Inspections shall be carried out by inspectors appointed by Member States.

In order to ensure the availability of necessary skills for each inspection, Member States may appoint teams of inspectors and appoint experts with appropriate qualifications to accompany inspectors.

Inspectors shall be entitled to inspect the clinical trial sites, documents, facilities, records, including individual patients' records, quality arrangements, data and any other resources and entities that are deemed by the competent authority to be related to the clinical trial.

When performing an inspection, the inspectors shall be empowered to enter into sites, other related premises, and to access to data, including individual patients' records.

Inspectors shall be entitled to make copies of records and hard copies, print-outs of electronic records and take photos of premises and equipment.

Inspectors shall be entitled to ask any representative or member of staff of the inspected entity and any party involved in the clinical trial for explanations relating to the subject matter and purpose of the inspection and to record the answer.

Inspectors shall be empowered to contact the trial subjects directly, in particular in case of reasonable suspicion that they were not informed adequately of their participation in the clinical trial.

Member States shall provide inspectors with suitable means of their identification.

Member States shall establish a legal and administrative framework to ensure that inspectors from other Member States, on request and where appropriate, have access to sites, any premise of any entity related to the clinical trial as well as to related data.