e.g., ADaM dataset models all have consistent fonts, shading, and column widths).
  • Document has been considered for potential impact on other CDISC teams or underlying models (e.g., STDM, BRIDG). They have been alerted and invited to comment. If structural modifications or extensions (e.g., new or changed variables, domains, classes, etc.) to an existing model (e.g., ADaM, BRIDG) are proposed, the rationale for these is described in the document package.
• Section 2 (Rules and References):
  • References have been updated and any links are working.
  • Every attempt has been made to include references from peer-reviewed journals.  (References such as Amazon or hospital newsletters are not acceptable.)
  • A copy of the reference, or link to the website reference, has been attached to the wiki supplement page when available.
    • None available.
  • QRS instrument is in the public domain or a copyright agreement has been obtained which allows for an ADaM supplement to be created.
    
    • QRS instrument is in the public domain.
    • QRS instrument is copyrighted.
• Section 3 (Scoring Software):
  • Published scoring software section has been updated and any links are working.
  • N/A - There is no published scoring software.
• Section 4 (Introduction to the Instrument):
  • Updated according to current QRS.
• Section 5 (Key Data Checks):
  
  • Updated according to current QRS.
• Section 6 (Example):
  • Section 6.1 (Introduction):
    • Updated according to current QRS template, providing information about the sample analysis being presented, rationale for the ADaM dataset class that was chosen, and any assumptions that have been made.
  • Section 6.2 (Analysis Dataset, Variable and Value Level Metadata):
    
    • Example Analysis Dataset Metadata:  Table has been updated and Structure and Keys are accurate and consistent.
    • Example Analysis Variable Metadata:  
      • Table has been updated and source/derivations are accurate.
      • Stems (QS., ADSL., etc.) are accurate.
      • Labels, Types, and Formats are accurate.
      • Controlled Terminology for ADaM that has been approved by the CT team and is part of the supplement.
      • Additional variables for this supplement have been added in blue text.
        • N/A - There are no new variables not already in the template.
    • Example Value Level Metadata:  
      
      • Table has been updated and source/derivations are accurate.
      • Stems (QS., ADSL., etc.) are accurate.
      • Where conditions, Types, and Formats are accurate.
      • AVALC been added in blue text if needed.
        • N/A - AVALC not needed for analysis.
          
  • Section 6.3 (Example of Analysis Dataset):
    • Example sort order is consistent with analysis dataset metadata.
    • PARAM and PARAMCD match controlled terminology.
    • Summary Analysis Dataset:  
      • A description is given of the summary dataset included, indicating key summary records included.
      • The summary dataset follows the structure provided in the Example Analysis Dataset Metadata in Section 6.2. for the key summary parameter (e.g. Total Score).
      • The summary dataset includes all variables from the Example Analysis Variable Metadata table in Section 6.2.
    • Complete Analysis Dataset:  
      • A description is given of the summary dataset included, indicating key summary records included.
      • The summary dataset follows the structure provided in the Example Analysis Dataset Metadata in Section 6.2.
      • The summary dataset includes all variables from the Example Analysis Variable Metadata table in Section 6.2.
  • Section 7 (References):
    
    • References match citations from Section 2.