Good Clinical Practice Guide
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Thread: SUSARs at Investigational Sites

  1. #1
    Forum Member
    Join Date
    Mar 2014

    Question SUSARs at Investigational Sites

    Please can someone give me some guidance on how quickly Principal Investigators (PIs) are expected to read, acknowledge and share updated safety information with their team? This is in relation to SUSAR reports.

    A SUSAR report was sent to a site by the Sponsor in May 13 but was not read by the PI until July 13. My question being was this too long? I can't see anything in the regulations so any feedback would be greatly received.


  2. #2
    Forum Member
    Join Date
    Nov 2011
    The MHRA GCP guide (2012) has some useful advice (well worth getting a copy):- "It is recommended that sponsors also consider how it can be demonstrated that these reports" [SUSARs] "have been reviewed by the investigator, as they may be sent electronically or made accessible through an internet portal. Typically, investigators sign and date paper reports to confirm their review, so this system would need to be replicated electronically. If ..via an internet portal, the sponsor should ensure that concerned investigators have access to the portal and have been trained on how to access the information, before the trial commences. ..., in one trial using such a portal, the inspectors found that the email notifications to alert the investigator of new information in the portal were all being held by the hospital’s spam filter ... ". 5.5.1 [Also 11.2.1 is also “commonly used ...” review of SUSARs]
    Documentation of Dissemination of safety information from PI to team is recommended by the MHRA. “It is recommended that consideration is given to how provision of information can be documented..... " "This could be addressed by the receiving member of staff countersigning CIOMs I forms or other trial related correspondence; documenting the provision of information within meeting minutes; or sending emailing confirmation of reading sent to the PI or trial coordinator”. 11.3.5

    If we look at the ideas about medical oversight by the PI we will get an idea of what the MHRA are suggesting as adequate.
    " is essential that there is clear, documented evidence of the PI’s oversight and involvement in the trial and that the PI is kept appraised of any issues regarding the trial. The following examples are commonly used to provide suitable evidence of that oversight and active trial management: ........
    • review of safety information (for example, line listings or SUSARs from other sites)
    • documented review of incoming data (for example, laboratory, ECG, imaging) in a timely manner". section11.2.1
    The words "Essential”, "typically", "could" and “Examples commonly used” are not codified in the GCP Guide & therefore this might be a suggestion for suitable oversight. Other suggestions of the MHRA are "recommendations" and these are codified as best practice but not legal requirements or guidance. The word "should" is used as meaning that there is guidance to be followed.
    Of course there is nothing stopping the sponsor from setting a standard for SUSAR review and requiring compliance with this by all investigators.

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