Inspectors shall verify the compliance with the requirements of Regulation (EU) No 536/2014, including protection of the rights and well-being of the clinical trial subjects, the quality and integrity of data generated in clinical trial, the compliance with principles of good clinical practice, including the ethical aspects and the relevant national legislation.
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.
The inspections may, where necessary, be carried out unannounced.
1.Member States shall collaborate with each other, with the Commission and with the European Medicines Agency to develop and improve commonly recognised standards of good clinical practice inspections. This collaboration may take the form of joint inspections, agreed processes and procedures and sharing of experience and training.
2.The Commission shall make publicly available any guidance documents on the commonly recognised standards for the conduct of inspections, developed in collaboration with Member States and the European Medicines Agency.
3.The European Medicines Agency shall process and make available to Member States information on inspections that are envisaged, scheduled, or conducted, in order to assist Member States to ensure the most efficient use of inspection resources when planning their inspections.
4.Member States may request assistance from the national competent authority of another Member State in the matter of inspection.
1.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.
2.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.
3.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.
4.Inspectors shall be entitled to make copies of records and hard copies, print-outs of electronic records and take photos of premises and equipment.
5.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.
6.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.
7.Member States shall provide inspectors with suitable means of their identification.
8.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.
Inspectors shall carry out inspections on behalf of the Union. The results of those inspections shall be recognised by all Member States.
In case of divergences between Member States in relation to the verification of compliance with the applicable legislation, the Member States, or the European Medicines Agency within the framework of its powers as provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council(1), shall inform the Commission. The Commission, after consulting those Member States and the European Medicines Agency, may request a new inspection.
Member Sates shall appoint an adequate number of inspectors to ensure effective verification of compliance of clinical trials with applicable requirements, as well as the timely reporting of inspection findings.
Without prejudice to the obligation to submit the inspection reports via the EU Portal in accordance with Article 78(6) of Regulation (EU) No 536/2014, Member States shall keep for at least 25 years relevant records of national inspections as well as of the inspections performed outside their territory, including information on the outcome of the inspection as regards good clinical practice compliance status as well as any action taken by the sponsor or Member State in the follow-up of the inspection. The inspection reports submitted through the EU portal shall not contain personal data of clinical trials' subjects.
The inspectors and experts appointed to the inspection team shall maintain the confidentiality of information to which they gain access as a result of good clinical practice inspections.
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).