Study Administration. The Investigator must read and acknowledge his/her understanding of the study protocol and ensure adequate training of staff for executing the study has occurred. Specifically, he/she must: Sign the Protocol Signature Page, Clinical Trial Agreement, Non- Disclosure Agreement and Financial Disclosure and provide a copy of each to the Pulmonx Clinical Research Department or designee. • Provide current copies of each Investigator’s, Sub-Investigator’s, and Coordinator’s Curriculum Vitae (CV) to the Pulmonx Clinical Research Department. • Provide current copies of each Investigator’s, and Sub-Investigator’s Medical License as required throughout the course of the study. • Provide documentation of GCP training for all study staff. • Complete training using the Pulmonx Chartis Assessment System prior to treating enrolled subjects. • Complete training using the Pulmonx Endobronchial Valve System prior to treating enrolled subjects. • Delegate appropriate and qualified staff as indicated on the Site Delegation of Authority Log. • Complete all required study procedures and documentation at all visits.
Appears in 2 contracts
Sources: Clinical Investigational Plan, Clinical Investigational Plan