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Thread: Investigator CVs and GCP training

  1. #1

    Investigator CVs and GCP training

    Hello everyone,

    I have five CV/GCP questions:

    1. For NON FDA 1572 studies, what guidance or regulations are there for checking of CVs collected at the study start? Specifically should CVs be signed and dated? How long before the start of a study is a CV valid for? Or if a CV states the correct job title for the investigator, location of the role and other aspects does it matter what the date on the CV is? Anything else? Under the FDA guidance the signing of the FDA 1572 is binding the investigator that his CV is up to date/accurate

    2. If a study is a long term study, should CVs be updated and collected?

    a) never, they are as collected at the start of the study
    b) if there is a change in job, education or training?
    c) yes because it says so in the regulations (if so where as under FDA 1572 guidance it does not need to be updated)
    d) yes because the SOP says so (SOP written but no regs quoted)
    e) yes every 2 years while study is ongoing from date of SIV because that seemed like a good idea?

    3. Should an investigator's CV contain details of GCP training
    a) contain the latest GCP course taken
    b) be updated if a GCP course is taken
    c) contain details of GCP training?
    d) no but there should be evidence of GCP training?

    4. How often should an investigator do GCP training?
    a) once
    b) every year
    c) every 2 years
    d) only if provided at investigator meeting
    e) never its not required

    5. If an Investigtor should be trained on GCP what should this course contain?
    a) the full works of GCP and should be a proper 2 day or so course
    b) at least 1 day covering investigator responsibilities and an understanding of all parts of GCP which he is not directly responsible for
    c) 20 mins at an investigator meeting

    For any of the above I would appreciate confirmation of the regulations or guidance which state anything on these questions.
    Thanks in advance.

  2. #2
    Forum Member
    Join Date
    Nov 2011
    At least one part of your question is answered by the MHRA Super Moderator (great to think that there is a "super" moderator) on the GCP Forum stream under Quality Systems. It is also covered in the MHRA GCP Guide (2012), buy a copy.
    GCP Forum:-
    1. What is the MHRAís 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 organisationís 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 personís 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 individualís 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 individualsí 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 organisationís 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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