For clinical trials of medicinal products in humans, a comprehensive procedure has been established to ensure quality in all stages of the trial. Guiding principles are set out in “Good Clinical Practice” (ICH-GCP).
SOPs, templates, checklists, forms and logs.For testing in connection with CE marking of medical devices involving humans, special requirements have been established. These are regulated in a separate regulation and the ISO standard “Clinical investigation of medical devices for human subjects – Good clinical practice”.
SOPs, templates, checklists, forms and logs.Interventional and observational studies that do not fall under the regulation for drug trials or medical device trials.
To SOP, templates, checklists, forms and logs.