September 2024
In brief
With determination No. 425 of 8 August 2024, the Italian Medicine Agency approved the new Guidelines for the Classification and Conduct of Observational Studies, implementing the provisions of Article 6(3) of the Ministerial Decree dated 30 November 2021.
Key takeaways
The new Guidelines, which replace those previously adopted by determination dated 20 March 2008, apply to all categories of pharmacological observational studies and respond to the objective of providing clear and precise guidance on their proper framework and the operational aspects to be taken into consideration in the regulatory activities concerning their conduct and evaluation by Ethics Committees.
Changes introduced by the new Guidelines include specific provisions on the types of studies falling within the scope of the same Guidelines and the conditions that said studies must meet in order to be classified as observational, a more detailed regulation of the procedural aspects related to the start and conclusion of studies, which now also include those concerning possible changes to the study protocol, and the introduction of a new paragraph dedicated to the consent to the processing of personal data.
