Hey, Dan! Nice video as per usual. I have had a few questions regarding adverse events, which I can't find a right answer: 1. Subject who has been diagnosed with a disease that needs to be surgically removed in a timeline of weeks/months (this procedure was not known to occurred at the time of enrollment). To my understanding, that would only need to be registered as a non serious adverse event. Nevertheless, would the end date be the day of the surgery, the day the symptoms have resolved (although there is the possibility the subject was asymptomatic) or else? And if the end date is registered previous to the surgery date, how would the documentation of the procedure be done? an amendment to the same adverse event should be done regarding the end date? 2. what would happen to a subject who was initially planned to follow an extension of a protocol, e.g., an amendment was made to include a booster vaccine, and the plan was for that subject to miss their last initial study visit? but in the end there are delays and it does not happen according to what was planned? Should this subject, since the study has already finished, sign not only the annex to the informed consent (which only explains the booster phase), but a new consent?
Great videos as always. Thanks Dan
This is awesome, thank you for the content.
Thank Dan … Sidi from Montréal
Very clear thank you for this pertinents informations , what about violations or deviations ? Have you made a video for that ?
Yes!
Where I can find a video about deviation or violation detection and report thank you Dan
Hey, Dan! Nice video as per usual. I have had a few questions regarding adverse events, which I can't find a right answer:
1. Subject who has been diagnosed with a disease that needs to be surgically removed in a timeline of weeks/months (this procedure was not known to occurred at the time of enrollment). To my understanding, that would only need to be registered as a non serious adverse event. Nevertheless, would the end date be the day of the surgery, the day the symptoms have resolved (although there is the possibility the subject was asymptomatic) or else? And if the end date is registered previous to the surgery date, how would the documentation of the procedure be done? an amendment to the same adverse event should be done regarding the end date?
2. what would happen to a subject who was initially planned to follow an extension of a protocol, e.g., an amendment was made to include a booster vaccine, and the plan was for that subject to miss their last initial study visit? but in the end there are delays and it does not happen according to what was planned?
Should this subject, since the study has already finished, sign not only the annex to the informed consent (which only explains the booster phase), but a new consent?
Wow. I need to know the protocols to make an educated statement here. This is definitely down in the weeds of the study particulars.
I believe if the surgery requires hospitalization it is an sae but the cra and med monitor ultimately decide