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DEVELOPER INFORMATION

Completed by:
Date Completed:

QUALITY-CONTROL REVIEWER INFORMATIONCompleted by:@name
Date Completed:

 (update date)

  •  All items meet checklist review
  •  Revisions needed
Name and Version of Project:

QRS Instrument Long NamePatient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, Version 1.0 (PRO-CTCAE v1.0), Supplement Version # v1.0


PROCESS: 

Two people - the developer and a quality-control reviewer - will need to review the checklist for each SDS QRS supplement developed as per QRS Subteam procedures (Flowchart - SDS QRS Supplement Development Process).  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.

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