Regulatory Compliance

Clinical studies conducted by OTG-i are designed 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
Regulatory Bodies
• Medicines and Healthcare products Regulatory Agency (MHRA)
• European Medicines Agency (EMEA)
• European Union Clinical Trial Directive
• European Union Good Clinical Practice Directive
• US Food and Drug Administration (FDA)
• FDA Database Search 510(k)
• Medical Devices Directive 93/42/EEC imp 13/6/98 (MDD)
Ethical Review
All clinical studies conducted in the United Kingdom require ethical review through the National Research Ethics Service (NRES The Integrated Research Application System (IRAS) is a single system for applying for the permissions and approvals. Applications are reviewed by either a full Research Ethics Committee (REC) or through the Proportionate Review Service (PRS) for research studies that raise no material ethical issues (no change in standard of care and low risk studies).
Studies conducted in France require regional Ethics Committee (CPP) and the Competent Authority (CA) applications.
Studies conducted in the United States will be submitted for ethical review to an Independent Review Board (IRB). The companies used by OTG-i are:
• Sterling IRB
• Chesapeake IRB
Professional Organisations
• American Academy of Optometry (AAO)
• American Association of Ophthalmologists (AAO)
• American Society of Cataract and Refractive Surgery (ASCRS)
• Association for Research in Vision and Ophthalmology (ARVO)
• British Contact Lens Association (BCLA)
• College of Optometrists
• European Contact Lens Society of Ophthalmologists (ECLSO)
• European Society of Cataract and Refractive Surgeons (ESCRS)
• General Optical Council
• International Society for Contact Lens Research (ISCLR)
• Institute of Clinical Research (ICR)
• Tear Film and Ocular Surface Society (TFOS).