Another topic very closely related to Good Clinical Practice, actually its part of GCP, is reporting adverse events. So whenever someone’s in a clinical trial, and whether it’s related to the study drug or not, any suspected side effect has to be thoroughly reported and investigated. The person may get a headache on a certain day. The person may develop a cold or flu-like symptoms on another day. On another study visit the study participant may be complaining of diarrhea, or constipation, may have nausea, dizziness, vertigo etc etc. Whatever it may be, and how insignificant you think his or her symptoms are that they are reporting to you, you must report this as an adverse event.
4.1 What is an Adverse Event (AE)
An adverse event, otherwise known as AE is an unwanted side effect, so anything unwanted that’s happening.
4.2 Serious Adverse Event (SAE)
I talked about choking on a chicken bone earlier. If they do that and end up in a hospital, that’s actually a serious adverse event because the serious adverse event, otherwise known as the SAE is anything that puts the study participant in immediate risk and requires hospitalization. Going to the hospital despite your reasoning for why that person went in the hospital is an SAE as long as the study participant is in a clinical trial.
So anytime you get any unwanted side effects, anytime the subject is reporting anything to you regardless of how significant or insignificant you think it is, you must report it in your source document as an adverse event, and if they ended up in a hospital because of it as a serious adverse event. And serious adverse events must be reported to the IRB. So anytime there’s a serious adverse event it must be reported to the IRB’s within 24 hours and they would like you to get the hospital records, including:
- Date of admission
- The reason for admission
- What study the patient is enrolled in
- What medication he or she recieved
Things like that because they want to make sure that the study participant is in the hospital. They want to find out what reason he or she is in the hospital for and they have to report it because it’s part of clinical trial data and it’s after all the reason they’re doing a clinical trial.
Whether it’s related to the study drug or not is not important at this stage, and not a reason to not document it.
4.3 Is the event related to the study drug?
There are forms, especially on the SAE forms and on the Adverse Event forms, that give the investigator the option to document whether in his or her opinion the adverse event or the serious adverse event was related to the study drug. The investigator can check “yes”, “no”, or “uncertain”. But the actual event must be documented. This is another important part of Good Clinical Practice – reporting adverse events and serious adverse events.