Has the treating physician or any other personnel who will be involved in this treatment had any of the follow:
- FDA Warning Letter
- NIDPOE (Noticed of Initiation of Disqualification Proceedings and Opportunity to Explain)
- Suspension or termination by an IRB
- Suspension by a federal or governmental agency (such as FDA, HHS, or Health Canada)
- OHRP Determination Letter, Health Canada Inspection Letter with observations, or similar
- Form FDA 483 in the past 5 years
-OR-
Has the treating physician or any other personnel who will be involved in this treatment had any of the following denied, revoked, suspended, reduced, limited, placed on probation, not renewed, relinquished, sanctioned, fined, or subject to disciplinary action?
- Clinical privileges at any site
- DEA licensure
- Fellowship/board certification
- Medical licensure in any state, nation, or province
- Membership on any hospital staff
- Prescribing privileges
- Professional sanctions including fines and public reprimands
- Professional society membership
- Research privileges at any site
-OR-
Is there any action or investigation currently pending before any court of law, federal agency, or state licensing board concerning the professional conduct of the treating physician or any other personnel who will be involved in this treatment in that individual's capacity as a research investigator or as a clinician?