Open the Gate – My Disclosure: The Dark Side of Clinical Trials Episode 2,


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Dear readers, I am Kico Aizaki.

This is the continuation of my previous blog post.

I showed three detectives the several recordings related to the massive GCP
violation and also the contract violation between the pharmaceutical
company, the clinic site, and the principal doctor.

In addition, there was guilty behavior by the monitors during SDV (= Source
Data Verification by the monitors).

What SDV does is that monitors visit the site to confirm registered subjects,
ensure compliance with GCP and SOP (= Standard Operating Procedures),
check the progress of the clinic's condition, and suggest countermeasures if
the site has problems.

So the 6 recordings totaling 700 minutes can show the three police detectives
about many monitors' corrupt behavior in the clinical trial, despite the clinic
having scheduled enough timely SDVs for the monitors of more than 40
registered subjects across 2 clinic sites.

Naturally, the three detectives were interested in the details of the recordings.

But, they seemed like they wanted to find out about bribery or corruption by
the pharmaceutical company and others, because one of the three detectives
was from the Bribery, Corruption and Intelligence Security Division.

To be continued...


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