SUSARs notification to Principal Investigators
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I would like some advice regarding the Principal Investigator's responsibilities regarding the review of SUSAR only accessible through an internet Portal.
I agree that the PI should review the SUSARs but I would like to know if they are obliged to download or print them to be kept at the ISF.
I think pharmacovigilance committee are best placed.
Such information will be part of the ISF. investigator TMF. So you need to ask yourself, how will you document access to and review if SUSAR reports by the PI? it is up to you to arrange a suitably compliant system to document this and have it readily available for inspectors. See final EMA guidance on TMF.
You could do it by electronic or paper means or a hybrid .
Other might have experience of how to manage a portal system to comply with inspection.
Feedback from others:-
others have used a vendor and associated system for this; no need to download or print, but they must acknowledge receipt of review of SUSARs in the system and be able to access/utilise information as and when required. This approach also comes with challenges with PI adherence!
At an investigator site level, I would also suggest that there is documentation of the dissemination of this information to other investigators at the site, other than the PI, who may be involved in the consent process and/or pharmacovigilance activities - eg minuted meetings
One more that you have to keep in mind is that if investigator submits SUSARs to the LEC for review, he need to receive it from somewhere. Hence, he have to upload it.
Another contribution;---- When it comes to inspections at site, it will be a matter of providing evidence that indeed the report were accessed. This can be viewed in the system, will be obvious what was accessed/opened and what not. It becomes more challenging after the end of the trial. The system is no longer active, thus this information is no longer available during the course of the trial, but reports can be produced by sponsor/CRO. This is often a request during inspections, similar to EDC data, especially when the reports are not downloaded or filed.
You need to think about what information will be available after the trial, if the reports are not downloaded.
It is essential to understand the purpose of the PIs reviewing SUSARs. It is for safety information not only to be known by the PIs but also to be formally shared with sub-investigators and nurses, to be taken into account with subjects participating to the clinical trials related to the IMP. The Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’) (https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/2011_c172_01/2011_c172_01_en.pdf
) provides processes at section 7.10 - Informing the investigator. Rather than forwarding single SUSARs, some periodical SUSAR listings as well as “a concise summary of evolving safety profile of the IMP” are recommended.
An extensive description about SUSARs at investigational sites is given in the MHRA forum at http://forums.mhra.gov.uk/showthread.php?1731-SUSARs-at-Investigational-Sites
I would consult a few-year old EMA document about some combined submissions highlighting still on-going issues with SUSARs at https://www.ema.europa.eu/en/documents/presentation/all-submissions-combined_en.pdf
. Please do a search or a find about the keyword “SUSARs”. Much emphasis is put on Eudravigilance, NCAs, and IECs. It is highlighted that ECs cannot efficiently assess and process single SUSARs within the evolving safety profile of the IMP. Same for PIs and Sub-Is.
Thank you all for your detailed responses.
Unfortunately, we still receive single SUSARs from some Sponsors. I work for an Oncology Hospital and the number of SUSARs received by each PI on a monthly basis is huge. The volume of work generated by these individual SUSARs is overwhelming.
I agree with you. PIs and ECs cannot assess and understand how the key issue, the safety profile of the IMP, is evolving over time. Only Eudravigilance, some CAs and all Sponsors have the personnel and technical means to carefully and thoroughly review all SUSARs and determine precisely the current safety profile of the IMP.
Maybe you could contact the Sponsors and highlight them the current guidance and its requirements (case listings and up-to-date safety profile). You could also work in collaboration with your IEC to defend together your case. Inspectors need to take more into account that reviewing SUSARs by PIs must always be associated with a statement about the current IMP safety profile. It is what the section 7.10 - Informing the investigator in CT-3 states.
Significant single SUSARs could still exist, but it should be done when they had critical and urgent information for sites and ECs to be promptly aware of.