Ask the average clinical research professional what the ICH-GCP timeframe is for the investigator to report an SAE to the sponsor, and the most commonly heard answer is "24 hours".
This may well be the timeframe that a company adheres to, but it's an interpretation of ICH-GCP, not the timeframe set by ICH-GCP.
4.11.1 : All serious adverse events (SAEs) should be reported immediately to the sponsor (...).
Assuming we all put the safety of our trial subjects first, this needs to be interpreted more strictly than 24 hours. If the investigator becomes aware of an SAE today at 15.00, we don't want him to wait for lunch time tomorrow to complete and submit the SAE form. We don't want the investigator to go home today, without having reported the SAE.wow gold
This may well be the timeframe that a company adheres to, but it's an interpretation of ICH-GCP, not the timeframe set by ICH-GCP.
4.11.1 : All serious adverse events (SAEs) should be reported immediately to the sponsor (...).
Assuming we all put the safety of our trial subjects first, this needs to be interpreted more strictly than 24 hours. If the investigator becomes aware of an SAE today at 15.00, we don't want him to wait for lunch time tomorrow to complete and submit the SAE form. We don't want the investigator to go home today, without having reported the SAE.wow gold
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