Let's reconnect with the real world, please [Study As­sess­ment]

posted by ElMaestro  – Denmark, 2016-06-20 01:55 (3163 d 09:41 ago) – Posting: # 16432
Views: 8,368

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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