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such ☆ 2008-09-09 16:37 (6502 d 01:38 ago) Posting: # 2341 Views: 5,241 |
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Hello friends, Can any one tell me if A subject has experienced an adverse event of mild severirty for first two days and then it progressed into moderate severity AE then while reporting are they considered as two different events or single event and how should they be captured in CRF? Thanks, Such |
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Ohlbe ★★★ France, 2008-09-09 19:14 (6501 d 23:02 ago) @ such Posting: # 2343 Views: 4,192 |
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Dear Such, This is one single event. You should report it only once, with the date when it started with mild severity as start date, and as moderate severity. Regards Ohlbe |
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such ☆ 2008-09-10 10:46 (6501 d 07:30 ago) @ Ohlbe Posting: # 2347 Views: 4,244 |
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At our place as per Data Management team consider these as two different events and is saying that it is in accordance with industrial proctice worldwide, so please help me and answer following questions. In CRF how would this be captured (ideally)- 1) will the mild episode have a stop date and 'outcome' as resolved and moderate is captured with the same start date as stop date of milder version OR 2) only stop date is captured and 'outcome' as not resolved and moderate episode on other page OR 3) Neither stop date nor outcome is captured and moderate episode is captured on other page in continuation to mild one. Thanks, Such |
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Ohlbe ★★★ France, 2008-09-10 12:30 (6501 d 05:46 ago) @ such Posting: # 2350 Views: 4,237 |
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Dear Such, ❝ 1) will the mild episode have a stop date and 'outcome' as resolved and ❝ moderate is captured with the same start date as stop date of milder ❝ version No. You can't consider it as resolved: the adverse event was still there, and it worsened. ❝ 2) only stop date is captured and 'outcome' as not resolved and moderate ❝ episode on other page Again not. It didn't stop. ❝ 3) Neither stop date nor outcome is captured and moderate episode is ❝ captured on other page in continuation to mild one. Mother Nature hates emptiness. Competent Authorities hate empty fields. ❝ At our place as per Data Management team consider these as two different ❝ events and is saying that it is in accordance with industrial practice ❝ worldwide Let's imagine your patient had a headache, first mild (at 09:15), later moderate (at 11:30, resolved at 17:30). The adverse event is "headache", not "mild" or "moderate" ! This is one single event, "headache". It started at 09:15 and was resolved at 17:30, and was of moderate intensity. Full stop. Most adverse events are mild in severity for at least the first minutes when they appear ! Do your data management people really intend to declare each AE twice ? Same thing for serious adverse events. Let's imagine one subject had a severe diarrhoea for several days, got dehydrated and had to be hospitalised after 3 days. Will your data management people declare the AE twice, first as non-serious, then as serious after he was hospitalised ? No, this is just one single event, "diarrhoea" (and not "hospitalisation", by the way ! This is a common mistake. The hospitalisation is what changed the AE into a SAE, it is not the AE itself. The SAE is what caused the hospitalisation). Start date for this SAE would be the date of the first loose stool, not the date the subject was hospitalised, even though it was not serious initially. Regards Ohlbe |
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such ☆ 2008-09-10 13:42 (6501 d 04:33 ago) @ Ohlbe Posting: # 2353 Views: 4,239 |
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Dear Ohlbe, Thanks a lot for your prompt responses. Your SAE example is more realistic one and i am talking about that type of AE's only. So as soon as AE occurs/informed investigator will fill in the AE form start date, severity, seriousness and symptom of AE (here I am referring to non-serious AE) then they will regularly keep a check at the resolution of AE now after four days (suppose) severity changes (still non-serious event) then what to do, how to make entry in the CRF that these two events could be related to each other and while presentation of AE listing it could be counted as one. Thanks, Such |
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Ohlbe ★★★ France, 2008-09-10 13:56 (6501 d 04:20 ago) @ such Posting: # 2354 Views: 4,176 |
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Dear Such, The problem will come mostly if your investigator uses the AE form in the CRF as a source document, with no other record. This is not an easy way to document AEs and their evolution, as the subject will be examined several times, and the form cannot capture information collected each and every time the subject is examined or asked questions. You will have much less trouble if you are using source documents separate form the CRF's AE form. Each time the investigator or study team examine the subject and ask him how he feels, they will enter on these source document the evolution, severity and seriousness of the event. The specific form in the CRF can be completed at a later stage. There are sometimes different forms in the CRFs for AEs and SAEs. If the investigator started completing an AE form and the AE later evolves to an SAE, it is always possible to switch to the SAE form, and note this on the AE form which had been used initially. I hope this helps. Regards Ohlbe |
Ing. Helmut Schütz