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Hi
as Donna mentioned, medical history is key....was it recorded there? also how about the other babies in the trial...are they experiencing similar or more less gas......if the IB states something about that and the sponsor probably wants to record gas as an AE it might be good to just keep track of it as maybe just one event with a start date and then see over the next few visits if the mom noticed any changes etc? that way atleast you have captured it once.......hope this helps

Hi,
Was doing some research for another topic and ran across your chain, I realize this was over two months ago now, but thought I would comment in case it helps. The only way gas would not be seen as AE is if it was documented in the patient's medical history to begin with. I didn't see this mentioned, so thought I would bring it up. Sounds to me like this pt had a hx of having gas (albeit i agree most babies do!).... I agree on the other point, it was totally unnecssary to record each event seperately.

Thanks
Yes, we all discussed it with the monitor and he was pretty adamant that these be listed AND be listed separately for each occassion.
I agree having a good professional relationship with monitors, however, but we do know that there are some circumstances where it just isn't black or white. Lately, there has been a string of these situations where the outcome is not what I've expected. Thanks for your comments! I'm trying not to become so frustrated!

Good Morning Diane,
Has the monitor spoken to the PI about this? May be you can also discuss it with the study medical Monitor, sometimes you have to by-pass the monitor...even thought fostering a good, professional relationship with monitors is the best practice :)

Thanks for your comments. According to the subject's mother AND the PI, this is considered normal for the patient. The diary has a column asking if the patient had gas and if it was mild moderate or severe. The monitor saw that Mild gas was ticked and he requests it to be listed as an AE, even though this is normal for the subject (and almost every 11month old). This information, I feel, may compromise data and further literature. Thoughts?

we have to take "untoward medical occurrence" in context- if this is not normal for the patient, then it is an adverses event, that is there has been a change. More information is needed. Especially as the diary is asking a leading question- you need to elicit if mild gas is normal or a change in the patient.

you are welcome, if it is a phase 4, check the drug insert and if you find passing gas as something expected you may have a chance not to report it with the monitor. Remember, that the company might be collecting data re. long term drug usage or long term drug reactions.

Thanks! It's a phase 4 study. I appreciate your comments and opinions.

Hi Diane,
My answer is yes! you have to report it as an AE and the casuality may be "not related" but you still have to report it. what phase is this trial? may be there is info in the investigator's brochure that outlines passing gas as something expected but still you have to report it as an expected AE. I am doing studies in Nuclear medicine and face similar situations where things are expedted to be felt or expirienced and i have to report them per protocol. Once again, good luck!

Thanks for your comments. I understand everything you are saying, but here is the example. 11 mo old participating in study. Diary is provided to parent to complete which asks about stools/gas/bloating/abdominal pain. Mom check marked 'mild gas' on the diary throughout diary maybe 5 times/week.
I was told to enter EACH one as an adverse event separately.
I pass gas every day, just like everyone else so I don't understand why I was told by the monitor to enter this as an adverse event AND enter them separately with a start time and an end time.
The parent did not say 'this is unusual for my baby' or anything suggesting the was different from their normal self.
Suggestions??

An AE is "any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment" (ICH E2A) therefore, if there is any change in the subject's health even a lab result, you should report it as an AE and the investigator should determine its relationship to the investigational product along with severity, seriousness, etc. I am sure the protocol of your study clarifies all this.
I hope this helps and good luck with your study!
Nancy Zambrana, CCRC