Procedures to be established by Member States
Article 7
1. Member States shall establish the relevant procedures for at least the following: (a) appointing experts to accompany inspectors, if additional expertise is required for an inspection; (b) arranging inspections outside the Union; (c) verification of good clinical practice compliance, including the modalities for examining the study management procedures and the conditions under which the clinical trial is planned, performed, monitored and recorded, as well as follow-up measures, such as a review of an analysis of the root cause of a significant non-compliance and verification of corrective and preventive actions implemented by the sponsor. Member States shall make those procedures and rules publicly available. 2. Member States shall also define the powers of experts appointed to accompany inspectors.