REGULATORY COMPLIANCE SIMPLIFIED
Surprisingly SIMPLE STEPS to PREVENT CRITICAL MISTAKES and SET YOUR STUDY UP FOR SUCCESS
“…it shouldn’t be a surprise that in order to be compliant, you first need to know what regulations you should be complying with…”
Put simply, regulatory compliance involves conforming to regulations. So it shouldn’t be a surprise that in order to be compliant you need to know what regulations you should be complying with.
Everyone wants to achieve the ELUSIVE GOAL OF SAVING, TIME, MONEY AND EFFORT. The easiest way to achieve this is to UNDERSTAND WHAT YOU NEED TO COMPLY WITH. This may not sound inspiring or instructive but think about it…if you know what you need to do and by when, you also KNOW WHAT YOU DON’T NEED TO DO. This way, you only spend time and energy on you need to do, rather than what others think you should do (…“we’ve always done it this way”). The result? You can REMOVE THE EXCESS BAGGAGE OF UNECESSARY TASKS AND SUPERFLUOUS PROCESSES, reducing timelines and effort, and ultimately making you and your team more productive.
These simple steps are easy to follow, take very little up-front effort. Whether you follow them or not is up to you!
Study-Level Classification = Determine the High-Level Regulatory Classification for your Proposed Research
Applicability of Local Regulations = Determine the Local Regulatory Classification for your Proposed Research
Country-Specific Start-up Requirements = Determine the Local Regulatory Requirements for your Study
“…by understanding what you need to comply with, you know what you don’t need to do, meaning you can confidently remove the excess baggage of unnecessary tasks…”