Tag Archives: current monitoring practices


Resetting the monetary system. A full length documentary coming late January 2021: https://www.planetlockdownfilm.com
Mirrored from https://www.youtube.com/watch?v=C1-0XKYAZII

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Here Comes Hyperinflation and Central Bank Digital Currencies

Repost from The  dollarvigilante.com
Only Crypto and Precious Metals Can Save You Now


Let’s look at all the things that have disappeared this year. Vanished. Ceased to exist. Became extinct.


People’s rationality. Which is defined as the quality of being able to think sensibly or logically and which is the one thing (apart from opposable thumbs) that distinguishes humans from animals…say…sheep.


Freedom of speech. And trade, and movement.


Our real videos on YouTube. Oh, and by the way, YouTube also announced last week that it had “removed tens of thousands of QAnon videos and terminated hundreds of channels” under its existing content rules. But that it would further expand “our hate and harassment policies to prohibit content that targets an individual or group with conspiracy theories that have been used to justify real-world violence.”


My last podcast on Spotify – taken down in violation of its communist policies.


The flu. Yup. Flu cases are down 95% from this time last year. It’s a miracle. The flu vaccine must finally be working.


And cash – because that’s been one of the objectives of this psychological warfare operation all along. Get people to believe that the deadly Coronavirus clings to cash and touchscreens for weeks, clearing the way for a Fed-controlled digital currency.


But don’t you worry your obedient little head. The USSA is not in the race to be “first” to roll out a national digital currency, but to “get it right”. Similar to their socialist/communist master plan.You can watch more about all these fast-fading dinosaurs in today’s Lucy and Jeff Show. As well as more reasons why you should really be into crypto and precious metals by now. But if you’re not, we can help you get started with TDV’s Bitcoin Basics eBook available on dollarvigilante.com/subscribe.
Watch on: LBRY Bitchute | Dtube
You see, gold and silver are great, but they still have to be held by you or a third party and ultimately be physically moved from point A to point B when exchanges are made.
So when I say these precious metals are only an airport scanner away from being seized by the government and then you would instantly lose all of that money, I mean that quite literally. And never has there been a better example of why crypto beat metals than in the case of the Indian guy who tried to smuggle in more than 2 pounds of gold into Kerala by hiding it in his rectum.
I shit you not.

Fair Use: In some instances, we include someone else’s footage that is covered in Fair Use for Documentary and Educational purposes with the intention of driving commentary and allowing freedom of speech.

A Risk-Based Approach To Monitoring

A risk is any uncertain event or condition that might affect your project. Not all risks are negative.

No single approach to monitoring is appropriate or necessary for every clinical trial. FDA recommends that each sponsor design a monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.

Not all risks are negative
Some events (like finding an easier way to do an
activity) or conditions (like lower prices for certain
materials) can help your project! When this happens,
we call it an opportunity… but it’s still handled just
like a risk.


Image Source: Head First PMP, by Jennifer Greene, PMP and Andrew Stellman, PMP

FDA has also recognized this fact and come out with a “Guidance for Industry Oversight of Clinical Trial Investigations – A Risk Based Approach to Monitoring”. As per this guidance the objective of the guidance is “to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof”.

Unfortunately, a lot of people in the industry are speaking about risk-based monitoring, but few have a broad understanding of the whole life-cycle process. Great opportunities exist for savings, but then again, most EDC platforms dont work effectively with risk-based monitoring. Switching to risk-based monitoring increases rather than decreases work because it can break the EDC workflow – refuting much of the value of EDC.

In conclusion, Risk-based monitoring is yet another desperate attempt to deal with what all Electronic Data Capture (EDCs) systems have failed to deliver – quality of clinical data.

Source: FDA Guidance

Your comments and questions are valued and encouraged.
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica, Open Source and Oracle Clinical.


anayansi gamboa