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Review & Sign-off of non-clinically significant tests and External AEs/SAEs

  • 1.  Review & Sign-off of non-clinically significant tests and External AEs/SAEs

    Posted 05-08-2020 13:50

    Dear colleagues,

    We are thinking of investigating the possibility of changing our current practice; I would love some input from other sites.

    Do you require your investigators review external SAE/AEs/INDSR if there is no language requiring it in the contract or the protocol?  If you do not require review and sign-off, have you gotten push-back from monitors and/or sponsors?  If you do require it, do you charge for the work involved?

    Thanks for your input.




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    Bucky Jones-Lombard
    Florida Cancer Specialists and Research Institute
    Tampa, FL
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  • 2.  RE: Review & Sign-off of non-clinically significant tests and External AEs/SAEs

    Posted 05-09-2020 10:53

    Thank you so much for sharing this question. I'm so curious to learn a solution for this. Ppl At our site, PI has to sign off on all the external SAE/AE/INDSR. It adds up a lot of workload on staff and PIs.


    Couple of the sponsors recently actually made it mandatory electronic sign off by the PI in their portal. This is even more harder because they change the password every 90 days and it's a whole process to change the password. We pushed back with this electronic review in their portal given how hard their portal is to navigate. Finally monitors agreed for manual review. 


    I wish we can acknowledge by email and it suffices. It still will be work load on research staff but in a way minimize some physician workload  (I heard some sites do this) but at our site, I hand sign off each of these documents as needed.

    please share if anyone have find best solution for this -






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    Ramya Thota MBBS
    Intermountain Healthcare
    Murray, UT
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  • 3.  RE: Review & Sign-off of non-clinically significant tests and External AEs/SAEs

    Posted 05-10-2020 11:45
    Good morning Ramya,

    I am happy to see more discussion on the topic generated.

    For IND safety reports on phase 2, 3 trials we are moving, as has many other academic organizations from our understanding, to only collecting/filing/logging and routing for PI review, those reports that: 1) meet the definition of an UPIRSO, 2) impact the consent or 3) result in a protocol modification (is increased safety monitoring). This should allow our investigators to expend an appropriate amount of time reviewing such reports in the context of his/her patients and communicating pertinent information to sub-Is. The PI then signs electronically through our digital signature platform and answers questions directly on the report to assess for local/central IRB submission. For early phase studies, clearly we don’t know enough about the intervention to apply this approach.

    For AEs we think we may have modified epic in a way that will allow us to route AEs to the treating physician electronically in Epic and are preparing to pilot. We will be happy to share our experience once we have gathered enough hands on knowledge and feedback. Currently we are limited by the technological constraints of the module.

    Hope this helps provide some perspective or generate additional conversation.

    Best of luck,
    T. Miller

    Sent remotely and may be more concise than usual.




  • 4.  RE: Review & Sign-off of non-clinically significant tests and External AEs/SAEs

    Posted 05-12-2020 22:41

    Thank you so much for sharing your experience. This is so helpful. Our site is in process of transitioning from paper to all electronic. We didn't realize the importance of it until this COVID. Although COVID has slowed down us a little bit, it helped us learn about new opportunities moving forward.

    I like the idea of having digital signature for these AE/IND reports. Do you send these documents for digital signature through email or through your CTMS? 

    We use icentra at our place. Looking forward to hear from other sites who use icentra if they are able to find a way for AE reporting in icentra.



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    Ramya Thota MBBS
    Intermountain Healthcare
    Murray, UT
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