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:
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.