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  • 1.  New Investigator Submissions

    This message was posted by a user wishing to remain anonymous
    Posted 18-Sep-2018 09:58
    This message was posted by a user wishing to remain anonymous

    Dear Community-

    21 CFR 312.30(c) states that the sponsor shall notify the FDA of the new investigator within 30 days of the investigator being added.  What triggers the start of the 30 days - is it site activation, first subject to consent or shipping drug?

    Thank you for you for your guidance!


  • 2.  RE: New Investigator Submissions

    Posted 19-Sep-2018 08:01
    Hello,

    Please see some input below.

    • Form 1572 must be signed before an investigator may begin participation in a clinical study conducted under the IND regulations. The investigator should sign this form only AFTER having been given enough information to be informed about the study and to understand the regulatory commitments made via the form. This typically means the investigator must have received, read, and understood the investigator brochure and protocol, and be familiar with the regulations before signing <g class="gr_ gr_41 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-del replaceWithoutSep" id="41" data-gr-id="41">a 1572</g>. For sponsors and sites, this means the FDA-1572 should be signed late in the process of initiating a site rather than as part of the site screening process, i.e., at or right before site initiation visit.
    Thanks,
    Prakash

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    Prakash Patel
    Sr. Manager Global Regulatory Affairs
    Cambridge MA
    United States
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  • 3.  RE: New Investigator Submissions

    Posted 19-Sep-2018 09:17
    The regulation is vague on your question, but based on the description in 21 CFR 312.30(c) you can count the 30 days from when the investigator is eligible to receive drug. I can tell you that we struggle all the time with the definition of when an investigator is added, or a study initiated, etc. Generally, we use eligibility to receive drug as the key time point.

    Note in 312.30(e) that new investigators can be combined and submitted monthly.

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    Glen Park
    Jersey City NJ
    United States
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  • 4.  RE: New Investigator Submissions

    This message was posted by a user wishing to remain anonymous
    Posted 19-Sep-2018 14:02
    This message was posted by a user wishing to remain anonymous

    ​Since this applies to a "previously submitted protocol", the study could be at any stage (e.g. in start-up mode, active with IP administration ongoing, etc.). We've had a few instances of this happening while studies are ongoing and the way we've handled this is as follows - update the protocol and the 1572 for FDA and IRB submissions. We start the 30-day clock from when the 1572 has been signed/dated. And this was the way we handled it for both Principal Investigator being changed or a co-investigator (listed on the 1572) being changed.  Hope this helps.

    21CFR 312.30(c)
    (c) New investigator. A sponsor shall submit a protocol amendment when a new investigator is added to carry out a previously submitted protocol, except that a protocol amendment is not required when a licensed practitioner is added in the case of a treatment protocol under 312.315 or 312.320. Once the investigator is added to the study, the investigational drug may be shipped to the investigator and the investigator may begin participating in the study. The sponsor shall notify FDA of the new investigator within 30 days of the investigator being added.