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Thread: GCP Training Certificates

  1. #1
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    GCP Training Certificates

    Hello

    I would like to know the best approach on how to document when an individual has conducted GCP training.

    Would it be fair to say that for commercially sponsored trials a File Note in a TMF or a site file would be sufficient to say that all GCP certificates are centrally located, hence so when the files are inspected the monitors can refer to the file note which would tell them that all GCP certificates are centrally located in one file and then they can then refer to this central file where ever it may be is this deemed sufficient.

    Or would the best approach be to ensure that all the current GCP certificates are available and filed in the site file or TMF so monitors can see that they are present.

    Thank You

  2. #2
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    Quote Originally Posted by SAMMY View Post
    Hello

    I would like to know the best approach on how to document when an individual has conducted GCP training.
    Take a look at the MHRA's GCP Inspection Dossier document con031151 (V3 02-08-10) - Section 2, item 1 covers a range of areas including Quality systems (QA & SOPs ) and training. Whatever solution you decide to implement would need to be reflected in both of these. Also, what does a certificate confirm? Attendance? Active participation? It would also be worthwhile to include the training agenda and methods used e.g. cases studies and group discussion or short presntation followed by Q&A. Training attendance helps but does not guarantee understanding so consider including Q&A session and also a reference to the materials used.
    You mentioned file notes - as signposts these have some value but they are overused and seldom described as part of documented processes so should be used sparingly. There is useful article on file notes by Carl Anderson called Note to self: no more notes to file - it is well worth a read.

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