Commission Implementing Regulation (EU) 2017/556Show full title

CHAPTER II INSPECTORS

Article 4 Qualifications, training and experience

1. Inspectors shall have completed education at university level, or have equivalent experience, in medicine, pharmacy, pharmacology, toxicology or other fields relevant to the principles of good clinical practice.

2. Inspectors shall receive appropriate training, including participation in inspections. Their training needs, necessary to maintain or improve their skills, shall be assessed regularly by a person appointed for that task.

3. Inspectors shall have knowledge of principles and processes that apply to the development of medicinal products and clinical research and have knowledge of applicable Union and national legislation and guidelines on the conduct of clinical trials and the granting of marketing authorisations.

4. Inspectors shall have the ability to make professional judgments in relation to the compliance with applicable Union and national legislation and guidelines. They shall be able to assess data integrity as well as aspects related to ethical conduct of clinical trials.

5. Inspectors shall be familiar with the procedures and technical methods for the recording and management of clinical data, and with the organisation and regulation of the healthcare systems in the relevant Member States and, where appropriate, in third countries.

6. Inspectors shall be able to assess the degree of risk as regards the safety of the subjects enrolled in the clinical trial as well as the data integrity.

7. Inspectors shall be aware of the applicable rules as regards confidentiality and protection of personal data.

8. Member States shall keep records of the qualifications, training and experience of each inspector and maintain those records up-to-date for as long as inspector is in active duty.

Article 5 Conflict of interest and impartiality

1. Inspectors shall be free from any influence which could affect their impartiality or their judgement.

2. Inspectors shall not have conflicts of interest. In particular, they shall be independent of all of the following parties:

(a) the sponsor;

(b) the investigators involved in the clinical trial;

(c) persons financing the clinical trial;

(d) any other party involved in the conduct of the clinical trial.

3. Each inspector shall make an annual declaration of their financial interests and other links to the parties to be potentially inspected. That declaration shall be taken into consideration for the purposes of assigning an inspector to a specific inspection.