Study Termination

[ULIrowa]

Forum members, please give me your opinion on this situation;
We (Sponsor B) was recently notified by an IRB and our study PI that another sponsor (Sponsor A) recently terminated their study with the site due to significant reoccurring GCP violations. We do not know what the violations are. what are our options. thank you

[a123456]

Sponsors are generally reluctant to close sites for non-compliance, so the fact that sponsor A has done this and informed the IRB is a measure of the seriousness. It would be wise to contact the IRB/IEC to see if they can at least give confirmation that the site was closed because of "significant reoccurring GCP violations." The sponsor really should have a process for dealing with significant deviations all the way up to outright fraud. Usually QA is heavily involved and a "for cause" audit is usually performed. Also the sponsor's legal department should be involved. The sponsor needs to examine the extent of company exposure to this potential persistent non-compliance. All previous studies by this site need examining in detail. Consider suspending recruitment until the case is resolved. If there is reason to believe that there is persistent non-compliance, close the site, remove the PI from your list of available investigators and inform the IRB/IECs and RAs. In some nations this might be a Serious Breach (SB) of GCP and need expedited reporting to the Regulatory Authorities (RA). Your company process must cover this. Some regulators (such as the MHRA) have the possibility for you to contact them and ask whether your case is an SB. Although the regulator will not give you details of the other cases, the fact that the regulator asks you to submit an SB (if they do) would suggest that your actions were prudent and sufficiently justified. Also look in the MHRA GCP Guide (2012) for help.