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Scientist fellow ☆ India, 2016-06-19 10:59 (3187 d 19:19 ago) Posting: # 16431 Views: 9,554 |
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Is it possible that study volunteer can hide investigational product inside their piriform fossa which can be stored there for few hours and later on can be removed. This has resulted in to BLQ in all study samples in both the periods !! This is how some smugglers used to steal diamonds or other small valuables. This has happened in our study but we could not find any relevant anatomy article which can support. please help Edit: Category changed; see also this post #1. Please follow the Forum’s Policy. [Helmut] |
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ElMaestro ★★★ Denmark, 2016-06-20 01:55 (3187 d 04:23 ago) @ Scientist fellow Posting: # 16432 Views: 8,418 |
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Hi Scientist fellow, ❝ Is it possible that study volunteer can hide investigational product inside their piriform fossa which can be stored there for few hours and later on can be removed. This has resulted in to BLQ in all study samples in both the periods !! This is how some smugglers used to steal diamonds or other small valuables. This has happened in our study but we could not find any relevant anatomy article which can support. I worked for years with BE and I learned the hard way never to say never and there truly are some highly skilled con artists among study volunteers now and then. However, this is a case where I am not overly inclined to go along with your suspicion. I can think of just about a million reasons why hiding an SODF in the piriform fossae isn't realistic. Reasons include but are not limited to the extensive innervation of the area, the need to actively instill the thing at a time when the subject is supervised by clinical staff and presumably spatula-checked (yes, I am aware the fossae are not generally too visible from the spatula check but that is besides my point), the tendency of SODF to stick to mucous membranes due to starch derivatives and gelatin, etc. Nevertheless I am intrigued why you bring forward the piriform fossa idea. Please let us hear some background. What have you done to investigate the BLQs? What about product failures, vomiting, inadequate/absent spatula tongue-mouth checks etc.? Do you represent a CRO or a Sponsor? — Pass or fail! ElMaestro |
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Scientist fellow ☆ India, 2016-06-22 13:46 (3184 d 16:31 ago) @ ElMaestro Posting: # 16439 Views: 8,183 |
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We have online two times mouth check procedure and close post dose monitoring by custodian. So it is difficult to say that we could not identify suspicious behaviour of volunteer during his in house stay in both the periods. When we got information from bioanalytical lab that there is a BLQ found in all samples in both the periods in one volunteer (culprit) we started investigation. We tried to contact volunteer (culprit) however he himself did not turn up to discuss this event. Then we called other volunteers of the same study and other volunteer revelled that he had skill to hide the pill inside his throat (they used lay man language naturally) and he (culprit) discussed his skills with them (Other volunteers of the same study). Other volunteer also revealed that he (culprit) is working in diamond industry and involved in diamond polishing work. With the same skill he used to steal diamonds!! Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5 and follow the Forum’s Policy! [Helmut] |
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Scientist fellow ☆ India, 2016-06-28 15:26 (3178 d 14:51 ago) @ Scientist fellow Posting: # 16456 Views: 8,095 |
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I am awaiting for the response. Please let me know if somebody has come across similar incidence. Thanks Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5 and #9! [Helmut] |
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Helmut ★★★   Vienna, Austria, 2016-06-28 16:24 (3178 d 13:54 ago) @ Scientist fellow Posting: # 16457 Views: 8,028 |
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Hi Scientist fellow, ❝ I am awaiting for the response. Please let me know if somebody has come across similar incidence. 1st warning; see this post #5 and #9. Please follow the Forum’s Policy (see here and there). Concerning your question: IMHO, most people would already consider your wording (using “culprit” four times) disproportionate. You suspect something without any hard evidence. Hearsay of other volunteers is completely irrelevant. According to all guidelines you could not remove the subject’s data (all BQLs in both periods) from the comparison without a clinical justification – which you don’t have. PS: I neither experienced all BQLs in both (!) periods in 36 years nor did I ever hear about it from colleagues. Face it: shit happens. — 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 |
