Risk-Adapted Approaches to the Management of Clinical ...

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extensive class data or pre-clinical and clinical evidence)* Table 1 (adapted from Adamon paper, excluding non-pharmacological interventions. 1) *If a grading other than those indicated is felt to be justified the rationale and evidence should be presented in the CTA application . 2. All other risks related to trial design and methods

  Applications, Clinical, Trail, Cta application