Childhood Adenotonsillectomy Trial
6.2 Structure and Responsibilities
The Polysomnography Reading Center (PRC) will be directed by Susan Redline, MD, MPH. She will direct the activities of the PRC Administrator, Quality Control Manager/Chief Polysomnologist, PSG scorers, Data Manager, Systems Administrator and ultimately be responsible for all goals specified above.
The Quality Control Manager/Chief Polysomnologist will be directly responsible for certification of scorers and central training of field research assistants. S/he will participate in the development of teaching materials for training and for procedures for certifying scorers and assuring high levels of accuracy and reproducibility of scoring procedures. S/he will review each PSG record within 48 hours of its receipt at the PRC, identifying Urgent Medical Referrals for priority scoring, and providing feedback on the quality of studies received to field site technicians, including assisting in identifying equipment problems. S/he will triage studies for formal scoring to the scorers, monitoring their performance, and provide support for interpreting ambiguous studies. S/he will implement on-going procedures for assuring accuracy and reproducibility of scored procedures.
The PRC Project Administrator prepares reports on scoring accuracy and reliability, assists in troubleshooting equipment problems, tracking study quality at various sites and scoring quality at the Reading Center. S/he also plays a key role in developing, implementing and modifying procedures for managing huge amounts of data from multicenter studies. S/he is responsible for tracking data flow from clinical sites to the Reading Center and then providing reports to the sites and the Coordinating Center.
The PRC will establish and maintain a database for tracking of PSG tests received, processing reports and monitoring quality. The following is a list of tasks and the party responsible for that task:
| Task | Responsible Party or Parties |
|---|---|
| Training and Certification of Site Staff | Chief Polysomnologist and RC Administrator |
| Receipt Processing & Tracking | RC Administrator |
| Preliminary Quality Review and Feedback to Sites | Chief Polysomnologist |
| Scoring, Quality and Data Report Generation, Outlier Check | Polysomnologists |
| Quality Control of Scoring Exercises, Statistical Reports | Chief Polysomnologist and RC Administrator |
| Summary Quality Reports to Sites, Investigators, Website Postings on Data Acquisition | Data Manager and RC Administrator |
| Archives and Creation of Analytical Files | Data Manager and RC Administrator |
| Approval of PRC protocols | Center Director |
| Training of staff on Systems procedures | Data Manager and Systems Administrator |
| Documentation of procedures and generation of reports | Data Manager, Systems Administrator, or trained SRC Staff |