Online Safety Community

Sponsors of clinical studies adapt many methods that are aimed at reducing the complexity of clinical trials. They also look for methods by which they can increase the efficacy of the results, while keeping the costs low. Risk-based monitoring is one of these methods.

How is risk-based monitoring understood?One can understand risk-based monitoring in several ways. This varied understanding is because there is no one definition or application of this concept. Risk-based monitoring is a method of evaluating and preventing risk in a clinical trial. This broad definition of course, conceals more than it reveals, since risk-based monitoring can happen in a number of ways and can be applied in a number of areas concerning the clinical research.

FDA and EMA guidelines on risk-based monitoringIn 2011, the FDA, as well as the European Medicines Agency (EMA) their respective sets of draft guidance aimed at helping sponsors of clinical research get a better understanding of the regulatory requirements and obligations for the conduct clinical trials using risk-based monitoring. However, these guidelines were not specific. Moreover, they did not make any procedure or methodology or rule relating to risk-based monitoring mandatory. Since these guidelines on were more or less prescriptive and suggestive by nature; they did not address the core issue relating to risk-based monitoring, leaving the topic rather hazy.

Since this is the current state of risk-based monitoring regulations, most clinical trials sponsors have stuck to the traditional mode of risk-based monitoring. These generally include:

riskBasedMonitoring
The importance of cloud technology to risk-based monitoringSince all these are generally disparate from each other; risk-based monitoring has now required more and more extensive use of technology that will enable his. Risk-based monitoring has now increasingly become technology-driven and technology reliant. As new technologies such as the cloud gain more acceptance; risk-based monitoring has grown with it, since it will help keep track of the various activities at various levels and helps integrate these in real time.

 

click to continue reading

Views: 6

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Forum

What's your favorite motivational/safety quote? 103 Replies

Favorite Motivational Quote: If you want something, you'll find a way - If not, you'll find an excuse.Favorite Safety Quote: Don't learn safety by accident!Continue

Started by Michelle Sears. Last reply by Lissa Jan 11.

Python Online Training by QA Training Hub

QA Training Hub is best Python Programing Online Training Center in India. Python Online Training provided by real time working Professional Mr. Dinesh. Data Scientist and RPA Expert  with 18+ years…Continue

Tags: Bangalore, delhi, Hyderabad, best, institute

Started by sonyagarwal Jan 3.

Business Intelligence with Big Data happens at Unipê 1 Reply

the college center of João Pessoa will preserve the 1st assembly at big records, geared toward professionals inside the regions of administration, economics, public control and facts technologies.…Continue

Tags: qliksensetraining, qliksenseonline, qliksense

Started by Soujanya Naganuri. Last reply by Manchun Jan 2.

VMware player error on install vmware tools. 1 Reply

 I've installed the last version of VMware player (4.0.2) and created a virtual machine with ubuntu 10.04. However, some operations with …Continue

Tags: training, online, vmware

Started by emmablisa. Last reply by Manchun Jan 2.

Forklift Training in Calgary

Do you wish to learn forklift driving? A forklift is a type of industrial vehicle that firstly lift the material and then transport it. The forklift machine is capable of lifting heavy loads by…Continue

Started by Gurjinderpal Sandhu Dec 27, 2017.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service