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Commission Directive 2005/28/ECShow full title
Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (Text with EEA relevance)
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Article 21
1.The inspectors, appointed by the Member States pursuant to Article 15(1) of Directive 2001/20/EC, shall be made aware of and maintain confidentiality whenever they gain access to confidential information as a result of good clinical practice inspections in accordance with applicable Community requirements, national laws or international agreements.
2.Member States shall ensure that inspectors have completed education at university level, or have equivalent experience, in medicine, pharmacy, pharmacology, toxicology or other relevant fields.
3.Member States shall ensure that inspectors receive appropriate training, that their training needs are assessed regularly and that appropriate action is taken to maintain and improve their skills.
Member States shall also ensure that the inspectors have knowledge of the principles and processes that apply to the development of medicinal products and clinical research. Inspectors shall also have knowledge of applicable Community and national legislation and guidelines applicable to the conduct of clinical trials and the granting of marketing authorisations.
The inspectors shall be familiar with the procedures and systems for recording clinical data, and with the organisation and regulation of the healthcare system in the relevant Member States and, where appropriate, in third countries.
4.Member States shall maintain up-to-date records of the qualifications, training and experience of each inspector.
5.Each inspector shall be provided with a document setting out standard operating procedures and giving details of the duties, responsibilities and ongoing training requirements. Those procedures shall be maintained up to date.
6.Inspectors shall be provided with suitable means of identification.
7.Each inspector shall sign a statement declaring any financial or other links to the parties to be inspected. That statement shall be taken into consideration when inspectors are to be assigned to a specific inspection.
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