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Scientist fellow ☆ India, 2016-07-06 10:56 (3170 d 19:22 ago) (edited on 2016-07-06 14:23) @ Helmut Posting: # 16467 Views: 7,775 |
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I agree that we don't have any strong evidence, but how we will get T/R ratio to include this data in statistical analysis as BLQ is found with both test as well as reference. Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Dr_Dan] |
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mittyri ★★ Russia, 2016-07-06 12:06 (3170 d 18:12 ago) @ Scientist fellow Posting: # 16470 Views: 7,808 |
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Hi Scientist fellow, ❝ I agree that we don't have any strong evidence, but how we will get T/R ratio to include this data in statistical analysis as BLQ is found with both test as well as reference. Hint (at least for EMA submission): you do not need to include this subject in statistical analysis if BLQ is found for Reference. By the way do you realize how to store the tablet in fossa more than 2 hours? It is not a diamond! Try to store the tablet in your mouth during 1 hour, it's getting to be dissolved with excessive volume of saliva! P.S. I suspect you'll be banned soon due to ignoring Forum's policy... C'est la vie — Kind regards, Mittyri |
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Dr_Dan ★★ Germany, 2016-07-06 16:24 (3170 d 13:53 ago) @ Scientist fellow Posting: # 16471 Views: 7,706 |
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Dear Scientist fellow This is the 2nd warning; see this post #5 and #9. Please follow the Forum’s Policy. — Kind regards and have a nice day Dr_Dan |
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Ohlbe ★★★ France, 2016-06-28 17:05 (3178 d 13:13 ago) @ Scientist fellow Posting: # 16458 Views: 8,133 |
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Dear Scientist fellow, ❝ With the same skill he used to steal diamonds!! If so, would he really need to apply as a healthy volunteer in a BE trial ?  In my experience subjects may succeed to spit out the tablet without getting caught when there is a gap in the supervision of the dosing process: instead of performing the mouth check immediately after dosing, the doser first documents the dosing in the CRF (sticking the label and signing) and the dosing supervisor watches the doser. So for a few seconds nobody keeps an eye on the subject, before the mouth check is done. — Regards Ohlbe |
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Scientist fellow ☆ India, 2016-07-06 11:03 (3170 d 19:15 ago) @ Ohlbe Posting: # 16468 Views: 7,834 |
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We have process of online supervision of dosing by dosing supervisor as well as Quality personnel. Dose administrator quickly glance on glass for its emptiness followed by mouth check with disposable tongue depressor and then he/she sticks the lable on CRF. During this process both monitors (Supervisor and Quality personnel) keep eye on volunteer. we have process of second mouth check as well. We do have custodians as well. In our case it seems that volunteer kept the pill somewhere inside the throat (We strongly believe that in pyriform fossa) and once posture restriction got over he flushed the pill in toilet.. Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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ElMaestro ★★★ Denmark, 2016-07-06 11:57 (3170 d 18:20 ago) (edited on 2016-07-06 14:27) @ Scientist fellow Posting: # 16469 Views: 7,700 |
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Dear Scientist Fellow, I must admit I feel I am still missing some of the intermediary calculations here. Can you tell: do you have a specific reason to think someone hid the tablet in the pyriform fossae, or has this proposal come up because you can't think of any other explanation? Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Dr_Dan] — Pass or fail! ElMaestro |
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jag009 ★★★ NJ, 2016-06-22 00:28 (3185 d 05:49 ago) @ Scientist fellow Posting: # 16434 Views: 8,148 |
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❝ Is it possible that study volunteer can hide investigational product inside their piriform fossa which can be stored there for few hours and later on can be removed. [...] This has happened in our study [...] Can you elaborate on how you discovered that the subject was using his p.fossa to hide the pill? John |
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Scientist fellow ☆ India, 2016-06-22 13:53 (3184 d 16:24 ago) @ jag009 Posting: # 16440 Views: 8,160 |
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❝ Can you elaborate on how you discovered that the subject was using his p.fossa to hide the pill? Dear John I have tried to explain our case in reply of above comment. I tried to find how smugglers use to smuggle small things and I found several text (news mostly) on internet that they use p. fossa Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut] |
Ing. Helmut Schütz