{"id":122599,"date":"2023-02-16T23:01:22","date_gmt":"2023-02-16T22:01:22","guid":{"rendered":"https:\/\/preprod.group-gac.com\/?p=122599"},"modified":"2023-05-24T14:34:42","modified_gmt":"2023-05-24T12:34:42","slug":"guide-cir-2022-nouveautes-etudes-cliniques-sante","status":"publish","type":"post","link":"https:\/\/group-gac.com\/en\/cir-2022-guide-new-clinical-studies-in-healthcare\/","title":{"rendered":"CIR 2022 Guide - Clinical studies: what's new for companies in the health and veterinary sector?"},"content":{"rendered":"
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Attention pharma and veterinary companies: significant changes have been made to the CIR 2022 Guide.\u00a0The paragraph dedicated to the field of clinical trials (human or animal pharmacy) has been virtually eliminated. <\/span>completely rewritten\u00a0<\/b>in this new vintage. Many changes have been made <\/span>confirm the current trend in tax audits<\/b>\u00a0The aim is to exclude certain activities from the scope of eligible studies (phase I to III clinical trials).<\/span><\/p>

Do you have doubts about the eligibility of your work? Do you need help justifying them to the tax authorities? Our experts are on hand to answer your questions:<\/p><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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CIR and clinical trials: what are the eligibility conditions? <\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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This new guide introduces a new paragraph \"Conditions governing the eligibility of phases of clinical trials\/studies for the CIR\".<\/em><\/strong> and draws a parallel between the identification of a clinical study by an EudraCT registration number and its eligibility, including for studies of phase 4 interventional<\/strong>which can be considered as R&D and are therefore eligible for the CIR<\/strong>.<\/p>

Exceptional eligibility <\/strong>of certain phase 4 observational<\/strong> is specified and is linked to an action considered as a strong search indicator<\/strong>These include, for example, the publication of results in original articles in top-level scientific journals.<\/p>

The new guide also specifies that sponsored clinical studies<\/strong> (Investigator Sponsored Studies, ISS) are not eligible for the CIR<\/strong>. It should be noted that these tests may give entitlement to tax reductions under the sponsorship scheme.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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What about the CIR eligibility table for the various stages of clinical trials? <\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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With regard to activities eligible for the CIR, the eligibility table for the different stages of clinical trials has disappeared<\/strong>However, the text explaining the activities to be considered as eligible remains virtually unchanged, and limits eligible activities to those essential to scientific investigations, to the exclusion of regulatory and organizational activities. Our expert opinion is that the deletion of this table does not change MESRI's position <\/strong>as to the non-eligibility of the feasibility stages, the setting up of clinical studies and the purely administrative steps involved in recruitment and registration. follow-up<\/em> patients.<\/p>

We also note the deletion of the reference allowing this eligibility analysis to be applied to CROs and other types of trials (medical devices, nutrients, cosmetics, animal health, agri-food for crop trials). In our opinion, this deletion should not change MESRI's position on the subject either.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Clinical trials: which personnel are eligible for the CIR?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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MESRI adds a new and final paragraph entitled \"Details of personnel eligible for the CIR\" in which it lists eligible personnel:<\/p>