Additional Training Information
Site initiation visits or other “hands on” training should be conducted by experienced research study staff to ensure that all critical staff members at the foreign site are familiar with the terms of the agreement and the processes mandated by law and regulation. Staff members at the foreign site need to be trained to create and maintain the requisite documentation and source documents in accordance with a detailed schedule. In the case of FDA-regulated research or research involving complex therapeutic interventions or healthy volunteers, it is also highly recommended that “on-site” monitoring be conducted. Confirm any in-country training requirements for study personnel and any associated costs.