A trial patient visited the site complaining breathlessness and tachycardia. The investigator advised hospitalization but as subject could not afford the expenses, he refused for admission. Is this an SAE because investigator advised hospitalization?
G Praveen Kumar.
If the patient was not hospitalized, it does not fall into SAE criteria of hospitalization. However, it appears from your mail that the PI felt that the event was serious enough to admit the subject for treatment. This makes it an “important medical event." As per ICH E2A such event also are considered serious. See the ICH E2A excerpt below:
Medical and scientific judgement should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the patient or may require intervention to prevent one of the other outcomes listed in the definition above. These should also usually be considered serious.
There is also one more problem here. As per Indian GCP, and recent DCGI directive, the cost of medical treatment has to be covered by the sponsor. Hence, the PI should have treated the patient free of charge and recovered the cost from the sponsor.
How often should the ICF be updated considering there are CIOMS generated on an ongoing basis during the course of a trial?