Childhood Adenotonsillectomy Trial
7.3.0 Role of Unblinded Research Coordinator
In addition to tracking all surgical cases and notifying the surgeon when intra-operative photos will be required (refer to section 2.4) the unblinded coordinator is responsible for providing the data collection forms/CRFs to the ENT surgeons for completion and to collect/obtain the information for entry into the DMS. The unblinded coordinator along with the site PI (when applicable) must act as a liaison between [their] research department and the ENT clinic to assure accurate and timely conduct of the following protocol specific procedures:
- Scheduling/obtaining initial ENT evaluation
- Providing data collection forms/CRFs to the ENT surgeon for completion
- Collecting forms and checking for completeness
- Entering data into the DMS
- Assuring AT is scheduled within the 4 week time period
- Tracking all surgical patients
- Informing Surgeons of PSG results as needed
- Contacting the surgeon when intra-operative photos are required
- Managing equipment for surgical photos (refer to section 2.4)
- Completing the follow up phone and clinical post operative assessments
- Scheduling the WWSC Month 8 re-evaluation at the time of randomization
Note: Although the process may vary from site-to-site, attaching the data collection forms to the subject’s chart prior to the scheduled appointment time (initial evaluation, surgery and reevaluation for the WWSC arm) may provide an efficient mechanism for collection.