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Thread: MHRA produced FAQs for Quality Systems (Including QA, SOPs & Training)

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    MHRA produced FAQs for Quality Systems (Including QA, SOPs & Training)

    1. What is the MHRA’s position on Good Clinical Practice (GCP) training?

    The UK Clinical Trials Regulations (SI 2004/1031, as amended) state that no person shall conduct a clinical trial otherwise than in accordance with the conditions and principles of GCP (Regulation 28) and that each individual involved in conducting a trial shall be qualified by education, training and experience to perform his tasks (Schedule 1, Part 2, 2). It therefore follows that each person involved in a clinical trial of an investigational medicinal product (CTIMP) must receive training in GCP commensurate with their roles and responsibilities.

    The frequency of GCP training is not defined in the regulations. However, it is recommended that training is given at appropriate intervals to ensure that staff maintain current awareness of the UK Regulations and applicable European guidelines. How often this training is repeated is a business decision for the organisation concerned. A fixed frequency such as every two years may not be appropriate. Systems should also be in place to allow for ad hoc training in between scheduled training events, for example in the event that there are significant regulatory updates, and this should be reflected in the organisation’s procedures.

    Training needs may range from a detailed knowledge of GCP principles and associated UK Regulations and European guidance to an awareness of particular GCP principles, and training can be tailored accordingly. If an activity is part of a person’s normal clinical role and all other protocol activities are undertaken by a member of the research team, then no GCP training may be required; however this should be reviewed as part of the risk assessment for a trial. The MHRA strongly recommends training in relevant aspects of GCP for anyone involved in conducting CTIMPs, even if the activities are part of an individual’s routine job (for example, tailored training in aspects such as documenting activities in source notes and recording adverse events). It is recommended that assessments of the scope or level of GCP training required by particular individuals or roles are documented.

    GCP training can be provided in a range of formats, including face-to-face, web-based and as self-directed reading. The organisation should assess the suitability of the training method prior to implementation.

    On inspection, MHRA GCP inspectors will look for evidence that individuals involved in the conduct of CTIMPs have received adequate training in GCP and appropriate legislative requirements commensurate with their roles and responsibilities. This is not limited to checking for the presence of a training certificate but is likely to involve discussions regarding individuals’ roles and responsibilities in the conduct of CTIMPS, the scope and format of the associated training and the rationale for the frequency of training. Inspectors will also review compliance with the organisation’s policies or procedures on GCP training and organisations involved in the conduct of CTIMPs are recommended to review their policies and procedures in light of this statement.

    This FAQ focuses on GCP training. Information on protocol-specific training and training in written procedures will also be made available in this section of the Forum.

    28 June 2012
    Last edited by MHRA Super Moderator; 28th Jun 2012 at 05:19 PM.

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