Childhood Adenotonsillectomy Trial

5.11.3 NP Quality Assurance Coordinating Site Control Procedures

The NP QA activities will be coordinated through the Neuropsychology Section at the University of Michigan, under the direction of Dr. Giordani.

5.11.3.1 Year 1

• NP QA Coordinating Site will compare the source documents and CRFs for the first 10 patients assessed at each site
• Photocopies of source documents and CRFs will be provided by each CS.
• CRF evaluations will include checks for accuracy, legibility, and proper coding procedures
• Any discrepancies that are found will be resolved within 7 days with the originating site and corrected CRFs will be sent to the DCC by the testing site

5.11.3.2 Following years

• NP QA Coordinating Site will complete above procedure on 20% of the CRFs from each site on a random basis
• For sites with significant errors on 2 consecutive scoring packages, the check rate for that year will be increased by 10% and further if necessary

5.11.3.3 Newsletter and follow-up

• Twice monthly, a summary of general information about errors that have been noted or other problems found related to CRF completion or test presentation will be sent by email newsletter to study personnel
• To supplement the continuous checking of CRFs during the study and in addition to front-end validation checks carried out by the data entry personnel (e.g., within range, correct data type, missing data, confirmed missing code data), descriptive statistics on the variables in the database (performed without breaking the code) will be completed twice annually in order to detect doubtful and/or unusual data
• An audit trail to allow step-by-step retrospective assessment of data quality and study performance will be kept by the NP QA site, including details of action taken, dates, and the individuals responsible.