All protocols and reports generated by Kathy Dumbleton are written to comply with the following standards and guidelines:
The World Medical Association’s Declaration of Helsinki
ISO 14155:2011(E) Clinical investigation of medical devices for human participants – Good clinical practice
ISO 19980:2012 (E) Ophthalmic optics – Contact lenses and contact lens care products – Guidance for clinical investigations
ICH E6: Good Clinical Practice: Consolidated guideline, CPMP/ICH/135/95 Good clinical practice; July 1996