crstnet.com - CRST: Discussion Forums

CRST Discussion Forum Log In (You must be a registered user to post to the discussion forum.)

( Back )

Categories

Categories » Regulations and Operations » New FDA Guidance on IRB Adverse Event Reporting

Threads [ Previous | Next ]

New FDA Guidance on IRB Adverse Event Reporting

Anonymous

4/21/09 9:07 AM

RE: New FDA Guidance on IRB Adverse Event Reporting

Anonymous

1/5/10 4:10 PM

RE: New FDA Guidance on IRB Adverse Event Reporting

Anonymous

2/21/10 7:42 AM

Anonymous

New FDA Guidance on IRB Adverse Event Reporting | 4/21/09 9:07 AM

Top

In January 2009 the FDA posted new guidance on the reporting of adverse events to IRBs. Is it the institution/IRB who is responsible for ensuring compliance with this guidance or is it the clinical research investigator?[/color]

Anonymous

RE: New FDA Guidance on IRB Adverse Event... | 1/5/10 4:10 PM as a reply to Anonymous.

Top

The guidance was created to help guide the sites/Investigators to know what to report to their IRB. Per 21CFR312.32, it is the Investigators responsibility to file the UPs that meet reporting critieria with the IRB.

Recently, I revisited the issue of IND safety reports being submitted at the site level. This is a difficult task for the investigative site since the site is commonly unable to determine if the single occurrence being reported in the IND safety report places subjects at greater risk of harm. I spoke to WIRB yesterday about this in length. WIRB’s report requires the site to indicate a corrective action plan and/or list the changes to the protocol/ICF and also include a summary about similar occurrences when reporting an IND safety report with the CIRB. The FDA regs requires the report “to identify all previous safety reports” of similarity and “the significance of the current adverse experience in light of previous reports.” The issue is that commonly the IND Saftey/CIOMS/SUSARs form does not capture those two requirements for the site to make the determination on whether the IND safety report should or should not be reported. The sponsor is in the position to evaluate the totality of AEs and perform analysis needed to determine if an event meets the Unanticipated Problem definition set forth by OHRP guidance 1/2007 and FDA guidance 1/2009. In addition, WIRB is requiring a corrective action plan. In a multi-center, industry sponsored trial, it is not routine for the PI to request ICF/protocol/IB amendments based upon their review of these reports.

As the site level, we are required to report to the IRB per 21CFR312.32 but I fear that we are not capable of making these determinations without vital information being provided. Our ultimate goal is to ensure human protection through compliance with FDA regs, but I am struggling with what the best answer is and what makes the most logically sense. Any suggestions on how to move forward?

How are other sites handling this? Have other sites experienced similar frustrations?

Anonymous

RE: New FDA Guidance on IRB Adverse Event... | 2/21/10 7:42 AM as a reply to Anonymous.

Top

Our site and PI shares the identical concerns regarding the new reporting guidance. We do not receive any other information from the sponsor regarding any trends or the significance of this report in relation to others, and the PI pointed out if he does not feel a report is overly concerning (based on limited information) and does not report it as such, and then later finds that this is actually part of a significant trend or safety issue, he will be viewed as inadequately monitoring the safety of subjects. We have included a statement that clarifies what exactly he has reviewed and the information available at the time to make the determination - which also seems to defeat the real purpose of reporting and is more of an administrative requirement or CYA manuever.

The new guidance makes sense if the study is an investigator initiated type of study with a local IRB, but the process does not fit well in multi-site studies in which the sponsor expects the site to submit all IND reports. In this case - I have discussed this with the sponsor and they started to submit on behalf of our site, but very reluctantly. The problem I see with this mechanism is we do not see what actually is reported to the IRB and if any assessment of risk has changed, and is the sponsor in the best position to make that determination (conflict of interest)? Good discussion and would welcome more feedback!