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Please do not edit this template. Instead, copy the checklist to a child page under the supplement before using the checklist. When you copy the checklist, please add the QRS Long Name/Short Name after the checklist title (e.g. 'Developer & Quality Control Review Checklist for SDS QRS Supplements - Suicidal Ideation Questionnaire (SIQ)'). Remove this information box from the supplement-specific checklist. |
DEVELOPER INFORMATION | Completed by: | |
Date Completed: | 13 2020 | |
QUALITY-CONTROL REVIEWER INFORMATION | Completed by: | @nameDana Booth |
Date Completed: | (update date)
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Name and Version of Project: | QRS Instrument Long NamePatient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Item Library 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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- Conforms to Study Data Tabulation Model Metadata Submission Guidelines (SDTM-MSG) annotated examples.
- Per the Metadata example, Domain abbreviation = "Domain Name" (e.g., QS=Questionnaires) appears at the top of the page in Arial 18 point font, black color, bolded, and italicized. It is enclosed in a black 1 point thickness text box with a light blue fill color.
- --CAT = QRS Short Name appears at the top of the page in Arial 12 point font, red color, bold, italicized, enclosed in a black 1 point thickness text box with a light blue fill color.
- Variable annotations are in Arial 10 or 12 point font, red color, bold, and italicized. They are enclosed in a black 1 point thickness text box with a light blue fill color. Be consistent within a page and use 12 point unless space is an issue and then use 10 pt.
- --ORRES, --STRESC and --STRESN are annotated if these results are clearly identified on the CRF. Repetition of these annotations may be eliminated if it clearly identifies these variables are repeated on subsequent questions.
- EVAL is only annotated on the CRF when clearly identified on the CRF.
- --EVAL is not listed on the CRF.
- QNAM is annotated on the CRF for supplemental qualifier variables.
- No QNAMs are used in the supplement.
- Copyright or Public domain CDISC text box is on the CRF.