See Guidance for the notification of serious breaches of GCP or the trial protocol ( PDF, 221 KB, 12 pages).Ĭomplete the notification of serious breaches of GCP or the trial protocol form ( MS Word Document, 228 KB) and send it to the annual summary of MHRA GCP referrals. You must notify MHRA of serious breaches of GCP or the trial protocol.
DOSSIER DEFINITION REGISTRATION
Guidance on good clinical practice has been produced by the International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH).
laboratories analysing samples originating from a clinical trial (including NHS, academic and commercial laboratories).Organisations that may have to comply with GCP include: Good clinical practice ( GCP) is a set of internationally-recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical trials that involve people. We have published guidance on managing clinical trials during the COVID-19 outbreak, and on clinical trials applications for COVID-19. This is a selection of industries that may have hazardous areas.Clinical Trials and coronavirus (COVID-19)
This may include compliance notices immediately prohibiting the use of electrical equipment in hazardous areas until risk controls are implemented and verified. Inspectors will take enforcement actions if unmanaged risks relating to fire and explosion are identified. engagement of a hazardous area classification specialist to determine zone requirements for electrical equipment in a hazardous area.adequate controls are implemented to reduce the fire and explosion risk at their workplace.compliance with the relevant work health and safety, and electrical safety requirements.The Electrical Safety Office (ESO) supported by WHSQ conduct workplace visits to ensure that the risks of fire and explosion have been identified, assessed and controlled. Workplace Health and Safety Queensland (WHSQ) and ESO Inspectors may request to view a completed copy of the self-assessment during site inspections. Manage the fire and explosion risks by conducting a self-assessment (DOCX, 0.4 MB) of your workplace with the self-assessment tool to ensure that explosive atmospheres are effectively controlled. Section 221 of the Electrical Safety Regulation 2013 (the ES Regulation) requires that an accredited auditor inspect electrical installations in hazardous areas prior to connection for the first time or reconnection, to the extent it is affected by the electrical work, to a source of electricity. Where electrical equipment is located within a hazardous area classification zone, specific requirements are mandated in AS/NZS 60079.14 Design selection, erection and initial inspection for the selection and installation of the electrical equipment. A list of hazardous area classification specialists hazardous area can be found on the fire and explosion prevention page. Any person with management or control for an installation with an explosive atmosphere risk has a duty to ensure such a classification has been made.įor more information on hazardous area classification and fire and explosion prevention, follow the link to the information page. Wherever flammable liquids, vapours, gases and combustible dusts are used, stored, handled or generated, a hazardous area classification is required to assess the risk of fire and explosion. The first step to identifying the fire and explosion risk of an installation is to conduct a hazardous area classification to determine whether any zones where an explosive atmosphere exists or may be expected to be present will affect the level of protection for electrical equipment. Special precautions are required for the construction, installation and use of potential ignition sources, as fire and explosion can result in catastrophic consequences for people and property. Electrical equipment within the hazardous area must be suitably rated and effectively earthed to ensure that any ignition risks are adequately controlled. A hazardous area is a three-dimensional space in which an explosive atmosphere is or may be expected to be present or form.
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