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soma pillai ☆ 2009-08-10 12:05 (6152 d 08:31 ago) Posting: # 4027 Views: 8,079 |
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Dear All, As per Good Clinical Practise whether the following case would be serious adverse event or not? A person involved in clinical study (Phase II) met with an accident and have injury and was admitted to hospital, but neither he was driving the car nor he was walking on the road. He was in the car but the car was driven by another person who is not involved in the study. This was discussed and few of my friends are considering it as serious adverse event as a part of study but I fully disagreee with them. Kindly, let me know. Thanking you, Regards, Soma Pillai Edit: Category and subject line changed. [Helmut] |
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SDavis ★★  UK, 2009-08-10 14:27 (6152 d 06:09 ago) (edited on 2009-08-10 15:37) @ soma pillai Posting: # 4029 Views: 6,795 |
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Dear Soma, In my experience, (6 years at a Phase I CRO), Adverse Events were coded; (before unblinding), by the clinician for not only Severity but also "Likelihood of relation to Study drug" with a scale similar to that below. Very Likely, Probable, Possible, Unlikely, Unrelated Most likely such a review would then class an event like this as Unrelated, and report it only in listings. However I am not a Clinician and would advise that you follow your own Clinician's assessment of the circumstances. Simon. — Simon Senior Scientific Trainer, Certara™ [link=https://www.youtube.com/watch?v=xX-yCO5Rzag[/link] https://www.certarauniversity.com/dashboard https://support.certara.com/forums/ |
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Helmut ★★★  Vienna, Austria, 2009-08-10 15:32 (6152 d 05:04 ago) @ soma pillai Posting: # 4030 Views: 6,548 |
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Dear Soma! ❝ This was discussed and few of my friends are considering it as serious ❝ adverse event as a part of study but I fully disagreee with them. I agree with Simon's post (and your friends). We once had a case where a volunteer in the washout-phase of a BE study was bitten by a dog (don't laugh!). The event was reported and classified as 'unrelated'. See ICH-E6(R1) (Section 1.2 Adverse Event (AE)): Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). According to ICH-E2A (Section II.) a car accident, even when the subject was only a fellow passenger is an Adverse Event, because Adverse Event [is] any [...] disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The AE should be rated as 'serious', because the subject[...] requires inpatient hospitalisation [...]. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz