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Is it ok not to report an SAE within 24 hours

By Jennifer Elston posted 08-25-2014 09:28 PM

  
I know, I know all SAE's should be reported in 24 hours, but I had to say something to get your attention :-). Seriously though! If you have a PI that is a hospitalist (makes rounds at the hospital), and he admits a subject to the hospital (true SAE) on Saturday. Is he required to report the SAE by Sunday if his office doesn't open until Monday morning? Should he carry SAE forms for all studies in his car just in case? This has come up in an audit, and I am not sure how to respond.

Thanks for the help!

Jennifer
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Comments

Michael Leon
11-17-2014 01:21 PM

In our technology filled world it is very easy to access an SAE document from a multitude of electronic gadgets, complete it, and send it to the sponsor and IRB. This is a SERIOUS Adverse Event and needs to be addressed in a serious manner.

Valera Bussell
09-11-2014 12:06 PM

My comment would have been identical to Carolie's. It is a PI responsibility that he accepted when he took on the trial. It is quite easy to quickly report the SAE with cursory info known and then file a follow up as required.

Carolie Horvath
09-02-2014 01:30 PM

The PI has an obligation to report all SAEs within the protocol-defined timeframe. I understand his dilemma, however that is the responsibility he agreed to as the PI. Not every detail of the SAE needs to be recorded on the initial SAE form if time doesn't permit. At a minimum, he should report the event, onsent date, severity, relationship to study drug, and then promptly submit a follow up report on MOnday with more detailed information. Maybe it would make sense for him to scan the SAE report forms and save onto a flash drive that he can utilize when offsite, or ask the sponsor to send him Adobe or Word versions that he can save? Alternatively, many protool have an SAE hotline that can be called-perhaps he should keep a list of sponsor contacts with him for this very reason.