The common concern in both bungee jumping and clinical research is safety and security.
Imagine the thought of jumping face-first off a bridge or a very high platform makes many people nauseous. Yet people opt for it, and do you know that several million successful jumps have taken place since 1980? Experts credit the safety record directly to bungee operators who strictly stick to standards and guidelines, like double checking fittings and calculations for every jump.
The cords also have several safety measures and are put in place before being manufactured.
On the day of the jump, the cords are tested, first manually and then with a bag of weights from the jumping height. Lastly, a pro bungee jumper takes the leap for a final test; risking their life to ensure your safety.
So will you take the leap knowing that your cord wasn’t thoroughly tested?..... A professional has not tested it? Or the test data was compromised?
Same is the scenario with clinical research. The volunteers worldwide take the leap, with a trust that protocols will be followed and that the drug they are taking has been analyzed and approved for them to test it. Consumers trust that when grabbing a bottle of vitamins or medication at the local pharmacy that these products are safe, all required tests have been completed, and the findings have been well documented prior to obtaining approval from the regulatory bodies.
Yet, in their April 2016 draft guidance the FDA indicated that in recent years, FDA has increasingly noticed CGMP violations involving data integrity during 39 CGMP inspections. FDA also added that the scenario is troubling because data accuracy is an important component of clinical trial responsibilities to ensure the efficacy, safety and drug quality and FDA’s ability to safe guard the public health.
Good clinical practice is the basic element in conducting clinical research. According to the FDA,good clinical practice is an international ethical and scientific quality standard for developing, conducting, recording, and reporting trials that involve human participation. And complying with this standard provides assurance that the rights, and safety of trial subjects are protected, being consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical data are credible.
So if you’re bungee jumping , volunteering in a clinical research or taking any medication you need to make sure that you are providing your health to an organization/system that takes data quality and integrity to heart.
So one must be very cautious before enrolling for volunteer service. You should go for organizations whose expertise and commitment are not questionable. It has to be high-quality data and very fundamental in accordance to with both the U.S. Food and Drug Administration and the National Institute on Drug Abuse.
The experienced QA team oversees looks after SOP management, audits, and GLP credit. All studies are conducted for the highest level of safety and compliance because there should be care about the study volunteers....this would eventually help advancing quality global health
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