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Thread: Definition of 'Start of Clinical Trial'

  1. #1
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    Definition of 'Start of Clinical Trial'

    Dear all,

    I tried a lot, but I haven't yet found a definitive answer to definition of 'Start of Clinical Trial'. I am not looking for the definition of 'Clinical Phase' of the trial, I am looking for definition of 'Start of Clinical Trial'.

    Can anyone help?

    Thanks,
    Amit

  2. #2
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    The EU PROPOSED regulation to replace Directive 2001/320/EC defines ‘Start of the clinical trial’: the first act of recruitment of a potential subject, unless
    defined differently in the protocol. Many sponsor define this as the date of the first subject signing the first consent form. I hasten to emphasize that this is PROPOSED regulation and may not be passed into law intact. I realize that you may say that this definition is the same as start of the clinical phase but this is what the regulators have given us! The new MHRA GCP Guide does not seem to define start of study but it does say this:- It is a legislative requirement7 that a trial does not start until an authorisation has been granted and favourable REC opinion has been received – ‘regulatory release’ and that IMP must27 not be sold or supplied until an authorisation has been granted and it has been certified by a Qualified Person (QP) where required -‘technical release.’ (7 = regulation 12 of SI 2004/1031) (27= regulation 13 of SI 2044/1031). The sponsor’s authorisation to start the trial is usually marked by the shipment of IMP to the investigator sites. However, there are occasions where this may vary". Good idea to buy a copy

  3. #3
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    Thanks for your reply!

  4. #4
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    Quote Originally Posted by a123456 View Post
    The EU PROPOSED regulation to replace Directive 2001/320/EC defines ‘Start of the clinical trial’: the first act of recruitment of a potential subject, unless
    defined differently in the protocol. Many sponsor define this as the date of the first subject signing the first consent form. I hasten to emphasize that this is PROPOSED regulation and may not be passed into law intact. I realize that you may say that this definition is the same as start of the clinical phase but this is what the regulators have given us! The new MHRA GCP Guide does not seem to define start of study but it does say this:- It is a legislative requirement7 that a trial does not start until an authorisation has been granted and favourable REC opinion has been received – ‘regulatory release’ and that IMP must27 not be sold or supplied until an authorisation has been granted and it has been certified by a Qualified Person (QP) where required -‘technical release.’ (7 = regulation 12 of SI 2004/1031) (27= regulation 13 of SI 2044/1031). The sponsor’s authorisation to start the trial is usually marked by the shipment of IMP to the investigator sites. However, there are occasions where this may vary". Good idea to buy a copy

  5. #5
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    The EU Clinical Trial Regulation 536/2014 has been made final and was published in the Official Journal on 27 May 2014. It does define start of a clinical trial.

    A2 (25) "‘Start of the clinical trial’: the first act of recruitment of a potential subject for a specific clinical trial, unless defined differently in the protocol";
    HOWEVER --- “Whereas: (38) The date of the first act of recruitment of a potential subject is the date on which the first act of the recruitment strategy described in the protocol was performed, e. g. the date of a contact with a potential subject or the date of the publication of an advertisement for a particular clinical trial”.
    Article 36 requires the reporting of both the start of CT (as in Article 2) and FSFV (First Subject First Visit) in each MS within 15 days! So lots of fast reporting to be done. There will be a need for a fast and reliable reporting system by sposors.
    Annex 1 Application dossier for the initial application K. RECRUITMENT ARRANGEMENTS(INFORMATION PER MS CONCERNED) 59. “Unless described in the protocol, a separate document shall describe in detail the procedures for inclusion of subjects and shall provide a clear indication of what the first act of recruitment is".
    So it is up to you to define things sensibly in the protocol or a separate document. There is advice (& webcast) on this sort of thing on the RQA website (www.theRQA.com).

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